AFMD - Affimed to pull U.S. trial application for leukemia candidate

With its Q2 financials for 2022, German biotech Affimed N.V. ( NASDAQ: AFMD ) announced on Thursday that following the feedback from the FDA, the company decided to voluntarily withdraw the investigational new drug (IND) application for myeloid leukemia candidate AFM28 in the U.S.

An innate cell engager, AFM28, is designed to target the receptor molecule CD16A on NK cells, macrophages, and CD123 detected in acute myeloid leukemia (AML).

Following the IND submission in June, the company has received feedback from the FDA regarding the design of the dose escalation study, leading to a “strategic decision to voluntarily withdraw the IND,” Affimed ( AFMD ) said.

The company will now focus on the clinical development of AFM28 outside the U.S. and plans to begin a Phase 1 clinical study in 1H 2023, a delay from the previously estimated 2H 2022 timeline.

Turning to Q2 financials, despite a ~25% YoY decline, the company reported €7.3M in revenue, mainly driven by collaborations with the Genentech unit of Roche ( OTCQX:RHHBY ) ( OTCQX:RHHBF ) and Roivant ( ROIV ).

While R&D expenses slipped ~5% YoY to €20.8M, the net loss rose ~3% YoY to €19.4M. The cash and equivalents climbed ~20% from 2021-end to €237.2M, which, according to the company, would support its operations into mid-2024.

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