Affimed Announces First Patient Successfully Dosed in First-in-Human Phase 1/2A Study of AFM24 for the Treatment of Advanced ...
April 16 2020 - 7:30AM
- AFM24, designed to activate innate immunity to broadly target
EGFR-expressing solid tumors regardless of mutational status, has
the potential to improve efficacy and safety over currently
available EGFR-targeted therapies
- AFM24 is the first innate cell redirecting immuno-oncology
therapeutic dosed in solid tumor patients
Heidelberg, Germany, April 16, 2020
– Affimed N.V. (Nasdaq: AFMD), a clinical-stage
immuno-oncology company committed to giving patients back their
innate ability to fight cancer, today announced that the first
patient was successfully dosed in a Phase 1/2a clinical trial of
AFM24, a first in human study evaluating AFM24 as
monotherapy in patients with advanced solid malignancies whose
disease has progressed after treatment with previous anticancer
therapies. AFM24, a tetravalent, bispecific epidermal growth factor
receptor (EGFR)- and CD16A-binding innate cell engager, is novel
due to its activation of innate immunity to kill solid tumors,
inducing both antibody-dependent cellular cytotoxicity (ADCC) and
antibody-dependent cellular phagocytosis (ADCP), as compared to
other therapies that rely heavily on signal or checkpoint
inhibition.
“Today is a landmark day for Affimed and, more
importantly, for patients whose solid tumors continue to progress,”
said Dr. Adi Hoess, Chief Executive Officer of Affimed. “This major
milestone marks the first time a patient with solid tumors has been
dosed with an innate cell engager. AFM24 has demonstrated
preclinically the ability to bridge NK cells and macrophages to
EGFR-expressing tumor cell lines, and to induce lysis through ADCC
and ADCP, respectively, independent of RAS mutational status. We
look forward to the continued study of this novel agent and further
validating its safety and efficacy through this human clinical
trial.”
“Initiation of dosing in the first in human
clinical trial of AFM24 is exciting news for the broad set of
patients with hard to treat EGFR-expressing cancers,” said Dr.
Anthony El-Khoueiry, Phase I program director at the USC Norris
Comprehensive Cancer Center and Keck School of Medicine, and
principal investigator for the study. “While available EGFR
therapies have improved the lives of patients, new therapeutic
options are needed that are broadly efficacious, easier for
patients to tolerate and can also address the issue of resistance
associated with currently available treatments.”
The study is an open-label, non-randomized,
multi-center, multiple ascending dose escalation/expansion study to
evaluate AFM24 as monotherapy in adult patients with advanced solid
malignancies known to be EGFR-positive. The aim of the dose
escalation phase is the determination of the maximum tolerated dose
and the establishment of a recommended Phase 2a dose. The dose
expansion phase is intended to collect preliminary evidence of
efficacy and to further confirm the safety of AFM24. For more
information including eligibility criteria, visit
www.clinicaltrials.gov, using Identifier NCT04259450.
About AFM24
AFM24 is a tetravalent, bispecific EGFR- and
CD16A-binding innate cell engager generated from Affimed’s
fit-for-purpose ROCK® platform. AFM24 uses the cytotoxic potential
of the innate immune system by redirecting and activating NK cells
and macrophages to kill EGFR-positive cancer cells through
antibody-dependent cellular cytotoxicity (ADCC) and
antibody-dependent cellular phagocytosis (ADCP), respectively. Due
to its unique mechanism of action, AFM24 is potentially not limited
to patient subtypes based on mutational status. 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 therapies.
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. 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. The
company’s initial clinical program, AFM13 for CD30-positive
lymphomas, is currently enrolling patients for a
registration-directed study in relapsed/refractory peripheral T
cell lymphoma. 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 potential of
AFM24, 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, 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,
impacts of the COVID-19 pandemic, the benefits to Affimed of orphan
drug designation 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
Contacts:
Gregory Gin, Head of Investor RelationsE-Mail:
IR@affimed.com
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