AFM24 is an innate cell engager with a novel and distinctive mechanism of action, designed to address the need of broader patient populations than current EGFR-targeting treatments.
Preclinical data demonstrate AFM24’s activation of the innate immune system, acting independently of EGFR-expression levels, EGFR-pathway mutations and downstream signal transduction.
A toxicity study in cynomolgus monkeys shows AFM24 was well tolerated up to the highest dose level (75 mg/kg) with no skin or organ toxicity observed.
The published data supported the Investigational New Drug application for the ongoing AFM24 Phase 1/2a dose escalation study.
Heidelberg, Germany, July 30, 2021 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today the publication of a comprehensive preclinical in vitro and in vivo data package of its innate cell engager (ICE®) AFM24 (CD16A/EGFR) in mAbs. The published data were the basis for the Investigational New Drug (IND) clearance for Affimed’s ongoing Phase 1/2a study with AFM24 monotherapy in patients with EGFR expressing solid tumors. The preclinical data demonstrates AFM24’s unique mechanism of action that harnesses the innate immune system to induce tumor cell killing via antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell phagocytosis (ADCP).
“These pre-clinical data are encouraging as they demonstrate the potential for AFM24 to effectively target a broad set of tumors expressing varying levels of EGFR, regardless of their mutational status, and with the potential for less pronounced EGFR-related toxicities than current treatment options,” said Arndt Schottelius, M.D., Ph.D., Chief Scientific Officer at Affimed. “This could be highly relevant for many patients with different tumor types despite existing EFGR-targeting therapies as these have limitations in efficacy and safety.”
Highlights of the recently published results include:
AFM24 binds with high affinity to CD16A on NK cells and macrophages in vitro.
AFM24 potently induces ADCC via NK cells, and ADCP via macrophages in vitro.
AFM24 is effective against many EGFR-positive tumor cells, regardless of EGFR expression level and KRAS/BRAF mutational status within in vitro studies.
AFM24 is well tolerated up to the highest dose level (75 mg/kg) with no skin and other toxicities in cynomolgus monkeys.
The full manuscript is available here: https://bit.ly/3zLDq3i