Today, Cancer drugmaker ADC Therapeutics Sarl announced that it has filed its first application to US health regulators for its lymphoma drug.
The company said that it has filed an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for a Phase I clinical trial for its ADCT-301, a novel antibody drug conjugate targeting CD25, a cell-surface antigen that is over-expressed in several patients with lymphoma. The submission marks the company’s first IND, as it moves its pipeline into clinical development.
“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,” said Michael Forer, Chief Executive Officer of ADC Therapeutics.
The early-stage trial will commence at four leading oncology centers in the US, and can expand into two centers in the United Kingdom. The dose-escalation study will include as many as 58 patients and will evaluate the tolerability, safety, pharmacokinetics and antitumor activity of the drug in patients with relapsed or refractory Hodgkin’s and Non-Hodgkin’s lymphoma. The company said that if the study is successful, it plans to rapidly expand the number of study participants and participating clinical centers.
ADCT-301 combines HuMax-TAC, a monoclonal antibody targeting CD25 created by Genmab, with a pyrrolobenzodiazepine (PBD) warhead. Preclinical in vivo models have shown that ADCT-301 exhibits strong dose-dependent anti-tumor activity against CD25-positive cell lines at low single doses. Additionally, in animal models, the drug outperformed Seattle Genetics’ Adcetris (brentuximab vedotin), an ADC approved for treatment of Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma. 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, the Principal Investigator for the Phase I study said, “There is a 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.”
Source: ADC Therapeutics
Last updated: 3/16/15; 12:00pm EST