Affimed to Present Preclinical Data Demonstrating Cytotoxic Activity of its Novel Innate Cell Engager AFM28 at the Annual Meeting of the European Hematology Association (EHA)

Rhea-AI Summary

Affimed N.V. (Nasdaq: AFMD) announced the upcoming first-in-human phase 1 study of its bispecific innate cell engager AFM28, targeting CD123 in patients with relapsed/refractory acute myeloid leukemia (AML). This innovative therapy showed promising results in preclinical studies, effectively destroying CD123-positive tumor cells while sparing healthy cells. Toxicology models indicated low risks of side effects such as cytokine release syndrome. The study is set to begin in the second half of 2022, with a poster presentation scheduled at the EHA Annual Meeting in June 2022.

Positive

• AFM28 demonstrated effective lysis of CD123-positive tumor cells, even at low expression levels.
• Preclinical models confirmed AFM28's good tolerability and low risk of cytokine release syndrome.
• The upcoming first-in-human phase 1 study aims to investigate safety and efficacy in a critical patient population.

Negative

• None.

• The novel bispecific innate cell engager AFM28 stimulates NK cells to destroy CD123-positive tumor cells via antibody-dependent cellular cytotoxicity.
• AFM28 induces effective lysis of hematological tumor cells even at low-levels of CD123 expression; leukemic cells in patient bone marrow are eliminated without affecting target antigen-negative cells suggesting a sparing of healthy hematopoietic progenitor cells.
• Preclinical toxicology models confirm potent biological activity and suggest good tolerability of AFM28 with low risk of cytokine release syndrome.
• The Company is planning to start a first-in-human phase 1 study investigating safety, efficacy and biological activity of AFM28 monotherapy in patients with relapsed/refractory acute myeloid leukemia in the second half of 2022.

HEIDELBERG, Germany, May 12, 2022 (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 an upcoming poster presentation demonstrating the cytotoxic potential of its CD123/CD16A-targeting innate cell engager (ICE^®) AFM28 at the Annual Meeting of the European Hematology Association (EHA) to be held in Vienna, Austria on June 9 - 12, 2022.

AFM28 is designed as a novel treatment for patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS).

Redirecting innate immune cells, particularly NK cells, to CD123 is very attractive as a novel treatment strategy in AML because both leukemic blasts and leukemic stem cells express this receptor and an efficient depletion of both cell types is critical for inducing long-term remission.

The data to be presented in a poster session at the EHA on June 10, 2022 summarize the preclinical proof-of-concept and toxicology studies for AFM28. The CD123 and CD16A targeting ICE^® exhibited high-affinity binding to CD16A expressed on NK cells and high avidity conferring long cell surface retention.

In in vitro assays, AFM28 engaged NK cells to destroy CD123-positive tumor cell lines and primary leukemic cells via antibody-dependent cell-mediated cytotoxicity (ADCC), even when CD123 was expressed at low levels.

Moreover, AFM28 demonstrated the ability to deplete leukemic cells from patient bone marrow without lysing CD34-positive/CD123-negative cells suggesting sparing of hematopoietic stem and progenitor cells.

In toxicology models using cynomolgus monkeys, AFM28 demonstrated highly effective target cell depletion which was associated with good tolerability and only minimal release of the inflammatory cytokine IL-6.

“CD123 is a highly interesting tumor antigen in AML that hasn’t reached its full therapeutic potential. We believe that engaging innate immune cells represents a differentiated therapeutic strategy to access the value of this target. Building on the promising data we have seen with AFM28 to date, we are excited to be preparing a first-in-human clinical study to investigate the safety, efficacy and biological activity of AFM28 as monotherapy. In parallel, we are planning a study to investigate AFM28 in combination with adoptive NK cell therapies,” said Dr. Arndt Schottelius, Chief Scientific Officer at Affimed. “NK cell therapies have already demonstrated promising clinical activity in relapsed/refractory AML and we believe that AFM28 will improve this effect.”

The abstract is accessible on the following website: https://ehaweb.org/congress/eha2022-hybrid/eha2022-congress/

Poster details:

Title: Novel bispecific innate cell engager AFM28 for the treatment of CD123-positive acute myeloid leukemia and myelodysplastic syndrome

Authors: Jana-Julia Siegler, Nanni Schmitt, Jens Pahl, Torsten Haneke, Izabela Kozlowska, Séverine Sarlang, Alexandra Beck, Stefan Knackmuss, Paulien Ravenstijn, Uwe Reusch, José Medina-Echeverz, Jan Endell, Thorsten Ross, Daniel Nowak, and Christian Merz

Final abstract code: P482

Session date and time: Poster session on Friday, June 10^th, 10:30 – 11:45 a.m. EDT / 16:30 - 17:45 CEST

About AFM28

AFM28, a tetravalent, bispecific CD123- and CD16A-binding 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 (AML) 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 monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123+ 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: www.affimed.com.

Investor Relations Contact

Alexander Fudukidis
Director, Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102

Media Contact

Mary Beth Sandin
Vice President, Marketing and Communications
E-Mail: m.sandin@affimed.com
Tel.: +1 (484) 888-8195

FAQ

What is AFM28 and what does it target?

AFM28 is a bispecific innate cell engager designed to stimulate NK cells to destroy CD123-positive tumor cells in patients with advanced hematological malignancies.

When is the first-in-human phase 1 study for AFM28 planned to start?

The first-in-human phase 1 study of AFM28 is planned to begin in the second half of 2022.

What are the expected benefits of AFM28 in treating AML?

AFM28 aims to provide effective tumor cell killing while sparing healthy hematopoietic progenitor cells, potentially leading to better treatment outcomes.

What results were shown in preclinical studies for AFM28?

Preclinical studies indicated that AFM28 effectively depletes leukemic cells from patient bone marrow and has good tolerability with minimal side effects.

What event will showcase AFM28's potential?

AFM28's cytotoxic potential will be presented at the Annual Meeting of the European Hematology Association (EHA) from June 9 to June 12, 2022.