Affimed Announces First Patient Successfully Dosed in First-in-Human Phase 1/2A Study of AFM24 for the Treatment of Advanced EGFR-Expressing Solid Tumors Including Colon, Lung and Other Cancers
AFM24, designed to activate innate immunity to broadly target EGFR-expressing solid tumors regardless of mutational status, has the potential to improve efficacy and safety over currently available EGFR-targeted therapies
AFM24 is the first innate cell redirecting immuno-oncology therapeutic dosed in solid tumor patients
Heidelberg, Germany, April 16, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the first patient was successfully dosed in a Phase 1/2a clinical trial of AFM24, a first in human study evaluating AFM24 as monotherapy in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24, a tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding innate cell engager, is novel due to its activation of innate immunity to kill solid tumors, inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as compared to other therapies that rely heavily on signal or checkpoint inhibition.
“Today is a landmark day for Affimed and, more importantly, for patients whose solid tumors continue to progress,” said Dr. Adi Hoess, Chief Executive Officer of Affimed. “This major milestone marks the first time a patient with solid tumors has been dosed with an innate cell engager. AFM24 has demonstrated preclinically the ability to bridge NK cells and macrophages to EGFR-expressing tumor cell lines, and to induce lysis through ADCC and ADCP, respectively, independent of RAS mutational status. We look forward to the continued study of this novel agent and further validating its safety and efficacy through this human clinical trial.”
“Initiation of dosing in the first in human clinical trial of AFM24 is exciting news for the broad set of patients with hard to treat EGFR-expressing cancers,” said Dr. Anthony El-Khoueiry, Phase I program director at the USC Norris Comprehensive Cancer Center and Keck School of Medicine, and principal investigator for the study. “While available EGFR therapies have improved the lives of patients, new therapeutic options are needed that are broadly efficacious, easier for patients to tolerate and can also address the issue of resistance associated with currently available treatments.”
The study is an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study to evaluate AFM24 as monotherapy in adult patients with advanced solid malignancies known to be EGFR-positive. The aim of the dose escalation phase is the determination of the maximum tolerated dose and the establishment of a recommended Phase 2a dose. The dose expansion phase is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24. For more information including eligibility criteria, visit www.clinicaltrials.gov, using Identifier NCT04259450.
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