Affimed Announces FDA Clearance of IND to Commence First-in-Human Phase 1/2a Study of AFM24 for the Treatment of EGFR-Express...
November 07 2019 - 04:01PM
- Activation of innate immunity to target EGFR-expressing solid
tumors has potential to address limitations associated with
currently available EGFR-targeted therapies
- Initiation of Phase 1/2a clinical trial expected in first half
of 2020
Heidelberg, Germany, November 7, 2019 - Affimed
N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company
committed to giving patients back their innate ability to fight
cancer, today announced that its Investigational New Drug
application (IND) has cleared the required 30-day review by the
U.S. Food and Drug Administration (FDA) and is in effect for a
Phase 1/2a clinical trial of AFM24, a tetravalent, bispecific
epidermal growth factor receptor (EGFR)- and CD16A-binding innate
cell engager, in patients with advanced cancers known to express
EGFR.
“The IND clearance of AFM24 enables us to
proceed with our planned Phase 1/2a study aimed at establishing
safety and identifying initial signals of efficacy in patients with
EGFR-expressing solid tumors,” said Dr. Adi Hoess, Chief Executive
Officer of Affimed. “There is a tremendous need for novel
immuno-oncology approaches and based on its novel mechanism of
activating the innate immune system, AFM24 has the potential to
address limitations, such as toxicities or resistance, associated
with other EGFR-targeted therapies.”
The initial goal of the planned Phase 1/2a study
is to determine the maximum tolerated dose and recommended Phase 2
dose of AFM24, as well as to evaluate the safety, pharmacokinetics,
pharmacodynamics, and preliminary efficacy. The second part of the
study is designed to evaluate the preliminary efficacy of AFM24 in
patients with select solid tumor subtypes. The study is planned to
initiate in the first half of 2020.
AFM24 has the potential to provide a meaningful
benefit to a broad set of patients suffering from EGFR-expressing
tumors, including those patients who currently are not being
addressed by existing EGFR-targeted therapies. According to
internal market research, leading clinical experts across multiple
cancer indications see a tremendous need for novel immuno-oncology
approaches for the treatment of solid tumors. Preclinical data
showed AFM24’s ability to bridge NK cells and macrophages to
EGFR-expressing tumor cell lines and induce cell lysis through
antibody-dependent cellular cytotoxicity (ADCC), independent of RAS
mutational status, and antibody-dependent cellular phagocytosis
(ADCP). In addition, AFM24 enhanced tumor infiltration of NK cells
and elicited dose-dependent anti-tumor efficacy in in vivo tumor
models. Treatment of cynomolgus monkeys with AFM24 showed a
favorable safety profile, even when the animals were treated at
high dose levels, demonstrating AFM24’s potential to have lower
toxicities in humans compared to other EGFR-targeted
therapeutics.
About AFM24
AFM24, a tetravalent, bispecific EGFR- and
CD16A-binding innate cell engager from Affimed’s fit-for-purpose
ROCK® platform, is designed to address limitations associated with
other EGFR-targeted therapies, such as toxicities or resistance, by
using a new mechanism of action to target EGFR-expressing solid
tumors through activation of innate immunity rather than inhibition
of EGFR-mediated signal transduction.
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 cell engagers to be designed for specific
patient populations. The Company is developing single and
combination therapies to treat hematologic and solid tumors. 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 and Media
Contact:Gregory Gin, Head of Investor RelationsE-Mail:
IR@affimed.com
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