Date: 2016-01-25
Type of information: Commercialisation agreement
Compound: AFM13 (NK-cell TandAb generated against EGFRvIII) and Keytruda® (pembrolizumab)
Company: Affimed (Germany) Merck&Co (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: monoclonal antibody/bispecific antibody/fusion protein. AFM13 is a first-in-class bispecific NK-cell TandAb®, which binds NK-cells (Natural Killer cells) specifically via CD16A and has a second binding domain for CD30, a cancer specific target. CD16A is expressed on NK-cells, highly potent cytotoxic effector cells of the innate immune system, enabling AFM13 to selectively bind these effector cells. AFM13 redirects the NK-cells to CD30-expressing cancer cells and binds both targets with high affinity, establishing a bridge whereby the NK-cells are activated and redirected to kill the cancer cells. AFM13 is designed to treat CD30-positive malignancies including Hodgkin lymphoma (HL) and T-cell lymphoma (TCL) and is currently in Phase 2 studies in HL patients. Keytruda® (pembrolizumab - MK-3475) is a 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. In April 2013, MK-3475 has received a Breakthrough Therapy designation for advanced melanoma from the FDA. In October 2014, the FDA has gralso anted Breakthrough Therapy Designation to Keytruda® (pembrolizumab) 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. Keytruda® is the first approved drug that blocks the PD-1 cellular pathway. The Keytruda® clinical development program includes patients with more than 30 tumor types in more than 160 clinical trials, including more than 80 trials that combine Keytruda® with other cancer treatments. Registration-enabling trials of Keytruda® are currently enrolling patients in melanoma, NSCLC, head and neck cancer, bladder cancer, gastric cancer, colorectal cancer, esophageal cancer, breast cancer, Hodgkin lymphoma, multiple myeloma and other tumors, with further trials in planning for other cancers.
Disease: patients with Hodgkin lymphoma whose disease has relapsed or is refractory to chemotherapy, including treatment with the marketed antibody-drug-conjugate Adcetris® (brentuximab vedotin)
Details: * On January 25, 2016, Affimed announced that it has entered into a clinical research collaboration in immuno-oncology with Merck&Co. Under the terms of the agreement, Affimed will fund and conduct a Phase 1b clinical trial to investigate the combination of Merck\'s anti-PD-1 therapy, Keytruda® (pembrolizumab), with Affimed\'s proprietary drug candidate AFM13 for the treatment of patients with Hodgkin lymphoma whose disease has relapsed or is refractory to chemotherapy, including treatment with the marketed antibody-drug-conjugate Adcetris® (brentuximab vedotin). Merck&Co will supply Affimed with Keytruda® for the clinical trial. The purpose of the study is to establish a dosing regimen for this combination therapy and assess its safety and efficacy. Affimed is on track to initiate the study in the first half of 2016. The agreement is between Affimed and Merck, through a subsidiary. The collaboration agreement includes a provision for the potential expansion of the collaboration to include a subsequent Phase 3 clinical trial. Additional details were not disclosed.
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