AFMD - Affimed gains FDA clearance to study lymphoma candidate
2023-05-23 07:16:13 ET
German biotech Affimed N.V. ( NASDAQ: AFMD ) announced Tuesday that the FDA cleared an Investigational New Drug Application (IND) permitting a Phase 2 trial to study its innate cell engager AFM13 as a combination therapy for certain patients with Hodgkin Lymphoma.
The open-label study is designed to evaluate AFM13 in combination with Artiva Biotherapeutics’ ( RTVA ) natural killer (NK) cell therapy, AB-101, in patients with relapsed or refractory (r/r) classical Hodgkin Lymphoma ((cHL)).
The trial named AFM13-203 (LuminICE-203) is anticipated to start in Q3 2023, and developers expect to report safety data from the study in H1 2024.
Noting that there remains an unmet medical need for r/r cHL patients, Chief Medical Officer of AFMD, Andreas Harstrick, remarked: “Therapies like the combination of AFM13 with NK cells that enable patients to achieve complete responses have the potential to contribute to this benefit.”
The announcement on IND clearance came ahead of Affimed’s ( AFMD ) Q1 2023 financials, for which a conference call is scheduled for May 23, 2023, at 8:30 a.m. EST.
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Affimed gains FDA clearance to study lymphoma candidate