Benzinga | Nov 8, 2021 06:34AM EST

Affimed And NKGen Biotech Announce Initiation Of Patient Recruitment In A First-in-human Phase 1/2a Trial Of Innate Cell Engager AFM24 In Combination With Autologous NK Cell Product SNK01

Affimed N.V. (NASDAQ:AFMD) and NKGen Biotech, both clinical stage biotech companies focused on harnessing the power of the body's innate immune system, announced today the initiation of patient recruitment in the open-label, multi-center phase 1/2a study (NCT05099549) evaluating the safety, tolerability, and anti-tumor activity of the innate cell engager (ICE(r)) AFM24 (Affimed's tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding ICE(r)) in combination with SNK01 (ex vivo expanded and activated autologous NK cell therapy from NKGen Biotech).

The objective of the phase 1 dose escalation is to evaluate safety and tolerability data for escalating AFM24 doses in combination with a fixed dose of SNK01 and to determine the maximum tolerated and recommended phase 2 dose for the expansion phase. Phase 2a will investigate additional tolerability, safety and anti-tumor activity. The trial will include patients with non-small cell lung cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and neck (SCCHN), as well as patients with microsatellite instability (MSI) low/DNA mismatch repair proficient colorectal cancer (CRC) regardless of KRAS mutational status.

"Existing therapeutics that target EGFR rely on inhibiting EGFR signaling, an approach that has been hampered by intrinsic and acquired resistance mechanisms," said Dr. Anthony El-Khoueiry, Phase I Program Director at the USC Norris Comprehensive Cancer Center, part of Keck Medicine of USC. El-Khoueiry is also associate professor of clinical medicine, Keck School of Medicine of USC and principal investigator for the study. "The combination of AFM24 with SNK01 represents a novel approach to leverage EGFR expression in multiple solid tumor types and optimally engage the innate immune system; this may be especially beneficial for patients with an impaired immune system or low NK cell numbers."

The clinical study is supported by preclinical data generated through the collaboration of Affimed and NKGen Biotech, including data that were recently presented at the AACR-NCI-EORTC conference on Molecular Targets and Cancer Therapeutics. In the preclinical studies, AFM24 demonstrated robust binding to SNK01 cells and enhancement of the cytotoxic activity of SNK01 cells towards EGFR-positive A-431 cells, compared to untargeted SNK01 cells. In addition, markers for NK cell degranulation and intracellular IFN? were increased in the combined therapy, indicating increased anti-tumor activity.

The AACR-NCI-EORTC conference presentation may be found at: https://www.affimed.com/rock-platform/publications-posters/ and https://nkgenbiotech.com/scientific-publications/