Affimed Presents Updated Data for AFM28 Demonstrating Efficient Elimination of Leukemic Stem and Progenitor Cells in Combination with Allogeneic NK cells in Preclinical Models of Acute Myeloid Leukemia and Myelodysplastic Syndrome at the Annual ASH 2022
December 12 2022 - 10:00AM
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 presented a poster
highlighting new preclinical data for its Innate Cell Engager
(ICE®) AFM28 targeting CD123 and CD16A at the 64th American Society
of Hematology (ASH) Annual Meeting and Exposition in New Orleans,
Louisiana.
The data demonstrated the ability of AFM28 to
effectively redirect allogeneic NK cells and induce depletion of
CD123-positive leukemic blasts and leukemic stem cells in ex vivo
patient samples, underscoring its potential as a novel therapeutic
agent in AML. AFM28 is a novel ICE® in development for treatment of
patients with myeloid diseases that have undergone multiple prior
treatments and have relapsed or are refractory (R/R) to standard of
care. It is designed to bind to natural killer (NK) cells and
CD123-positive tumor cells to induce tumor cell killing. To date,
the program has shown strong anti-tumor activity in vivo while
maintaining a good safety profile.
“The evidence for AFM28’s ability to deplete
leukemic stem and progenitor cells through allogeneic NK cells
encourages us in our development path and provides hope that AFM28
could be a novel treatment option to induce long-term remissions in
refractory AML patients”, said Dr. Arndt Schottelius, Chief
Scientific Officer at Affimed. “We plan to initiate our first
in-human study in the first half of 2023.”
AML is a difficult-to-treat disease with low
cure rates and significant toxicities associated with available
therapies. There is an urgent need for new approaches that are
effective, provide long-term, relapse-free survival and are better
tolerated.
AFM28 holds promise as a novel safe and
effective therapeutic that could address the needs of underserved
patients with AML.
The poster presented at ASH featured detailed
preclinical evaluations further characterizing AFM28 and its
mechanisms of action in models of AML. The data confirmed a
concentration-dependent, NK cell-mediated lysis of CD123-positive
target cells in different tumor lines, irrespective of low CD123
expression or mutational status. In addition, high CD64 expression,
which negatively affects antibody-dependent cellular cytotoxicity
(ADCC) of conventional and Fc-enhanced anti-CD123 antibodies, did
not affect AFM28 efficacy.
A critical factor for long-term remission in AML
patients is the efficient and safe depletion of leukemic blasts and
corresponding stem cells. In ex vivo AML and MDS bone marrow
samples, AFM28 induced the depletion of CD123-positive leukemia
stem cells and leukemic progenitor cells while sparing healthy
cells, suggesting the ability to induce deep, anti-tumor responses
without irreversible bone marrow suppression. The ICE also showed
inhibition of tumor growth in murine AML models, underscoring the
anti-tumor activity of the program.
Affimed remains on track to initiate clinical
development of AFM28 with a first-in-human phase 1 monotherapy
trial in adult patients with R/R AML in the first half of 2023. In
addition, Affimed plans to investigate AFM28 in combination with
allogeneic NK cell therapy after a safe starting dose has been
determined.
The full poster is accessible through the following
link:https://affimed.com/affimed-science-technology/publications-and-posters/
Poster details:
Title: The Novel Bispecific Innate Cell Engager
(ICE®) AFM28 Efficiently Directs Allogeneic NK Cells to
CD123-positive leukemic cells Session: Molecular
Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster
IIIPresentation Date & Time: Monday, December
12, 2022, 6:00 - 8:00 p.m. CSTLocation: Ernest N.
Morial Convention Center, Hall D
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+
myeloid malignancies, including acute myeloid leukemia and
myelodysplastic syndrome. It engages natural killer (NK) cells to
initiate tumor cell killing via antibody-dependent cellular
cytotoxicity, 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 giving patients back their
innate ability to fight cancer by actualizing the untapped
potential of the innate immune system. The Company’s proprietary
Redirected Optimized Cell Killing (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 ContactAlexander
FudukidisDirector, Investor RelationsE-Mail:
a.fudukidis@affimed.com Tel.: +1 (917) 436-8102
Media ContactMary Beth SandinVice President,
Marketing and CommunicationsE-Mail: m.sandin@affimed.com Tel:
+1 (484) 888-8195
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