• Treatment with AFM28 innate cell engager (ICE®), designed to target CD123-positive cancer cells in patients with acute myeloid leukemia (AML), led to dose-dependent tumor growth control in a validated in vivo mouse model
  
• AFM28 led to an effective reduction of CD123-expressing AML patient-derived leukemic blasts and stem cells in a newly engineered ex vivo bone marrow niche model

MANNHEIM, Germany, May 14, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the publication of an abstract for the annual congress of the European Hematology Association (EHA), taking place in Madrid, Spain, June 13 – 16, 2024. The abstract presents preclinical data of Affimed’s CD16A/CD123-targeting ICE®, AFM28, in an acute myeloid leukemia (AML) mouse xenograft model and shows that increasing doses of AFM28 lead to a dose-dependent tumor growth control, resulting in an increased median life span of the treated mice compared to controls.

In addition, the abstract shows a data set from a collaboration with Dr. Hind Medyouf’s group at the Institute for Tumor Biology and Experimental Therapy, Georg-Speyer-Haus, Frankfurt am Main, Germany. In a newly engineered ex vivo Human Organotypic Marrow Environment (HOME) model, the combination of AFM28 and allogeneic NK cells can lead to an effective reduction of CD123-expressing AML patient-derived leukemic blasts and stem cells. Importantly, the HOME model exhibits key immune suppressive cellular components, i.e. mesenchymal niche cells, enhancing the translational relevance of AFM28 preclinical activity.

“The significant anti-leukemic activity of AFM28 observed in in vivo as well as in vitro settings is encouraging,” said Dr. Wolfgang Fischer, COO of Affimed. “In combination with the previously demonstrated safety profile in cynomolgus monkeys, these data indicate AFM28’s potential to eradicate residual disease in patients with AML in an effective and safe manner.”

Details of the poster presentation are as follows:

Title: The Bispecific Innate Cell Engager AFM28 Induces Potent Anti-tumor Activity against AML in a Xenograft Mouse Model and in a Bone Marrow Niche In Vitro Model

Presenting Author: Ioanna Tsoukala

Date and Time:  Friday, June 14, 18:00 - 19:00 CET / 12:00 – 1:00 p.m. EDT

Final Abstract Code: P478

For more details on the EHA conference, please visit: EHA2024 Hybrid Congress (ehaweb.org)

About AFM28

AFM28, a tetravalent, bispecific CD123- and CD16A-binding ICE®, is designed to bring our immunotherapeutic approach to patients with acute myeloid leukemia (AML). It engages NK cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity, even at low CD123 expression levels. AFM28 is currently in clinical development as monotherapy in patients with AML (NCT05817058) and a combination with an allogeneic off-the-shelf NK cell product is being explored.

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 innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by the 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. 

Forward-Looking Statement

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of acimtamig (AFM13), AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK® platform, its ongoing and planned preclinical development and clinical trials, its corporate restructuring, the associated headcount reduction and the impact this may have on Company’s anticipated savings and total costs and expenses, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of acimtamig in combination with NK cell therapy is based on acimtamig precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AlloNK® NK cells and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

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