Affimed Announces Pipeline and Business Update
07 January 2021 - 10:30PM
- Continued progress for AFM13 and AFM24 clinical studies
- Strengthened cash position provides anticipated runway into the
first half of 2023
Heidelberg, Germany, January 7, 2021 – Affimed
N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company
committed to giving patients back their innate ability to fight
cancer, today announced an update on its pipeline and business.
“Affimed ended 2020 with significant momentum across all major
programs and a strong balance sheet that provides cash runway into
the first half of 2023,” commented CEO Adi Hoess. “With three
innate cell engagers in clinical development and multiple active
collaborations, Affimed is positioned for numerous catalysts in
2021 and beyond.”
Clinical Stage Program Updates
AFM13 (CD30/CD16A ICE®)
- AFM13-202, a Phase 2 registration-directed study of AFM13 as
monotherapy in relapsed or refractory patients with CD30-positive
peripheral T-cell lymphoma (pTCL), remains ahead of schedule and
Affimed expects to complete the interim data analysis during the
first half of 2021.
- The first dose cohort of AFM13-104, an investigator sponsored
Phase 1 study at The University of Texas MD Anderson Cancer Center
evaluating the tolerability and efficacy of AFM13 preloaded cord
blood-derived NK cells (cbNK) followed by weekly AFM13 monotherapy
in patients with refractory CD30 expressing lymphomas, is
ongoing.
AFM24 (EGFR/CD16A ICE®)
- AFM24-101, a Phase 1/2a clinical trial of AFM24, the EGFR/CD16A
targeted ICE® for treatment of patients with EGFR-expressing solid
tumors, has completed dose cohort 3 (80 mg per patient) without
showing dose limiting side effects and patients are currently being
enrolled and treated in dose cohort 4 (160 mg per patient).
- Affimed and NKMax America completed a pre-IND meeting with the
U.S. Food and Drug Administration in December 2020. The
companies plan to submit an IND in the first half of 2021 for a
Phase1/2a study to investigate different dose levels of AFM24 in
combination with NKMax America`s autologous NK cell product SNK01
in patients with EGFR expressing solid tumors.
Other Business Updates
- As of December 31, 2020, Affimed’s preliminary unaudited cash
and cash equivalents were approximately €147 million. Based on its
current operating plan and assumptions, Affimed anticipates that
its cash and cash equivalents will support operations into the
first half of 2023.
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 our ICE®
molecules, 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.comTel.: +1 (917) 436-8102
Media Contact
Mary Beth Sandin Head of Marketing and CommunicationsE-Mail:
m.sandin@affimed.com
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