On January 25, 2016 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported that it has entered into a clinical research collaboration in immunooncology with Merck (NYSE: M RK), known as MSD outside the United States and Canada (Press release, Affimed Therapeutics, JAN 25, 2016, View Source [SID:SID1234515606]). 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 TM (brentuximab vedotin). Merck 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.
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AFM13 is a bispecific antibody targeting CD30, an antigen specifically expressed in a variety of T - and B - cell lymphomas and targeting CD16A, an antigen expressed on natural killer (NK - ) cells, which are important for the activation of the innate immune system and the subsequent killing of tumor cells. KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD - 1 and its ligands, PD - L1 a nd PD - L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.
In patient - derived xenograft models, AFM13, in combination with an antiPD1 antibody, demonstrated impressive synergy, with up to 90 percent of the tumor eradicated. In this preclinical work, conducted at Stanford University, it was also shown that both NK and Tcells infiltrated the tumors and that cytokine levels, including notably interferongamma, were elevated.
"Our development strategy is to combine our NKcell engagers with other immunotherapies that could enhance their efficacy through the uptake of both NK - cells and Tcells, and the collaboration with Merck is an important step in executing this strategy," said Dr. Adi Hoess, CEO of Affimed.
"AFM13, a firstinclass NKcell engager, has shown an acceptable safety profile and preliminary antitumor activity in the firstinhuman Phase 1 study . Additionally, preclinical studies indicate that a combination with an anti PD1 therapy could act synergistically and rep resent an additional future treatment option for patients." "Evaluating the potential for innovative combination therapies through strategic collaborations in difficulttotreat tumor types continues to be an important part of our clinical development program for KEYTRUDA," said Dr. Eric Rubin, vice president and therapeutic area head, oncology early - stage development, Merck Research Laboratories . "In partnering with companies such as Affimed, we continue our efforts to bring forward new scientific breakthroughs for patients with Hodgkin lymphoma and the field of immuno-oncology overall."
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.