Full Press Release Details
Places AFM11 (CD19/CD3-Targeting T cell Engager) Phase 1 Program on Clinical Hold
Germany, October 8, 2018 - Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering
and developing highly targeted cancer immunotherapies that harness the power of innate and adaptive immunity (NK and T cells),
today announced that it has placed AFM11 (CD19/CD3-targeting T cell engager) on clinical hold, and has notified the global health
authorities of its decision. AFM11 is being evaluated in two Phase 1 clinical studies for the treatment of patients with relapsed
or refractory CD19 positive B-cell non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL). The clinical hold was initiated
after the occurrence of Serious Adverse Events (SAEs) in three patients, which included a death in the ALL study and two life-threatening
events in the NHL study.
occurred in patients enrolled in the highest dose cohorts of each study. Thirty-three patients have been treated in total in the
two Phase 1 studies, with preliminary signs of clinical activity observed in several patients.
be working closely with the global health authorities, the Safety Monitoring Committees, and the studies' clinical investigators
to review the events, carefully assess all of the data and determine next steps for the AFM11 program. Affimed intends to provide
an update on AFM11 upon completion of the evaluation.
hold does not affect the ongoing development of Affimed's NK cell engager programs, which are based on targeting the NK
cell receptor CD16A, a different approach than used for AFM11, which targets T cells through CD3.
AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK
and T cells). We are developing single and combination therapies to treat cancers and other life-threatening diseases. For more
information, please visit www.affimed.com.
FORWARD-LOOKING STATEMENTS
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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.
Gregory Gin, Head of Investor
E-Mail: IR@affimed.com
Anca Alexandru, Head of Communications,
E-Mail: media@affimed.com