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, has announced the
presentation of new data on AFM24 and AFM28 in two posters at the
19th Meeting of the Society for Natural Immunity (NK2022).
The AFM24 presentation showed correlative
science data of the exposure and pharmacodynamic effects of the
compound in patients with epidermal growth factor receptor
(EGFR)-expressing solid tumors from the ongoing phase 1/2a study.
The poster featured an analysis of the longitudinal effects of
AFM24, a CD16A/EGFR‑targeting bispecific innate cell engager
(ICE®), in patients treated in the AFM24-101 phase 1/2a clinical
study, confirming the mechanism of action of AFM24 on the innate
immune system.
The correlative science data further supports
the rationale for combining different therapeutic approaches in
patients with EGFR-expressing solid tumors. AFM24 engages CD16A on
natural killer (NK) cells and macrophages with higher affinity than
monoclonal antibodies, and triggers antibody-dependent cellular
cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis
(ADCP), respectively, directed at EGFR-expressing cancer cells.
Preclinical data have shown that AFM24 can induce NK cell-mediated
killing of EGFR-positive solid tumor cell lines, independent of
EGFR mutational status.
The analysis also showed activation of cytotoxic
T cells in the periphery, and infiltration of T cells into the
tumor bed, suggesting stimulation of anti-cancer immunity beyond
the innate immune system and the possible engagement of the
adaptive immune system. These data support the rationale for AFM24
as monotherapy and the two combinations that are currently under
way in separate phase 1/2a studies – with autologous NK cell
therapy and with immune checkpoint inhibition.
The AFM28 poster featured preclinical data on
the anti-leukemic activity of the compound when pre-complexed and
co-administered with allogeneic NK cells.
AFM28 is a novel ICE® binding to CD16A on NK
cells, and CD123 on acute myeloid leukemia (AML) and
myelodysplastic syndrome (MDS) tumor cells. The novel bispecific
engager binds with high affinity to NK cells stimulating them to
destroy CD123-positive tumor cells via ADCC. In addition, AFM28
exhibits greater cell surface retention than conventional
monoclonal antibodies, including Fc-enhanced IgG1.
Furthermore, the data presented at the
conference demonstrate that AFM28 stimulates lysis of
CD123-positive tumor cells in both formats, pre-complexed or when
co-administered with NK cells. The poster also demonstrated the
feasibility of cryopreserving AFM28 pre-complexed with NK cells
whilst maintaining anti-tumor activity suggesting the promise for
an off-the-shelf therapy targeting leukemic blasts and leukemic
stem cells in patients with AML and MDS.
Poster details:
Title: Analysis of the
Longitudinal Effects of AFM24, a CD16A/Epidermal Growth Factor
Receptor-Targeting (EGFR) Bispecific Innate Cell Engager, Confirms
the Mechanism of Action and Supports the Rationale for Combination
Approaches in Patients with EGFR-Expressing Solid
Tumors
Authors: Gabriele Hintzen,
Susanne Wingert, Michael Emig, Kerstin Pietzko, Uwe Reusch, Melissa
M. Berrien‐Elliott, Todd A. Fehniger, Mark Foster, Paolo Nuciforo,
Tyler Burns, Paulien Ravenstijn, Stefan Knackmuss, Bettina Rehbein,
Joachim Koch, Arndt Schottelius, and Erich Rajkovic
Title: Novel Bispecific
Innate Cell Engager AFM28 in Combination with
Allogeneic NK Cells for the Treatment of
CD123+ Acute Myeloid Leukemia and
Myelodysplastic Syndrome
Authors: Jens Pahl, Jana-Julia
Siegler, Armin Beez, Rebecca Hussong, Sabrina Purr, Lena Wagner,
Nicole Schulze, Tatjana Kosbar, Uwe Reusch, Joachim Koch, Arndt
Schottelius, Thorsten Ross, Christian Merz and Sheena Pinto
About AFM24
AFM24 is a tetravalent, bispecific innate cell
engager (ICE®) that activates the innate immune system by binding
to CD16A on innate immune cells and EGFR, a protein widely
expressed on solid tumors, to kill cancer cells. Generated by
Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a
distinctive mechanism of action that uses EGFR as a docking site to
engage innate immune cells for tumor cell killing through
antibody-dependent cellular cytotoxicity and antibody-dependent
cellular phagocytosis.
Affimed is evaluating AFM24 in patients with
advanced EGFR-expressing solid malignancies whose disease has
progressed after treatment with previous anticancer therapies as
monotherapy and in combinations with other cancer treatments.
AFM24-101, a monotherapy, first-in-human phase 1/2a open-label, is
a non-randomized, multi-center, multiple ascending dose escalation
and expansion study. Additional details may be found
at www.clinicaltrials.gov using the identifier
NCT04259450. Furthermore, AFM24 is being evaluated in a phase 1/2a
study in combination with Roche’s anti-PD-L1 checkpoint inhibitor
atezolizumab (AFM24-102, NCT05109442). Affimed and NKGen Biotech
have initiated a phase 1/2a study (AFM24-103), investigating AFM24
in combination with SNK01, NKGen Biotech’s NK cell product
(NCT05099549).
About AFM28
AFM28 is a tetravalent, bispecific innate cell
engager (ICE®) that activates the innate immune system by binding
to CD16A on innate immune cells and CD123-positive cells on myeloid
malignancies.
Developed on Affimed’s ROCK® platform, it is
designed to bring a new immunotherapeutic approach to patients with
CD123-positive myeloid malignancies, including acute myeloid
leukemia and myelodysplastic syndrome (MDS). AFM28 engages NK cells
to initiate tumor cell killing via antibody-dependent cellular
cytotoxicity (ADCC), and binds CD123-positive cancer cells even at
low 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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