Heidelberg, Germany, April 1, 2019 – Affimed
N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company
committed to giving patients back their innate ability to fight
cancer, today announced data highlights from two presentations
featuring the Company’s fit-for-purpose ROCK® (Redirected Optimized
Cell Killing) platform, which enables the generation of
first-in-class, tetravalent, multi-specific innate cell engagers,
at the American Association of Cancer Research (AACR) Annual
Meeting 2019 being held March 29-April 3, 2019 in Atlanta, GA.
Data include preclinical advances with AFM24 and
AFM13. AFM24 is a tetravalent, bispecific EGFR- and CD16A-binding
innate cell engager built off the ROCK® platform designed to target
EGFR-expressing solid tumors by using a new mechanism of action
that activates innate immunity rather than working through
inhibition of EGFR-mediated signal transduction. This approach
shows that innate cell engagers enable targeting of clinically
validated tumor antigens where current therapies have shown limited
efficacy and/or dose-limiting toxicities. The second poster is
about AFM13, the Company’s first-in-class tetravalent, bispecific
innate cell engager that specifically binds to CD30 on tumor cells
and to CD16A on innate immune cells (natural killer (NK) cells and
macrophages).
“The preclinical characterization shows AFM24’s
potential to redirect innate immune cells to EGFR-expressing solid
tumors. We believe AFM24 could provide broader efficacy through
higher potency as compared to current therapeutic anti-EGFR
monoclonal antibodies, while potentially offering a more favorable
safety profile,” said Dr. Adi Hoess, Chief Executive Officer of
Affimed. “In addition, we are focused on developing AFM13 in
combination therapy with adoptive NK cell-based therapies and the
new preclinical data with AFM13 presented at AACR substantiate this
strategy.”
Preclinical characterization of the
bispecific EGFR/CD16A innate immune cell engager AFM24 for the
treatment of EGFR-expressing solid tumors (Abstract
#559)
Affimed presented data that highlight
potentially differentiating features of AFM24 versus standard of
care anti-EGFR therapies, such as cetuximab. AFM24 demonstrated the
ability to bridge NK cells and macrophages to EGFR expressing tumor
cell lines, and induced lysis through antibody-dependent cellular
cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis
(ADCP), respectively, which was independent of RAS mutational
status. AFM24 enhanced tumor infiltration of NK cells and elicited
dose-dependent anti-tumor efficacy in in vivo tumor models.
Importantly, AFM24 showed reduced inhibition of EGFR
phosphorylation relative to the standard of care, the monoclonal
antibody cetuximab. Treatment of cynomolgus monkeys with AFM24
resulted in a favorable safety profile, even when treated at high
dose levels, demonstrating AFM24’s potential to have significantly
lower toxicities in humans compared to standard of care.
Affimed anticipates completing investigational
new drug (IND)-enabling studies of AFM24 by mid-year 2019 to
support the initiation of the first-in-human study of AFM24 in the
second half of 2019.
The CD30/CD16A bispecific innate immune
cell engager AFM13 elicits heterogeneous single cell NK cell
responses and effectively triggers memory like (ML) NK cells
(Abstract #1546)
Affimed with its collaboration partners from
Washington University School of Medicine, St. Louis, MO, led by
Todd A. Fehniger, M.D., Ph.D., Associate Professor of Medicine,
Oncology Division, presented data that describe functional
responses of conventional and cytokine-induced memory-like (CIML)
NK cells in the presence or absence of AFM13. In particular,
applying functional mass cytometry (CyTOF), AFM13-triggered
functional responses were evaluated at single cell resolution,
providing important insights into AFM13’s effects on NK cells on a
molecular level.
In detail, the study showed that AFM13
significantly enhanced NK cell recognition of CD30-positive tumor
cells and this enhanced tumor recognition correlated with superior
NK cell activation. The combination of CIML NK cells with AFM13
potentiated cytokine secretion and cytotoxicity towards tumor
target cells, thereby further substantiating Affimed’s rationale
for combining AFM13 with adoptive NK cell-based therapies as a
promising therapeutic approach for treating CD30-positive
malignancies. In addition, the methodology applied here could be
used to identify key factors mediated by AFM13, which may possibly
lead to the identification of rational combinations of AFM13 with
other target molecules.
Affimed anticipates a clinical study of AFM13
pre-mixed with expanded cord blood-derived allogeneic NK cells,
under the sponsorship of its clinical collaborators at The
University of Texas MD Anderson Cancer Center (MDACC), could
commence in the first half of 2019.
Abstracts can be found at www.aacr.org.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical stage
biopharmaceutical company committed to giving patients back their
innate ability to fight cancer. Affimed’s fit-for-purpose ROCK®
platform allows innate immune engagers to be designed for specific
patient populations. The Company is developing single and
combination therapies to treat cancers. For more information,
please visit www.affimed.com.
FORWARD-LOOKING STATEMENTS This
press release contains forward-looking statements. All statements
other than statements of historical fact are forward-looking
statements, which are often indicated by terms such as
"anticipate," "believe," "could," "estimate," "expect," "goal,"
"intend," "look forward to", "may," "plan," "potential," "predict,"
"project," "should," "will," "would" and similar expressions.
Forward-looking statements appear in a number of places throughout
this release and include statements regarding our intentions,
beliefs, projections, outlook, analyses and current expectations
concerning, among other things, the value of our ROCK® platform,
our ongoing and planned preclinical development and clinical
trials, our collaborations and development of our products in
combination with other therapies, the timing of and our ability to
make regulatory filings and obtain and maintain regulatory
approvals for our product candidates our intellectual property
position, our collaboration activities, our ability to develop
commercial functions, expectations regarding clinical trial data,
our results of operations, cash needs, financial condition,
liquidity, prospects, future transactions, growth and strategies,
the industry in which we operate, the trends that may affect the
industry or us and the risks uncertainties and other factors
described under the heading “Risk Factors” in Affimed’s filings
with the Securities and Exchange Commission. Given these risks,
uncertainties and other factors, you should not place undue
reliance on these forward-looking statements, and we assume no
obligation to update these forward-looking statements, even if new
information becomes available in the future.
Affimed Investor Contact: Gregory
Gin, Head of Investor RelationsE-Mail: IR@affimed.com
Affimed Media Contact: Anca
Alexandru, Head of Communications, EU IRE-Mail:
media@affimed.com
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