– Favorable tolerability and efficacy results of ADCT-301 in extensively pretreated patients
Lausanne, Switzerland, June 16, 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 interim data from an ongoing Phase I clinical trial evaluating ADCT-301 for the treatment of relapsed or refractory Hodgkin’s and non-Hodgkin’s lymphoma has been presented at the 14th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. ADCT-301 is a novel antibody-drug conjugate (ADC) composed of HuMax®-TAC, a monoclonal antibody directed against CD25 conjugated to ADCT’s highly potent proprietary pyrrolobenzodiazepine (PBD)-based warhead. CD25 is expressed in a wide range of hematological malignancies, including certain forms of lymphomas and leukemias, while its expression in healthy organs is restricted.
In a poster session at the 14th ICML, interim results from the ongoing Phase I, open label, dose-escalating study of ADCT-301 evaluating tolerability, safety, pharmacokinetics and efficacy in patients with relapsed or refractory Hodgkin’s and non-Hodgkin’s lymphoma (r/r HL/NHL) were presented. Data were reported from 37 extensively pretreated patients with a median age of 46 years, a median treatment duration of 43 days and 2 treatment cycles. Among all patients enrolled at the time of the data cutoff for presentation and evaluable for safety, the most common treatment emergent adverse events have been related to skin and decreased blood counts. The overall response rate for evaluable patients with HL treated with doses ³30µg/kg was 38.5% while 8 of 25 (32%) efficacy evaluable patients at all dose levels with HL and NHL have achieved stable disease as their best response. ADCT-301 was well tolerated and toxicities manageable. Dose escalation continues.
“The results seen in this early analysis are impressive for these patients with relapsed or refractory Hodgkin’s and non-Hodgkin’s lymphoma have been heavily pre-treated. These data, combined with the positive results we have seen in preclinical studies continue to highlight what we believe to be the significant potential of our ADC technology platform based on PBD-warheads,” said Dr. Jay Feingold, Chief Medical Officer and Senior Vice President of Clinical Development at ADCT.
“Patients with multiply relapsed or refractory Hodgkin’s or non-Hodgkin’s lymphoma have limited treatment options. These early findings are very encouraging as they demonstrate a clear clinical benefit even at low doses for patients who failed, or are intolerant to any established therapy” said principal investigator Steven M. Horwitz, Medical Oncologist at Memorial Sloan Kettering Cancer Center in New York City. “We look forward to continuing this study to further identify the maximum tolerable dose of ADCT-301 and provide a preliminary assessment of its single-agent anti-tumor activity and toxicity profile.”
In addition to the ongoing Phase I trial, ADCT-301 is currently being evaluated in an ongoing Phase I clinical trial in Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL). ADC Therapeutics has four PBD-based antibody drug conjugates in six ongoing Phase I clinical trials in the USA and in Europe.
See the video with Dr Steven Horwitz’s comments under the followimg link: www.adctherapeutics.com/library/301
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-301 is an antibody-drug conjugate (ADC) composed of a monoclonal antibody specific for CD25 (HuMax®-TAC, licensed from Genmab A/S), conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD25-expresing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. CD25 is an attractive target for an ADC approach as it is expressed in a wide range of hematological malignancies, including certain forms of lymphomas and leukemias, while its expression in healthy organs is restricted. ADCT-301 is being evaluated in two ongoing phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL), and in patients with relapsed or refractory CD25-positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). (www.adct-301.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