Affimed Announces New Innate Cell Engager AFM28 Targeting CD123 to Treat Acute Myeloid Leukemia


  • Derived from Affimed’s ROCK® platform, AFM28 binds selectively and with high affinity the surface antigens CD123 and CD16A

  • AFM28 shows better killing of primary leukemic blasts in comparison to monoclonal antibodies which may lead to enhanced ADCC in patients

  • In a preclinical toxicology study AFM28 was safe and well-tolerated and exhibited the expected pharmacodynamic activity

  • The high affinity of AFM28 to CD16A is well suited for the combination with allogeneic NK cells

  • The AFM28 program is planned to advance to an IND filing in the first half of 2022; a clinical study is expected to begin in the second half of 2022

  • The clinical program will investigate AFM28 as treatment designed to address the needs of patients with Acute Myeloid Leukemia (AML) and other CD123+ myeloid malignancies, such as high-risk Myelodysplastic Syndrome (HR-MDS)

Heidelberg, Germany, November 4, 2021 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that AFM28, its novel Innate Cell Engager (ICE®), is designed to treat patients with Acute Myeloid Leukemia (AML) and other CD123+ myeloid malignancies, such as high-risk myelodysplastic syndrome (MDS).


Affimed will describe AFM28 in a poster covering initial preclinical data at the upcoming ASH conference. The company plans to submit an IND application in the first half of 2022, and initiate a first-in-human study in the second half of 2022.


“Redirecting innate immune cells, particularly NK cells, to CD123 is highly attractive as a novel treatment strategy in AML, because CD123 is almost universally expressed on leukemic blasts and leukemic stem cells, and we know that efficient depletion of both these cell types is critical for inducing long-term remission. Further, NK cell-based therapies have been demonstrated to be clinically active in AML,” said Arndt Schottelius, Chief Scientific Officer at Affimed. “We believe that engaging NK cells with our new ICE® AFM28 will enable new immunotherapeutic approaches to address the unmet needs in AML, either as monotherapy or in combination with adoptive NK cell therapy.”


AFM28 was developed on Affimed’s proprietary ROCK® platform and is a bispecific, tetravalent ICE® that targets CD16A on NK cells and macrophages as well as CD123 on leukemic cells and leukemic stem cells in AML. The high affinity to CD123 and to CD16A is initiating antibody-dependent cell-mediated cytotoxicity (ADCC) against CD123+ tumor cells. Preclinical data demonstrate that AFM28 induces tumor cell lysis more potently than conventional anti-CD123 antibodies, even at low CD123 expression. Further, AFM28 shows a 100-fold more potent NK cell activation in an ex vivo analysis, compared to Fc-enhanced IgG1 antibodies. In a preclinical toxicology study in cynomolgus monkey, AFM28 was safe and well-tolerated and exhibited the expected pharmacodynamic activity suggesting a good safety profile and the potential to eliminate CD123+ cells in vivo. Clinical investigation of AFM28 is planned as monotherapy and in combination with allogeneic NK cell therapy.


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