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Affimed Begins Clinical Trial of Innate Cell Engager AFM24 for Advanced EGFR-Positive Solid Tumors

NEW YORK – Germany-based immuno-oncology company Affimed today announced that it had successfully dosed its first patient with AFM24, an EGFR- and CD16A-binding innate cell engager therapy.

The news marks the start of the company's Phase I/IIb trial of AFM24 in adult patients with EGFR-positive advanced solid tumors. The open-label, non-randomized, multi-center study will assess the maximum tolerated dose of AFM24 as a monotherapy in patients whose disease has progressed after previous lines of treatment, as well as gather preliminary evidence on safety and efficacy.

According to Affimed, AFM24 is the first innate cell redirecting immuno-oncology therapeutic for solid tumor patients. The therapy is designed to work by activating a patient's innate immunity to target EGFR-expressing solid tumors regardless of RAS mutational status. The therapy engages the body's natural killer cells and macrophages to attack the cancer by recognizing EGFR receptors on tumor cells.

The company's CEO Adi Hoess said in a statement that AFM24 has demonstrated preclinically the ability to bridge natural killer cells and macrophages to EGFR-expressing tumor cell lines, in turn inducing lysis through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis, respectively.

The drug will be tested in these early-phase studies in any EGFR-expressing solid tumor. The company believes the therapy has the potential to be particularly beneficial to patients with colorectal cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, glioblastoma, and triple-negative breast cancer, all of which are known to overexpress EGFR.

Affimed believes that by relying on EGFR overexpression, more patients will be eligible for AFM24 compared to current standard-of-care treatments, such as EGFR-targeting monoclonal antibodies and tyrosine kinase inhibitors, which are indicated for patients with specific mutations.

"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's principal investigator Anthony El-Khoueiry of the USC Norris Comprehensive Cancer Center and Keck School of Medicine said in a statement.

The company has also highlighted the potential for the therapy to result in fewer side effects than available EGFR therapies, as suggested by the safety profile in animal models treated with high doses of the drug.

Affimed developed this therapy using its Redirected Optimized Cell Killing ("ROCK") platform, which it is using to advance other innate cell engagers in its pipeline, including AFM13, which targets CD30 across multiple cancer types such as T cell lymphomas and Hodgkin's lymphoma.