Tom3 schreef op 31 maart 2021 13:58:
Affimed and NKMax America Announce FDA Clearance of IND Application to Study the
Combination of AFM24, an EGFR Targeted Innate Cell Engager, with SNK-01 Natural
Killer Cell Therapy in Solid Tumors
Heidelberg, Germany and Santa Ana, Calif., March 31, 2021 - Affimed N.V. (NASDAQ: AFMD), a
clinical-stage immuno-oncology company, and NKMax America Inc., a clinical stage biotech
company, announced today 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. 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.
“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.
Geen pre- loaded cells dus.