Affimed Highlights Study Design of its AFM13 REDIRECT Trial at the ASCO 2020 Virtual Meeting
May 29 2020 - 8:05AM
REDIRECT is a Registration-directed Phase II
Open-label Multicenter Study to Assess the Efficacy and Safety of
AFM13 in Patients with Relapsed or Refractory CD30 positive
Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides
(REDIRECT)
Heidelberg, Germany, May 29, 2020 – Affimed
N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company
committed to giving patients back their innate ability to fight
cancer, today shared details of its AFM13 REDIRECT clinical trial
design and rationale at the American Society of Clinical Oncology
(ASCO) 2020 Annual Meeting, being held in virtual format on May
29-31, 2020.
AFM13 is a first-in-class innate cell engager
that induces specific and selective killing of CD30-positive tumor
cells by engaging and activating NK cells and macrophages thereby
leveraging the power of the innate immune system. As
detailed in the poster at ASCO, REDIRECT is a registration-directed
trial with AFM13 as monotherapy in patients with
relapsed/refractory peripheral T cell lymphoma or transformed
mycosis fungoides. The study is actively recruiting.
“We recognize that we target difficult to treat
malignancies and we are committed to advancing AFM13 in the clinic
for patients who currently have limited treatment options,” said
Dr. Andreas Harstrick, Affimed’s Chief Medical Officer. “Having
received the U.S. FDA orphan drug designation for AFM13 last month
further reinforced our commitment to this area with high unmet
medical need and the importance of developing new therapies.”
The REDIRECT poster presented at ASCO is available online
at https://meetinglibrary.asco.org/record/191832/poster.
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 and macrophages. 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. The
company is currently enrolling patients into a
registration-directed study of AFM13 for CD30-positive
relapsed/refractory peripheral T cell lymphoma and into a Phase
1/2a dose escalation/expansion study of AFM24 for the treatment of
advanced EGFR-expressing 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 potential of AFM13
and AFM24, 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 Contact
Alexander Fudukidis, Head of Investor
Relations
E-Mail: IR@affimed.com
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