Affimed Announces Collaboration with Roche to Study AFM24 in Combination with PD-L1 Checkpoint Inhibitor in EGFR Expressing S...
Heidelberg, Germany, February 3, 2021 – Affimed
N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company
committed to giving patients back their innate ability to fight
cancer, announced today that it has entered into a clinical
research collaboration with Roche to explore the combination of
Affimed’s innate cell engager (ICE®) AFM24 with Roche’s PD-L1
checkpoint inhibitor atezolizumab (Tecentriq®).
Under the terms of the agreement, Affimed will fund and conduct
a Phase 1/2a clinical trial to investigate the combination of AFM24
and atezolizumab for the treatment of advanced solid epidermal
growth factor receptor (EGFR) expressing malignancies in patients
whose disease has progressed after treatment with previous
anticancer therapies. Roche will supply Affimed with atezolizumab
for the clinical trial. The Phase 1/2a study will establish a
dosing regimen for the combination therapy and assess safety and
“AFM24 is a first-in-class innate cell engager that we believe
has the potential to bring benefit to a broad set of patients as
monotherapy and in combination with other I/O therapies to address
disease states where co-activation of the innate and adaptive
immune systems is beneficial,” said Dr. Adi Hoess, CEO of Affimed.
“This collaboration with Roche is an important step in our
continued execution of AFM24’s clinical development strategy.
Importantly, preclinical and clinical studies indicate that ICE®
and PD-(L)1 checkpoint inhibition therapy could act
synergistically, which drives our optimism about the combination of
AFM24 with atezolizumab and its promise as a possible treatment
option for patients with EGFR expressing solid tumors.”
AFM24 is a novel tetravalent, bispecific EGFR- and CD16A-binding
innate cell engager that activates innate immunity by inducing both
antibody-dependent cellular cytotoxicity (ADCC) and
antibody-dependent cellular phagocytosis (ADCP). AFM24 has shown an
acceptable safety profile and antitumor activity in preclinical
studies. AFM24 is currently being evaluated as monotherapy in adult
patients with advanced solid malignancies known to be EGFR-positive
in an open-label, non-randomized, multi-center, multiple ascending
dose escalation/expansion study.
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.
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.
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