AFMD - Affimed gets FDA green light to go ahead with AFM24+SNK-01 study in solid tumors shares up 4%

Affimed N.V. (AFMD) and NKMax America announce that the FDA has cleared an investigational new drug application ((IND)) for Phase 1/2a dose escalation and expansion study investigating the combination of AFM24 and SNK-01 in patients suffering from tumors known to express EGFR. The primary objective of the Phase 1 study part will be to establish the safety and the recommended Phase 2 dose of AFM24/SNK-01 combination, as well as to evaluate pharmacokinetics, pharmacodynamics, and preliminary activity in patients with advanced cancers expressing EGFR.The phase 2a portion will evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes.AFM24 is an EGFR/CD16A innate cell engager, and SNK-01 is an autologous NK-cell product.AFMD shares up 4% premarket trading at $7.65.

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Affimed gets FDA green light to go ahead with AFM24+SNK-01 study in solid tumors, shares up 4%