Affimed and NKMax America Announce FDA Clearance of IND Application to Study the Combination of AFM24, an EGFR Targeted Innat...
March 31 2021 - 6:30AM
Heidelberg, Germany and Santa Ana, Calif., March 31,
2021 - Affimed N.V. (NASDAQ: AFMD), a clinical-stage
immuno-oncology company, and NKMax America Inc., a clinical stage
biotech company, announced today that the U.S. Food and Drug
Administration (FDA) cleared an investigational new drug
application (IND) for an Affimed and NKMax America co-sponsored
Phase 1/2a dose escalation and expansion study in which the
two companies will investigate the combination of AFM24, an
EGFR/CD16A innate cell engager (ICE®), and SNK-01, an autologous
NK-cell product, in patients suffering from tumors known to express
EGFR. The combination represents a novel approach to exploring
innate immunity-based therapeutics to treat patients with solid
tumors who failed conventional therapy with the aim to improve
outcomes for high-medical need patient populations.
“This combination is part of our overall development strategy
for AFM24, the first and only innate cell engager in clinical
development for solid tumors. In addition to NK cell-based
combinations, we are also developing AFM24 as single agent and in
combination with atezolizumab in several tumor indications,” said
Dr. Andreas Harstrick, Affimed’s Chief Medical Officer. “The
mechanism of action of the two compounds could be highly
synergistic as AFM24 has strong binding affinity to NK cells,
directing them to kill tumor cells. Moreover, this combination
approach represents an opportunity to supplement patients with
dysregulated innate immune systems with targeted cellular
therapy.”
“The FDA clearance of our IND application for SNK-01 in
combination with AFM24 is an important milestone for our Natural
Killer cell therapy development program,” said Stephen Chen, Chief
Operating Officer and Chief Technical Officer of NKMax
America. “We look forward to investigating this combination
as part of our comprehensive strategy aimed at producing a cell
therapy for patients with advanced/metastatic EGFR-expressing
cancers.”
Further Information About the AFM24/SNK-01 Phase 1/2a
study
The Phase 1/2a study is based on preclinical in vitro testing,
combining Affimed’s ICE® AFM24 with NKMax America autologous
NK-cell product SNK-01, which showed enhanced activity of NK cell
induced target cell killing. The Phase 1/2a study will be an
open-label, non-randomized, multi-center, US only, dose escalation
trial to evaluate the combination in adult patients with
EGFR-expressing tumors. The primary objective of the phase 1 study
part will be to establish the safety and the recommended phase 2
dose of AFM24/SNK-01 combination, as well as to evaluate
pharmacokinetics, pharmacodynamics, and preliminary activity in
patients with advanced cancers expressing EGFR. The phase 2a
portion of the study will evaluate the preliminary efficacy of
AFM24 in patients with select solid tumor subtypes.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology
company committed to give patients back their innate ability to
fight cancer by actualizing the untapped potential of the innate
immune system. The company’s proprietary ROCK® platform enables a
tumor-targeted approach to recognize and kill a range of
hematologic and solid tumors, enabling a broad pipeline of
wholly-owned and partnered single agent and combination therapy
programs. The ROCK® platform predictably generates customized
innate cell engager (ICE®) molecules, which use patients’ immune
cells to destroy tumor cells. This innovative approach enabled
Affimed to become the first company with a clinical-stage ICE®.
Headquartered in Heidelberg, Germany, with offices in New York, NY,
Affimed is led by an experienced team of biotechnology and
pharmaceutical leaders united by a bold vision to stop cancer from
ever derailing patients’ lives. For more about the company’s
people, pipeline and partners, please visit: www.affimed.com.
About NKMax America
NKMax America Inc. is a clinical stage biotechnology company
dedicated to restoring and enhancing overall immune integrity. Our
proprietary natural killer cell expansion and activation technology
achieves infinite fold natural killer cell expansion with greatly
enhanced cytotoxicity across its autologous and allogeneic products
which are all derived from peripheral blood. Our first in class
autologous product, SNK-01, is currently in a Phase I clinical
trial in advanced refractory solid tumors and in a Phase 1/2a
combination trial with Keytruda in Stage IV non-small cell lung
cancer. The company and its commercially licensed cGMP facility are
headquartered in Santa Ana, California, USA.
www.nkmaxamerica.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 intentions, beliefs,
projections, outlook, analyses and current expectations concerning,
among other things, the potential of Affimed’s ROCK® platform, ICE®
product candidates and AFM24, NKMax America’s NK cell technology
and SNK-01, and preclinical development and clinical trials, 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
neither company assumes any obligation to update these
forward-looking statements, even if new information becomes
available in the future.
Affimed Investor Contact
Alex FudukidisHead of Investor RelationsEmail:
a.fudukidis@affimed.com Tel.: +1 (917) 436-8102
NK Max America Contact
Denise Chua, MBA, CLS, MT (ASCP)Vice President, MarketingEmail:
dchua@nkmaxamerica.com Tel.: +1 (949)
396-6830
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