Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a
clinical-stage immuno-oncology company committed to giving patients
back their innate ability to fight cancer, today announced topline
data from its phase 2 REDIRECT study investigating AFM13
monotherapy in patients with advanced-stage r/r PTCL.
Primary efficacy measures include ORR of 32.4%
and a complete response (CR) rate of 10.2%. Key secondary and
exploratory outcome measures include safety, durability of
response, progression free survival and overall survival. The
safety profile of AFM13 was well managed and consistent with
previously reported data of prior and ongoing clinical studies with
AFM13. Median DoR was 2.3 months, median PFS was 3.5 months and
median OS was 13.8 months.
“These are remarkable data for AFM13 as a single
agent and they confirm that the activation of innate immunity can
lead to robust clinical activity,” said Dr. Adi Hoess, Chief
Executive Officer at Affimed. “Our parallel study investigating
AFM13 in combination with allogeneic NK cells shows that this
combination can materially improve clinical outcomes for patients
with CD30-postive lymphomas. We will therefore be focusing further
development of AFM13 in PTCL on the combination with NK cells to
improve the durability of response and build on the already
meaningful activity with the goal of obtaining regulatory approval
to give this difficult to treat patient population another
therapeutic option.”
“The activity of AFM13 in heavily pretreated
patients with peripheral T cell lymphoma is very encouraging with
an objective response rate of 32% and a PFS of 3.5 months,” said
Dr. Won Seog Kim, Professor of Hematology-Oncology at Samsung
Medical Center in Seoul and a principal investigator for the study.
“The data demonstrate that the innate immune system can
successfully attack lymphomas and thus AFM13 provides a new
mechanism of action that could expand our options in treating this
difficult disease.”
REDIRECT is a registration-directed phase 2
open-label, multicenter, global study investigating the efficacy
and safety of AFM13 monotherapy in patients with CD30-positive r/r
PTCL. The primary outcome measure was the objective response rate
(ORR) following treatment with AFM13 as measured by an independent
review committee (IRC) by FDG-PET. Secondary and exploratory
outcome measures included DoR, PFS, OS, the safety of AFM13 as well
as pharmacokinetics and immunogenicity of AFM13. In the trial, 108
patients received treatment with AFM13 as weekly intravenous
infusions of 200 mg for the duration of the trial participation.
Disease assessment was conducted at screenings every 8 weeks for
the first 2 assessments and every 12 weeks thereafter.
Peripheral T cell lymphomas are highly
aggressive and one of the most difficult to treat forms of lymphoma
with very poor prognosis for patients. Based on the compelling data
seen in Hodgkin lymphoma for the combination of AFM13 with cord
blood-derived NK cells in the AFM13-104 study, the Company believes
that the combination with AB-101 has a higher probability to
deliver increased anti-tumor activity and a more durable clinical
benefit to address the unmet need in this patient population.
Accordingly, Affimed does not intend to pursue an accelerated
approval for AFM13 monotherapy in PTCL and will focus investment on
clinical development in the combination of AFM13 with Artiva’s
AB-101 NK cell product.
Investor Event & Webcast
Details
Affimed will host an investor event to review
AFM13 clinical data and development plans in CD30 expressing
malignancies. The investor event will take place in-person and
virtually and a webcast of the event will be available in the
“Webcasts” section on the “Investors” page of Affimed’s website
at https://www.affimed.com/investors/webcasts-and-corporate-presentation/.
To access the event via phone, please dial +1 (929) 205-6099 for
U.S. callers, or +44 (203) 481-5240 for international callers, and
reference meeting ID 847 4106 6227 approximately 15 minutes prior
to the call. To reserve your place in the live event, please
contact Alex Fudukidis via e-mail at a.fudukidis@affimed.com.
A replay of the webcast/call will be archived on Affimed’s website
for 30 days after the call.
About AFM13
AFM13 is a first-in-class innate cell engager
(ICE®) that uniquely activates the innate immune system to destroy
CD30-positive hematologic tumors. AFM13 induces specific and
selective killing of CD30-positive tumor cells, leveraging the
power of the innate immune system by engaging and activating
natural killer (NK) cells and macrophages. AFM13 is Affimed’s most
advanced ICE® clinical program and is currently being evaluated as
monotherapy in a registration-directed trial in patients with
relapsed/refractory peripheral T-cell lymphoma (REDIRECT).
Additional details can be found at www.clinicaltrials.gov
(NCT04101331).
The study achieved an ORR of 32.4% demonstrating
anti-tumor activity with a DOR of 2.3 months and a well-managed
safety profile. AFM13 is a tetravalent bispecific innate cell
engager designed to act as a bridge between the innate immune cells
and the tumor creating the necessary proximity for the innate
immune cells to specifically destroy the tumor cells.
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 by actualizing the untapped
potential of the innate immune system. The Company’s proprietary
ROCK® platform enables a tumor-targeted approach to recognize and
kill a range of hematologic and solid tumors, enabling a broad
pipeline of wholly-owned and partnered single agent and combination
therapy programs. The ROCK® platform predictably generates
customized innate cell engager (ICE®) molecules, which use
patients’ immune cells to destroy tumor cells. This innovative
approach enabled Affimed to become the first company with a
clinical-stage ICE®. Headquartered in Heidelberg, Germany, with
offices in New York, NY, Affimed is led by an experienced team of
biotechnology and pharmaceutical leaders united by a bold vision to
stop cancer from ever derailing patients’ lives. For more about the
Company’s people, pipeline and partners, 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 the
Company’s intentions, beliefs, projections, outlook, analyses and
current expectations concerning, among other things, the potential
of AFM13, AFM24, AFM28 and the Company’s other product candidates,
the value of its ROCK® platform, its ongoing and planned
preclinical development and clinical trials, its collaborations and
development of its products in combination with other therapies,
the timing of and its ability to make regulatory filings and obtain
and maintain regulatory approvals for its product candidates, its
intellectual property position, its collaboration activities, its
ability to develop commercial functions, clinical trial data, its
results of operations, cash needs, financial condition, liquidity,
prospects, future transactions, growth and strategies, the industry
in which it operates, the trends that may affect the industry or
the Company, impacts of the COVID-19 pandemic, the benefits to
Affimed of orphan drug designation, the impact on its business by
political events, war, terrorism, business interruptions and other
geopolitical events and uncertainties, such as the Russia-Ukraine
conflict, the fact that the current clinical data of AFM13 in
combination with NK cell therapy is based on AFM13 precomplexed
with fresh allogeneic cord blood-derived NK cells from The
University of Texas MD Anderson Cancer Center, as opposed to
Artiva’s AB-101 and other uncertainties and factors described under
the heading “Risk Factors” in Affimed’s filings with the SEC. Given
these risks, uncertainties, and other factors, you should not place
undue reliance on these forward-looking statements, and the Company
assumes no obligation to update these forward-looking statements,
even if new information becomes available in the future.
Investor Relations Contact
Alexander FudukidisDirector, Investor RelationsE-Mail:
a.fudukidis@affimed.com Tel.: +1 (917) 436-8102
Media ContactMary Beth Sandin Vice President,
Marketing and CommunicationsE-Mail: m.sandin@affimed.com Tel: +1
(484) 888-8195
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Aug 2024 to Sep 2024
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Sep 2023 to Sep 2024