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Affirmed Therapeutics BV (AFMD) – Committed to provide a clinical study – Press Release

  • Selected Phase 2 Recommended Dose (RP2D) of 480 mg with ongoing enrollment in disease-specific cohorts; maximum tolerated dose (MTD) not reached
  • Stable disease was observed in 10 of 27 evaluable patients in an unselected patient population
  • Extensive pharmacodynamic studies indicate activation of the innate and adaptive immune systems
  • Well maintained security profile

HEIDELBERG, Germany, Sept. 04, 2022 (GLOBE NEWSWIRE) — Affimed NV AFMDa clinical-stage immuno-oncology company committed to restoring patients’ innate ability to fight cancer, today announced that a summary of clinical trial results for its innate cell gager (ICE®) AFM24 was selected for a poster presentation at the European Society for Medical Oncology (ESMO) Congress, 9-13. Accepted in Paris September 2022.

The summary includes phase 1 safety, immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) data in patients with locally advanced or metastatic, treatment-refractory EGFR-positive solid tumors treated with AFM24 monotherapy.

“These results represent an important milestone in our broad development program, which continues to evaluate the efficacy of AFM24 as monotherapy and in combinations,” said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. “AFM24 has now demonstrated the ability to activate both innate and adaptive immune cells, potentially helping to overcome resistance to current therapies.”

More details on the study and poster presentation

In the study, AFM24 was administered intravenously once weekly at doses up to 720 mg until disease progression, intolerable toxicity, patient discontinuation, or discontinuation, at the discretion of the investigator. The tumor types mainly included colorectal and non-small cell lung cancer.

AFM24-related treatment-emergent adverse reactions included infusion-related reactions, nausea, and acne-like dermatitis. There were no deaths during the study. The maximum tolerated dose was not reached. Stable course of illness from March 2022…

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