Affimed Announces Acceptance of Three Abstracts at the 2024 ASH Annual Meeting Including an Oral Presentation Underscoring Advancing Clinical Pipeline in Leukemia and Lymphoma

MANNHEIM, Germany, Nov. 05, 2024 (GLOBE NEWSWIRE) -- 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, today announced three abstracts on two of its innate cell engagers (ICE^®) are accepted for presentation at the 66th ASH Annual Meeting and Exposition taking place December 7-10, 2024, in San Diego, California. An oral presentation will feature clinical results including promising efficacy and safety data from the AFM28 phase 1 dose escalation study in relapsed/refractory acute myeloid leukemia (AML). A poster with preclinical data will highlight the in vitro efficacy of AFM28 in combination with both patient-derived autologous NK cells and healthy volunteer-derived allogeneic NK cells against leukemic blasts.

Updated clinical results from all 4 cohorts of the run-in phase from the LuminICE-203 study evaluating acimtamig (AFM13) in combination with AlloNK^® (AB-101) for relapsed/ refractory Hodgkin Lymphoma will be shared in a poster session.

Details for the oral presentation and poster sessions are as follows:

Abstract Title	Date / Time / Presenter	Session Name / Location
“Investigating the Novel Combination of the Innate Cell Engager (ICE®) Acimtamig with Off-the-Shelf Allogeneic Natural Killer Cells AlloNK® in Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL): Initial Results of the Phase 2 Luminice-203 Study”	December 8, 2024 6:00 PM - 8:00 PM PT Joseph Maakaron, MD Division of Hematology, Oncology and Transplantation, Department of Medicine, Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA	Session Name: 624. Hodgkin Lymphomas: Clinical and Epidemiological: Poster II Location: San Diego Convention Center, Halls G-H Publication Number: 3052
“Engaging Innate Immunity by AFM28, an Innate Cell Engager (ICE®) Targeting CD123-Positive Leukemic Cells in Patients with Relapsed/Refractory Acute Myeloid Leukemia: Safety and Efficacy Results of a First-in-Human Phase 1 Study”	December 9, 2024 10:30 AM - 12:00 PM PT Oral Presentation Time: 11:45 AM PT Pau Montesinos, MD, PhD Hospital Universitari i Politècnic La Fe, Valencia, Spain	Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: New Treatment Approaches for AML Room: Manchester Grand Hyatt San Diego, Grand Hall B
“The Bispecific Innate Cell Engager AFM28 Can Leverage AML Patient’s NK Cells in Addition to Allogeneic NK Cells, Enabling Elimination of CD123+ Leukemic Stem and Progenitor Cells in AML and MDS”	December 9, 2024 6:00 PM - 8:00 PM PT Nanni Schmitt, Dr. sc. hum. Department of Hematology and Oncology, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany	Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III Location: San Diego Convention Center, Halls G-H

The abstracts are available online at the 66^th ASH Annual Meeting and Exposition – Hematology.

The final oral presentation and clinical poster will be available after the congress on Affimed’s website at Publications & Posters.

About Acimtamig

Acimtamig (AFM13) is a first-in-class ICE^® that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. Acimtamig induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. Acimtamig is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor, creating the necessary proximity for the innate immune cells to destroy the tumor cells.

About LuminICE-203 (AFM13-203)

LuminICE-203 (AFM13-203) is a Phase 2 open-label, multicenter, multi-cohort study. The trial is evaluating the safety and efficacy of the combination of acimtamig (AFM13) with Artiva Biotherapeutics’ allogeneic NK cell AlloNK^® (AB-101) in patients with relapsed/refractory classical Hodgkin lymphoma and CD30-positive peripheral T cell lymphoma (NCT05883449).

The study builds on the unprecedented efficacy results from an investigator sponsored study, AFM13-104, which investigated acimtamig in combination with cord blood-derived NK cells in patients with refractory/recurrent CD30-positive Hodgkin or non-Hodgkin lymphoma (NCT04074746).

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).

About AFM28-101

AFM28-101 is a first-in-human Phase 1 open-label, nonrandomized, multicenter, multiple ascending dose escalation study evaluating AFM28 monotherapy in patients with relapsed/refractory CD123-positive AML (NCT05817058).

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 Statements

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 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 AB-101; 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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