Affimed Provides Regulatory Update on AFM11 Clinical Program
April 17 2019 - 4:05PM
Heidelberg, Germany, April 17, 2019 - Affimed
N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company
committed to giving patients back their innate ability to fight
cancer, today announced that it has submitted to the U.S. Food and
Drug Administration (FDA) additional information to Affimed’s
initial response document submitted in early March relating to the
previously-announced clinical hold on AFM11. The additional
information addresses the request from the FDA for the clinical
trial protocol for the study of AFM11 for treatment of acute
lymphocytic leukemia (ALL). Affimed anticipates receiving a
response from the FDA regarding the status of the AFM11 clinical
program in the second quarter of 2019.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical stage
biopharmaceutical company committed to giving patients back their
innate ability to fight cancer. Affimed’s fit-for-purpose ROCK®
platform allows innate immune engagers to be designed for specific
patient populations. The Company is developing single and
combination therapies to treat cancers. 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, expectations regarding 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 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 Contact:Gregory Gin,
Head of Investor RelationsE-Mail: IR@affimed.com
Affimed Media Contact:Anca Alexandru,
Head of Communications, EU IRE-Mail: media@affimed.com
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