Affimed Gains Fast Track for AFM24 and Atezolizumab Combo in EGFR Wild-Type NSCLC

Affimed N.V., a clinical-stage immuno-oncology company based in Mannheim, Germany, has announced that the FDA has granted Fast Track designation to AFM24 combined with the checkpoint inhibitor atezolizumab. This combination therapy is aimed at patients with advanced or metastatic non-small cell lung cancer (NSCLC) without activating EGFR mutations (EGFR wild-type), who have progressed following PD-(L)1 targeted therapy and platinum-based chemotherapy. This decision was made following a review of initial efficacy data from the AFM24-102 phase 1/2a study, which is currently investigating the efficacy and safety of AFM24 with atezolizumab in a cohort of NSCLC patients.

Dr. Wolfgang Fischer, Chief Operating Officer at Affimed, highlighted the significance of this development, noting that the combination therapy has shown meaningful responses in patients who had previously resisted checkpoint inhibitor treatments. This advancement underscores the potential of AFM24 combined with atezolizumab to address an unmet medical need in this patient population.

The Fast Track designation by the FDA is a process designed to expedite the development and review of drugs that treat serious conditions and fill unmet medical needs. This status allows for more frequent communications with the FDA to discuss the drug's development plan and data collection necessary for drug approval. It also makes the drug eligible for accelerated approval and priority review, provided certain criteria are met. This means sections of the drug’s application can be reviewed by the FDA as they are completed, rather than waiting for the entire application to be finished.

Affimed will present updated data from the AFM24-102 study at the annual meeting of the American Society of Clinical Oncology on June 1, 2024. Additionally, the company will host a conference call and webcast on the same day to discuss these findings further with the financial community.

AFM24 is a tetravalent, bispecific innate cell engager (ICE®) developed using Affimed’s proprietary ROCK® platform. It binds to CD16A on innate immune cells and epidermal growth factor receptors (EGFR) on tumors, leading to tumor cell destruction through antibody-dependent cellular cytotoxicity and phagocytosis. This innovative mechanism leverages the body's innate immune response to target and kill cancer cells, offering a novel approach to cancer treatment.

Affimed is dedicated to harnessing the innate immune system’s untapped potential to fight cancer. The company’s ICE® molecules, generated on the ROCK® platform, are being explored in various clinical trials either as standalone treatments or in combination with other therapies. The company’s mission is to prevent cancer from disrupting patients' lives by developing effective immuno-oncology therapies.

This Fast Track designation is seen as a significant step forward, offering hope to patients with advanced NSCLC who have no other standard treatment options available. Through ongoing trials and the unique capabilities of its ICE® molecules, Affimed aims to provide new therapeutic strategies in the fight against cancer.