Affimed Announces Acimtamig as International Nonproprietary Name for AFM13
09 Novembre 2023 - 12:30PM
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 the
International Nonproprietary Names (INN) Expert Committee of the
World Health Organization (WHO) has selected "acimtamig" for the
nonproprietary name of the Company’s investigational drug for
CD30-positive Lymphomas, previously known as AFM13. Following the
WHO nomenclature scheme, the name recognizes the drug as a tumor
targeting bispecific antibody.
Acimtamig (AFM13) is currently being evaluated in combination
with AlloNK® (formerly AB-101) natural killer (NK) cells in
patients with relapsed or refractory (r/r) Hodgkin Lymphoma in
LuminICE-203, a phase 2, open-label, multi-center study
(NCT05883449); the study also includes an exploratory cohort of
CD30-positive peripheral T-cell lymphoma patients (PTCL). Acimtamig
and AlloNK® therapy was recently granted fast track designation by
the FDA, a process designed to facilitate the development and
expedite the review of drugs to treat serious conditions and fill
an unmet medical need.
“Selection of the INN acimtamig by the WHO is an important
milestone in the clinical development of AFM13 with initiation of
the LuminICE-203 study underway,” said Dr. Adi Hoess, Chief
Executive Officer at Affimed. “It adds to the momentum of the fast
track designation awarded by the FDA earlier this year to the
acimtamig and AlloNK® combination. We look forward to reporting the
first data from the LuminICE-203 study in the first half of 2024
and to bringing this important therapy to patients with high unmet
needs.”
About Acimtamig
(AFM13)Acimtamig is a first-in-class ICE® that uniquely
activates the innate immune system to destroy CD30-positive
hematologic tumors. Acimtamig induces specific and selective
killing of CD30-positive tumor cells, leveraging the power of the
innate immune system by engaging and activating natural killer (NK)
cells and macrophages. Acimtamig is a tetravalent bispecific innate
cell engager designed to act as a bridge between the innate immune
cells and the tumor creating the necessary proximity for the innate
immune cells to specifically destroy the tumor cells.
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 Mannheim, 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 StatementThis
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
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.com
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