Affimed and NKMax America to Study the Combination of AFM24, an EGFR-Targeted Innate Cell Engager, with SNK01 Natural Killer ...
October 20 2020 - 6:30AM
- Proof of Concept study to establish safety and recommended dose
of Affimed’s innate cell engager (ICE®) AFM24 in combination with
NKMax America’s Natural Killer (NK) cells in solid tumors
- Pre-clinical data substantiates synergy between Affimed’s ICE®
molecules and both NKMax America’s autologous and cryopreserved
allogeneic NK cell therapy products
Heidelberg, Germany, and Santa Ana, California, October
20, 2020 – Affimed N.V. (NASDAQ: AFMD) and NKMax America
Inc., both clinical stage biotech companies focused on harnessing
the power of the body’s innate immune system, announced today that
they entered into a clinical collaboration agreement to investigate
the combination of AFM24, a CD16A/EGFR-targeted ICE®, with the
autologous NK cell product SNK01. Pursuant to the collaboration,
the companies plan to explore the combination in a first-in-human
proof-of-concept (POC) trial in patients with EGFR-expressing
tumors. The agreement follows a previous collaboration between the
two companies in the preclinical setting to better understand the
combined activity of their respective platforms. The results of the
preclinical collaboration have shown substantive synergy between
Affimed’s ICE® molecules and NKMax America’s autologous and
cryopreserved allogeneic natural killer cell products.
Under the agreement, the companies will contribute their
respective product candidates and resources towards submitting an
Investigational New Drug (IND) application to the U.S. Food and
Drug Administration (FDA) and a subsequent clinical trial. The
clinical trial will combine NKMax America’s SNK01 (enhanced natural
killer cells) with AFM24 in the autologous setting with the option
to expand the clinical trial to the allogeneic setting. The cost of
the clinical study will be shared by Affimed and NKMax America. The
agreement also provides for the opportunity to pursue further
clinical study combinations with additional product candidates from
both parties.
NKMax America has developed a proprietary NK cell expansion and
activation technology platform which allows it to produce
unprecedented commercial amounts of autologous and allogeneic NK
cells from numerous donors that have near total expression of
activating receptors like CD16A, NKG2D, NKp30 and NKp46. In
addition, its unique technology increases the cytotoxicity of the
expanded NK cells by nearly 8000 percent. In addition, the SNK01
product does not require lymphodepletion or cytokine support.
Using its ROCK® (Redirected Optimized Cell Killing) platform,
Affimed has developed a novel pipeline of ICE® products. AFM24, a
tetravalent, bispecific epidermal growth factor receptor (EGFR)-
and CD16A-binding ICE®, is unique due to its activation of innate
immunity to kill solid tumors, inducing both antibody-dependent
cellular cytotoxicity (ADCC) and antibody-dependent cellular
phagocytosis (ADCP), whereas other EGFR-directed therapies rely
heavily on signal transduction inhibition. A first-in-human Phase
1/2a open-label, non-randomized, multi-center, multiple ascending
dose escalation/expansion study is underway evaluating AFM24 as
monotherapy in patients with advanced solid EGFR-expressing
malignancies whose disease has progressed after treatment with
previous anticancer therapies.
“We believe combining ICE® molecules generated from our ROCK®
platform with adoptive NK cell transfer can improve patient
outcomes by ensuring patients have active and viable innate cells
to be directed to the tumor and induce cytotoxic killing. In
addition, through the high affinity binding to CD16A, our ICE®
molecules can ensure delivery of potent innate cells even to those
tumors with very low tumor antigen expression,” said Dr. Adi Hoess,
Affimed’s Chief Executive Officer. “Studies have shown that higher
numbers of NK cells are associated with improved patient responses.
By combining AFM24 with the autologous NK cell product from NKMax
America, we intend to provide clinically meaningful benefit to more
patients suffering from EGFR-expressing solid tumors where
mortality rates remain high.”
“By combining our two innovative technologies, we have the
potential to rapidly develop an entirely new class of therapeutics,
Chimeric Antigen-Like engaged NK cells, to better benefit patients
without the need for lymphodepletion,” said Paul Song, M.D., Vice
Chairman and Chief Medical Officer, NKMax America. “We believe this
approach offers a better alternative to the current process of
manufacturing genetically engineered cell therapies such as CAR-T
and CAR-NK products, which are expensive and inefficient,” he
concluded.
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.
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 I/IIa
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.
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
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.
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