Full Press Release Details
Affimed Provides Regulatory Update on
AFM11 Clinical Program
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.
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
Affimed Investor Contact:
Gregory Gin, Head of Investor Relations
E-Mail: IR@affimed.com
Affimed Media Contact:
Anca Alexandru, Head of Communications, EU IR
E-Mail: media@affimed.com