HEIDELBERG, Germany, April 21, 2016 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq:AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, announced today 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.
In a poster presented on Monday, April 18, 2016, the Company, together with its collaboration partner Stanford University, provided further evidence for a synergy between its CD30/CD16A-specific NK-cell engager AFM13 and an anti-PD-1 antibody, shedding light on the molecular mechanisms underlying AFM13's previously reported tumor cell-killing properties.
Affimed 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 U.S. Food and Drug Administration (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.
"Combination therapy with checkpoint modulators is emerging as one of the most promising approaches in cancer immunotherapy and activating both components of the immune system, innate and adaptive immunity, is a major advantage," said Dr. Jens-Peter Marschner, CMO of Affimed. "We have shown that the combination of our NK-cell engager AFM13 with an anti-PD-1 antibody had this effect in the PDX model and we are now looking forward to developing this encouraging combination in the clinic with the intention to provide an effective but safe treatment to patients that have no further treatment options."
Data from in vivo PDX models with human CD30+ Hodgkin lymphoma (HL) tumors and immune cells derived from the patients' own PBMCs corroborated the previously described enhancement of AFM13 tumor cell lysis through combination with checkpoint modulators. The effect was most prominent for AFM13 in combination with anti PD-1. Tumor size, tumor-infiltrating human lymphocytes, myeloid cells and intratumoral cytokines were evaluated 2, 16 and 30 days after initiation of treatment. When both AFM13 and PD-1 were combined, a strong correlation between inhibition of tumor growth and increasing levels of tumor-infiltrating NK-cells, T-cells, myeloid cells and intratumoral cytokines such as IFNγ were observed, indicating a crosstalk between the innate and adaptive immune system. Over the course of the 30-day treatment period, the initial immune response is characterized by infiltration and activation of NK-cells and macrophages driven by AFM13 followed by the adaptive immune response via T-cells and activated dendritic cells driven by the combination.
The data presented at AACR strongly indicate that AFM13-mediated tumor infiltration and activation of different immune cell subpopulations is the molecular basis for the higher efficacy observed for AFM13 in combination with anti-PD-1 treatment.
About Affimed N.V.
Affimed (Nasdaq:AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK- and T-cells). We are developing single and combination therapies to treat cancers and other life-threatening diseases. For more information, please visit www.affimed.com.
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Anca Alexandru, Head of Communications
Phone: +49 6221 64793341