Affimed presents preclinical data of a new innate cell

  • AFM28 induced potent, effective and specific antitumor activity against CD123 positive cells, regardless of mutation status
  • The study demonstrated a specific anti-tumor response even at low levels of CD123 expression without evidence of off-target cytotoxic activity towards healthy CD123-negative bone marrow progenitors
  • invivo studies of a mouse model of AML demonstrated anti-tumor efficacy; cynomolgus toxicology models showed pharmacodynamic activity with a well-tolerated safety profile suggesting a low risk of cytokine release
  • First-in-man Phase 1 clinical trial of AFM28 monotherapy expected to start in 2H 2022

HEIDELBERG, Germany, June 10, 2022 (GLOBE NEWSWIRE) — Affimed NV (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to restoring patients’ innate ability to fight cancer, presented a poster today at the annual meeting of the European Hematology Association (EHA) in Vienna, Austria. The data demonstrate the cytotoxic potential of the bispecific innate cellular activator targeting CD123/CD16A (ICE®) AFM28 which is being developed as a new treatment for patients with myeloid diseases, e.g. relapsed/refractory (R/R) acute myeloid leukemia (AML). AFM28 binds to natural killer (NK) cells and CD123 positive tumor cells and has been shown to induce tumor cell killing in vitro and good tolerance and strong antitumor activity live.

“It is widely recognized that targeting CD123 holds significant untapped promise in the development of better therapies for AML. We believe our differentiated approach in targeting CD123 has the potential to provide a novel therapy engaging the innate immune system to improve clinical outcomes,” said Dr. Arndt Schottelius, Chief Scientific Officer at Affimed. “Following these encouraging proof-of-concept preclinical data and the experience we have gained so far from our AFM13 studies, we will initiate a first-in-man clinical study to investigate the safety, efficacy and biological activity of the compound as monotherapy later this year and in combination with adoptive NK cells shortly thereafter.

The data presented at EHA today provides validation of the mechanism of action (MoA) as well as preclinical proof of concept for AFM28 in a range of in vitro and live dosages. AFM28 exhibited high affinity binding to CD16A expressed on NK cells and high avidity conferring long cell surface retention compared to Fc-enhanced anti-CD123 antibody. Additionally, AFM28 has been shown to destroy CD123-positive tumor cell lines and primary leukemic cells via antibody-dependent cell-mediated cytotoxicity (ADCC).

Importantly, AFM28 was active regardless of tumor cell mutation status and also induced depletion when CD123 expression was very low. Strikingly, AFM28 was also active against cells not killed by a comparator antibody targeting Fc-enhanced CD123, suggesting the potential for improved clinical efficacy. Moreover, AFM28 also depleted leukemia cells from the patient’s bone marrow without destroying CD34-positive/CD123-negative cells, suggesting sparing of hematopoietic stem and progenitor cells.

invivo studies in a mouse model of AML demonstrated anti-tumor efficacy, and cynomolgus toxicology models predicted pharmacodynamic activity with a well-tolerated safety profile and low risk of cytokine release syndrome.

Effective depletion of leukemic blasts and leukemic stem cells is essential to induce long-term remission in patients with AML. As both cell types express CD123, the ability of AFM28 to redirect NK cells to this target by killing both leukemic blasts and leukemic stem cells makes it an attractive treatment strategy. Currently, there are no curative immunotherapies available, the only option is allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Affimed plans to initiate clinical development of AFM28 with a first-in-man Phase 1 monotherapy trial in adult patients with R/R AML in the second half of 2022. In addition, Affimed plans to study AFM28 in combination with allogeneic NK cell therapy after a safe starting dose has been determined.

The complete poster is accessible via the following link: Publications and Posters – Affimed

Poster details:

Title: Novel Bispecific Innate Cell Commitment Agent 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

Date and time of the session: Poster session on Friday, June 10e10:30 a.m. – 11:45 a.m. EDT / 4:30 p.m. – 5:45 p.m. CEST

About AFM28

AFM28, a tetravalent, bispecific CD123- and CD16A-binding ICE® developed on Affimed’s ROCK® is designed to provide a novel immunotherapeutic treatment for patients with CD123+ myeloid malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). It engages NK cells to initiate tumor cell destruction via antibody-dependent cellular cytotoxicity (ADCC), even at low levels of CD123 expression. Clinical development is planned both as monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123-positive leukaemias.

About Affirmed NV

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to restoring patients’ innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s exclusive ROCK® The platform enables a tumor-targeted approach to recognize and kill a range of hematological and solid tumors, enabling a broad pipeline of single-agent and combination therapy programs in wholly owned and partnered ownership. The rock® the platform predictably generates personalized innate cellular engagement (ICE®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach allowed Affimed to become the first company to have a clinical-stage ICE®. Based in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotech and pharmaceutical leaders united by a bold vision to prevent cancer from derailing patients’ lives. To learn more about the company’s employees, pipeline and partners, please visit: www.affimed.com.

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