Heidelberg, Germany, February 3, 2021 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it has entered into a clinical research collaboration with Roche to explore the combination of Affimed’s innate cell engager (ICE®) AFM24 with Roche’s PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®).
Under the terms of the agreement, Affimed will fund and conduct a Phase 1/2a clinical trial to investigate the combination of AFM24 and atezolizumab for the treatment of advanced solid epidermal growth factor receptor (EGFR) expressing malignancies in patients whose disease has progressed after treatment with previous anticancer therapies. Roche will supply Affimed with atezolizumab for the clinical trial. The Phase 1/2a study will establish a dosing regimen for the combination therapy and assess safety and potential activity.
“AFM24 is a first-in-class innate cell engager that we believe has the potential to bring benefit to a broad set of patients as monotherapy and in combination with other I/O therapies to address disease states where co-activation of the innate and adaptive immune systems is beneficial,” said Dr. Adi Hoess, CEO of Affimed. “This collaboration with Roche is an important step in our continued execution of AFM24’s clinical development strategy. Importantly, preclinical and clinical studies indicate that ICE® and PD-(L)1 checkpoint inhibition therapy could act synergistically, which drives our optimism about the combination of AFM24 with atezolizumab and its promise as a possible treatment option for patients with EGFR expressing solid tumors.”
AFM24 is a novel tetravalent, bispecific EGFR- and CD16A-binding innate cell engager that activates innate immunity by inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). AFM24 has shown an acceptable safety profile and antitumor activity in preclinical studies. AFM24 is currently being evaluated as monotherapy in adult patients with advanced solid malignancies known to be EGFR-positive in an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study.