On March 31, 2021 Affimed N.V. (NASDAQ: AFMD), a clinical-stage immuno-oncology company, and NKMax America Inc., a clinical stage biotech company, reported that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug application (IND) for an Affimed and NKMax America co-sponsored Phase 1/2a dose escalation and expansion study in which the two companies will investigate the combination of AFM24, an EGFR/CD16A innate cell engager (ICE), and SNK-01, an autologous NK-cell product, in patients suffering from tumors known to express EGFR (Press release, NKMax America, MAR 31, 2021, View Source [SID1234577434]). The combination represents a novel approach to exploring innate immunity-based therapeutics to treat patients with solid tumors who failed conventional therapy with the aim to improve outcomes for high-medical need patient populations.

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"This combination is part of our overall development strategy for AFM24, the first and only innate cell engager in clinical development for solid tumors. In addition to NK cell-based combinations, we are also developing AFM24 as single agent and in combination with atezolizumab in several tumor indications," said Dr. Andreas Harstrick, Affimed’s Chief Medical Officer. "The mechanism of action of the two compounds could be highly synergistic as AFM24 has strong binding affinity to NK cells, directing them to kill tumor cells. Moreover, this combination approach represents an opportunity to supplement patients with dysregulated innate immune systems with targeted cellular therapy."

"The FDA clearance of our IND application for SNK-01 in combination with AFM24 is an important milestone for our Natural Killer cell therapy development program," said Stephen Chen, Chief Operating Officer and Chief Technical Officer of NKMax America. "We look forward to investigating this combination as part of our comprehensive strategy aimed at producing a cell therapy for patients with advanced/metastatic EGFR-expressing cancers."

Further Information About the AFM24/SNK-01 Phase 1/2a study

The Phase 1/2a study is based on preclinical in vitro testing, combining Affimed’s ICE AFM24 with NKMax America autologous NK-cell product SNK-01, which showed enhanced activity of NK cell induced target cell killing. The Phase 1/2a study will be an open-label, non-randomized, multi-center, US only, dose escalation trial to evaluate the combination in adult patients with EGFR-expressing tumors. 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 of the study will evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes.