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First Patient Dosed in Phase Ib Clinical Trial of Camidanlumab Tesirine in Patients with Advanced Solid Tumors

A first patient has been dosed in Phase Ib clinical trial of camidanlumab tesirine, also know ADCT-301, a proprietary antibody-drug conjugate or ADC being developed by ADC Therapeutics, for the treatment of patients with advanced solid tumors.[1]

The Phase Ib clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of camidanlumab tesirine in patients with selected solid tumors that are locally advanced or metastatic.

Camidanlumab tesirine is an antibody-drug conjugate composed of HuMax®-TAC (licensed from Genmab), conjugated to a pyrrolobenzodiazepine (PBD) dimer toxin.

The HuMax-TAC monoclonal antibody targets the cell-surface antigen CD25 (the alpha chain of the Interleukin-2 receptor or IL2R-α) which is over-expressed on a variety of hematological tumors and shows limited expression on normal tissues.

IL2R-α [*], one of a heterotrimer that makes up the IL2R, has been recognized to play an important role in signal transduction pathways involved in the pathogenesis of autoimmunity and graft rejection. [2] Scientists have also confirmed the preponderance of CD25+ cells in hematological malignancies (malignant lymphomas including B-cell malignancies) [3] and the relationship between increased CD25 expression and poor prognosis [4] raising the possibility of using an anti-CD25 antibody to deliver a cytotoxin to these cells in vivo.

Once bound to a CD25-expresing cell, the investigational agent is internalized into the cell where enzymes release the PBD-based payload. The intra-tumor release of its PBD payload may cause bystander killing of neighboring tumor cells. In addition, the PBD payload will trigger immunogenic cell death, which in turn will strengthen the immune response against tumor cells.

Camidanlumab tesirine is already being evaluated in relapsed and refractory Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).[1][5]

American Society of Hematology
At the 2018 American Society of Hematology (ASH) Annual Meeting, ADC Therapeutics presented interim data on 113 patients dosed in its Phase Ia/Ib clinical trial in lymphoma. In hodgkin lymphoma patients with a median of five prior lines of therapy and no other approved therapy options, the overall response rate was 86.5%, including a 43% complete response rate, at the dose being considered for a pivotal Phase II clinical trial that the Company anticipates initiating in 2019.

“We continue to be very encouraged by the anti-tumor activity of [camidanlumab tesirine] in Hodgkin lymphoma and non-Hodgkin lymphoma,” said Jay Feingold, MD, Ph.D, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics/

“In addition, based on the immune-oncology potential [camidanlumab tesirine] has demonstrated in preclinical studies, we are excited to be starting this clinical trial for ADCT-301 in solid tumors to see if we can make an impact and improve patient outcomes in multiple difficult-to-treat solid tumor cancers,” Feingold added.

Solid Tumors
At the Society for Immunotherapy of Cancer’s (SITC) 33rd Annual Meeting, ADC Therapeutics presented preclinical data showing that an engineered version of camidanlumab tesirine demonstrated highly potent anti-tumor activity, both as a monotherapy and in combination with a checkpoint inhibitor, in multiple solid tumor models with infiltrating CD25-positive regulatory T cells (Tregs).

“[Camidanlumab tesirine] targets CD25, which is expressed on Tregs that infiltrate the local tumor environment,” noted Patrick van Berkel, PhD, Senior Vice President of Research and Development at ADC Therapeutics.

“In preclinical models, a single dose of the CD25-targeted ADC induced strong and durable anti-tumor activity against established CD25-negative solid tumors with infiltrating Tregs both as a monotherapy and in combination with a checkpoint inhibitor. Moreover, re-challenged mice did not develop new tumors indicating the CD25-targeted ADC was able to induce tumor-specific protective immunity,” Van Berkel, Ph.D, added.

The Phase Ib trial of camidanlumab tesirine in patients with advanced solid tumors has both dose escalation and cohort expansion parts. The dose escalation part is designed to establish a safe and tolerated dose and dosing schedule of camidanlumab tesirine in these patients.

The identified dose and dosing schedule will be studied in the dose expansion part. Approximately 50 patients will be enrolled in the trial.

[1] Study of ADCT-301 in Patients With Selected Advanced Solid Tumors – NCT03621982
[2] Burchill MA, Yang J, Vang KB, Farrar MA. Interleukin-2 receptor signaling in regulatory T cell development and homeostasis. Immunol Lett. 2007 Nov 30;114(1):1-8. Epub 2007 Sep 14.
[3] Srivastava MD, Srivastava A, Srivastava BI. Soluble interleukin-2 receptor, soluble CD8 and soluble intercellular adhesion molecule-1 levels in hematologic malignancies. Leuk Lymphoma. 1994 Jan;12(3-4):241-51.
[4] Yoshida N, Oda M, Kuroda Y, Katayama Y, Okikawa Y, Masunari T, Fujiwara M, Nishisaka T, et al. Clinical significance of sIL-2R levels in B-cell lymphomas. PLoS One. 2013 Nov 13;8(11):e78730. doi: 10.1371/journal.pone.0078730. eCollection 2013.
[5] Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma – NCT02432235 

[*] The interleukin-2 (IL-2) receptor includes three different IL-2 receptor chains: α, β, and γ. Among these, the α-chain (CD25) on the cell membrane is cleaved by proteolytic processing, and the cleaved α-chain is detected as sIL-2R. The ligand of IL-2R, IL-2, plays a critical role in the development of T and NK lymphocyte as a growth factor.

Last Editorial Review: January 7, 2019

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Updates from the 14th International Conference on Malignant Lymphoma (ICML)

Since the inaugurational meeting in 1981, the International Conference on Malignant Lymphoma (ICML), traditionally takes place in Lugano, Switzerland, has become one of the ‘must-attend events’ for anyone involved in the study and treatment of lymphoid neoplasms.

Organized once every two years,in collaboration with the American Association for Cancer Research (AACR), the meeting offers hematologists, clinical oncologists, radio-oncologists, pediatricians, pathologists and leading researchers in the field a great opportunity to to present and discuss the most recent basic and clinical data on a specific morphologic subtype or on a pathways or other biological aspect. Translational and/or pathological aspects are also discussed.

This year a large number of high-quality presentations included the latest updated about Antibody-drug Conjugates.

A New Role for CD37
AGS67E (Astellas Pharma/Agensys) is an antibody-drug conjugate targeting CD37, a tetraspanin expressed on malignant B cells, which includes a fully human monoclonal IgG2 antibody (AGS67C) conjugated to the cytotoxic, microtubule-disrupting, payload monomethyl auristatin E (MMAE) which is linked to reduced cysteines of the antibody via a protease-cleavable linker (maleimidocaproyl-valine-citrulline-p-aminobenzylcarbamoyl). The trial drug is being investigated in patients with relapsed/refractory non-Hodgkin Lymphoma (NHL) in a phase I dose-escalation study.

The data presented this year at the International Conference on Malignant Lymphoma demonstrates a high level of CD37 detection of ≥80% in NHL, including diffuse large B-cell lymphomas (DBCL), making it a potential drug target. But the results also suggest that AGS67E may serve as a potential therapeutic for B-cell malignancies [1][2]

ADCT-301 and ADCT-402
ADCT-301 (ADC Therapeutics), an antibody drug conjugate comprising a human monoclonal antibody against CD25 conjugated to a potent pyrrolobenzodiazepine dimer toxin,  has demonstrated potent anti-tumor activity in pre-clinical studies against CD25-expressing hematological malignancies. Interim results from an ongoing Phase I, open label, dose-escalating study evaluating ADCT-301, included in a poster, confirm that the investigational agent was well tolerated with manageable toxicities. [3]

Interim results from the Phase I, open label, dose-escalating study of ADCT- 402 (ADC Therapeutics), targeting CD19, evaluating tolerability, safety, pharmacokinetics and efficacy in patients with relapsed or refractory non- Hodgkin’s lymphoma (r/r NHL) confirm efficacy and tolerability of ADCT-402. [4]

STRO-001 is a novel CD74-targeting antibody-drug conjugate based on Sutro’s lead human IgG1 antibody (SP7219) conjugated to non-cleavable DBCO-maytansinoid linker-payload with an average drug-antibody ratios (DAR) of 2. The investigational agent, which demonstrates potent in vitro cytotoxicity in NHL cell lines and anti-tumor activity in NHL xenograft models, was developed using  precise site-specific conjugation enabled by Sutro’s cell-free antibody synthesis technology. Study results presented at 14th-ICML confirm potent anti-tumor activity in diffuse large B-cell lymphoma and mantle cell lymphoma tumor models while reducing the potential for toxic secondary effects on adjacent healthy cells. clinical studies of this novel ADC for treatment of B-cell malignancies are under development. [5]

Polatuzumab vedotin
Results from a multicenter, open-label, dose-escalation study evaluating the safety and anti-tumor activity of polatuzumab vedotin (DCDS4501A or RG-7596; Genentech/Roche) in combination with rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) in patients with non-Hodgkin’s lymphoma, were presented at 14th-ICML.

CD79b is a signaling component of the B-cell receptor or BCR restricted to the B-cell lineage. In a study published in 2009, Droman et al reported the detection of surface expression of CD79b in almost all non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia patients.  Based on this finding, these researchers concluded that anti-CD79b-vcMMAE could be widely used in these malignancies. [6]

The researchers concluded that a combination of  polatuzumab vedotin at 1.8 mg/kg with R-CHP has an acceptable safety profile and produced promising response rates at the end of treatment, warranting further exploration the investigational drug. [7]

A separate presentation showing updated evaluation of polatuzumab vedotin + bendamustine to polatuzumab vedotinrituximab and substituting obinutuzumab for rituximab shows promising durable responses and an acceptable safety profile in heavily pre-treated transplant ineligible patients with relapsed/refractory (R/R) Follicular or Diffuse Large B-Cell Lymphoma, which generally have poor treatment outcomes.[8]

Brentuximab Vedotin
The complete remission (CR) rate of Hodgkin lymphoma after first line treatment is generally between 80% and 90%. However, about 10% of these patients are refractory and 10% to 30% relapse after achieving a complete remission. The standard of care for suitable patients with relapsed/refractory Hodgkin lymphoma includes high dose chemotherapy followed by autologous stem cell transplant or ASCT.  But patients who relapse after ASCT have a dismal prognosis.

New treatment options including the anti-CD30 antibody-drug conjugate brentuximab vedotin (Adcetris®; Seattle Genetics) are associated with an overall response rate or ORR of 75% and CR rate of 34%.  Results presented during the 14th-ICML report results from a study in which researchers evaluated toxicity, efficacy, and duration of response (DOR) of a combination of brentuximab vedotin and bendamustine, which has demonstrated efficacy in several lymphoproliferative disorders.

The data showed a high response rate (87% ORR and 54% CR) with the combination of brentuximab vedotin and bendamustine, showing a PFS of 80% at 12 months. The median DOR of the CR remission group was 14 months, highlighting durable responses.

The combination of brentuximab vedotin and bendamustine has shown an acceptable toxic profile with only 1 grade 4 adverse event and was able to be delivered as an outpatient regimen. The researchers concluded that the combination is a promising salvage treatment for heavily pretreated patients with R/R Hodgkin lymphoma. They conclude that large investigational trials are necessary to warrant these initial results. [9]

Diagram 1.0: Study of Brentuximab Vedotin (SGN-35) in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma (NCT01492088)

Trial results from a separate trial confirm that high-dose bendamustine plus brentuximab has shown relevant efficacy and a relatively good safety profile in a setting of heavily pretreated patients with Hodgkin lymphoma.  The combination could be considered as a bridge to second autologous or allogenic stem cell transplant.[10]

In an unrelated study, brentuximab vedotin showed clinically meaningful response rates in patients with this R/R Hodgkin lymphoma and Systemic Anaplastic Large-Cell Lymphoma (sALCL). In this study, 47% of patients proceeded to transplant.

The results of the study show that brentuximab vedotin is a feasible treatment option in pediatric Hodgkin lymphoma and Systemic Anaplastic Large-Cell Lymphoma that can facilitate relapsed patients proceeding to transplant. [11]

Last editorial review: June 16, 2017

Featured Image: Close-up cityscape of Lugano city waterfront along Lugano Lake. Facades of historic houses in front of alp mountains. Courtesy: © 2017. Fotolia. Used with permission.

Copyright © 2017 InPress Media Group, LLC. 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.


ADC Therapeutics Raises US$ 80 million to Advance ADC Pipeline

ADC Therapeutics, an oncology drug discovery and development company headquartered in Lausanne, Switzerland and London, UK, that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, has raised $80 million through a private placement of equity. New investors include leading European and US-based investors alongside founding investor Auven Therapeutics and participation from AstraZeneca.

The proceeds will be used to progress ADC Therapeutics’ product portfolio. The development pipeline includes the company’s lead program, ADCT-301, for the treatment of relapsed/refractory Non-Hodgkin or Hodgkin lymphoma, which entered Phase I clinical trials (NCT02432235) earlier this year.  The proceeds will also benefit the collaboration to develop up to two ADCs for commercialization with MedImmune, the global biologics research and development arm of AstraZeneca.

The antibody-drug conjugates being developed by ADC Therapeutics are highly targeted drug constructs which combine monoclonal antibodies (mAbs) specific to surface antigens on particular tumor cells with highly potent pyrrolobenzodiazepine (PBD)-based warheads. The company anticipates having seven drug candidates in human clinical trials in 2017.

ADCT-301, the company’s lead program, is an antibody-drug conjugate composed of a recombinant human IgG1, HuMax®-TAC against human CD25 attached to a PBD warhead. [1]

The Interleukin-2 receptor-α (IL2R-α, CD25) is one of a heterotrimer making up the IL2R. It plays a major role in signal transduction pathways involved in the pathogenesis of autoimmunity and graft rejection. [1]  Based on the preponderance of CD25+ cells in hematological malignancies as well as the relationship between increased CD25 expression and poor prognosis, researchers became interested in investigating the possibility of using an anti-CD25 antibody to deliver a cytotoxin to these specific cells in patients. The clinical proof of concept for treatment of CD25-positive malignancies was established using radio-immunoconjugates and immunotoxins with antibodies basiliximab, a chimeric mouse-human monoclonal antibody to the α chain (CD25) of the IL-2 receptor of T cells, and the humanized monoclonal antibody daclizumab[2][3]

During the 56th Annual Meeting of the American Society of Hematology (ASH) in December 2014, investigators reported that ADCT-301 demonstrated dose-dependent in vivo antitumor activity against SUDHL1 and Karpas 299 xenograft and disseminated models. The investigators showed that the trial drug, at a single dose of 0.2 mg/kg, significantly delayed Karpas 299 tumor growth compared to vehicle-treated and isotype control ADC-treated mice, and at 0.4 and 0.6 mg/kg gave 3/10 and 10/10 tumor-free survivors, respectively. [1]

The investigators also observed 10/10 tumor-free survivors  at a single dose of 0.5 mg/kg.  In contrast, treatment with brentuximab vedotin (Adcetris®, Seattle Genetics) only resulted in a modest delay in mean tumor growth at a single dose of 0.5 mg/kg despite this tumor expressing three times the level of the brentuximab vedotin target CD30 antigen compared to CD25.  The investigators also reported that ADCT-301 was well tolerated with no signs of toxicity at 6 mg/kg, which was, at the time of the presentation, currently the highest dose tested. [1]

Joint collaboration
ADC Therapeutics was established in 2012 by private equity firm Auven Therapeutics. In 2013, MedImmune acquired an equity stake in the company and entered into a joint collaboration for two of the antibody-drig conjugates being developed by ADC Therapeutics.

To facilitate the development, ADC Therapeutics has built a highly experienced R&D team in the UK, as well as legal, finance and EU clinical teams in Switzerland, and regulatory, clinical and manufacturing teams in the US.  The company also works closely with a number of specialist partners in Europe and the US for regulatory, clinical trial management and manufacturing activities.

In June, Chris Martin, PhD, a co-founder of Spirogen Ltd and its Chief Executive Officer leading up to the sale of Spirogen to MedImmune and a recognized leader in the ADC space, joined ADC Therapeutics as Chief Executive Officer, after having played a key role in the formation and strategy of the company as a member of its Board of Directors. Martin has also served as a member of MedImmune’s Leadership Team.

Commenting on securing the funding, Martin noted: “The significant advances we have made in progressing our pipeline of ADCs have been recognized by this financing round. In a major milestone for the company, our first ADC candidate drug entered the clinic earlier this year and we are on track to file for our second IND with the FDA by the end of October.”

“The quality of investors we have been able to attract and the size of this investment round, just over three years since the Company was founded, is a great endorsement of our strategy and potential. This financing provides the funds required to aggressively develop our pipeline of proprietary ADCs with best-in-class PBD-based warheads and linkers as an important part of the next-generation of cancer drugs, with the potential to impact cancer patients worldwide,”  Peter B. Corr, MD, PhD, Chairman of the Board of ADC Therapeutics and co-founder and Managing General Partner of Auven Therapeutics, added.

The Company was advised by Christoph Ladanyi, co-founder and Managing Director of BLMS Capital, and its corporate legal counsel Homburger AG.

Last Editorial Review: September 2, 2015

Photo/Featured Image: Queen Mary Bioenterprises Innovation Center. Photo Courtesy: Queen Mary BioEnterprises Ltd , The QMB Innovation Centre 42 New Road, London E1 2AX.

Copyright © 2015 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.

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Antigen Shedding and Targeted Delivery of Immunotoxins in Solid Tumors: A Mathematical Model

Cells modulate responses to signals in the extracellular environment by shedding cell surface antigens. Understanding this process is important because antibody-based anti-cancer therapies target cell surface antigens. This process affects tumor responses to this type of therapy.

In an article published in the December 15, 2008 issues of Clinical Cancer Research, Yujian Zhang and Ira Pastan at the Laboratory of Molecular Biology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland, described that the concentration of the tumor antigen mesothelin, a tumor differentiation antigen that is normally present on the mesothelial cells lining the pleura, peritoneum and pericardium, is extremely high within the interstitial space of tumors, where it can block antibody action. They also showed that the concentration of shed mesothelin within the tumor is lowered by chemotherapy.[1]

This observation, they believed, may have important implications for the successful treatment of solid tumors by antibody-drug conjugates and whole antibodies. But to date, it’s still poorly understood why many cancer-specific antigens are shed and how the shedding affects delivery efficiency of antibody-based protein drugs. For a long time scientists assumed that antigen shedding would reduce the efficacy of antibody-drug conjugates and immunotoxins.

Mathematical model
However, Youngshang Pak at the Department of Chemistry and Institute of Functional Materials, Pusan National University, Busan, Republic of Korea and Ira Pastan, Robert J. Kreitman, Byungkook Lee at the Laboratory of Molecular Biology, National Cancer Institute, NIH, Bethesda, Maryland, showed that by using a comprehensive mathematical model antigen shedding can significantly improve the efficacy of SS1P, a recombinant immunotoxin, composed of an antimesothelin Fv fused to a 38 kDa fragment of Pseudomonas exotoxin A. SSPI targets mesothelin, a cell surface glycoprotein that is highly expressed in many cancers including malignant mesothelioma.[2]

In their study, Pak et al. used experimental data with SS1P to develop a mathematical model that describes the relationship between tumor volume changes and the dose level of the administered antibody-drug conjugate, while accounting for the potential effects of antigen shedding

The scientists suggested that receptor shedding can be a general mechanism for enhancing the effect of inter-cellular signaling molecules.

New study
Now, in a new study, published in Plos One (October 24, 2014) Pak and his colleagues improved their model and applied it to both SS1P and another recombinant immunotoxin, LMB-2 (anti-Tac(Fv)-PE38), an anti-CD25 recombinant immunotoxin that contains an antibody Fv fragment fused to truncated Pseudomonas exotoxin. In this study, they showed that the effect of antigen shedding is influenced by a number of factors including the number of antigen molecules on the cell surface and the endocytosis rate. [2][3]

The scientists concluded that the high shedding rate of mesothelin is beneficial for SS1P, for which the antigen is large in number and endocytosed rapidly. On the other hand, they determined that slow shedding of CD25 is beneficial for LMB-2, for which the antigen is small in number and endocytosed slowly.


ADC Therapeutics and Genmab Agree to Develop Antibody-drug Conjugate

Earlier this week Swiss-based oncology drug development company ADC Therapeutics Sarl and Danish Genmab A/S agreed to develop a new antibody-drug conjugate (ADC) combining HuMax®-TAC antibody and a PBD-based warhead and linker technology. The companies have been conducting in vitro and in vivo studies since 2012 to investigate different warhead and linker combinations with HuMax-TAC, and are now starting pre-IND preclinical development. The new product will be developed for multiple cancer indications.

HuMax-TAC is a high-affinity fully human antibody targeting CD25, a therapeutic target with strong clinical validation, which offers superior inhibition of IL-2 binding to the IL-2 receptor and also blocked the proliferation of activated T-cells that express the receptor and play an important role in inflammation. CD25 is expressed on a variety of hematological tumors and shows limited expression on normal tissues, which makes it a very attractive target for antibody-payload approaches.

Blocking T-cell mediated diseases
TAC (IL-2Rα, CD25) is the unique α-chain of the Interleukin-2 or IL-2 receptor (IL-2R). The IL-2 receptor consists of three chains. While the beta and gamma chains are shared with other cytokine receptors, the alpha chain is unique for this receptor. Once T-cells are activated they over-express the alpha chain of the IL-2R (the name TAC is derived from activated T-Cell). The IL-2R binds IL-2 (or T- cell growth factor) which is a key regulator of the normal immune system function and acts on T-lymphocytes, Blymphocytes and natural killer (NK) cells. A antibody that blocks the IL-2 receptor can inhibit T-cell proliferation. Hence, novel TAC-specific mAb targeted therapies targeting the IL-2R have the potential to block a number of T-cell mediated diseases, including organ transplant rejection and autoimmune disease, such as multiple sclerosis (MS) and uveitis.

The HuMax-TAC-ADC will be a first-in-class antibody-drug conjugate for the potential treatment of CD25-expressing lymphomas and leukemias.

“HuMax-TAC antibody has optimal characteristics for creation of an ultra-potent antibody-drug conjugate when used in combination with ADC Therapeutics’ novel PBD-based warhead and linker technology, which employs an emerging class of highly potent anticancer agents,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Pyrrolobenzodiazepine (PBD) Warheads & Linkers
ADCs developed using ADC Therapeutics’ technology combine monoclonal antibodies specific to particular tumor targets with highly potent pyrrolobenzodiazepine (PBD) based warheads developed by ADC Therapeutic’s partner Spirogen Limited. These PBD warheads are joined to antibodies by linkers that release the PBD warhead in the targeted cancer cells.

PBDs are sequence selective DNA alkylating agents with highly potent antineoplastic activity. They are either naturally produced by actinomycetes or synthetically produced. The unique broad spectrum of activities of the naturally produced PBDs encouraged the synthesis of several PBDs, including dimeric and hybrid PBDs yielding to an improvement in the DNA-binding sequence specificity and in the potency of this class of compounds.[1]

“Our warhead payload technology enjoys exquisite potency, optimized conjugation and pharmaceutical properties that maintain activity in highly resistant cancers,” noted Peter B. Corr, Ph.D, Chairman of ADC Therapeutics. “Pre-clinical data for this product indicate the potential for curative efficacy in highly resistant populations at low ADC doses of this product in several oncology indications, an area with critical unmet needs.”

Genmab and ADC Therapeutics will each initially have an equal share in the product. In the first instance, ADC Therapeutics will lead and fund preclinical development. Prior to the submission of an application to conduct clinical studies in patients (IND filing), Genmab may elect to retain equal ownership of the product. Genmab will not incur any development costs prior to the IND filing decision and Genmab will maintain a minimum 25% ownership stake in the product as it moves into clinical development.

Last Editorial Review, June 24, 2013

Copyright © 2013 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.

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