Affimed Receives Fast Track Designation for Combination Therapy of AFM24 with Atezolizumab for EGFR Wild-Type Non-Small Cell Lung Cancer

Core Insights - The FDA has granted Fast Track designation to Affimed's AFM24 in combination with atezolizumab for treating advanced/metastatic non-small cell lung cancer (NSCLC) patients with EGFR wild-type after prior treatment failure [1][2] - The Fast Track designation aims to expedite the development and review of drugs addressing serious conditions and unmet medical needs, allowing for more frequent communication with the FDA [2][3] Company Overview - Affimed N.V. is a clinical-stage immuno-oncology company focused on harnessing the innate immune system to combat cancer, utilizing its proprietary ROCK® platform to develop innate cell engagers (ICE®) [7] - The company is headquartered in Mannheim, Germany, and is led by a team of experienced biotechnology and pharmaceutical leaders [7] Product Information - AFM24 is a tetravalent, bispecific ICE® that activates the innate immune system by targeting CD16A on immune cells and epidermal growth factor receptors (EGFR) on tumors, facilitating cancer cell destruction [6] - The ongoing AFM24-102 study is evaluating the efficacy and safety of AFM24 combined with atezolizumab in NSCLC patients who have not responded to standard treatments [1][2] Clinical Development - Initial data from the AFM24-102 study has shown meaningful responses in heavily pretreated NSCLC patients, leading to the Fast Track designation [2] - The updated data from the AFM24-102 trial will be presented at the American Society of Clinical Oncology annual meeting on June 1, 2024 [1] Conference Call Information - Affimed will host a conference call and webcast on June 1, 2024, at 7:00 p.m. EDT to discuss the updated data from the AFM24-102 trial [1][4]