Affimed Announces Promising Phase 1 Results for AFM28 in Relapsed/Refractory AML

MANNHEIM, Germany I December 09, 2024 I Affimed N.V., a clinical-stage company in immuno-oncology, recently shared encouraging data on AFM28 at the 66th ASH Annual Meeting and Exposition. This presentation focused on initial findings from a Phase 1 trial of AFM28, targeting patients with relapsed/refractory acute myeloid leukemia (R/R AML). The study demonstrated clinical promise and a manageable safety profile for doses up to 300 mg administered weekly.

The clinical trial enrolled 29 patients with heavily pretreated R/R AML, testing six different dose levels of AFM28. Participants had undergone a median of two prior treatment regimens, and 86% presented an adverse risk profile as per the European LeukemiaNet 2022 guidelines. AFM28 was delivered intravenously, with doses varying from 25 mg to 300 mg weekly. The treatment was generally well received, with infusion-related reactions (IRRs) being the most frequently reported adverse events, appearing in 45% of patients. These IRRs were mostly mild to moderate in severity. Only one case of grade 1 cytokine release syndrome (CRS) was recorded, and there were no signs of neurotoxicity or immune-effector related issues.

In terms of efficacy, at a dose level of 250 mg, one out of six patients achieved a complete remission (CR) and maintained this status for 6.5 months. For those receiving the 300 mg dose, 10 evaluable patients experienced a composite complete remission rate (CRcR) of 40%, with one CR and three complete remissions with incomplete blood count recovery (CRi). Four patients remain in treatment, with options to further enhance their responses.

Dr. Andreas Harstrick, MD, Chief Medical Officer at Affimed, commented on the findings, highlighting the achievement of a 40% CRcR in a challenging patient group. He noted the treatment's effectiveness was independent of genetic mutations, including in those with negative prognostic molecular profiles. The manageable safety profile supports further AFM28 development, potentially as a standalone therapy or in combination regimens.

AFM28, under continual investigation in Phase 1 trials, is a tetravalent, bispecific CD123- and CD16A-binding immune cell engager (ICE). This innovative therapeutic approach aims to treat acute myeloid leukemia by harnessing the power of natural killer (NK) cells to kill leukemic cells through antibody-dependent cellular cytotoxicity, even at low CD123 expression levels. The clinical development of AFM28 focuses on its use as a monotherapy in patients with R/R AML.

Affimed N.V., headquartered in Mannheim, Germany, is dedicated to empowering the innate immune system to combat cancer. Their ICE molecules provide a targeted approach to recognizing and eliminating various hematologic and solid tumors. These ICE molecules are produced using Affimed’s proprietary ROCK platform, which reliably creates customized molecules that optimize the capabilities of innate immune cells to destroy cancer cells. Several ICE molecules are currently in clinical trials, being assessed as either monotherapy or in combination therapies. Affimed's mission is led by a seasoned team of biotechnology and pharmaceutical experts sharing a commitment to preventing cancer from disrupting patients’ lives.