Lausanne, Switzerland, June 9, 2017 – ADC Therapeutics (ADCT), an oncology drug discovery and development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ADCT-402 for the treatment of diffuse large B-cell lymphoma and mantle cell lymphoma. ADCT-402 is a novel antibody-drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated to ADCT’s highly potent proprietary pyrrolobenzodiazepine (PBD) dimer toxin.
Dr. Jay Feingold, Chief Medical Officer and Senior Vice President of Clinical Development at ADCT said: “This Orphan Drug Designation for ADCT-402 recognizes the significant unmet need in patients with diffuse large B-cell lymphoma and mantle cell lymphoma. Many patients have limited treatment options as they have failed or are intolerant to any established therapy. We remain committed to further develop our pipeline to bring valuable new treatment to patients in urgent need. ”
The FDA Orphan Drug Designation program grants a special status to drug candidates intended to treat rare diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven year marketing exclusivity period, in addition to certain incentives, including R&D grants, tax credits and waived FDA fees.
ADCT-402 is being evaluated in two ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory B-cell lineage non-Hodgkin lymphoma and relapsed or refractory B-cell lineage acute lymphoblastic leukemia. ADC Therapeutics has four PBD-based antibody drug conjugates in six ongoing Phase I clinical trials in the USA and in Europe.
Lymphoma is a cancer that begins in cells of the immune system, in particular in the lymph system. The lymph is rich in lymphocytes, a type of white blood cells that help the body fight off infections and other diseases. Lymphoma develops when lymphocytes become cancerous which can occur in both children and adults. The two main types of lymphomas are Hodgkin lymphoma (HL) and non-Hodgkin lymphomas (NHL), and are differentiated by the type of lymphocytes affected and their appearance under the microscope. According to the National Cancer Institute around 72,000 new people are diagnosed with non-Hodgkin lymphoma in the United States and around 9’000 new people are diagnosed with Hodgkin lymphoma.
ADCT-402 is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD)-dimer toxin. Once bound to a CD19-expresing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is a clinically validated target for the treatment of certain CD19-expressing B-cell malignancies. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and resulting in cell death. ADCT-402 is being evaluated in two ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory B-cell lineage non-Hodgkin lymphoma and relapsed or refractory B-cell lineage acute lymphoblastic leukemia. (www.adct-402.com)
About ADC Therapeutics
Founded in 2012, ADC Therapeutics SA (ADCT) is an oncology drug development company that specializes in the development of proprietary antibody drug conjugates (ADCs) targeting major types of hematological malignancies and solid tumors. The Company’s ADCs are highly targeted biopharmaceutical drugs that combine monoclonal antibodies specific to surface antigens present on particular tumor cells with a novel class of highly potent pyrrolobenzodiazepine (PBD) based warheads via a chemical linker. Its three lead programs, ADCT-301, ADCT-402, and ADCT-502 are in five Phase I clinical trials in the USA and in Europe. ADCT enjoys strong relationships with world class partners, including AstraZeneca and its global biologics research and development arm, MedImmune. The Company is based in Lausanne, Switzerland and has operations in London, San Francisco and New Jersey (www.adctherapeutics.com).
For more information please contact:
Dr. Chris Martin
Chief Executive Officer
Tel.: +41 (0) 21 653 0200
Tel: +41 (0) 43 268 3231