Affimed Announces FDA Granted Orphan Drug Designation for Lead Innate Cell Engager AFM13 for the Treatment of T-cell Lymphoma...
April 01 2020 - 4:01PM
Heidelberg, Germany, April 1, 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 the U.S. Food
and Drug Administration (FDA) has granted orphan drug designation
to AFM13, its lead CD30- and CD16A-binding innate cell engager, for
the treatment of patients with T-cell lymphoma. The granted
designation includes peripheral T cell lymphoma (pTCL), a subtype
of T-cell lymphoma. AFM13 is being investigated as a monotherapy
for the treatment of relapsed or refractory CD30-positive pTCL in a
Phase 2 registration-directed study.
The FDA may grant orphan designation to drugs
and biologics intended to treat a rare disease or condition
affecting fewer than 200,000 persons in the U.S. The designation
qualifies a company for certain benefits, including financial
incentives to support clinical development and the potential for
seven years of market exclusivity in the U.S. upon regulatory
approval.
About AFM13
AFM13 is a first-in-class tetravalent,
bispecific innate cell engager that specifically binds to CD30 on
tumor cells and to CD16A on NK cells. AFM13 is being developed in
peripheral T cell lymphoma (pTCL) and in other CD30-positive
lymphomas. AFM13 has shown a favorable safety profile and signs of
therapeutic efficacy as a monotherapy in CD30-positive non-Hodgkin
lymphoma with cutaneous manifestation. In addition, data from a
combination study of AFM13 with Merck’s anti-PD-1 antibody
Keytruda® (pembrolizumab) in Hodgkin lymphoma (HL) supports proof
of principle for the combination of NK cell engagement with
checkpoint inhibition. AFM13 has been granted orphan drug
designation by the U.S. Food and Drug Administration for HL.
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. 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 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.
Affimed Investor and Media
Contacts
Gregory Gin, Head of Investor RelationsE-Mail:
IR@affimed.com
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