Affimed Announces First Patient Successfully Dosed in the First-in-Human Study of AFM28 for the Treatment of Patients with Relapsed / Refractory CD123-Positive Acute Myeloid Leukemia

HEIDELBERG, Germany, March 29, 2023 (GLOBE NEWSWIRE) -- 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 the first patient was dosed in a phase 1 multicenter, open label, first-in-human dose escalation study of the innate cell engager (ICE^®) AFM28 monotherapy in patients with CD123-positive relapsed/refractory (r/r) acute myeloid leukemia (AML). AFM28 efficiently directs natural killer (NK) cells to CD123-positive leukemic cells, including blasts and leukemic stem and progenitor cells, inducing their depletion in samples of patients with AML and myelodysplastic syndrome (MDS).

"I’m proud of this milestone as AFM28 represents Affimed’s third wholly owned ICE^® molecule to enter the clinic. AFM28 has been designed to improve outcomes for AML patients in a differentiated manner from drugs currently used or in development for the treatment of AML,” said Dr. Adi Hoess, Chief Executive Officer at Affimed. “AFM28 broadens our footprint in hematological malignancies in addition to AFM13’s encouraging clinical activity as a single agent and in combination with NK cells, and adds to our clinically validated pipeline with multiple expected data readouts in 2023. Moreover, it demonstrates the broad potential of ICE^® molecules across hematological and solid tumors where there is demonstrated need for new and innovative therapies.”

“The initiation of this first in-human clinical trial of AFM28 is exciting news for the broad set of patients who are suffering from one of the most aggressive blood cancers and are in desperate need for viable new treatment options. We are happy to see our first patient successfully dosed and look forward to the continued study of this novel agent. We hope to be able to further validate the safety and biological activity of AFM28 through this clinical trial,” said the principal investigator of the study, Pau Montesinos, MD, hematologist at La Fe University Hospital, Valencia, Spain and coordinator of the Spanish group of acute myeloblastic leukemia (PETHEMA).

The study (AFM28-101) is designed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AFM28 monotherapy in patients with CD123-positive r/r AML. The goal of dose escalation is to establish the maximum tolerated dose (MTD) and/or one or more recommended phase 2 doses (RP2D). Affimed also intends to develop AFM28 in combination with 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 give patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The company’s proprietary 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: .

Investor Relations Contact

Alexander Fudukidis

Director, Investor Relations

E-Mail:

Tel.: +1 (917) 436-8102

Media Contact

Mary Beth Sandin

Vice President, Marketing and Communications

E-Mail:

Tel.: +1 (484) 888-8195