Affimed Announces Successful Completion of First Dose Cohort in First-in-Human Phase 1/2A Study of AFM24 for the Treatment of...
June 17 2020 - 6:30AM
- 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
- The 2nd dose cohort is open for patient recruitment
Heidelberg, Germany, June 17,
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 the successful
completion of the first dose cohort in a Phase 1/2a clinical trial
of AFM24. This first-in-human study evaluates AFM24 as
monotherapy in patients with advanced solid EGFR expressing
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). Other therapies rely heavily on signal or checkpoint
inhibition.
The company reports that no dose limiting toxicity was observed
and the study is cleared to proceed the next dose level (cohort
2). No efficacy yet was observed, however, efficacy was not
expected at this dose level.
“As we progress to the 2nd dose cohort, we take
another step closer to giving patients a new treatment option with
a distinctive mechanism that mobilizes the innate immune system to
attack cancer cells” said Dr. Andreas Harstrick, Chief Medical
Officer of Affimed. “The innate immune system is inherently
powerful, yet it has been largely untapped as a therapeutic
approach to fight cancer. With the clinical progress we are
making we are hopeful that AFM24 will become an important option to
provide long-lasting, multilayered tumor control.”
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 or BRAF mutational status.
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. Toxicology studies
in 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 is currently enrolling patients into a
registration-directed study of AFM13 for CD30-positive
relapsed/refractory peripheral T cell lymphoma and into a Phase
1/2a dose escalation/expansion study of AFM24 for the treatment of
advanced EGFR-expressing 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 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.
Investor & Media Contact:
Alex Fudukidis, Head of Investor RelationsE-Mail:
IR@affimed.com
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