Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a
clinical-stage immuno-oncology company committed to giving patients
back their innate ability to fight cancer, today announced that an
abstract with clinical trial results of its innate cell engager
(ICE®) AFM24 in combination with NKGen Biotech’s SNK01 (autologous
non-genetically modified NK cells), has been accepted for a poster
presentation at the ASCO Breakthrough conference from 3-5 August
2023 in Yokohama, Japan. The presentation includes dose escalation
phase data on safety and efficacy of the phase 1 study in patients
with advanced or metastatic EGFR-expressing solid tumors
(NCT05099549).
As of June 2023, seven patients with a mean number of five prior
therapies received the combination of AFM24 and SNK01. No
unexpected or dose-limiting toxicities were observed, and the PK
properties were similar to AFM24 monotherapy. The best objective
response was stable disease in three out of the seven patients,
including patients with heavily pretreated microsatellite stable
colorectal cancer (MSS CRC).
“The poster at ASCO Breakthrough is the first clinical
presentation of a bispecific NK cell engager in combination with
autologous NK cells,” said Dr. Anthony El-Khoueiry, Associate
Director of Clinical Research and Phase I Program Director at the
USC Norris Comprehensive Cancer Center and principal investigator
of the AFM24 studies. “Our data establish the feasibility of this
novel combinatorial approach; the stabilization of disease in
heavily pre-treated patients with microsatellite stable colorectal
cancer was clinically meaningful.”
“The data presented provide proof-of-concept for the combination
of AFM24 with NK cells with good tolerability,” said Dr. Andreas
Harstrick, Chief Medical Officer at Affimed. “Despite this, Affimed
and NKGen Biotech mutually decided to discontinue the presented
study. In line with Affimed’s NK cell combination experience for
AFM13, Affimed is currently evaluating the best option to advance
AFM24 with an allogeneic off-the-shelf NK cell product.”
Details of the poster presentation are as follows:
Title: AFM24 in combination with autologous NK
cells (SNK01) in patients with advanced/metastatic epidermal growth
factor receptor (EGFR) expressing solid tumors: Initial results
from the Phase 1 dose‑escalation study
Presenting Author: Anthony B. El-Khoueiry
Poster Session: Poster Session A, August 3,
2023, 11:45 – 13:15 JST (GMT+9)
Poster Number: 26
More details about the ASCO Breakthrough conference are
available online at Breakthrough: ASCO in Asia | ASCO
Breakthrough
About AFM24
AFM24 is a tetravalent, bispecific innate cell engager (ICE®)
that activates the innate immune system by binding to CD16A on
innate immune cells and EGFR, a protein widely expressed on solid
tumors, to kill cancer cells. Generated by Affimed’s
fit-for-purpose ROCK® platform, AFM24 represents a distinctive
mechanism of action that uses EGFR as a docking site to engage
innate immune cells for tumor cell killing through
antibody-dependent cellular cytotoxicity and antibody-dependent
cellular phagocytosis.
Affimed is evaluating AFM24 as monotherapy and in combinations
with other cancer treatments in patients with advanced
EGFR-expressing solid malignancies whose disease has progressed
after treatment with previous anticancer therapies.
AFM24-101, a monotherapy, first-in-human phase 1/2a open-label,
is a non-randomized, multi-center, multiple ascending dose
escalation and expansion study. Additional details may be found at
www.clinicaltrials.gov using the identifier NCT04259450.
AFM24 is also being evaluated in a phase 1/2a study in
combination with Roche’s PD-L1 checkpoint inhibitor atezolizumab
(AFM24-102, NCT05109442).
Furthermore, Affimed and NKGen Biotech are investigating AFM24
in combination with NKGen Biotech’s NK cell SNK01 in a phase 1/2a
study (AFM24-SNK01-103, NCT05099549).
Based on the totality of the data accumulated for AFM24, the
Company has decided to focus AFM24’s near-term development on
advancing AFM24 in combination with checkpoint inhibitors. Affimed
is also evaluating options for a combination of AFM24 with an
allogeneic off-the-shelf NK cell product which the Company expects
to be well suited for heavily pretreated patient populations.
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 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.
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 the Company’s
intentions, beliefs, projections, outlook, analyses and current
expectations concerning, among other things, the potential of
AFM13, AFM24, AFM28 and the Company’s other product candidates, the
value of its ROCK® platform, its ongoing and planned preclinical
development and clinical trials, its collaborations and development
of its products in combination with other therapies, the timing of
and its ability to make regulatory filings and obtain and maintain
regulatory approvals for its product candidates, its intellectual
property position, its collaboration activities, its ability to
develop commercial functions, clinical trial data, its results of
operations, cash needs, financial condition, liquidity, prospects,
future transactions, growth and strategies, the industry in which
it operates, the macroeconomic trends that may affect the industry
or the Company, such as the instability in the banking sector
experienced in the first quarter of 2023, impacts of the COVID-19
pandemic, the benefits to Affimed of orphan drug designation, the
impact on its business by political events, war, terrorism,
business interruptions and other geopolitical events and
uncertainties, such as the Russia-Ukraine conflict, the fact that
the current clinical data of AFM13 in combination with NK cell
therapy is based on AFM13 precomplexed with fresh allogeneic cord
blood-derived NK cells from The University of Texas MD Anderson
Cancer Center, as opposed to Artiva’s AB-101 and other
uncertainties and factors described under the heading “Risk
Factors” in Affimed’s filings with the SEC. Given these risks,
uncertainties, and other factors, you should not place undue
reliance on these forward-looking statements, and the Company
assumes no obligation to update these forward-looking statements,
even if new information becomes available in the future.
Investor Relations Contact
Alexander FudukidisDirector, Investor
RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102
Media Contact
Mary Beth Sandin Vice President, Marketing and
CommunicationsE-Mail: m.sandin@affimed.com
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