Affimed Announces Publication in the Journal mAbs on Leveraging FcRn-pH-HPLC as a Method to Select Bispecific Antibodies with Optimal Developability
August 22 2023 - 5:00AM
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 the
publication of a manuscript that demonstrates how the FcRn-pH-HPLC
technology can be leveraged to predict PK properties of various
ICE® formats built on the ROCK® platform.
“The earlier we know which antibody format has the highest
probability to succeed in the clinic, the better,” states Dr. Arndt
Schottelius, Chief Scientific Officer at Affimed. “We want to
develop ICE® molecules that are effective and safe, and the
optimized FcRn-pH-HPLC methodology enables us to make accurate
estimations of the in vivo serum half-life of our antibodies.”
PK parameters – such as half-life – impact the efficacy,
tolerability, dose, and administration schedule of therapeutic
antibodies. Identification of antibody candidates with optimal PK
properties can therefore inform on the antibody with the best
clinical developability. The PK profiles of therapeutic antibodies
in vivo are largely governed by their pH-dependent binding to the
human neonatal Fc receptor, FcRn. In the presented study, the
FcRn-HPLC methodology has been further optimized by coupling it to
a pH monitor and determining the pH of FcRn dissociation of
antibodies, thus providing a potential surrogate assay for
estimating in vivo serum half-lives.
Leveraging the FcRn-pH-HPLC revealed that the antibody
architecture, e.g. sequence of antigen-binding domains, as well as
number, structure, and orientation of these domains significantly
alters the FcRn dissociation pH. Certain antibody structures are
therefore predicted to have better PK properties in vivo than
others.
Please find the publication on the website of mAbs here.
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
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statements other than statements of historical fact are
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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
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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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