Affimed Announces Acimtamig and AlloNK® Combination Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the U.S. Food and Drug Administration (FDA)

Core Insights - The U.S. FDA has granted RMAT designation to Affimed's combination therapy of acimtamig and Artiva's AlloNK for treating relapsed or refractory Hodgkin Lymphoma, based on early efficacy data showing an 83.3% overall response rate and a 50% complete response rate [1][3][2] Group 1: Regulatory Milestone - RMAT designation aims to expedite the development and review of regenerative medicine therapies, providing benefits similar to Breakthrough Therapy Designation, specifically for regenerative medicine products [2] - This designation allows Affimed enhanced access to FDA resources, potentially leading to accelerated approval and priority review, which could significantly reduce the time to market for the combination therapy [2] Group 2: Clinical Data and Efficacy - Early efficacy data from the LuminICE-203 trial indicated an overall response rate of 83.3% (10 out of 12 patients) and a complete response rate of 50% (6 out of 12 patients), with a well-managed safety profile [1][3] - Data from all cohorts of the LuminICE-203 trial will be presented at the 66th ASH Annual Meeting on December 8, 2024 [3] Group 3: Broader Applications - The combination therapy has potential applicability in other CD30 positive lymphomas, such as peripheral T-cell lymphoma, which is resistant to conventional therapies and has a high risk of relapse [4] - Establishing clinical proof-of-concept in peripheral T-cell lymphoma could enhance the commercial potential of the combination therapy significantly [4] Group 4: Product Information - Acimtamig (AFM13) is a first-in-class innate cell engager designed to activate the innate immune system to target and destroy CD30-positive hematologic tumors [5] - The LuminICE-203 trial is a Phase 2 open-label, multicenter, multi-cohort study evaluating the safety and efficacy of acimtamig in combination with Artiva's AlloNK in patients with relapsed/refractory classical Hodgkin lymphoma and CD30-positive peripheral T-cell lymphoma [6]