Affimed Presents Preclinical Data of Novel Innate Cell Engager AFM28 at the Annual Meeting of the European Hematology Association (EHA)
June 10 2022 - 10:31AM
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
at the Annual Meeting of the European Hematology Association (EHA)
in Vienna, Austria. The data demonstrate the cytotoxic
potential of the CD123/CD16A-targeting bispecific innate cell
engager (ICE®) AFM28 which is in development as a novel 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 demonstrated the induction
of tumor cell killing in vitro and a good tolerability and strong
anti-tumor activity in vivo.
“It is widely acknowledged that targeting CD123
holds significant untapped promise in developing better AML
therapies. We believe our differentiated approach in targeting
CD123 has the potential to provide a novel, innate immune
system-engaging therapy to improve clinical outcomes,” said Dr.
Arndt Schottelius, Chief Scientific Officer at Affimed. “Following
these encouraging pre-clinical proof-of-concept data and the
experience we have gained from our AFM13 studies so far, we will be
launching a first-in-human clinical study to investigate the
compound’s safety, efficacy and biological activity as monotherapy
later this year and in combination with adoptive NK cells soon
after.”
The data presented at EHA today provide
validation of the mechanism of action (MoA) as well as preclinical
proof-of-concept for AFM28 in a range of in vitro and in vivo
assays. AFM28 exhibited high-affinity binding to CD16A expressed on
NK cells and high avidity conferring long cell surface retention in
comparison to Fc-enhanced anti-CD123 antibody. Moreover, AFM28
demonstrated the ability to destroy CD123-positive tumor cell lines
and primary leukemic cells via antibody-dependent cell-mediated
cytotoxicity (ADCC).
Importantly, AFM28 was active irrespective of
mutational status of tumor cells and also induced depletion when
CD123 expression was very low. Strikingly, AFM28 was also active
against cells not killed by an Fc-enhanced CD123-targeting
comparator antibody suggesting the potential for improved clinical
effectiveness. Moreover, AFM28 also depleted leukemic cells from
patient bone marrow without destroying CD34-positive/CD123-negative
cells, suggesting sparing of hematopoietic stem and progenitor
cells.
In vivo studies in an AML murine model
demonstrated anti-tumor efficacy, and cynomolgus toxicology models
predicted pharmacodynamic activity with a well-tolerated safety
profile and low risk of cytokine release syndrome.
Efficient depletion of leukemic blasts and
leukemic stem cells is critical for inducing long-term remission in
AML patients. As both cell types express CD123, AFM28’s ability to
redirect NK cells to this target killing both leukemic blasts and
leukemic stem cells makes this an attractive treatment strategy.
Currently, there are no curative immunotherapies available, the
only option is allogenic hematopoietic stem cell transplantation
(allo-HSCT).
Affimed plans to initiate clinical development
of AFM28 with a first-in-human phase 1 monotherapy trial in adult
patients with R/R AML in the second half of 2022. 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: Publications and Posters - Affimed
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 10th, 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 treatment 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-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:
www.affimed.com.
Investor Relations Contact
Alexander FudukidisDirector, Investor
RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102
Media Contact
Mary Beth Sandin Vice President, Marketing and
CommunicationsE-Mail: m.sandin@affimed.com Tel.: +1 (484)
888-8195
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