Affimed Announces Approval of Clinical Trial Application in France for a Phase 1 Study of AFM28 in Relapsed/Refractory Acute Myeloid Leukemia
December 22 2022 - 6:30AM
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, announced today that the
ANSM has authorized a CTA for the phase 1 study of AFM28
(AFM28-101) in relapsed/refractory acute myeloid leukemia (AML).
“The CTA approval in France is an important
milestone in our strategy to develop AFM28 as quickly as possible,”
said Dr. Wolfgang Fischer, Chief Operating Officer at Affimed. “AML
is one of the worst blood cancers with poor patient prognosis,
especially in the relapsed or refractory setting, with no
standard-of-care salvage regimen currently available. Given the
aggressive nature of the disease, and the desperate need for viable
treatment options, it is a high priority for Affimed to advance the
clinical development of AFM28 for relapsed/refractory AML
patients.”
CTA applications for AFM28-101 in other European
jurisdictions are ongoing, and additional applications are planned
for submission early in 2023. Additionally, Affimed plans to
investigate AFM28 in combination with allogenic natural killer (NK)
cell therapy.
About AFM28-101
AFM28-101 is a phase 1 multicenter, open label,
first-in-human dose escalation study of AFM28, a bispecific Innate
Cell Engager (ICE®) that targets CD123 and CD16A in patients with
CD123–positive relapsed/refractory (r/r) acute myeloid leukemia
(AML). The study is planned to investigate the safety,
tolerability, PK and PD of AFM28 IV monotherapy in patients with
CD123-positive r/r AML. The goal of dose escalation is to establish
the maximum tolerated dose and/or one or more recommended phase 2
doses to guide clinical development of AFM28 as a monotherapy
and/or in combination with other therapeutic approaches, e.g.,
allogeneic natural killer (NK) cell therapy.
About AFM28
AFM28, a tetravalent bispecific CD123- and
CD16A-binding Innate Cell Engager (ICE®) developed on Affimed’s
Redirected Optimized Cell Killing (ROCK®) platform, is designed to
bring a new immunotherapeutic approach to patients with
CD123-positive myeloid malignancies, including acute myeloid
leukemia (AML) and myelodysplastic syndrome (MDS) by engaging
natural killer (NK) cells to initiate tumor cell killing via
antibody-dependent cellular cytotoxicity (ADCC), even at low CD123
expression levels. Clinical development is planned as both
monotherapy and in combination with allogeneic NK cells in patients
with relapsed/refractory CD123-positive leukemias.
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
Redirected Optimized Cell Killing (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 AFM28 and the Company’s other product candidates, the value of
its Redirected Optimized Cell Killing (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 trends that may affect the industry or the Company,
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 and
other uncertainties and factors described under the heading “Risk
Factors” in Affimed’s filings with the United States Securities and
Exchange Commission. 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.com Tel.: +1 (917) 436-8102
Media ContactMary Beth Sandin Vice President,
Marketing and CommunicationsE-Mail: m.sandin@affimed.com Tel: +1
(484) 888-8195
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