Date: 2016-04-21
Type of information: Clinical trial autorization
phase: 1b
Announcement: clinical trial authorization
Company: Affimed (Germany)
Product: AFM13 in combination with Keytruda® (pembrolizumab)
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor/bispecific antibody. AFM13 is a bispecific TandAb®antibody recruiting host NK cells via its CD16A-binding domains to engage and kill CD30-positive malignant cells. TandAbs®, which were invented and developed by Affimed, are tetravalent bispecific antibody formats that have two binding sites for each antigen. They bind to target molecules on the surface of tumor cells and specifically activate immune effector cells such as cytotoxic T-cells or natural killer (NK) cells in the presence of tumor cells. The TandAb® AFM13 is specifically designed to treat CD30-positive malignancies. It targets CD30 on malignant cells and CD16A on NK-cells. The simultaneous binding to both cells leads to an effective lysis of the tumor cells. In cytotoxicity assays, AFM13 has been shown to possess higher potency than antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced CD30 IgGs. Keytruda® (pembrolizumab - MK-3475) is an highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, pembrolizumab enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. Pembrolizumab is being evaluated across more than 30 types of cancers, as monotherapy and in combination. It has received a Breakthrough Therapy designation for advanced melanoma, for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC) whose disease has progressed on or following platinum-based chemotherapy. In November 2015, the FDA has granted Breakthrough Therapy Designation to Keytruda® for the treatment of patients with microsatellite instability high (MSI-H)metastatic colorectal cancer.
Disease: treatment of Hodgkin lymphoma patients relapsed or refractory to chemotherapy
Therapeutic area: Cancer - Oncology
Country: USA
Trial details:
Latest
news: * On April 21, 2016, Affimed announced the presentation of preclinical data from a combination study of Affimed's lead candidate AFM13 and checkpoint modulators at the American Association for Cancer Research (AACR) 2016 Annual Meeting in New Orleans, LA. The company also announced that it expects to initiate a Phase 1b combination clinical trial this quarter and the Company's investigational new drug (IND) application for AFM13 in combination with pembrolizumab has recently been accepted by the FDA and is now active. In the Phase1b study, Affimed will investigate AFM13 in combination with Merck's Keytruda® for treatment of HL patients relapsed or refractory to chemotherapy, including Adcetris™. The trial is designed to assess safety and efficacy and to establish an optimal dosing regimen for the combination therapy.
