Affimed Announces Publication of Comprehensive Preclinical Data Demonstrating the Therapeutic Potential of AFM24 in EGFR-expressing Tumors
July 30 2021 - 6:30AM
Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology
company committed to giving patients back their innate ability to
fight cancer, announced today the publication of a comprehensive
preclinical in vitro and in vivo data package of its innate cell
engager (ICE®) AFM24 (CD16A/EGFR) in mAbs. The published data were
the basis for the Investigational New Drug (IND) clearance for
Affimed’s ongoing Phase 1/2a study with AFM24 monotherapy in
patients with EGFR expressing solid tumors. The preclinical data
demonstrates AFM24’s unique mechanism of action that harnesses the
innate immune system to induce tumor cell killing via
antibody-dependent cell-mediated cytotoxicity (ADCC) and
antibody-dependent cell phagocytosis (ADCP).
“These pre-clinical data are encouraging as they demonstrate the
potential for AFM24 to effectively target a broad set of tumors
expressing varying levels of EGFR, regardless of their mutational
status, and with the potential for less pronounced EGFR-related
toxicities than current treatment options,” said Arndt Schottelius,
M.D., Ph.D., Chief Scientific Officer at Affimed. “This could be
highly relevant for many patients with different tumor types
despite existing EFGR-targeting therapies as these have limitations
in efficacy and safety.”
Highlights of the recently published results include:
- AFM24 binds with high affinity to CD16A on NK cells
and macrophages in vitro.
- AFM24 potently induces ADCC via NK cells, and ADCP via
macrophages in vitro.
- AFM24 is effective against many
EGFR-positive tumor cells, regardless of EGFR expression
level and KRAS/BRAF mutational status within in vitro studies.
- AFM24 is well tolerated up to the highest dose level
(75 mg/kg) with no skin and other toxicities in cynomolgus
monkeys.
The full manuscript is available here:
https://bit.ly/3zLDq3i
About AFM24AFM24 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 a monotherapy for
patients with advanced EGFR-expressing solid malignancies whose
disease has progressed after treatment with previous anticancer
therapies. AFM24-101 is a first-in-human Phase 1/2a open-label,
non-randomized, multi-center, multiple ascending dose escalation
and expansion study and can be found at www.clinicaltrials.gov
using the identifier NCT04259450. In addition, Affimed is planning
to initiate further studies evaluating AFM24 in combination with
Roche’s atezolizumab, an anti-PD-L1 checkpoint inhibitor and,
separately, an investigation of AFM24 in combination with NKGen
Biotech’s autologous NK cell product.
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 StatementsThis
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 AFM13, AFM24, and
our other product candidates, 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 SEC. 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.
Affimed Investor ContactAlexander
FudukidisDirector, Investor RelationsE-Mail:
A.Fudukidis@affimed.comTel.: +1 (917) 436-8102
Media ContactMary Beth Sandin Vice President,
Marketing and CommunicationsE-Mail: M.Sandin@affimed.comTel: +1
(484) 888-8195
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Apr 2023 to Apr 2024