• AFM28 monotherapy receives authorization of a Clinical Trial Application (CTA) for the phase 1 study by the French National Agency for the Safety of Medicines and Health Products (ANSM)
  • Initiation of AFM28 clinical development in the first half of 2023 on track

HEIDELBERG, Germany I December 22, 2022 I Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that the ANSM has authorized a CTA for the phase 1 study of AFM28 (AFM28-101) in relapsed/refractory acute myeloid leukemia (AML).

“The CTA approval in France is an important milestone in our strategy to develop AFM28 as quickly as possible,” said Dr. Wolfgang Fischer, Chief Operating Officer at Affimed. “AML is one of the worst blood cancers with poor patient prognosis, especially in the relapsed or refractory setting, with no standard-of-care salvage regimen currently available. Given the aggressive nature of the disease, and the desperate need for viable treatment options, it is a high priority for Affimed to advance the clinical development of AFM28 for relapsed/refractory AML patients.”

CTA applications for AFM28-101 in other European jurisdictions are ongoing, and additional applications are planned for submission early in 2023. Additionally, Affimed plans to investigate AFM28 in combination with allogenic natural killer (NK) cell therapy.

About AFM28-101

AFM28-101 is a phase 1 multicenter, open label, first-in-human dose escalation study of AFM28, a bispecific Innate Cell Engager (ICE®) that targets CD123 and CD16A in patients with CD123–positive relapsed/refractory (r/r) acute myeloid leukemia (AML). The study is planned to investigate the safety, tolerability, PK and PD of AFM28 IV monotherapy in patients with CD123-positive r/r AML. The goal of dose escalation is to establish the maximum tolerated dose and/or one or more recommended phase 2 doses to guide clinical development of AFM28 as a monotherapy and/or in combination with other therapeutic approaches, e.g., allogeneic natural killer (NK) cell therapy.

About AFM28

AFM28, a tetravalent bispecific CD123- and CD16A-binding Innate Cell Engager (ICE®) developed on Affimed’s Redirected Optimized Cell Killing (ROCK®) platform, is designed to bring a new immunotherapeutic approach to patients with CD123-positive myeloid malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) by engaging natural killer (NK) cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), even at low CD123 expression levels. Clinical development is planned as both monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123-positive leukemias.

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology Company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s proprietary Redirected Optimized Cell Killing (ROCK®) platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized Innate Cell Engager (ICE®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com.

SOURCE: Affimed