Affimed Announces Presentation of Data on Genentech’s RO7297089 and AFM24, Both Innate Cell Engagers Developed from Affimed...
June 22 2020 - 09:20AM
- Data Presented at AACR Virtual Annual Meeting II demonstrate
that Affimed’s ROCK® platform has the ability to produce diverse
Innate Cell Engagers for a multitude of hematologic and solid tumor
cancers with consistent profiles in tumor lyses and safety
- Data on both Affimed’s AFM24 (CD16A/EGFR) and Genentech’s
RO797089 (CD16A/BCMA) show potent killing in tumor cell lines at
low target expression in the relevant pre-clinical models
- Both Innate Cell Engagers show dual Mode of Action through
activation of CD16A on NK cells and macrophages, inducing ADCC and
ADCP respectively
- In cynomolgus monkeys both AFM24 and RO7297089 demonstrate a
promising safety profile
Heidelberg, Germany, June 22,
2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage
immuno-oncology company committed to giving patients back their
innate ability to fight cancer, today announced that data from two
investigational Innate Cell Engagers (ICE) developed from its
fit-for-purpose ROCK® platform were presented as posters at the
American Association for Cancer Research (AACR) Virtual Annual
Meeting II. Affimed researchers presented data on AFM24, a
bispecific EGFR/CD16A ICE with the potential to overcome resistance
to current targeted treatments for EGFR-positive
malignancies. Researchers from Genentech, a member of the
Roche Group, presented preclinical data on the pharmacology and
safety of RO7297089, a novel anti-BCMA/CD16A bispecific antibody
for the treatment of multiple myeloma built from the ROCK®
platform; Affimed researchers contributed as co-authors on the
poster.
“The data presented at AACR on AFM24 and
RO7297089 further confirm the importance of activating the innate
immune system to deliver transformative medicines to patients,”
said Dr. Arndt Schottelius, Affimed’s Chief Scientific
Officer. “Moreover, it is very exciting to see that both
molecules show potent and targeted killing of tumor cells in vitro
without high levels of cytokine release. With AFM24, we have
already progressed to the 2nd dose cohort in our Phase 1/2A
clinical study and very much look forward to seeing continued
consistent safety profile and early signs of activity in future
cohorts.“
AFM24 activates innate immunity to kill solid tumors,
inducing both ADCC and ADCP
The data presented on Affimed’s AFM24 further elucidated its
preclinical profile as a novel ICE that harnesses the innate immune
system to induce potent tumor cell killing via ADCC and ADCP.
Due to its distinctive mechanism of action (MOA), AFM24 is
potentially eligible for treatment of EGFR-positive tumors,
regardless of EGFR-pathway mutations and EGFR receptor
density. Unlike other EGFR targeted therapies, EGFR is used
as a docking site only, AFM24’s cytotoxicity is independent of EGFR
functionality and the downstream signal cascade. The pre-clinical
data suggest that AFM24 is well tolerated with no toxicity in
cynomolgus monkeys. Based on its preclinical profile, AFM24 shows
promising therapeutic benefit for a broad set of patients with
hard-to-treat EGFR-expressing cancers. AFM24 is currently being
studied in a Phase1/2A study.
RO7297089 shows potent cell killing of
BCMA positive tumor cell lines employing NK cells and
macrophages
The data presented on Genentech’s RO7297089
provided preclinical characterization of a novel BCMA/CD16A ICE,
also based on the ROCK® platform, for the treatment of multiple
myeloma. It was shown that RO7297089 is a potent therapeutic agent
in vitro and selectively kills BCMA expressing multiple myeloma
tumor cells by activating innate immunity (ADCC and ADCP). The in
vitro assessment demonstrated that, unlike T cell redirecting
therapies, RO7297089 is unlikely to have a risk of acute cytokine
release. In a one-month repeat-dose study in cynomolgus
monkeys, RO7297089 was well tolerated, and there were no test
article-related adverse effects at up to 50 mg/kg, with no
significant cytokine release. RO7297089 represents a novel
and promising MOA with a favorable safety profile, distinct from
the T cell-based BCMA-targeting modalities in the clinic.
More details about the program for the AACR
Virtual Annual Meeting II including the abstracts and poster
presentations on AFM24 and RO7297089 are available online at
www.aacr.org.
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.
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 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.
Investor Contact
Alex Fudukidis, Head of Investor Relations
Email: IR@affimed.com
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