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Annual Resource Guide

AB SCIEX

AB SCIEX helps to improve the world we live in by enabling scientists and laboratory analysts to find answers to their complex analytical challenges, whether it is for the traditional small molecule drugs or complex biotherapeutics.

The latest in the world of biotherapeutics are Antibody Drug Conjugates or ADCs, which represent a major leap forward in therapeutic efficacy. However, their inherent complexity poses significant analytical challenges to the scientist. Continuing with the legacy of being the most trusted partner when it comes to offering robust, reliable analytical solutions, for ADCs too, all leading organizations that either launched or are in the process of launching ADC therapeutics use analytical solutions from AB SCIEX.

With over 25 years of proven innovation, AB SCIEX’s success embody the company’s global leadership and world-class service and support in the liquid chromatography-mass spectrometry industry that have made it a trusted partner to thousands of the scientists and lab analysts worldwide who are focused on basic research, drug discovery and development, food and environmental testing, forensics and clinical research.

AB SCIEX continues to innovate and ensure success for its customers by listening to and understanding the ever-evolving needs of its customers to develop reliable, sensitive and intuitive solutions that continue to redefine what is achievable in routine and complex analysis.
500 Old Connecticut Path
Framingham, MA 01701
USA

Web: AB SCIEX

AbbVie Inc.

AbbVie Inc. began as the pharmaceutical leader, Abbott, which was founded in 1888 by Chicago physician, Dr. Wallace Abbott. Since then, Abbott has evolved to become a global healthcare leader, delivering innovative pharmaceutical, nutritional, diagnostic, and medical products to people in more than 150 countries. The new company,  which is focused on developing leading-edge therapies and innovations, was founded on January 1, 2013 following the separation from Abbott Laboratories.

Among the products in development is ABT-414, an investigational anti-EGFR (epidermal growth factor receptor) monoclonal antibody drug conjugate or ADC being evaluated for the treatment of patients with various cancer and tumor types. As an ADC, ABT-414 is designed to be stable in the bloodstream and only release the potent cytotoxic agent once inside targeted cancer cells, thereby reducing the toxic side effects of traditional chemotherapy while enhancing anti-tumor activity. Being developed by AbbVie researchers, ABT-414 is currently being investigated in Phase I/II for the treatment of glioblastoma multiforme, the most common and most aggressive malignant primary brain tumor. ABT-414 is also in clinical trials for the treatment of patients with squamous cell tumors.

1 N. Waukegan Rd.
North Chicago, IL, 60064
USA

Web: AbbVie

Abzena PLC

Abzena PLC provides a suite of complementary services and technologies to R&D organizations to improve the chances of successful development of therapeutic proteins and antibodies, The company is expected to capitalize on the growth of the biopharmaceutical market. Abzena has significant know-how, supported by a broad patent estate, to enable it to create better biopharmaceuticals for its customers.

Abzena operates a balanced business model with growing revenues from its service business and the potential for significant future growth through royalty bearing licences for the application of its technologies to biopharmaceutical products. The Group’s technologies and services are provided through its wholly-owned subsidiaries, PolyTherics and Antitope.

PolyTherics and Antitope have been developing and offering their technologies and services for over 10 years and their scientists have provided expertise to a wide range of companies, including most of the top 20 biopharmaceutical companies, many large and small public and private biotech, and academic groups, across the world.

Babraham Research Campus
Babraham
Cambridge CB22 3AT
United Kingdom

Web: Abzena

ACES Pharma

ACES Pharma is a leading manufacturer and supplier of specialty biochemicals and pharmaceutical fine chemicals. The company focuses on custom synthesis and technology (development) services, including:

  • Custom-synthesis of cytotoxins from grams to hundreds of grams
  • MMAE, MMAF and analogs
  • MMAE-linkers and MMAF-linkers
  • Ansamitocin, Maytansine and derivates
  • Maytansinoid-linkers, such as DM1, DM3 and DM4
  • Calicheamicin and analogs
  • Linkers (cleavable and non-cleavable linkers)
  • Customized new toxins, linkers and ADCs

1 Deer Park Drive, Suite L-3
Monmouth Jct, NJ 08852
USA

Web: ACES Pharma

ADC Bio

ADC Bio is developing new process technology to speed, simplify and significantly lower the costs of the conjugation process to produce new antibody drug conjugate (ADC)-based anti-cancer drugs.

With surging numbers of “second generation” drugs in development (currently around 200) tumour-selective ADCs are building a significant position in the oncology field – the fastest growing sector in healthcare. The company’s technology aims to become a new paradigm in the way ADCs are developed and manufactured, increasing accessibility for patients by helping to contain ADC production complexity and cost.

ADC Bio’s patented Lock-Release technology results in fast, simple and robust conjugation processes, with the potential to eliminate several process steps whilst enhancing product quality.

OpTIC Technium,
Ffordd William Morgan,
St Asaph Business Park,
St Asaph
Denbighshire
LL17 0JD
United Kingdom

Web: ADC Biotechnology Ltd.

ADC Therapeutics

ADC Therapeutics, founded in 2011 with financial backing of US $50 million by Auven Therapeutics, is developing a pipeline of proprietary Antibody Drug Conjugates (ADCs) for the treatment of both solid and hematological cancers.
Monoclonal antibodies specific to particular types of tumor cells are combined with a novel class of highly potent pyrrolobenzodiazepine (PDB)-based warheads (developed by ADC Therapeutics’ partner Spirogen Limited) to selectively kill cancer cells. Selective targeting should mean fewer side effects for patients and avoids repair-related resistance in continued treatment faced by other anti-cancer products on the market.

Rue Saint-Pierre 2,
Lausanne, 1003,
Switzerland

Web: ADC Therapeutics S.a.r.l

Agensys, Inc.

Agensys, Inc., founded by oncologists at UCLA, began operations in Santa Monica in 1997. In 2007, Astellas Pharma Inc. acquired Agensys with the plan to make it the center of the company’s antibody product discovery and development operations. Today, the company specializes in therapeutic antibody research and development in cancer. Agensys is developing a pipeline of therapeutic fully human monoclonal antibodies (MAbs) to treat solid tumor cancers.

The MAb product pipeline is being generated to Agensys’ diverse portfolio of proprietary, clinically relevant cancer targets that encompass 14 types of solid tumors. Agensys’ target portfolio and related products are protected by 119 issued/33 allowed patents and over 300 applications. The company has full capabilities to generate, develop and manufacture antibody products.

Agensys is progressing a pipeline of both naked and antibody-drug conjugated (ADC) therapeutic antibodies, directed at a variety of cancer indications, including those of the prostate, kidney, pancreas, ovary, bladder, lung, colon, breast and skin. ADC products are based on toxin platform technologies developed by Seattle Genetics.

Agensys has a rich pipeline that includes four monoclonal antibody products in clinical trials:

  1. AGS-1C4D4, directed to Prostate Stem Cell Antigen (PSCA), a novel target for prostate, pancreatic, and bladder cancers (NCT01608711NCT00519233NCT00902291)
  2. AGS-5ME, Agensys’ first ADC, directed to AGS-5, a novel target in multiple epithelial tumors, co-developed with Seattle Genetics;
  3. AGS-16M8F, an ADC developed for the treatment of metastatic renal cancer (NCT01114230); and
  4. AGS-22M6E, an ADC developed for multiple solid tumors to include breast, bladder, lung, and pancreatic cancers (NCT01409135)

Agensys’ pre-clinical pipeline encompasses over 10 different MAb programs.

2225 Colorado Ave.
Santa Monica, CA 90404
U.S.A.

Web: Agensys

Allozyne

There are two key facets to Allozyne’s technology that enable the development of next generation Antibody-drug Conjugates (ADCs) including core expertise and IP covering both the site-specific incorporation of non-natural amino acids (NNAAs) into antibodies as well as the orthogonal chemistries that are highly specific for these NNAAs. These fundamental components of Allozyne’s technology are compatible with virtually all linker and toxin types.

Allozyne’s approach offers the potential to create next generation ADCs that come with the following advantages:

  • First-in-class linker stability
  • Significantly broader therapeutic window than ADCs created using conventional conjugation chemistries
  • PK profile similar to parental antibody
  • Biophysical properties that reduce aggregate formation
  • Simplified and more efficient manufacturing processSite-specific bioconjugation to NNAAs recognized by FDA as a key next generation approach

1600 Fairview Ave E., Suite 300.
Seattle, WA 98102
U.S.A.

Web: Allozyne

Almac Group

The Almac Group provides a comprehensive range of services extending from research through pharmaceutical and clinical development to commercialisation of product. The company has significant experience in the manufacture of 14C-labelled Antibody Drug Conjugates (ADCs).

In recent years the interest in antibody drug conjugates for the targeted treatment of various cancer types has grown massively, and the need for evaluation of their pharmacokinetic profile is becoming more important. As a result the 14C labelling of ADCs for ADME evaluation has become a critical part of their development. The 14C label is typically placed on either the active drug or the linker moiety, or can be incorporated into both.

Almac’s expertise in this area comes from the integration of a number of diverse disciplines within the Isotope chemistry group. These disciplines include biology, chemistry, peptide and purification science, analytical and quality assurance. The ability to prepare labelled linkers and/or payloads, and to complete the bioconjugation within one team shortens timelines and results in a more cost effective solution for our clients.

20 Seagoe Industrial Estate
Craigavon BT63 5QD
United Kingdom

Web: Almac Group

Althea

Expanding upon our existing capabilities in biologics manufacturing, Althea is establishing itself as a premier, US-based provider for high-containment ADC bioconjugate manufacturing as well as fill and finish services for both HPAPIs and ADCs. Our state-of-the-art 57,000 sq ft facility is located a few miles from our Roselle Street campus in San Diego, CA.

The facility and our service offerings have been designed to meet the current and future needs of ADC developers in order to ensure a stable supply of your promising therapeutics. Our new facility will include capability for process development, analytical development, formulation, clinical and commercial manufacturing for bioconjugation and fill finish along with supporting services for release and stability testing.

The Althea staff will provide you with technical expertise, robust quality systems and experienced personnel to support interactions with regulatory bodies world-wide at all stages of your drug development process.

11040 Roselle Street
San Diego, CA 92121

Web: Ajinomoto Althea

Ambrx Inc.

Ambrx®, Inc. is a biopharmaceutical company with a mission to deliver breakthrough protein therapeutics using an expanded genetic code. Unlike conventional conjugation techniques designed to create a mixture of suboptimal molecules, Ambrx’s technology combines site specific conjugation with proprietary linkers, payloads and PK extenders optimized for safety, efficacy and biophysical properties.

By using conjugation chemistries that are orthogonal to the native twenty amino acids, the company creates antibody conjugates with unprecedented homogeneity with respect to the site of drug attachment. Furthermore, quantitative experimentation with homogenous antibody conjugates enables an efficient, robust and science driven path for optimizing efficacy, safety and biophysical properties to meet target product profiles.

Ambrx is developing antibody drug conjugates (ADCs) for oncology as well as non-oncology indications. The company’s ADCs have demonstrated high potency and a significantly wider therapeutic index than ADCs created using conventional non-specific conjugation.

10975 North Torrey Pines Road
La Jolla, CA 92037
U.S.A.

Web: Ambrx Inc.

AMRI Inc.

AMRI Inc. (Albany Molecular Research provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The company’s services include drug discovery, such as medicinal chemistry, discovery biology and in vitro ADME; development, such as pre-formulation, formulation and validation; and manufacturing, such as cGMP API manufacturing.

26 Corporate Circle
Albany, New York 12203
U.S.A.

Web: AMRI Inc.

AnaptysBio

AnaptysBio is a privately-held company focused on the generation of antibody therapeutics and is the leader in the use of somatic hypermutation (SHM) for antibody discovery and optimization. We are developing a pipeline of novel therapeutic antibody candidates, including differentiated programs in cancer immunotherapy, inflammation, fibrosis, muscle wasting disorders and antibody-drug conjugate applications. AnaptysBio’s proprietary SHM-XEL™ platform, which couples fully human antibody libraries with in vitro somatic hypermutation in mammalian cells to generate high affinity antibodies, replicates key features of the human immune system and overcomes limitations of prior antibody technologies. By harnessing the natural mechanism of antibody maturation under controlled conditions, SHM-XEL allows for the selection of optimal antibody properties such as high affinity, stability, function, cross-reactivity, epitope diversity and manufacturability. The Company has previously announced partnerships with Merck, Roche, Novartis, Celgene, Gilead, DARPA and DTRA.

10421 Pacific Center Court, Suite 200
San Diego, CA 92121
U.S.A.

Web: AnaptysBio

 

AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

In October 2013 AstraZeneca’s global biologics research and development arm, MedImmune, acquired Spirogen, a biotech company focused on antibody-drug conjugate technology for use in oncology.

Antibody-drug conjugates are a clinically-validated cancer drug technology that offers both high potency and selective targeting of cancer cells. Spirogen’s proprietary pyrrolobenzodiazepine (PBD) technology attaches highly potent cytotoxic agents, or ‘payloads’ to specific cancer-targeting antibodies using biodegradable ‘linkers’. This targeting optimises the delivery of the cancer drug to the tumour cells only and provides the greatest degree of tumour killing while minimising the toxicity to the patient.

AstraZeneca PLC
2 Kingdom Street
London, W2 6BD
United Kingdom

Web: AstraZeneca

Baxter BioPharma Solutions

BioPharma Solutions, a business unit of Baxter, partners with pharmaceutical companies to support their commercialization objectives by providing scientific expertise, sterile contract manufacturing solutions, parenteral delivery systems, and customized support services needed to meet the unique challenges that parenteral products face.

The company meets market demand, from form/fill/finish of small molecule parenterals to production of cytotoxins and biologics, including monoclonal antibodies, recombinant proteins and antibody-drug conjugates (ADCs). From clinical scale up through full commercial production, Baxter’s extensive and advanced manufacturing capabilities and filling capacity, offers a wide spectrum of solutions to meet client’s requirements.

  • Diverse experience with a variety of drug categories and parenteral delivery systems;
  • Scientific and manufacturing expertise, including our Lyophilization Center of Excellence;
  • Worldwide manufacturing capabilities;
  • Customized support services including formulation development and sales and marketing capabilities;
  • Experience with worldwide regulatory agencies.

Baxter International Inc.
One Baxter Parkway
Deerfield, IL 60015

Web: Baxter BioPharma Solutions

Bayer HealthCare

For many types of cancer classic chemotherapy is often the only form of treatment available. It functions on the basis of a cytotoxic effect – a cytotoxin kills cancer cells, halting tumor growth. However, these drugs also damage healthy cells and patients may, as a result, suffer severe side effects. With modern cancer therapies physicians are able to target the cancer more precisely.

They include the recently developed approach of antibody-drug conjugates (ADC). This new approach attacks the cancer in a much more targeted way and healthy cells are less severely affected.

Bayer HealthCare currently has several projects using this approach in its research pipeline. The company has the worldwide rights to utilize Seattle Genetics’ auristatin-based ADC technology with antibodies to several oncology targets.

6 West Belt
Wayne, NJ 07470
U.S.A

Web: Bayer HealthCare

BioAgilytix Labs

BioAgilytix Labs provides support for the development of Antibody-Drug Conjugates or  ADCs, including ligand binding and cell based assay development and validation on multiple platforms.

Specifically, the company’s antibody services include labeling of antibody reagents, ADA purification, and oversight of surrogate positive control antibody generation. BioAgilytix Labs’ scientists are experienced in supporting immunogenicity and PK studies in a variety of species including rodents, humans, and nonhuman primates on ELISA, MSD-ECL, and Gyros platforms

2300 Englert Drive
Durham, NC 27713

Web: BioAgilytix Labs

BioOutsource

BioOutsource is the industry leading expert in the biological analysis of monoclonal antibodies and can utilize this experience to provide comprehensive services for the characterization of Antibody-drug Conjugates (ADCs)

With years of experience in the performance of cell based bioassays and variety of binding assays, the company provides comprehensive expertise to support the development of Antibody-drug Conjugate products for all phases of drug development from discovery through to GMP Lot release for marketed products.

1 Technology Terrace
Todd Campus
West of Scotland Science Park
Glasgow, G20 0XA

Web: BioOutsource Limited

Bristol Myers Squibb's (BMS)

Bristol Myers Squibb’s (BMS) oncology R&D pipeline of about 20 compounds in development represents a wide range of proven and potential treatment platforms, including traditional cytotoxins as well as biologics, immunotherapies and other novel and targeted approaches such as Antibody-drug Conjugates (ADCs) in which a cancer-killing drug is linked to a monoclonal antibody. The antibody specifically targets a particular cancer cell antigen, thus ignoring most normal cells and delivering the drug directly to the cancer cell.

The company is conducting about 200 oncology clinical trials, addressing 20 different tumor types. Among the most exciting areas of research is immuno-oncology. Bristol-Myers Squibb’s work in the field of immuno-oncology began in the mid-1990s, and picked up momentum in 2005 when the company formed a collaborative alliance with Medarex Inc, a biotechnology company now owned by BMS and based in Princeton, New Jersey. BMS acquired Medarex in August 2009 and assumed full rights to ipilimumab – an investigational, naked, therapeutic antibody in late-stage development for metastatic melanoma which the FDA approved in March 2011 as Yervoy, and other early-stage investigational cancer compounds.  As a result, the company is positioning itself for long-term leadership in this area.  A clinical Phase I trial (NCT00944905) with BMS’s lead ADC candidate, MDX-1203, a duocarmycin-based toxin conjugated to an anti-CD70 Medarex antibody was recently completed. The purpose of this study was to determine if MDX-1203 is safe for the treatment of renal cell carcinoma or non-hodgkin’s lymphoma.

345 Park Avenue
New York, New York 10154-0037.
U.S.A.

Web: Bristol Myers Squibb (BMS)

BSP Pharmaceuticals

BSP Pharmaceuticals, a contract manufacturing organization (CMO) based in Italy, offers a range of dedicated services designed for pharmaceutical industry players focused on antineoplastic products. The company offers customized ‘one-stop shop’ service to support its client from development to commercial manufacturing of injectables and oral formulations.

BSP Pharmaceuticals focuses on innovative therapies including proteasome inhibitors, antibody-drug conjugates (ADCs) and liposomal formulations.  The BSP Pharmaceutical CMO plant is dedicated to the development and manufacturing of high potency & cytotoxic drugs.  The company also offers formulation, analytical and process formulation services.

Via Appia km. 65,561
04013 Latina Scalo (Lt)
Italy

Web: BSP Pharmaceuticals

 

Carbogen Amcis

Carbogen Amcis is a leading provider of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries, at all stages of drug development.

The integrated services offered by the company provide innovative, timely and safe drug development solutions that allow customers to make the best use of their available resources. Carbogen Amcis focus is on supporting the development process from bench to market. The breadth of capabilities spans from contract chemical process research and development to the supply of Active Pharmaceutical Ingredients (APIs) and drug products for preclinical studies, clinical trials and commercial use.

As part of a formal collaboration with UK-based ADC Biotechnology (ADC Bio) the company provides customers with seamless development and manufacturing services for antibody drug conjugates (ADCs) – a key anti-cancer treatment platform. The two companies offer a complete range of services to customers for the development, scale-up, manufacturing and formulation of protein-based drug conjugates.

Hauptstrasse 171
CH-4416 Bubendorf
Switzerland

Web: Carbogen Amcis

Catalent Pharma Solutions

From drug and biologic development services to delivery technologies to supply solutions, Catalent Pharma Solutions is a catalyst for success. With over 75 years of experience, the company offers the deepest expertise, the broadest offerings, and the most innovative technologies to help customers get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing results.

Catalent serves thousands of innovators, large and small, in over 100 markets, including 36 of the top 50 biotech companies and 49 of the top 50 pharmaceutical companies. More than 1,000 talented scientists supports 40% of recent new drug approvals, and the company’s nearly 30 global sites make or package over 100 billion units annually.

Catalent has entered into an exclusive license and co-marketing agreement with Redwood Bioscience to offer its customers Redwood’s advanced site-specific conjugation SMARTag™ technology to develop optimized Antibody Drug Conjugates. Redwood Bioscience are experts within Antibody Drug Conjugation and the SMARTag™ technology is a proprietary approach to develop optimized Antibody Drug Conjugates.

14 Schoolhouse Road
Somerset, NJ 08873
U.S.A.

Web: Catalent Pharma Solutions

 

celares GmbH

celares GmbH, established 2003, is a Contract Development and Manufacturing Organization (CDMO) providing customized services as well as innovative solutions for antibody-drug conjugates or ADCs.

The company uniquely combines expertise in both synthetic and protein chemistry and has experiences in handling toxins, synthesis of activated linkers, toxin-linker-precursors, and ADCs.  celares also offers its proprietary PaSmax® linker technology for next generation ADCs. PaSmax® linkers are made from non-dispersed PEGs and are capable of:

  • Increasing DAR without the need for additional attachment sites;
  • Modulating solubility of the toxin;
  • Reducing risk of aggregation, and
  • Simplifying analytics. In particular, antibody fragments, site-specifically modified antibodies, or scaffold proteins benefit from this technology.

celares offers services ranging from early feasibility studies to a complete development of the manufacturing process and analytical methods. Several of celares’ developments and optimized processes have been established in a GMP environment for the manufacturing of drug product for clinical trials and market supply over the last years. celares has clients from pharma and biotech all over the world.

celares operates on a modular business model. Feasibility studies, also including PaSmax® conjugates, as well as customized developments and manufacturing are offered on a fee-for-service basis. Development of ADC candidates employing celares’ proprietary technologies requires milestones and royalty bearing license agreements.

Otto Warburg Building D80
Robert-Roessle-Str. 10
13125 Berlin
Germany

Web: celares

Celldex Therapeutics

Celldex Therapeutics  was founded based on a fundamental scientific belief that harnessing the power of the immune system would break significant barriers in drug development for a host of devastating diseases. The Company’s pipeline is comprised of therapeutic antibodies, antibody drug conjugates, immune system modulators and vaccines that we believe have a higher probability of success because they are targeted to specific patient populations with high unmet medical need whose diseases express specific markers—including many underserved or completely un-served orphan indications. This has created a leading pipeline in immunotherapy comprised of two candidates in pivotal trials, one in brain cancer and one in triple negative breast cancer, four additional clinical candidates in a range of difficult-to-treat indications and a robust preclinical engine.

Many of Celldex’ clinical programs seek to leverage the power of the immune system’s response by combining therapeutic approaches to maximize their potential. Key to this strategy is our ability to understand our own asset base while also identifying promising external technologies that will complement it.

In 2005, Celldex was spun out of the New Jersey based biopharmaceutical company Medarex (now a subsidiary of the Bristol-Myers Squibb Company) and, in connection with this transaction, Celldex retains the rights to obtain exclusive commercial licenses to proprietary monoclonal antibodies raised against certain antigens utilizing the Medarex UltiMAb technology platform. Since its inception, Celldex has also acquired four companies, folding in three assets, and in-licensed/purchased an additional two assets. With the potential for positive results in ongoing late stage programs, the next stage in Celldex’s development is to become a fully-integrated commercial entity.

222 Cameron Drive, Suite 400
Phillipsburg, NJ 08865
U.S.A.

Web: Celldex Therapeutics

Coldstream Laboratories

Coldstream Laboratories, Inc., turns pharmaceutical development ideas into safe, pure, and effective pharmaceutical dosage forms. Since 2007, the company has delivered unique solutions to complex development and manufacturing projects.

The Coldstream team is dedicated to delivering high quality products to satisfy international standards for both clinical and commercial applications. They are resolute in their commitment to provide quality pharmaceutical products to patients. The company’s regulatory history includes a successful FDA inspection and completion of numerous client audits.

Together with Goodwin Biotechnology, Inc. (GBI) the company develops and manufactures highly potent, cytotoxic biologics and bioconjucates (e.g., protein toxins, cytotoxic antibody drug conjugates, and other bioconjugates).

The area of potent bioconjugates has been growing for several years and due to the nature of the complexity of these molecules, the supply chain for developing these drugs can be quite challenging to manage. The Coldstream/Goodwin team is able to meet the needs of this industry.  Together, the two companies bring their particular expertise to support the manufacture of these cytotoxic bioconjugates including analytical testing, formulation, and process development of liquid and lyophilized sterile highly-potent antibody-drug conjugates (ADCs).

1500 Bull Lea Road
Suite 250
Lexington, KY 40511

Web: Coldstream Laboratories

Concortis Biosystems

Concortis Biosystems, Corp is a biotechnology company creating next generation biotherapeutics using proprietary conjugation technologies and novel drug delivery systems, including antibody-drug conjugates (ADCs). ADCs are a new type of targeted therapy. They covalently connect potent cytotoxic drugs (referred as toxins) to an antibody or antibody fragment via chemical linkers, providing a means to increase the effectiveness of chemotherapy by targeting the drug to cancer cells while reducing side effects. The antibody in use directs the ADC to bind to the target cancer cells, and then delivers the ADC to lysosome by receptor-mediated endocytosis, where the drugs are released to kill the cancer cells. The therapeutic index will be expanded because of the targeting effects

Linkers are designed to allow ADCs to remain inactive while in circulation, and should be readily cleavable once inside the target cells. Concortis’ miniPEG-based hydrophilic linkers help prevent the drug being pumped out of resistant cancer cells through MDR (multiple drug resistance) transporters.

Internalization and affinity of the mAb, linker stability, and potency of the cytotoxic are all key considerations when optimizing and developing an ADC. Over the past years, Concortis has developed diverse classes of cytotoxic drugs and linkers that are ready to empower therapeutic antibodies and to achieve synergistic effects.

11760 Sorrento Valley, Suite R,
San Diego, CA 92121
U.S.A.

Web: Concortis Biosystems, Corp

Covagen AG

Covagen AG is a clinical stage company that develops bispecific FynomAbs by fusing its human Fynomer binding proteins to antibodies resulting in therapeutics with novel modes-of-action and enhanced efficacy in the treatment of inflammatory diseases and cancer.

Fynomers are small binding proteins that can be engineered to bind an antigen of interest. The ability to fuse Fynomers to multiple sites on an antibody allows Covagen to create FynomAbs with tailored architectures to maximize efficacy. Covagen is a privately held Swiss Biotech company with an internal lead bispecific anti-TNF/IL-17A FynomAb COVA322. In 2012, the company entered into a strategic alliance, which was recently expanded, with Mitsubishi Tanabe Pharma Corporation for the development of bispecific FynomAbs.

Wagistrasse 25
CH-8952 Zurich-Schlieren
Switzerland.

Web: Covagen AG

CytomX

CytomX is a biotechnology company developing the next generation of highly targeted antibody therapeutics. The company’s Probody™ Platform represents an approach designed to develop empowered antibodies, including Probodies, Probody-Drug Conjugates (PDCs), bispecifics, multispecifics and other formats, addressing previously undruggable targets in cancer, inflammation and other areas of significant unmet medical need.

Through precise targeting of the disease microenvironment, Probodies have the potential to address diseases in ways that have not been possible to-date, enabling a new level of tissue targeting, selectivity and activation. CytomX has optimized its Probody Platform and established preclinical proof of concept for Probodies. To accomplish its mission, the CytomX team embraces its corporate values of integrity, commitment, creativity, teamwork, accountability and fun.

CytomX Therapeutics Inc. was formed in 2010 from a precursor company, CytomX LLC, originally spun out of University of California, Santa Barbara in 2006. CytomX is led by a seasoned and proven management team and is well-financed by leading life science investors, including Third Rock Ventures, Canaan Partners and the Roche Venture Fund.

650 Gateway Blvd., Suite 125
South San Francisco, CA 94080-7014
USA

Web: CytomX Therapeutics Inc.

Eisai

Eisai Co., Ltd., together with it’s research institute (the KAN Research Institute, Inc. or KRI) aims to discover and develop new drugs based on novel therapeutic concepts

The company is dedicated to conducting discovery research based on the concept of Integrative Cell Biology for Medicine in its three areas of therapeutic focus – refractory immune diseases, neurodegenerative diseases and cancer relapse and metastasis, and aims to discover and develop biologic therapies such as antibodies. Eisai (KRI) laboratories are prepared with future installation of an antibody-drug conjugate (ADC) production facility and collaborative lab spaces for academic and medical researchers which has strengthened the company’s antibody research capability while further promoting its open innovation initiatives with external partnerships, one of the core strategies of the company.

4-6-10 Koishikawa, Bunkyo-ku,
Tokyo 112-8088, Japan

Web: Eisai Co., Ltd.

Endocyte

Traditional cytotoxic cancer chemotherapies kill rapidly dividing cancer and normal cells in an indiscriminate manner.  this leads to significant toxicity in patients being treated. In response to this limitation, a number of targeted therapies were developed to be more selective, including monoclonal antibody-based therapies. For certain cancers, antibodies alone are not sufficiently effective to achieve meaningful clinical benefit. This limitation has led to the development of a new class of agents called antibody drug conjugates or ADCs.  These ADCs are comprised of a monoclonal antibody, which is used to target the specific cancer, attached via a linker system to a cell-killing drug.

Endocyte’s proprietary technology platform to create novel small molecule drug conjugates or  SMDC represents a new approach, comparable to ADCs, in its ability to deliver highly active drug payloads in a targeted manner.  Endocyte’s SMDCs actively target receptors that are over-expressed on diseased cells, relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly active drugs at greater doses, delivered more frequently, and over longer periods of time than would be possible with the untargeted drug alone.

The company is also developing companion imaging diagnostics for each of the SMDCs they are developing.  These diagnostic tools are designed to identify patients whose disease over-expresses the target of the therapy and who are therefore more likely to benefit from treatment. This combination of an SMDC with its companion imaging diagnostic is designed to personalize the treatment of patients by delivering effective therapy, selectively to diseased cells, in patients most likely to benefit.

Researchers expect that Endocyte’s  SMDC technology platform offers a number of potential advantages:

  • Small size to better penetrate solid tumors
  • Rapid clearance for reduced toxicity
  • Companion imaging diagnostics for targeted therapy
  • Cost-effective and simple to manufacture

3000 Kent Avenue, Suite A1-100,
West Lafayette, IN, 47906.

Web: Endocyte, Inc.

Evonik Industries

Evonik Industries, a German based global leader in specialty chemicals, offers the strength and breadth that comes with working with one of the world’s largest specialty chemical companies. The company covers a large part of the pharmaceutical value chain, from manufacturing of API’s (including HPAPI) and functional excipients to development of drug formulations and specialty manufacturing of drug products.

Evonik’s strong global research laboratory network supports pharmaceutical companies in developing better manufacturing routes for their high value APIs. The company ensures their successful and economic scale-up and secure supply through clinical trials all the way to commercial launch and beyond. The same companies are then helped to develop better and more efficient formulations with advanced drug delivery technologies.

With the acquisition of Birmingham Laboratories (USA), Evonik is able to offer full development and manufacturing services in the area of injectable controlled release formulations. Evonik’s Eudragit and Resomer functional polymer platforms further impart controlled release functionality to sophisticated oral and parenteral dosage forms.

The broad competencies in APIs and drug delivery systems combine to support clients in new ways, including the design and production of antibody drug conjugates (ADCs). This new type of targeted therapy binds an antibody directly to, for example, specific markers at the surface of cancer cells. The ADC is then internalized within the cancer cell and the active ingredient released exactly where it is needed, thus reducing side effects and widening the therapeutic window.

Rellinghauser Straße 1—11
45128 Essen
Germany

Web: Evonik Industries AG

F-star

F-star is an oncology-focused biopharmaceutical company dedicated to developing novel bispecific antibody products that significantly improve the standard of care for patients.

The company’s Modular Antibody Technology™ allows developers to rapidly discover and develop bispecific antibodies by introducing additional binding sites to the constant region of an antibody. It combines the power of our Fcab™ technology with traditional antibodies to identify the most appropriate target combinations, thus providing the opportunity to deliver products with the greatest therapeutic advantage to patients.

Schwarzenbergplatz 7,
A-1030 Vienna, Austria

Web: F-star

Fabrus

Fabrus, founded in 2007 as the first company in Pfizer’s La Jolla incubator to develop a next generation antibody discovery platform that expands the therapeutic applications of antibodies beyond those identifiable through existing discovery platforms, it is the first company to bring the speed and flexibility of small molecule screening to the field of fully human antibody therapeutics while being unencumbered by existing antibody engineering intellectual property. The novel discovery format is analogous to a combinatorial chemistry library and enables direct cell based screening, opening novel targets to antibody therapeutics like G-protein coupled receptors or ion channels.

in 2010 Ambrx and Fabrus entered into a collaboration whereby Fabrus will discover novel antibodies to beused with Ambrx’s Antibody Drug Conjugate technology. The agreement grants Ambrx the exclusive right to commercialize conjugated forms of the antibodies generated under the collaboration.

11099 North Torrey Pines Road, Suite 230
La Jolla, CA 92037
U.S.A.

Web: Fabrus

Fujifilm Diosynth Biotechnologies

Fujifilm Diosynth Biotechnologies combines novel technologies with over 25 years of biopharmaceutical contract manufacturing experience to bring you the best in process development and cGMP manufacturing.

In October, 2012 Fujifilm Diosynth Biotechnologies entered into a strategic alliance with Piramal Healthcare UK Ltd, whereby the two parties offer the seamless contract development and manufacture of antibody drug conjugates (ADCs), a growing niche in the development of biopharmaceuticals. The combined experience of both companies covers work on more than 150 biopharmaceuticals and over 300 batches of ADCs spanning over more than 30 different NCEs, including the world’s only FDA-approved ADCs.

Belasis Avenue
Billingham, TS23 1LH
United Kingdom.

Web: Fujifilm Diosynth Biotechnologies

Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California,

Genentech is aggressively researching ADCs and their potential to play an important role in clinical medicine and to expand the therapeutic options available to patients

1 DNA Way
South San Francisco, CA 94080
U.S.A.

Web: Genentech

Glykos

Antibody drug conjugates (ADCs) are formed by attaching drug substances to antibodies using a special linker moiety. The ideal ADC will specifically target antigen-expressing cells and release the drug in active form inside the cell. ADCs combine the specificity of monoclonal antibodies with high potency of cytotoxic drugs, leading to highly improved therapeutic efficacy and less side effects. However, the current challenges in ADC technology are related to creating highly homogeneous ADC products with high drug-to-antibody ratio as well as applying the technology to various drug substances.

Glykos focuses on discovery and development of products and technologies which are based on bioactive glycans. The company’s ADC technology includes novel linker technology and cytotoxic drug derivatives which overcome several limitations of current ADC applications. The key benefits of Glykos’ technology include flexible optimization of the hydrophilic character of the drug component using the company’s linkers and the ability to site-specifically conjugate practically any monoclonal antibody with the client’s toxin of choice.

Other benefits include homogeneous drug-to-antibody ratio (DAR) and significantly improved payload efficacy particularly against drug-resistant cells and low-abundance target antigens.

Glykos’ linkers can be used with practically any monoclonal antibody and with a large selection of potent toxins making our technology highly flexible as it can be integrated into clients existing development programs.

Viikinkaari 6
00790 Helsinki
Finland

Web: Glykos Finland Ltd

Goodwin Biotechnology

Goodwin Biotechnology offers a unique and unrivaled expertise in the research, development, validation and multi-gram manufacture of Antibody Drug Conjugates (ADCs), radioimmunoconjugates, and other protein bioconjugates. The company has more than a decade of experience and multiple patents pending in protein modifications through chemical bioconjugation of cancer drugs, protein toxins, bifunctional ligands and metal chelates (for radio-isotope labeling), antibodies and other biological molecules onto monoclonal antibodies and recombinant proteins.

1850 N.W. 69th Avenue
Plantation, FL 33313

Web: Goodwin Biotechnology, Inc.

 

Heidelberg Pharma

Heidelberg Pharma GmbH provides pre-clinical drug discovery and development services, including explorative pharmacology in the field of cancer, autoimmunity and inflammation, hand-in-hand with bioanalytical methods. The company’s services are characterized by a high degree of flexibility, rapid turn-around and consistent high quality.

Heidelberg Pharma’s own R&D flagship is its proprietary 2nd generation ADC technology for more effective anti-cancer drugs. The company has developed a new ADC technology based on the most potent RNA-polymerase II inhibitor amanitin, a bicyclic octapeptide isolated from the Green Deathcap mushroom Amanita phalloides.

Amanitin interferes with the eukaryotic transcription process at very low intracellular concentrations, making it an ideal drug for the use with antibodies binding at low-copy number antigens.

Heidelberg Pharma and its cooperation partners have shown outstanding activity of amanitin-based ADCs in therapy-resistant tumor cells, e.g. cells expressing multi-drug resistant transporters, tumor-initiating cells and non-dividing cells at picomolar concentrations. The tolerability and therapeutic window of amanitin-ADCs has been determined in different rodent and non-human primate models. Furthermore, amanitin has a water-soluble structure, resulting in ADCs with low tendency for aggregation, even using higher DAR (Drug to Antibody) ratios.

Schriesheimer Str. 101
68526 Ladenburg
Germany

Web: Heidelberg Pharma

Heraeus Precious Metals

Heraeus Precious Metals (formerly W. C. Heraeus) has been one of the top names in industrial precious metal trading and processing for more than160 years. Since the early 1980s theBusiness Unit Pharmaceutical Ingredients specializes in the production of generic APIs as well as the contract development and manufacture of New Chemical Entities (NCEs).

With a focus on highly potent anti-cancer Active Pharmaceutical Ingredients (hAPIs) for cancer therapy and traditionally coming from precious metal compounds like Cisplatin, Carboplatin and Oxaliplatin the Business Unit Pharmaceutical Ingredients today offers a variety of technical expertise. The company’s capabilities range from precious metal compounds to organic chemistry and fermentation processes. Heraeus is currently expanding custom development and manufacturing expertise into the field of Antibody Drug Conjugates (ADCs)

Business Unit Pharmaceutical Ingredients
Heraeusstr. 12-14
63450 Hanau
Germany

Web: Heraeus Business, Unit Pharmaceutical Ingredients

Igenica

Igenica, a biopharmaceutical company founded in 2009, focuses on the development of antibody-based therapies for the treatment of patients with cancer.

Although recombinant monoclonal antibodies (mAbs) are considered to be one of the most promising reagents for immune-based cancer therapy, relatively few products have been approved for use in humans. In fact, there appears to be an increasing reliance on an overlapping portfolio of mAb drugs and drug targets, discovered by a process that has evolved very little over the past two decades. Igenica contends that the key to next generation mAb-based medicines lies in both the identification of new targets and the deployment of novel antibody discovery approaches.

To this end, the company has developed two unique technology platforms that collectively offer a function-orientated screening strategy to systematically discover new tumor antigens and effective antibody drug candidates. The first platform, sTAg (surface-tagged antigen profiling), is an innovative proteomics-based technology designed to identify new surface antigens that are amenable to antibody targeting in cancer settings. The second platform, iTAb (in vivo anti-tumor antibody screening), is a monoclonal antibody discovery platform which provides a function-based,in vivo methodology for screening monoclonal antibody drug candidates against newly discovered antigens that are effective in eliminating or controlling cancer.

863 Mitten Rd., Suite 102
Burlingame, CA 94010
U.S.A.

Web: Igenica, Inc.

 

ImmunoGen

ImmunoGen, Inc. develops targeted anticancer therapeutics. The company’s proprietary Targeted Antibody Payload (TAP) technology and strong antibody expertise form the basis for our development of our own products as well as of our partnerships with other companies.

Ten TAP compounds are now in the clinic, of which three are wholly owned by the Company. The most advanced compound using ImmunoGen’s TAP technology, ado-trastuzumab emtansine (Kadcyla™), has been approved for marketing in the US and Switzerland, and is undergoing regulatory review in the European Union and Japan. ado-trastuzumab emtansine is being commercialized in the US by Genentech, a member of the Roche Group.

830 Winter Street
Waltham, MA 02451-1477
U.S.A

Web: ImmunoGen, Inc.

Immunomedics

Immunomedics is a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. The company has developed a number of advanced proprietary technologies designed to create humanized antibodies that can be used either alone in unlabeled or “naked” form, or “conjugated” with radioactive isotopes, chemotherapeutics, cytokines or toxins, in each case they create highly targeted agents. Using these technologies, Immunomedics has built a pipeline of therapeutic product candidates that utilize several different mechanisms of action.

Immunomedics is conducting clinical trials with yttrium-90-labeled (90Y) Clivatuzumab for pancreas cancer therapy, Veltuzumab combined with 90Y Epratuzumab in patients with non-Hodgkin’s lymphoma, Milatuzumab and Veltuzumab as therapies for patients with chronic lymphocytic leukemia. The company also has two antibody-drug conjugate (ADC) agents in the clinic. The first ADC is milatuzumab-doxorubicin, which is in a Phase I study in patients with relapsed multiple myeloma. Another ADC, labetuzumab-SN-38, is in a dose-escalation study in patients with colorectal cancer.

300 The American Road
Morris Plains, NJ 07950
USA

Web: Immunomedics, Inc

Innate Pharma

Innate Pharma, a French biopharmaceutical company founded in 1999, is developing first-in-class immunotherapy drugs for cancer and inflammatory diseases. The company’s drug-candidates belong to a new class of therapeutic agents and consist of monoclonal antibodies aimed at immune regulatory checkpoints with a unique focus on the innate immunity compartment.

Innate Pharma develops drug candidates with immuno-stimulating properties in cancer and with immuno-blocking properties in inflammatory conditions. Furthermore, many of the ligands to the innate immunity receptors are expressed on tumor cells, opening the way to the development of directly cytotoxic antibodies.

The company’s most advanced drug-candidates are licensed to major biopharmaceutical groups. Lirilumab (IPH2102/BMS-986015) currently in Phase I clinical trial (NCT01714739) in cancer. The purpose of this study is to assess the safety and tolerability of Lirilumab given in combination with BMS-936558 and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination, in subjects with advanced (metastatic and/or unresectable) solid tumors. The drug is licensed to Bristol-Myers Squibb. Another drug, and IPH2201, developed in inflammation and currently in a Phase I clinical trial in rheumatoid arthritis, is licensed to Novo-Nordisk A/S, one of the company’s major shareholders.

117 Avenue de Luminy
13276 Marseille
France

Web: Innate Pharma, S.A.

Intellect Neurosciences

Intellect Neurosciences, Inc. develops innovative approaches aimed at arresting or preventing Alzheimer’s disease and other neurodegenerative diseases, with a specific focus on proteinopathies. Intellect’s pipeline includes therapeutic vaccines, antibodies and neuroprotective antibody drug conjugates (ADCs).  Intellect’s flagship CONJUMAB platform empowers monoclonal antibodies targeting amyloidogenic proteins with additional neuroprotective properties by combining them chemically with a small molecule such as an antioxidant.

The company’s ADC- based technology has the potential to improve on current methods of passive immunotherapy by increasing clearance of amyloid proteins while delivering potent cytoprotective molecules to sites of damage in the brain and other organs.  CONJUMAB-A, the first compound from this platform, is designed to reduce inflammation caused by amyloidosis while avoiding vasogenic edema, a side effect of plaque dissolution that occurs in some patients.

The company’s lead CONJUMAB-A candidate is IN-N01-OX2, a non-activating, stabilized IgG4 humanized antibody specific for beta amyloid protein conjugated to melatonin, which is a naturally occurring molecule with potent anti-oxidant and anti-fibrillogenic properties.

Beta amyloid, when it accumulates in the retina of the eye, causes damage by oxidative stress. The conjugate is anticipated to increase the therapeutic window for melatonin to protect retinal epithelial cells, promote clearance of beta-amyloid away from sites of damage and limit potential off-target side-effects.

CONJUMAB-A may also have potential applications for diabetic retinopathy, glaucoma, traumatic brain injury, and Alzheimer’s disease.

45 West 36th Street, 3rd Floor
New York, NY 10018

Web: Intellect Neurosciences Inc.

Lonza

Antibody Drug Conjugates (ADCs) are monoclonal antibodies (mAbs) attached to biologically active drugs by chemical linkers with labile bonds.  By combining the unique targeting of mAbs with the cancer-killing ability of cytotoxic drugs, ADCs allow sensitive discrimination between healthy and diseased tissue.  ADCs are part of a specialized subset of highly potent APIs.  This technically challenging type of therapy combines innovations from biotechnology and chemistry to form a new class of highly potent biopharmaceutical drugs.

At Lonza experts in mammalian manufacturing begin the process by using a proprietary expression systems to produce and purify the specific antibody of choice.  Then mammalian teams work together with chemical experts at Lonza’s manufacturing plant in Visp, Switzerland, to complete the conjugation. To explore a virtual tour of Lonza’s ADC manufacturing facility, visit the company’s Visp (Switzerland) site page.

Advances in coupling antibodies to cytotoxic drugs permit greater control of drug pharmacokinetics and significantly improve delivery to target tissue. Potent new anti-cancer drugs can now be used to target cancers while minimizing exposure of healthy tissue.  To learn about Lonza’s capabilities in cytotoxic drug development and manufacturing, visit the company’s Cytotoxics page or download Lonza’s Antibody Drug Conjugate Flyer for more information on the latest conjugate technology.

Rottenstrasse 6,
3930 Visp
Switzerland

Web: Lonza

MabPlex

MabPlex, founded in 2013, is a specialized, global CRO/CMO service provider, offering one-stop biologics development and manufacturing solutions to customers with a services from cell line development and process development to GMP manufacturing.

The company’s technical expertise allows them to provide effective and high-quality solutions for monoclonal antibody therapeutics and antibody-drug conjugate (ADC) to the biopharmaceutical industry.

MabPlex USA, Inc.
2978 Scott Blvd
Santa Clara, CA 95054

Web: MabPlex USA, Inc

MacroGenics

MacroGenics is a leader in the discovery and development of innovative medicinces that utilize the next generation antibody-based technologies. With a team of 150+ dedicated individuals advancing a pipeline of product candidates to treat patients with cancer and other serious, complex diseases, the company’s products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

MacroGenics’ innovative product candidates leverage fully-integrated capabilities around the discovery, development, and production of antibodies and incorporate three proprietary technology platforms:

  • Dual-Affinity Re-Targeting (DART™) platform enables. This technology platform allows scientists to design candidate therapeutics that target multiple disease-causing cells or redundant disease-associated pathways with a single molecule;
  • The Fc Optimization platform enhances the natural immune system’s ability to mediate killing of cancer cells; and
  • The company’s Cancer Stem Cell platform provides new approaches to target cancers unresponsive to current therapy.

9640 Medical Center Drive
Rockville, MD 20850
U.S.A.

Web: MacroGenics, Inc.

 

MedImmune

MedImmune, the global biologics research and development arm of AstraZeneca, MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including oncology, respiratory disease, inflammation, autoimmunity, cardiovascular disease, metabolic disease, neuroscience, and infection and vaccines. Since its founding of the company in 1988, MedImmune has remained committed to scientific innovation and medical progress, continually looking beyond standard expectations and pushing the boundaries of what is possible.

Together with AstraZeneca, MedImmune has an exciting and balanced pipeline underpinned by great science. Uniquely positioned with both large and small molecules, the development pipeline, which includes more than 120 research projects and product candidates, forms a robust portfolio of investigational therapies in varied stages of clinical development. This unique pipeline comprise approximately half of AstraZeneca’s overall R&D portfolio.

MedImmune Oncology is a core therapy area for AstraZeneca spanning both small molecule and biologics research and development. MedImmune is developing a comprehensive portfolio with an emphasis on two key areas in oncology development: antibody-drug conjugates and immune-mediated cancer therapy, which aims to harness the power of the patient’s own immune system to fight cancer. Together, immune-mediated cancer therapies and antibody-drug conjugates have the potential to treat cancer in a way that current therapies are unable to do.

In October 2013 MedImmune acquired Spirogen, a company focused on antibody-drug conjugate technology for use in oncology. Spirogen develops pyrrolobenzodiazepine-armed antibody-drug conjugates. The proprietary pyrrolobenzodiazepine (PBD) technology attaches highly potent cytotoxic agents, or ‘payloads’ to specific cancer-targeting antibodies using biodegradable ‘linkers’. This targeting optimises the delivery of the cancer drug to the tumour cells only and provides the greatest degree of tumour killing while minimising the toxicity to the patient.  The technology is expected to emerge as a critical component in the next generation of cancer biologics with the potential to make a difference for oncologists and their patients.

MedImmune Inc.
1 MedImmune Way
Gaithersburg MD 20878

Web: MedImmune Inc

Meditope Biosciences

Meditope Biosciences is a biotechnology company developing best-in-class antibody-based cancer products. Discovered at City of Hope National Medical Center (a private, not-for-profit clinical research center, hospital and graduate medical school located in Duarte, California, USA), Meditope’s technology is capable of turning any monoclonal antibody (mAb) into a proprietary, site-specific “Lego-like” system that is able to attach and detach drugs to antibodies without the need for chemical conjugation.

The result is a memAb (meditope-enabled mAb) product that is significantly more effective and offers multiple manufacturing advantages compared to existing antibody-drug conjugate (ADC) technologies.

Meditope’s technology is poised to advance the antibody market by producing an array of new therapeutic and diagnostic products.

301 N. Lake Ave, Suite 900
Pasadena, CA 91101
U.S.A.

Web: Meditope Biosciences Inc

Merrimack

Merrimack is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer.

The company seeks to gain a deeper understanding of underlying cancer biology through its systems biology-based approach and develop new insights, therapeutics and diagnostics to improve outcomes for cancer patients.

Merrimack currently has six oncology therapeutics in clinical development and three additional candidates in late stage preclinical development. Merrimack’s lead product candidate, MM-398, recently completed a Phase III trial in post-gemcitabine pancreatic cancer. Based on the results of this trial, Merrimack intends to file a New Drug Application for MM-398 in 2014.

MM-302 is another drug in development by Merrimack. This novel antibody-drug conjugated liposomal doxorubicin that targets and binds to HER2, a protein that when overexpressed can lead to the development and aggressive progression of breast cancer. In December 2013, the reported encouraging trial results from an ongoing Phase 1 trial of MM-302 at SABCS, noting that patients treated with the nanoliposomal candidate showed no cardiotoxicity related to MM-302, a side effect that has limited the use of anthracyclines, particularly in HER2-positive breast cancer.

In august 2014 the company  initiated a new, global, open-label, randomized Phase II trial of MM-302 in combination with trastuzumab (Herceptin®; Genetech/Roche) in patients with HER2-positive locally advanced or metastatic breast cancer.  This trial is  trial designed with input from the U.S. Food and Drug Administration (FDA) to support a potential accelerated approval application of the trial drug.

One Kendall Square, Suite B7201
Cambridge, MA 02139
U.S.A.

Web: Merrimack Pharmaceuticals, Inc.

Mersana

Researchers and engineers at Mersana develop novel drug conjugates that maximize the potential of new and established therapeutic classes. The company’s technology harnesses the power and synergy of nanotechnology, biologics and small molecules. Mersana is advancing its own pipeline of next-generation drugs with best-in-class potential to address unmet needs and improve patient outcomes in multiple oncology indications.

Utilizing the company’s proprietary technology, researchers we are developing a portfolio of next-generation antibody-drug conjugates (ADC) with superior properties not found with current ADC technologies. The clinical pipeline consists of two cancer therapeutics with blockbuster potential. XMT-1001 is a potentially best-in-class novel “tecan” conjugate that is currently being investigated in a Phase Ib extension trial in patients with lung cancers. XMT-1107 is a first-in-class anti-angiogenic conjugate with a unique mechanism of action that has completed a Phase I trial in patients with refractory, advanced solid tumors. XMT-1107 was licensed to Teva on a worldwide basis except for Japan, where Mersana elected to retain rights.

These clinical candidates reflect the successful application of our unique conjugation system. This versatile conjugation system integrates Fleximer®, a clinically validated biodegradable polymer, with a broad array of customized linker chemistries designed to control conjugation, stability and release of diverse classes of therapeutic payloads. This system provides important benefits required for the development of next-generation drugs across therapeutic modalities, including ADCs, antibody fragments, small molecules and biologics, as well as synergistic drug combinations.

840 Memorial Drive
Cambridge, MA 02139
U.S.A.

Web: Mersana Therapeutics, Inc.

Moradec

Moradec LLC, founded in 2012 by Helen (Hongyuan) Mao, PhD, provides novel research tools. The company’s novel secondary antibody-drug conjugates (2°ADCs) are used as a research tools for pre-screening antibody leads as ADC candidates.

Moradec has formed a strategic alliance with Concortis Biosystems, a leading provider of custom toxin and linker synthesis and antibody conjugation services for developing next generation ADCs. Together, these two companies have accumulated in-depth knowledge of small molecule toxins and linkers.

11760 Sorrento Valley Rd, Suite R
San Diego, CA 92121
USAd

Web: Moradec, LLC

NBE Therapeutics

Located in Basel (Switzerland),  NBE-Therapeutics’ vision is to become an internationally recognized leader and pioneer for the development of innovative and effective antibody-based medicines, with initially a strong focus on developing Antibody- drug Conjugates (ADCs) for the treatment of cancer.

In order to achieve this, NBE Therapeutics has developed potent antibody discovery and specific drug conjugation technologies and plans to utilize these pioneering technologies for the development of a robust therapeutic antibody and ADC drug pipeline, while continuing the development of its enabling technology platforms. The company is financially backed by the Boehringer Ingelheim Venture Fund.

Technology Parc Basel
Hochbergerstrasse 60C
CH-4057 Basel
Switzerland

Web: NBE Therapeutics

Nektar Therapeutics

Nektar Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms, which are designed to improve the benefits of drugs for patients. Its product pipeline consists of drug candidates across a number of therapeutic areas, including oncology, pain, anti-infectives, anti-viral and immunology.

Nektar’s research and development activities involve small molecule drugs, peptides and other potential biologic drug candidates. Its drug candidates are designed to improve the pharmacokinetics, pharmacodynamics, half-life, bioavailability, metabolism or distribution of drugs and improve the overall benefits and use of a drug for the patient.

455 Mission Bay Boulevard
South San Francisco, California 94158
U.S.A.

Web: Nektar Therapeutics

Nerviano Medical Sciences

Nerviano Medical Sciences is the largest pharmaceutical R&D facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe.

The company benefits from the it’s long standing heritage of research and development performed on three key components of antibody drug conjugate (ADC) molecules: drug/payload,linker and targeting carrier. Direct experience includes:

  • Drug/Payload: toxins with different mechanism of action, including intercalating agents, microtubule binders, topoisomerase I inhibitors, DNA minor groove binders.
  • Linker: various linker molecules have been generated and characterized, including uncleavable and cleavable (acidic, proteolytic, redox cleavage).
  • Carrier: carriers include synthetic polymers and proteins.

Nerviano’s integrated Capabilities allow not only the discovery, synthesis and characterization of payloads and linkers, but also conjugation to carrier, and extensive characterization of the resulting conjugates, including affinity measurements, internalization testing, confirmation of antiproliferative activity in cells and efficacy testing in animal models, allowing selection of appropriate Product Candidates.

Viale Pasteur, 10
20014 Nerviano (MI)
Italy

Web: Nerviano Medical Sciences

Oxford BioTherapeutics

Oxford BioTherapeutics (OBT) is a leading international biotechnology company focused on delivering innovative and cost-effective first-in-class medicines to fulfill major unmet patient needs in the field of cancer. OBT is developing cutting-edge antibody-based cancer medicines, with integrated diagnostics, against novel targets that it has discovered through its unique OGAP® proteomic database.

OBT has access to the most advanced antibody technologies and expertise through its partnerships with many of the world leaders in antibody development, including Seattle Genetics, BMS (Medarex), Amgen, Alere (formerly Biosite) and BioWa, and through its development alliances with GlaxoSmithKline and Sanofi. OBT’s diagnostic collaboration with Alere also provides the opportunity to develop tailored diagnostics for OBT’s therapeutic products.

These unique partnerships have enabled OBT to convert its world leading capabilities in the discovery of novel oncology targets into a highly attractive pipeline of therapeutic antibodies, which includes various antibody and antibody drug conjugate (ADC) programs, each of which addresses a different cancer indication via a different novel oncology target.

94a Innovation Drive
Milton Park
Abingdon
Oxon
OX14 4RZ

Web: Oxford BioTherapeutics

Pfizer

Pfizer Inc. applies science and global resources to bring therapies to people that extend and significantly improve their lives.  The company strives to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Pfizer’s global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. The company strives to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.  As one of the world’s premier innovative biopharmaceutical companies, the company collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.

By building on internal expertise and fostering strategic partnerships to access the best technologies with patent protection and technical capabilities that provide a competitive advantage, the company is developing a R&D platform to work on finding some next-gen antibody-drug conjugates (ADCs) for cancer targets.  Pfizer is currently working on novel ADC platforms, novel payloads, linkers, conjugation sites, bioconjugation technologies, novel approaches that enhance antibody function or improve site-specific bioconjugation and combinatorial biologics such as bi-specific and multi-functional platforms with promising biophysical and manufacturing properties.

235 East 42nd Street
NY, NY 10017
U.S.A.

Web: Pfizer Inc

PhotoBiotics

Antibody-drug Conjugates (ADCs) are expected to be the next generation of antibody therapeutics. Current unmodified monoclonal antibodies (MAbs) do not cure, and can only extend survival by 5-6 months. In addition, many antibodies suffer from drug resistance due to mutations in cell-signalling pathways. The main method for conjugating drugs to MAbs has been via the thiol side-chains of cysteine residues (Cys-SH). Though affording a certain degree of stoichiometric control during conjugation, this protocol yields only low drug-loading ratios, due mainly to the large Mab-drug conjugate becoming notoriously insoluble at higher drug loadings.

With its proprietary OptiLink technology platform, PhotoBiotics has adopted an altogether more novel approach using much smaller antibody fragments (scFvs) that are relatively easy to bioengineer with lysine residues for multiple drug-molecule conjugation to their -NH2 side-chains. Quite counter-intuitively, this approach provides far higher drug loadings than have so far been achieved with whole MAbs, without running the risk of drug-scFv-conjugate insolubility. This provides:

  • Applications in both therapy and diagnostic imaging
  • ‘See & Treat’ as a time-saving and therapeutically enhancing opportunity

Chemistry and Biochemistry Building
Imperial College London, Exhibition Rd
London, SW7 2AZ,
United Kingdom

Web: PhotoBiotics

Pierre Fabre

Immunoconjugates are currently a growing therapeutic class for the treatment of cancer. These molecules combine a protein (of biological origin) with a cytotoxic agent (of synthetic or plant origin) and direct active (cytotoxic) substances to the very heart of a tumorous cell without affecting healthy cells.

Research teams at le Centre d’Immu-nologie Pierre Fabre(CIPF; Pierre Fabre immunology center), a subsidiary of the Pierre Fabre Group, discover, develop and evaluating these molecules, combining the company’s expertise of targeted biotherapeutics, cytotoxic agents and the chemical engineering.

The Centre d’Immunologie Pierre Fabre develops research programs in the field of cancer immunotherapy and biotherapy, in particular in the identification of monoclonal antibodies for therapeutic purposes. Inaugurated in 1990, the CIPF has gained notoriety through the discover of the powerful role of recombinant protein production and bacterial biomass. Long focused on vaccine approaches, since 2003 CIPF refocused research on the discovery and characterization monoclonal antibodies in oncology.

5, avenue Napoléon 3
BP 60497
74164 Saint Julien-en-Genevois Cedex
France

Web: le Centre d’Immu-nologie Pierre Fabre (CIPF)

45 Place Abel Gance
92100 Boulogne Billancourt
France

Web: Pierre-Fabre Group

Piramal Healtcare

Piramal Healtcare is a pioneers in the field of GMP Manufacturing of Antibody Drug Conjugates (ADCs) and offers a wealth of experience in proof-of-concept studies to scale-up and commercial supplies. The company’s facilities in Scotland are dedicated to process development, scale up and manufacturing of bioconjugates with primary focus on ADCs. For over a decade, Piramal has partnered with leading ADC technology companies and their licensees to develop robust processes used in pre-clinical, clinical and commercial supplies.

A – Wing, 6th floor, 247 Park
LBS Marg, Vikhroli West
Mumbai – 400 083
India

Web: Piramal Healthcare

PolyTherics

PolyTherics provides a range of proprietary technologies to enable the development of better biopharmaceuticals. The company’s site-specific conjugation technologies, for example, have the flexibility to conjugate any therapeutic or diagnostic payload (e.g. cytotoxic drug, toxin or radionuclide) to virtually any protein, including antibodies, antibody fragments, or alternative protein scaffolds, and peptides, that bind a specific target. The key benefits of the company’s technologies for production of protein drug conjugates include:

  • More homogeneous product produced so simpler purification and less biological variability
  • Stable link between protein and polymer so conjugate remains intact in vitro and in vivo.

Researchers at PolyTherics have developed a range of heterobifunctional reagents for site-specific conjugation of a variety of payloads to therapeutic proteins and peptides depending on the target of interest.  This toolbox of technologies enables tailoring the linker to the requirements of your protein and payload combination. Incorporating a polymer into the linker brings additional advantages, including:

  • Reduced risk of protein aggregation
  • Improved solubility of the conjugate
  • Easier to monitor conjugation reaction

The London BioScience Innovation Centre
2 Royal College Street
London
NW1 0NH
United Kingdom

Web: PolyTherics

ProJect Pharmaceuticals

ProJect Pharmaceuticals offers pharmaceutical development of ADCs and other cytotoxic drugs in a new safety laboratory with predictive analytical methods and high end freeze drying capabilities implemented.

The ability to develop Antibody Drug Conjugates (ADCs) by combining protein formulation and process know how with cytotoxic drug expertise puts ProJect Pharmaceutics in a unique position within the biopharmaceutical industry. The company’s new safety facilities in dedicated labs and a deep understanding of the challenges when processing highly potent drugs enable us to provide specific solutions for ADCs and other cytostatic agents.

Many pharmaceutical ingredients of this class show limited solubility in water and degrade rapidly during compounding, filling and freeze-drying. ADCs in particular have a lower thermodynamic and colloidal stability due to the attachment of hydrophobic drug moieties leading to modified charge pattern and stronger hydrophobic interactions. Reduced solubility and a pronounced tendency to aggregation and denaturation may be the consequences. ProJect Pharmaceutics´s Predictive Formulation Analytics is the proven technology to quickly and reliably identify promising formulation candidates for ADCs and to overcome drug specific stability issues.

Fraunhoferstraße 22
D – 82152 Martinsried
Germany

Web: ProJect Pharmaceutics GmbH

QPS Holdings

Founded in 1995, QPS is a contract research organization (CRO) that tests drug candidates for major pharmaceutical companies.  The company is GLP/GCP-compliant, supporting discovery, preclinical and clinical drug development.  As part of the services, the company provides quality services to pharmaceutical and biotechnology clients worldwide. Their linearly integrated core competencies include Neuropharmacology, DMPK, Toxicology, Bioanalysis. Translational medicine, Early Stage Clinical Research, Phase II – IV Clinical Research and Program Management.  QPS’s mission is to accelerate the development of medicines worldwide by enabling cost effective breakthroughs in pharmaceutical innovation.  The company supports several pre-clinical and clinical drug development programs for a number of pharmaceutical clients involved in antibody-drug conjugates (ADCs) worldwide

Three Innovation Way, Suite 240
Newark, DE 19711
U.S.A.

Web: QPS Holdings

Quanta BioDesign, Ltd

Quanta BioDesign, Ltd.  in was founded 1997 for the purpose of developing and commercializing an extensive line of products for companies involved in drug discovery and diagnostic development programs.  The company’s products are based on  proprietary discrete polyethylene glycol (dPEG®) chemistries, including a the processes for making these compounds.  The single molecular weight ethylene glycol conjugation technology, dPEG eliminates common problems found in the development of diagnostic and therapeutic products, such as aggregation and non-specific interactions, poor water solubility, poor delivery, delivery issues/options, short serum half-life, toxicity and antigenicity.

Like traditional PEGs, Quanta BioDesign’s products contain a hydrophilic, water-soluble backbone consisting of repeating ethylene oxide units. However unlike traditional PEGs each of the company’s products represents a single compound with a unique, specific, single molecular weight (MW).  Quanta BioDesign’s products are synthesized from pure building blocks (e.g. triethylene glycol or tetraethylene glycol) in a series of step-wise reactions to provide specific MWs, architectures, functional groups, and organic moieties suited for a wide variety of applications. These products have now been used for the modification of therapeutic macromolecules, as linkers in antibody-drug conjugates (ADCs), for bioconjugation of biologics, for surface modification, and in diagnostics.

195 West Olentangy Street (Suite O)
Powell, Ohio 43065-8720
U.S.A.

Web: Quanta BioDesign, Ltd

Redwood Bioscience Inc

Redwood Bioscience Inc., a biopharmaceutical company, engages in developing precision protein-chemical engineering technology designed for developing and optimizing the next-generation antibody-drug conjugates and other semi-synthetic biotherapeutics. The company’s site specific protein modification platform provides control over cargo placement on a protein, cargo orientation, and stoichiometry, enabling the creation of conjugate libraries from which homogenous compounds can be selected.

5703 Hollis Street
Emeryville, CA 94608
U.S.A.

Web: Redwood Bioscience Inc.

Regeneron Pharmaceuticals, Inc.

Regeneron Pharmaceuticals, Inc. is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.

Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi.  Phase III studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727.  Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.

777 Old Saw Mill River Rd
Tarrytown, NY
U.S.A

Web: Regeneron Pharmaceuticals, Inc.

SAFC Global / SAFC Biosciences

Antibody-drug conjugation (ADC) technology uses monoclonal antibodies or other biologics to deliver conjugated highly-potent APIs (HPAPIs) to targeted cells. In conjugated form, the HPAPI exhibits more selective cytotoxicity, thereby, sparing non-target cells from many of the toxic effects.

For antibody drug conjugates (ADCs), SAFC®, a member of Sigma-Aldrich, can conjugate biological molecules with high-potent APIs (HPAPIs) to meet pharmaceutical industry demands for development of new oncology products that are more targeted and exponentially more powerful.

Often cytotoxic or neurotoxic, HPAPIs must be managed with the highest level of containment. SAFC facilities incorporate appropriate room pressurization, airlocks, ventilation and isolators to ensure proper handling of these highly-potent materials within cGMP suites designed especially for biologics manufacturing process:

  • SAFC manufactured HPAPIs;
  • Traditional (non-potent) APIs from SAFC or the customer;
  • SAFC or customer manufactured linkers with unique conjugation properties;
  • Proven and experienced quality assurance oversight for HPAPIs;
  • Clinical trials APIs manufactured to ICH Q7A guidelines;
  • Conjugation for linking of non-potent APIs to other biologic carriers, including polyamino acids or polynucleotides.

13804 W. 107th Street
Lenexa, KS 66215
USA

Web: SAFC Global / SAFC Biosciences

Sanofi

Sanofi is a global integrated healthcare company focused on patients’ needs with a diversified offer of medicines, vaccines and innovative therapeutic solutions, engaged in the research, development, manufacturing and marketing of healthcare products. As part of their oncology portfolio, the company develops, manufactures and commercialize antibody drug conjugate (ADC), including SAR3419, a novel anti-CD19 ADC. SAR3419 includes an anti-CD19 monoclonal antibody and a maytansine derivate. SAR3419 combines tubulin inhibition with the B-cell selectivity of an anti-CD19 antibody.

Clinical trials with SAR3419 include:

  • NCT01472887– SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients (STARLYTE)
  • NCT00796731 – SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin’s Lymphoma/span>
  • NCT01440179 – SAR3419 in Acute Lymphoblastic Leukemia (MYRALL)
  • NCT00549185 – Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin’s Lymphoma
  • NCT01470456 – Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

55 Corporate Drive
Bridgewater, NJ 08807
U.S.A.

Web: Sanofi Oncology

Seattle Genetics

Seattle Genetics is a biotechnology company focused on developing and commercializing innovative, empowered antibody-based therapies for the treatment of cancer.

The company is the industry leader in antibody-drug conjugates (ADCs), a technology designed to harness the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells. ADCs are intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy, while potentially enhancing antitumor activity.

The company’s first ADC product brentuximab vedotin (Adcetris®) received accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2011 and approval with conditions from Health Canada in February 2013 for relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma, an aggressive type of T-cell non-Hodgkin lymphoma.  Additionally, the European Commission granted Takeda Pharmaceutical Company Limited and Millennium: The Takeda Oncology Company conditional marketing authorization in October 2012. Millennium has exclusive rights to commercialize the product candidate for Seattle Genetics outside the United States and Canada.

21823 – 30th Drive S.E. – Mailing address
21717 – 30th Drive S.E. – Building 3/Reception
Bothell, WA 98021
U.S.A.

Web: Seattle Genetics, Inc

Sepax Technologies, Inc

Sepax Technologies, Inc  a privately held company, was founded in Delaware, USA in November 2002.

The company develops and manufactures HPLC consumables, bulk media, and equipment in liquid chromatography for chemical and biological separations. It is a fast growing technology company and owns patents, proprietary technologies and know-how.

Sepax has emerged as a leader in the biological separation industry in the global market.

Sepax Technologies, Inc.
Delaware Technology Park
5-100 Innovation Way
Newark, Delaware 19711
U.S.A.

Sepax Technologies, Inc

Sorrento Therapeutics

Sorrento Therapeutics is developing Antibody Formulated Drug Conjugates or AfDC technology as foundation for next-generation antibody-drug conjugates (ADCs), a promising drug class that combines specific tumor targeting with the delivery of potent oncolytic therapeutics. As foundation for our AfDC, Sorrento acquired IG-004 (formerly known as TOCOSOL™-paclitaxel), a tocopheryl polyethelyene glycol succinate (“TPGS”)-based drug formulation from IGDRASOL. IG-004 has been clinically-validated and completed Phase II trials in NSCLC, pancreatic cancer, ovarian cancer, colorectal cancer and bladder cancer as well as completed Phase III studies in MBC in the US and/or ex-US.

While ADCs are an improved therapeutic approach to combat cancer, current ADC technology has limitations, such as required prodrug synthesis, development of linker and drug release strategies, potential systemic toxicities upon premature drug release and requirement of ADC internalization into the tumor cell for efficient anti-cancer effect.

These bottlenecks are addressed by our proprietary AfDC technology, including rapid generation of AfDC therapeutics, greater flexibility for mAb-drug combinations, targeting of the tumor site rather than individual cancer cells, higher avidity for target cells via multiple antibody molecules per AfDC, and potentially increased cytotoxic payload including delivery of one or more distint oncolytic drugs into the tumor.

The significant therapeutic promise of ADCs, together with increasing biopharma interest in ADC-type technologies and a validated regulatory approval pathway, create an exciting opportunity for developing improved, next-generation AfDC candidates.

6042 Cornerstone Ct. West, Suite B
San Diego, CA 92121
U.S.A.

Web: Sorrento Therapeutics, Inc.

Spirogen, Ltd

Spirogen, Ltd. is a clinical stage biotechnology company specializing in novel, sequence-selective, DNA minor groove-binding molecules with potent therapeutic properties. Spirogen’s principal technology involves modification of members of a group of naturally occurring antibiotics called pyrrolobenzodiazepines (PBDs). The company was founded in 2000, has 18 employees and is private equity funded. The company’s lead oncology drug candidate, SG2000, has completed solid tumour Phase I studies in the USA (through the NCI) and Europe (through Cancer Research UK).

Spirogen’s pipeline comprises two well characterized DNA minor-groove binding, interstrand cross-linking PBD dimer molecules, SG2000 and SG2285, plus a number of earlier stage leads. Additionally, the achiral duocarmycin analogue, AS-1-145 (Centanamycin), is now in pre-clinical development with the NCI.

A number of the company’s highly potent antineoplastic molecules are under development and evaluation with pharmaceutical companies as candidates for development as part of antibody drug conjugate (ADC) therapies. Spirogen also has its own active program of ADC cytotoxic and linker development. The company works closely with ADC Therapeutics sarl in the development of its ADCs.

On October 15, 2013 AstraZeneca announced that MedImmune, its global biologics research and development arm, had acquired Spirogen. Today the company is a wholy-owned subsidiary of MedImmune.

Spirogen Ltd
The QMB Innovation centre
London E1 2AX
UK

Web: Spirogen, Ltd.

Sutro

Sutro’s cell-free expression technology provides a rapid and powerful platform for the discovery and development of next generation antibody-drug conjugates (ADCs).

Current ADCs in development have immense promise, but they are limited by the fact that they are structurally heterogeneous populations in which the position and number of conjugated linkers and warheads vary significantly. Such heterogeneity prevents the definition of structure-activity relationships (SARs). Consequently, using traditional ADC technologies prevents researchers from discovering and developing candidates with optimal therapeutic indices and can result in products with unpredictable and sub-optimal pharmacokinetic properties, stability and efficacy.

Sutro can incorporate non-natural amino acids (nnAA) at any site in an antibody structure, thereby allowing for single-species ADCs with site-specific conjugation of linker and warhead. Of vital importance in this process is Sutro’s ability to perform rapid and parallel synthesis of numerous variants taking advantage of a substantial number of different sites, enabling analyses early in discovery to define SARs and locate the best positions for nnAA incorporation based on:

  • Protein expression levels
  • Efficiency of incorporation of the nnAA
  • Linker / warhead conjugation efficiency
  • Target binding efficiency
  • Cell killing efficiency
  • Internalization characteristics

It has been well documented that the cell-killing effects of ADCs are highly dependent on the location of the warhead as well as the drug to antibody ratio. Sutro can control both of these variables with exquisite specificity, resulting in truly optimized product candidates.

Sutro has also addressed the challenge of manufacturing nnAA-containing ADCs by engineering additional versions of cell-free extract that achieve high rates of incorporation of nnAAs and by developing chemistries that allow for efficient conjugation of linkers and warheads to antibodies.

3310 Utah Ave
Suite 150
South San Francisco, CA 94080
U.S.A.

Web: Sutro Biopharma, Inc.

Tagworks Pharmaceuticals

Tagworks Pharmaceuticals is developing a unique approach towards antibody-based imaging and therapy. Tagworks’ technology enables the actuation of tagged antibodies through selective chemical manipulation in vivo, improving the efficacy of established approaches such as Radioimmuno-imaging and –therapy and Antibody-Drug Conjugates (ADCs).

ADCs are highly potent biopharmaceuticals that use the targeting ability of monoclonal antibodies (mAbs) to selectively bind to tumor cells where the conjugated cancer drug is released. The antibody and the small molecule drug are bound by a linker. Only when the linker is cleaved do these cell-killing drugs become active. This generates an excellent control mechanism of drug activation, allowing an increase of the therapeutic window and thereby the use of highly potent drugs. Current ADC technologies rely on biological cleavage of the linker. The ADC has to bind to a tumor cell-specific membrane receptor and subsequently be internalized in the tumor cell for cleavage of the linker – and thus activation of the drug – to occur. As the number of tumor-specific receptors that ensure efficient internalization is limited, especially in solid tumors, a wide range of cancer-targets remains out of reach of ADCs.

Tagworks tackles this problem by focusing on chemically triggered release mechanisms for ADCs. Recently, the company succeeded in modifying the fastest and highly selective click reaction, the inverse-electron-demand-Diels-Alder reaction, in such a way that we achieved selective bioorthogonal release. An unprecedented approach that holds great promise for employing chemically triggered release of a drug from a tumor-bound ADC. This would mean a substantial expansion of the scope of suitable ADC targets to include for example slow- or non-internalizing targets and extracellular-matrix constituents that are not suitable for biological cleavage mechanisms.

Tagworks Pharmaceuticals is a privately held pharmaceutical company based in Eindhoven, The Netherlands, focused on the in vivo assembly and actuation of diagnostic and therapeutic antibody conjugates. Founded in 2011, Tagworks is a spin-out of Royal Philips Electronics, and originates from Philips’ molecular imaging expertise.

The company’s is headquartered at the High Tech Campus in the Center for Imaging Research and Education (CIRE), which is a shared life science facility between Philips, the Technical University Eindhoven, and third parties. The >2000 m2 infrastructure at CIRE, supported by dedicated scientists and technicians, includes organic and protein chemistry, molecular and cell biology, radiochemistry, and imaging labs. In addition, the Company works with several CRO partners.

High Tech Campus 11
5656 AE Eindhoven
The Netherlands

Web: Tagworks Pharmaceuticals

The Chemistry Research Solution, LLC

The Chemistry Research Solution, LLC (TCRS) has ample experience in providing antibody-drug conjugate (ADC) related services to its clients. Currently, the company is engaged in supporting several biotech and pharmaceutical companies in the development of their ADC development programs. TCRS has a variety of highly potent “warheads” or payloads in stock for advancing its clients’ ADC projects. A selection of cleavable and non-cleavable linkers and spacer molecules is also available.

The company offers a variety of services, including:

  • Preparation of ADCs, Antibody-Enzyme and Antibody-Liposome conjugates
  • Design and synthesis of potent cytotoxic compounds and payloads with linkers
  • Customized design and synthesis of generic linkers
  • Preparation and purification of bioconjugates from milligram- to gram- scale
  • Modification of carbohydrates, polysaccharides, and glycoconjugates
  • Preparation of fluorescent probes.

TCRS conducts all work with highly toxic/cytotoxic compounds and payloads in its specially designed containment laboratory, which is accessible only to authorized and trained chemists. This laboratory has an independent air-handling (HVAC) system and is equipped with certified chemical fume hoods, HEPA-filtered ventilation and enclosed, HEPA-ventilated weighing stations. Compounds of high toxicity are handled in a glove box with a closed-loop containment (CLC) system that operates under negative pressure.

360 George Patterson Blvd.
Suite 108
Bristol, PA 19007
U.S.A.

Web: The Chemistry Research Solution, LLC

ThioLogics

ThioLogics is a new biotechnology company that has developed a groundbreaking site-specific conjugation platform that will enable the assembly of the next generation of antibody-drug conjugates or ADCs.

Based on propriety chemistries arising from the laboratories of its University College London founders, Professor Stephen Caddick and Dr. James Baker, Thiologics has developed a conjugation platform that allows the selective, stable and functional modification of disulfide bonds or free cysteine in peptides, proteins and antibodies.

ThioLogics groundbreaking conjugation platform allows the selective, stable, functional modification of disulfide bonds or free cysteine in proteins and peptides. Technology that will allow versatile modification of proteins to yield well-defined, homogeneous products is highly desirable. In particular, it has been demonstrated that homogeneous ADCs have a greatly improved therapeutic index over analogous heterogeneous formulations. Introducing greater homogeneity into protein conjugates will also greatly simplify process and development issues, thus reducing costs.

The ThioLogics conjugation platform is being exemplified for a range of modalities across the biologics sector. These include: (i) peptide and protein therapeutics, (ii) the creation of stable and simple to manufacture bispecific antibodies, and (iii) the development of stable and homogenous antibody-drug conjugates for full antibodies and antibody fragments.

The Network Building
97 Tottenham Court Road
London
W1T 4TP

Web: ThioLogics

Viventia Bio Inc.

Viventia Bio Inc. is developing and advancing the next generation of human antibody-based therapeutics for use in oncology. The company’s approach combines the specificity of an antibody with the potency of a cytotoxic payload to provide targeted therapies for the safer and more efficacious treatment of cancer patients.

Viventia has developed a potent payload called deBouganin. When coupled to a targeting antibody this drug can effectively kill cancer cells without harming normal cells. This differential targeting enhances the therapeutic potential of Viventia’s drugs and provides prolonged clinical benefit. deBouganin has been chemically conjugated to full length antibodies as well as fused to numerous antibody fragments and has been found to be safe and efficacious in the clinic.

Viventia has built a product pipeline using its innovative antibody discovery platform, IDAP (Immune Driven Antibody Platform). IDAP is a collection of technologies designed to create a portfolio of fully human cancer specific antibodies and identify novel oncology drug targets on the surface of cancer cells. The company has 3 products in clinical development, VB6-845, Vicinium™ and Proxinium™. VB6-845, a deBouganin therapeutic designed for the systemic treatment of various EpCAM-positive solid tumors. VB6-845 has undergone exploratory investigation in a Phase I clinical trial and was shown to be safe and well-tolerated. Vicinium™ and Proxinium™ are used for the treatment of non-muscle invasive bladder cancer and squamous cell cancer of the head & neck, respectively. Both have successfully completed Phase II trials.

147 Hamelin Street
Winnipeg, MB
R3T 3Z1
Canada

Web: Viventia Bio Inc.

Wilex AG

Wilex AG is a biopharmaceutical company and develops drugs based on antibodies and small molecules with a low side effect profile and targeted treatment of different types of cancer as well as diagnostic agents for specific detection of tumors. The company’s aim is to help oncologists administer targeted treatments to carefully diagnosed patients and to enhance patients’ health related Quality of Life (hrQoL).

Since its formation Wilex has focused its activities on oncology, pursuing the development of new cancer therapies to enable efficacious well-tolerated treatments.  Over the years, the business model has been expanded to include new technologies intended to raise the company’s profile in oncology and improve its competitive position.

Today Wilex offers a combined portfolio of both therapeutics and diagnostics. Its aim is to help oncologists and other specialists administer targeted treatments to carefully diagnosed patients and offer therapy options tailored to different types and stages of cancer.

Grillparzerstr. 10
81675 Munich
Germany

Web: Wilex AG


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