Affimed Announces Updated AFM13 Clinical Data Presentation at the American Society of Hematology Annual Meeting, Demonstratin...
December 07 2020 - 10:01AM
- AFM13 monotherapy was well tolerated and reached an Objective
Response Rate of 42 percent among heavily pretreated patients with
R/R CD30-positive lymphoma with cutaneous presentation
- Immunological analyses revealed that innate cell engagers
modulate NK and T cell populations in peripheral blood and
tumors
Heidelberg, Germany, December 7, 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 the presentation of a clinical data set on
AFM13 at the 62nd American Society of Hematology Annual Meeting and
Exposition. Dr. Ahmed Sawas, Assistant Professor of Medicine at
Columbia University College of Physicians and Surgeons and the New
York-Presbyterian Hospital, and principal investigator presented
the updated results of a phase 1b/2a study in patients with
CD30-expressing lymphoma with cutaneous involvement.
AFM13 is a bispecific tetravalent Innate Cell Engager (ICE®)
targeting CD30 on tumor cells and CD16A on NK cells and
macrophages.
2971: Clinical and Biological Evaluation of the Novel
CD30/CD16A Tetravalent Bispecific Antibody (AFM13) in Relapsed or
Refractory CD30-Positive Lymphoma with Cutaneous Presentation: A
Biomarker Phase Ib/IIa Study (NCT03192202)
This updated analysis of the AFM13 monotherapy study in patients
with relapsed or refractory CD30-positive lymphoma with cutaneous
presentation showed an Objective Response Rate (ORR) of 42 percent
(6/14) and demonstrated clinical activity after brentuximab vedotin
failure in two of four patients. Flow cytometry of peripheral blood
revealed decreased circulating NK cell numbers during therapy and
tumor biopsies of responders exhibited an increased pre-therapy
CD56+ NK cell infiltration versus non-responders. Granzyme B
expression was detected in responders, indicating NK cell
cytotoxicity. Together, these data suggest that AFM13 may initiate
NK cell tumor infiltration and recruit and engage NK cells. In
addition, AFM13 was well tolerated.
“The therapeutic need for this heavily pretreated patient group
is extremely high. We are therefore happy to see that AFM13
monotherapy was well tolerated and demonstrated a promising ORR,”
commented Dr. Ahmed Sawas. “Our biological evaluation is the first
to demonstrate that innate cell engagers modulate NK cell
populations in patient peripheral blood and tumors, which seems to
be associated with patient benefit.”
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, 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.
Investor Relations Contact
Alexander FudukidisHead of Investor RelationsE-Mail:
a.fudukidis@affimed.com
Media Contact
Mary Beth Sandin Head of Marketing and CommunicationsE-Mail:
m.sandin@affimed.com
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