Our services

ADC Review
is made possible by:




PEER-REVIEWED ARTICLES

Rapidly Expanding MabPlex International Secures U.S. $ 59.1 Million Series A Financing

In an announcement made to the international business and financial press, MabPlex International, a global Contract Development and Manufacturing Organization or CDMO based in Yantai, China, confirmed that it had closed a Series A funding round of U.S.$ 59.1 million (RMB Yuan 400 million).

The financing round was backed by multiple global investors lead by China’s State Development & Investment Corporation (SDIC) and Shenzhen Venture Capital based in Shenzhen, Guangdong, China.

International expansion and recognition
China’s population has, over the last decades, aged much faster than similar populations in other countries. * The growth in the number of older people poses challenges to the delivery of healthcare, among which the most common are a surging costs and a rising difficulty in managing these costs as well as the and distribution of care.

Photo 1.0: MabPlex’s Jianmin Fang during the opening ceremony of the company’s facility expansion on September 6, 2018, explained that “… With a growing number of novel and increasingly complex drug constructs in early development pipelines and new targeted therapies, such as antibody-drug conjugates (ADCs), in late stage development and moving to commercialization, there is a growing global demand for specialized CDMOs.

Confronted with this aging population* and, in addition, facing significant unmet medical needs in a number of therapeutic areas, including cancer and diabetes, various private and Chinese state-owned investment corporations have, in an attempt to improve care, increased their funding of a number of biotechnology companies.  This growth in venture capital investment funding has also benefited MabPlex.

MabPlex, which offers biologics development and manufacturing services, including monoclonal antibodies (mAbs), recombinant proteins, antibody-drug conjugates and bispecifics, has, since the founding of the company in 2013, rapidly expanded operations.  Today, these operations include two sites in China (Yantai and Shanghai) and one site in the United States (San Diego, CA).

The rapid growth is primarily based on the company’s expertise, from gene sequencing to cell line development and commercial production. MabPlex’s Chinese Hamster Ovary (CHO) cell line, for example, used for the production of recombinant therapeutic proteins, is uniquely designed to move novel drug candidates in the shortest possible time from DNA to finished recombinant protein products.

The company’s expertise and high standards in development and manufacturing, coupled with a state-of-the-art facilities and cGMP quality management, have been recognized by regulators in the United States, Australia and China.  This recognition demonstrates the strength of MabPlex’s global CDMO service, making it valuable partner for biotechnology companies involved in the development of antibody-drug conjugates.

Funding
The receipt of the Series A funding, which represents a significant round of venture capital financing, is expected to support the upgrades to MabPlex’s technology platform, Phase III and commercial production expansion, as well as the company’s international strategy.

Since investors in Series A funding, a critical phase in any company’s growth, are not just looking for great ideas, but are generally looking for companies with ideas, a strong management team and a strategy designed to establish a successful, money-making business, this funding round is yet another recognition confirming the strength of the MabPlex’s management and offerings.

“With our professional services and international standards, R&D companies can not only shorten product development time, but more importantly, they can use limited funds for new drug projects themselves, reduce R&D risks and increase corporate value,” said Jianmin Fang, Ph.D., Chairman and Chief Executive Officer of MabPlex International, Ltd.

“This financing round will greatly enhance our service capabilities, we will continue to provide high quality services to our customers,” Fang concluded.

Expansion
The Series A funding round follows a number of milestones in the past 12 months, including expanding the MabPlex’s manufacturing facility to a total of approximately 750,000 ft²; with 400,000 ft² devoted specifically to cGMP execution, in Yantai, China.

According to reports published by the company, the newly completed facility includes six independent cell culture suites, four independent purification suites, and a cGMP warehouse. Each of the six cell culture suites will support up to two single-use bioreactors at volumes of up to 2,000L (with a maximum capacity of 24,000L).

Following the opening ceremony, which took place on September 6, 2018, MabPlex’s Jianmin Fang said that “… With a growing number of novel and increasingly complex drug constructs in early development pipelines and new targeted therapies, such as ADCs, in late stage development and moving to commercialization, there is a growing global demand for specialized CDMOs.” MabPlex expects to be among these specialized companies.

Fang further explained that MabPlex, with the opening of the new facility, along with process development sites and a state-of-the-art Process Development Center of Excellence in San Diego/La Jolla and Shanghai, is expected to meet the needs of the company’s new and current clients as they progress to commercialization of their novel, investigational, agents.


*According to “China Country Assessment Report on Ageing and Health,” published by the World Health Organization (WHO) in 2015,  the pace of population ageing is much faster in China than many other high-income or low-and middle-income countries. The reports states that in the next 25 years, the percentage of people in China aged 60 years or over is expected to more than double, from 12.4% (168 million people) in 2010 to 28% (402 million) in 2040. In contrast, it took France 115 years, Sweden 85 years and the United States 69 years for the proportion of the population aged over 60 years to double from 7% to 14%.

Last Editorial Review: January 29, 2019

Featured Image: Opening of MabPlex new facility in Yantai, China, on September 6, 2018. Courtesy: © 2010 – 2019 MabPlex. Used with permission.

Copyright © 2010 – 2019 InPress Media Group. All rights reserved. Republication or redistribution of InPress Media Group content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group. InPress Media Group shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. ADC Review / Journal of Antibody-drug Conjugates is a registered trademarks and trademarks of InPress Media Group around the world.

Share

ADC Biotechnology Secures Funding for Strategic move into Downstream Formulation and Fill Finish

UK-based ADC Biotechnology, an innovative biotechnology company developing new process technology to speed, simplify and significantly lower the production costs of antibody-drug conjugates, has secured additional funding of £2.5 million (U.S. $ 3.2 million) from existing investors and company management.

The additional funds will be use to finance the company’s strategic move into downstream formulation and fill finish capabilities.

“We are delighted to have obtained this additional injection of funds that will be used to support the company’s strategic aspirations, including conceptual design of a downstream formulation and filling operation to complement our existing bioconjugation operations at the Deeside facility,” said Charlie Johnson, Chief Executive Officer of ADC Biotechnology.

Photo 1.0: Charlie Johnson, CEO of ADC Biotechnology.

“We are also looking to fully exploit our core Lock-Release technology to create a transformative manufacturing paradigm that will significantly streamline ADC manufacturing supply chains,” he added.

Lock-Release
The proprietary Lock-Release technology developed by ADC biotechnology is a fast, simple, cost efficient and robust system to guarantee ADCs of a consistently high quality and purity. The technology is the only commercially available system that controls aggregation at source, is scaleable and capable of meeting cGMP regulatory requirements required to produce materials for use in human clinical trials.

Additional funding
This follows the announcement last April in which the company unveiled that it had secured funding from Downing LLP to bolster the company’s marketing and new business drive for quicker penetration into the main US market.

“The investment has been secured in response to strong supportive trends from the ADC development sector and will be put to good use in our planned strategy to further differentiate our company’s unique technology and service offering,” Johnson noted:

The investment syndicate consists of Maven Capital Partners, Seneca Partners, the Development Bank of Wales and Downing LLP.


Editorial Review: November 18, 2018

Featured Image: Funding Contract. Courtesy: © 2010 – 2018 Fotolia. Used with permission.

Copyright © 2018 InPress Media Group. All rights reserved. Republication or redistribution of InPress Media Group content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group. InPress Media Group shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. ADC Review / Journal of Antibody-drug Conjugates is a registered trademarks and trademarks of InPress Media Group around the world.

Share

Novartis Plans to Acquire Endocyte to Expand Expertise in Radiopharmaceuticals

Novartis announced that it has entered into an agreement and plan of merger with Endocyte, a US-based biopharmaceutical company focused on developing targeted therapeutics for cancer treatment. The planned merger will expand Novartis’ expertise in radiopharmaceuticals and build on commitment to transformational therapeutic platforms.

Targeted therapies
Endocyte uses drug conjugation technology to develop targeted therapies with companion imaging agents, including 177Lu-PSMA-617, a potential first-in-class investigational radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The company’s lead drug, 177Lu-PSMA-617 targets the prostate-specific membrane antigen (PSMA), present in the majority of patients with mCRPC, and has shown promising Phase II data.

“Since acquiring exclusive worldwide rights to develop and commercialize PSMA-617 agents in 2017, the entire Endocyte team, along with our partners, have worked tirelessly to build a leading radioligand [therapy] portfolio and create value for patients and shareholders alike. We are thrilled that Novartis recognizes the potential for 177Lu-PSMA-617 to change the treatment landscape for men with metastatic castration-resistant prostate cancer (mCRPC), as well as the broader role that radioligand [therapy] may potentially play in the treatment of cancer,” said Mike Sherman, president and CEO of Endocyte.

“The global reach and expertise of Novartis in developing and commercializing radioligand [therapy] therapies will be critical in efforts for patients to benefit from these therapies as quickly as possible,” Sherman added.

The investigational drug currently included in the Phase III global VISION clinical trial in men with mCRPC, a disease with limited treatment options and significant unmet medical need.

If completed, the Endocyte acquisition would expand the Novartis radioligand therapy platform with both a potential near-term product launch and early-stage clinical development programs. The deal would also enable Novartis to harness its research and development expertise to investigate the potential development of 177Lu-PSMA-617 for use in earlier lines of prostate cancer therapy.

“Novartis has a strong legacy of addressing unmet needs with transformative therapies and is building a leadership capability in new, technology-driven platforms that address some of the world’s most complex health challenges, including cancer,”said Liz Barrett, Chief Executive Officer of Novartis Oncology.

“Today’s announcement about the proposed acquisition of Endocyte builds on our growing capability in radiopharmaceuticals, which is expected to be an increasingly important treatment option for patients and a key growth driver for our business. We are also excited about the opportunity to break into the prostate cancer arena with a near-term product that has the potential to make a meaningful impact for patients in great need of more options,” Barrett added.

Clinical trial
In a Phase II study, 50 patients with PSMA-positive mCRPC treated with 177Lu-PSMA-617 showed a median prostate specific antigen (PSA) progression free survival (PFS) of 7.6 months (p<0.0001).[1] Median overall survival for the first cohort of 30 patients enrolled was 13.5 months (p=0.0201).[1]

VISION is a global, prospective, open-label, multi-center, randomized Phase III trial of 177Lu-PSMA-617 in combination with best supportive care versus best supportive care alone. The trial is currently enrolling patients with mCRPC. In September, the US Food and Drug Administration (FDA) agreed to radiographic progression-free survival (rPFS) as an alternative primary endpoint to OS in the trial.

The Endocyte pipeline includes additional investigational radioligand therapys, including 225Ac-PSMA-617 in preclinical studies for the treatment of mCRPC.

Radioisotopes
Radiopharmaceuticals such as 177Lu-PSMA-617 are innovative medicinal formulations containing radioisotopes that are used clinically for both diagnosis and therapy.

Through the acquisition of Advanced Accelerator Applications (AAA), Novartis acquired Lutathera® (lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) – the first ever approved Peptide Receptor Radionuclide Therapy – for the treatment of somatostatin-receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), an orphan disease.

In addition to these agents, also expects to have an Investigational New Drug application submitted in the fourth quarter of 2018 for its adaptor-controlled CAR T-cell therapy which will be studied initially in osteosarcoma.

Transaction Details
The transaction would be in the form of a merger of Endocyte and a newly formed Novartis subsidiary. Under the terms of the agreement and plan of merger, upon closing, holders of Endocyte common stock would receive US $ 24.00 in cash per share. This offer represents a premium of 54% percent to Endocyte’s closing price of US $ 15.56 on October 17, 2018.

The offer was unanimously approved by the board of directors of Endocyte and values Endocyte’s equity at US $ 2.1 billion.

Closing of the transaction is expected in the first half of 2019 and is subject to customary closing conditions, including the approval of Endocyte’s stockholders and receipt of regulatory approvals. Until closing, Endocyte will continue to operate as a separate and independent company.

The acquisition of Endocyte is planned to be funded through available cash.


This article was first published in Onco’Zine. Republished with permission.

Last Editorial Review: October 22, 2018

Featured Image: Business. Courtesy: © 2010 – 2018 Fotolia. Used with permission.

Copyright © 2018 InPress Media Group. All rights reserved. Republication or redistribution of InPress Media Group content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group. InPress Media Group shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. ADC Review / Journal of Antibody-drug Conjugates is a registered trademarks and trademarks of InPress Media Group around the world.

Share

ADC Biotechnology Secures UK £1.14 million Investment

ADC Biotechnology has successfully secured UK £1.14 million in funding from, Downing LLP, a London-based investment management firm.

The company, founded in 2010, is developing new process technology to speed,simplify and significantly lower the production costs of the manufacturing of antibody-drug conjugates (ADCs).

The investment funds are expected to help the company bolster the company’s drive for faster penetration of the main U.S. market. The investment will also assist the development of an advanced bioconjugation method – an entirely new ADC manufacturing approach set to transform the industry, and a conceptual design for implementation of a fill-finish operation within the existing facility at Deeside (Glannau Dyfrdwy) in Flintshire close to the Wales–England border.


… funding will in part help [ADC Biotechnology] to continue to lead further industry innovation, specifically, the investigation and validation of our upstream bioconjugation method…


The funding vehicle – Downing FOUR VCT Healthcare – was established through a partnership between BioScience Managers, the leading healthcare investment specialists, and Downing LLP to provide a new healthcare share class to Venture Capital Trust (VCT) investors.

New upstream bioconjugation approach
Earlier this year ADC Biotechnology announced that it is in the process of developing and internally validating its new upstream bioconjugation approach. The highly disruptive method, which leverages the company’s patented Lock-Release technology, would save several months of manufacturing time and up to 25% of overall manufacturing costs.

The Lock-Release technology is the only commercially available system that controls aggregation at source, is scaleable and capable of meeting GMP regulatory requirements required to produce materials for use in human clinical trials.

“We are very pleased to have been selected by Downing LLP and BioScience Managers for this investment and we look forward to putting the capital to great use in two major elements of our overall strategy for continued growth.” Charlie Johnson, CEO of ADC Biotechnology said.

“The funding will in part help us to continue to lead further industry innovation, specifically, the investigation and validation of our upstream bioconjugation method – the benefits of which we then intend to bring to the market. Moreover, the investment also provides us with more resources to implement the latest phase in our business development plan, namely, securing more contracts from the main US market in our drive to further expand our international client base and thereby to increase total revenues,” Johnson added.

“ADC Biotechnology is an incredibly innovative CDMO, helping its clients to develop a new class of drugs to combat cancer. The healthcare industry is growing globally and it will continue to grow, funded by the increasing requirements of not just Western economies but those in China, India and Japan. A key driver of the market opportunity is the increasing demands on healthcare generally, and for cures for diseases previously without effective treatment,” Richard Lewis, director at Downing LLP noted.


Last Editorial Review: May 1, 2018

Featured Image: Microscope Courtesy: © 2018. Fotolia Used with permission.

Copyright © 2017 InPress Media Group. All rights reserved. Republication or redistribution of InPress Media Group content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group. InPress Media Group shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. ADC Review / Journal of Antibody-drug Conjugates is a registered trademarks and trademarks of InPress Media Group around the world.

Share

Piramal Expands Coldstream Laboratories’ ADC Capacity

Piramal Pharma Solutions has confirmed that it is planning an expansion Coldstream Laboratories, its sterile injectable manufacturer the company purchased in early 2015. The the US$ 10 million expansion is expected to add 40 jobs at Piramal’s Coldstream Research Campus location in Lexington, KY. As part of the planned expansion Piramal is expected to add specialist containment and chemical handling capabilities, allowing the ability to handle high potency APIs and develop and deliver novel drug products.

Kentucky’s newly elected Governor, Matthew Griswold “Matt” Bevin and Lexington Mayor Jim Gray announced the planned expansion and the expected economic impact on the area.

Strengthening Industry
“Growth in private-sector employment—particularly high-paying, skilled jobs like these—moves Kentucky forward on the national and global level,” Bevin said. “I congratulate and thank Piramal Pharma Solutions and Coldstream for this investment to further strengthen Kentucky’s pharmaceutical industry. We are excited by this opportunity to become an increasingly important part of Piramal’s global footprint and look forward to many years of partnership with them.”

“Our state’s institutions are training biomedical scientists including pharmacologists, laboratory technicians and population researchers,” Senator Ralph Alvarado M.D., of Winchester, Kentucky, added. “The continued growth and success of pharmaceutical developers and innovators such as Coldstream Labs not only improves the Bluegrass region’s industry but also helps secure a source of employment for Kentucky’s talented graduates,” Alvarado said.

Coldstream Labs started in 1991 as the Center for Pharmaceutical Science & Technology, a unit of the University of Kentucky College of Pharmacy. It completed more than 200 development projects that led to clinical trials. In 2007, the college spun off Coldstream Labs as a private company owned by the University of Kentucky Research Foundation.

Technical expertise and expansion
As a separate independent business, Coldstream Labs gained the ability and technical expertise to manufacture liquid and freeze-dried injectable products. In January 2015, the Research Foundation sold Coldstream Labs to Piramal Pharma Solutions, a global leader in pharmaceutical contract services, and the flagship division of the Mumbai, India-based Piramal Group for a total of US$ 30.65 million.

The Piramal Group operates in more than 30 countries with a presence in 100-plus markets around the world. Piramal Pharma Solutions, a division of Piramal’s flagship company Piramal Enterprises Limited, also maintains U.S. operations in Bethlehem, Pa. in addition to Coldstream Labs. As part of Piramal, Coldstream Labs can access the financial resources needed to expand its facilities and meet its customers’ needs.

“The excellence of the University of Kentucky Pharmacy program and the brainpower it has brought to Lexington are creating good jobs for our citizens,” Lexington’s Mayor Gray noted. “These are homegrown jobs that build on our growing reputation in the pharmaceutical industry.”

Tax incentives
To encourage the investment and job growth in Lexington, the Kentucky Economic Development Finance Authority (KEDFA) preliminarily approved the company for tax incentives up to $800,000 through the Kentucky Business Investment program. The performance-based incentive allows a company to keep a portion of its investment over the agreement term through corporate income tax credits and wage assessments by meeting job and investment targets.

Photo 1.0: Vivek Sharma, CEO of Piramal Pharma Solutions: “The Coldstream Labs acquisition helped augment our service offerings to potential partners, while also allowing Piramal to participate in the growing injectable segment. Piramal Pharma Solutions now offers an end to end suite of high quality services to our partners, and is well positioned as one of the global leaders in contract manufacturing.”

KEDFA also gave Coldstream Labs preliminary approval for up to $140,000 in tax incentives through the Kentucky Enterprise Initiative Act (KEIA). KEIA allows approved companies to recoup Kentucky sales and use tax on construction costs, building fixtures, equipment used in research and development and electronic processing.

Coldstream Labs can receive resources from the Kentucky Skills Network. Through the Kentucky Skills Network, companies are eligible to receive no-cost recruitment and job placement services, reduced-cost customized training and job training incentives. Last year, the Kentucky Skills Network trained more than 84,000 employees from more than 5,600 Kentucky companies.

Growth Plan
Piramal confirmed that the planned investment fits the company’s strategic growth plan for its antibody-drug conjugate business. The Coldstream Laboratory facility allows clients developing ADCs to forward integrated and address their fill-finish needs.

According to William “Bill” Wedlake, president, Formulations & Antibody Drug Conjugates (ADC), Piramal Pharma Solutions, the investment aligns well with Piramal’s long term growth strategy.

“In addition to developing new clients, the Kentucky facility also allows our current ADC clients to forward integrate seamlessly and address their fill-finish needs,” Wedlake said. “As oncology becomes key in our collaborators portfolio, our ability to handle high potency APIs, develop and deliver high quality, robust, cost effective drug product solutions becomes a key differentiator. I am optimistic that the Kentucky site, will help us achieve that objective.”

The project is expected to help the Lexington facility grow into a significant player in the contract manufacturing market for injectable pharmaceuticals.

“The Coldstream Labs acquisition helped augment our service offerings to potential partners, while also allowing Piramal to participate in the growing injectable segment. Piramal Pharma Solutions now offers an end to end suite of high quality services to our partners, and is well positioned as one of the global leaders in contract manufacturing. Since our initial investment the Kentucky site has demonstrated both leadership and growth, and we are pleased to announce this subsequent phase of investment to enhance capability and capacity. We appreciate the active support from the State of Kentucky, the local Government, and most importantly, the community, as we continue our growth plans in Lexington,” Vivek Sharma, Chief Executive Office of Piramal Pharma Solutions, concluded.


Last Editorial Review: Februari 8, 2016

Featured Image: Coldstream Laboratories uses both a LyoStar™II and LyoStar™3 R&D freeze dryer to develop lyophilized formulations that are based on robust and cost-efficient processes. The company’s rapid-response formulation team has experience in screening effective combinations of solvents (both aqueous and non-aqueous), buffers, bulking agents, and lyo/cryo-protectants. This experience leads to a robust final product that has low residual moisture/solvent, forms a solid and attractive cake, reconstitutes readily and completely, and resists physical and chemical degradation. Using the company’s lab-scale freeze dryers, Coldstream Laboratories’ formulation team develops compounding processes and lyophilization cycles that can be successfully and readily transferred to our cGMP production scale freeze dryer. Coldstream’s development team oversees the scale-up of any process developed in the company’s laboratories to ensure a seamless transition from lab-scale to manufacturing. Coldstream’s formulation experts work first-hand with the Coldstream production team to effect a smooth and efficient transition to plant-scale operation. Courtesy: © Coldstream Laboratories/Piramal Pharma Solutions. Used with permission. Photo 1.0: Vivek Sharma, CEO of Piramal Pharma Solutions. Courtesy: © Piramal Pharma Solutions. Used with permission.

Copyright © 2016 InPress Media Group. All rights reserved. Republication or redistribution of InPress Media Group content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group. InPress Media Group shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. ADC Review / Journal of Antibody-drug Conjugates is a registered trademarks and trademarks of InPress Media Group around the world.

Share

Skip to toolbar