LAUSANNE, Switzerland & LONDON--(BUSINESS WIRE)--ADC Therapeutics Sarl (the “Company”), the oncology drug development company focused on Antibody Drug Conjugates (ADCs), today announced that it has filed an Investigational New Drug application (IND) with the US Food and Drug Administration as it moves its pipeline into clinical development. The IND is for a Phase I clinical trial for ADCT-301, a novel antibody drug conjugate targeting CD25, a cell-surface antigen, which is over-expressed in many patients with lymphomas.
The Phase I clinical trial will commence at four leading oncology centres in the USA, and can expand into two centres in the United Kingdom. The initial up to 58 patient adaptive designed dose-escalation study, will evaluate the tolerability, safety, pharmacokinetics and antitumor activity of ADCT-301 in patients with relapsed or refractory Hodgkin’s and Non-Hodgkin’s lymphoma. Subject to study results, ADC Therapeutics intends to rapidly expand the numbers of patients in the trial and the participating clinical centres.
ADCT-301 combines HuMax®-TAC™, a monoclonal antibody targeting CD25 (the alpha chain of the IL-2 receptor) created by Genmab A/S, with a pyrrolobenzodiazepine (PBD) warhead. In preclinical in vivo models, ADCT-301 exhibited strong dose-dependent anti-tumor activity against CD25-positive cell lines at low single doses. It also outperformed AdcetrisTM (brentuximab vedotin), an ADC approved for treatment of Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma, in animal models. In preclinical studies the PBD warhead has been shown to be a highly potent killer of cancer cells even when such cancer cells are resistant to current best therapies.
Dr. Steven M. Horwitz, Medical Oncologist at Memorial Sloan Kettering Cancer Center in New York City, is the Principal Investigator for the Phase I study. Dr. Horwitz said: “There is significant unmet medical need for patients with relapsed or refractory disease in Hodgkin’s and non-Hodgkin’s Lymphoma. An ADC targeting CD25, which is widely expressed in lymphomas, is a very rational therapeutic approach and could have very broad activity. We are delighted to be working with ADC Therapeutics to bring this potential treatment to patients.”
Michael Forer, Chief Executive Officer of ADC Therapeutics said: “The filing of our first IND is a significant milestone for ADC Therapeutics. We are delighted to be working with Memorial Sloan Kettering and other leading clinical centers. We believe this is a significant endorsement of the prospects for ADCT-301. In addition, we expect to file four more INDs with additional proprietary ADCs over the next two years as we continue to build our clinical pipeline.”
ADC Therapeutics has a license to the PBD warheads from Spirogen now owned by MedImmune, and the HuMax®-TAC™ antibody was developed by Genmab under license from Medarex. In June 2013, Genmab and ADC Therapeutics entered into a Collaboration and License Agreement for the development of ADCT-301, and Genmab holds a 25% ownership share in ADCT-301. No other financial terms were disclosed.
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About ADC Therapeutics (www.adctherapeutics.com)
ADC Therapeutics is an oncology drug development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) against solid and haematological cancers. The Company’s ADCs are targeted drug constructs which combine monoclonal antibodies specific to surface antigens on particular tumor cells with a novel class of highly potent pyrrolobenzodiazepine (PBD)-based warheads. The Company’s PBD-based warhead and linker chemistry is under license from Spirogen, a wholly-owned subsidiary of AstraZeneca’s MedImmune. ADC Therapeutics is developing a pipeline of eleven ADCs and up to ten non-antibody based targeted drug constructs.
The Company was established in 2012 by private equity firm Auven Therapeutics. In 2013, AstraZeneca acquired an equity stake in the Company and entered into a corporate partnership for two ADC programs. The Company has more than $100 million in committed capital to develop its pipeline. ADC Therapeutics is based in Lausanne, Switzerland, and conducts its R&D activities from facilities at the Queen Mary Bioenterprises Innovation Centre in London, UK.
Contacts
Instinctif Partners
Sue Charles / Gemma Howe
T: +44 (0)20 7866 7860
adctherapeutics@instinctif.com
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