On 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, reported 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) (Press release, Affimed, NOV 4, 2021, View Source [SID1234594505]).

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Affimed will describe AFM28 in a poster covering initial preclinical data at the upcoming ASH (Free ASH Whitepaper) 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.

About Acute Myeloid Leukemia
Acute Myeloid Leukemia is the most common form of adult leukemia, with approximately 20,000 new cases diagnosed every year in the US alone. Despite recent advances in the management of hematological malignancies, progress in the treatment of AML has lagged behind and the overall outcome for patients remains very poor; while complete remission (CR) can be initially achieved in most patients, the majority of patients become primary refractory or relapse within 1 year. Treatment options for these patients are very limited, and the prognosis is dismal with 1-year and 5-year overall survival (OS) of 29% and 11%, respectively. Novel treatments that prevent relapse and are effective in relapsed / refractory disease constitute a major unmet need.

About AFM28
AFM28, a tetravalent, bispecific CD123- and CD16A-binding innate cell engager (ICE) developed on Affimed’s ROCK platform, is designed to bring a new immunotherapeutic approach to patients with CD123+ myeloid malignancies, including Acute Myeloid Leukemia and Myelodysplastic Syndrome (MDS). It engages 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 single-agent and within a novel combination regimen aimed at bringing an NK cell-based mode of actions to patients with CD123+ myeloid disease.