- AFM13 in combination with natural killer (NK) cells
demonstrated improved tumor recognition and enhanced tumor cell
killing in vitro and in vivo.
- Preclinical data from this publication supported the
Investigational New Drug (IND) application for the ongoing Phase I
clinical study of AFM13 pre-complexed with NK cells.
Heidelberg, Germany, May 13, 2021
– Affimed N.V. (Nasdaq: AFMD), a clinical-stage
immuno-oncology company committed to giving patients back their
innate ability to fight cancer, announced today the publication of
preclinical in vitro and in vivo research of its lead innate cell
engager (ICE®), AFM13 (CD16A/CD30), combined with healthy
donor-derived NK cells in Clinical Cancer Research. The preclinical
data demonstrated that AFM13 strongly binds to NK cells, including
cytokine-activated or cord blood-derived NK (cbNK) cells, resulting
in enhanced tumor recognition and antibody-dependent cellular
cytotoxicity (ADCC). The research was generated through a
collaboration with The University of Texas MD Anderson Cancer
Center and Washington University School of Medicine and supports
use of AFM13 combined with NK cells as a promising therapy for
CD30-positive hematological malignancies.
“Our ROCK® platform forms the basis to generate ICE® molecules
which have the ability to strongly and durably bind to CD16A on NK
cells, resulting in unique antitumor properties,” said Arndt
Schottelius, M.D., Ph.D., Chief Scientific Officer of Affimed. “As
demonstrated by the recent presentation of initial Phase 1 data at
the American Association for Cancer Research (AACR) Annual Meeting
2021 – which showed an emerging profile that appears to have the
potential to provide meaningful benefit with a safety profile
consistent with previous AFM13 data – pre-complexing AFM13 with NK
cells presents an innovative and promising therapeutic approach for
patients with impaired NK cell activity.”
“This study provided new insights into how ICE® molecules such
as AFM13 may be impacted by NK cell receptor ligand alterations
using multidimensional mass cytometry,” said Todd Fehniger, M.D.,
Ph.D., Professor of Medicine, Oncology Division, at Washington
University. “Further, blood NK cells primed and differentiated into
memory NK cells exhibit potent responses to CD30+ cancer cells when
directed by AFM13, providing further evidence for their powerful
CD16-triggered cytokine production and killing.”
Additional key findings from the research are outlined
below:
- AFM13 combined with donor NK cells, including conventional NK
cells from healthy donors, cytokine-induced memory-like NK cells
from peripheral blood and preactivated and expanded cbNK cells,
enhanced tumor cell killing compared to NK cells alone.
- When combined with AFM13, Hodgkin lymphoma patient-derived NK
cells do not reach the same level of cytotoxicity compared to
healthy donor-derived NK cells in vitro.
- AFM13-directed tumor cell killing was enhanced when combined
with cytokine (IL-12, IL-15 and IL-18) preactivated cbNK cells
compared to non-cytokine preactivated cbNK cells.
- Cytokine preactivated cbNK cells express different markers when
compared to noncytokine preactivated cbNK cells, potentially
accounting for superior cytotoxicity which is further enhanced with
AFM13.
“This preclinical study confirmed the synergy between the cbNK
cell platform developed at MD Anderson and AFM13 as a precomplexed
product and provided the rationale to test this novel NK cell-based
adoptive immunotherapy strategy for patients with
relapsed/refractory CD30+ malignancies,” said Katy Rezvani, M.D.,
Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy
at MD Anderson.
The preclinical data published in Clinical Cancer Research
supported the Investigational New Drug (IND) application for the
ongoing Phase I clinical study of AFM13 precomplexed with
cytokine-preactivated cbNK cells followed by AFM13 monotherapy in
patients with CD30-positivemalignancies. Results of the Phase 1
study as of March 31, 2021, demonstrated an objective response rate
of 100% (ORR=4/4; PR=2/4; CR=2/4) among the first patients enrolled
who were all heavily pretreated. There were no observed events of
cytokine release syndrome, neurotoxicity, or graft-versus-host
disease. The study will progress to the higher dose cohorts with
additional updates expected throughout this year.
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 a monotherapy in a registration-directed trial
in patients with relapsed/refractory peripheral T-cell lymphoma or
transformed mycosis fungoides (REDIRECT). The study is actively
recruiting, and additional details can be found at
www.clinicaltrials.gov (NCT04101331).
In addition, The University of Texas MD Anderson Cancer Center
is studying AFM13 in an investigator-sponsored Phase 1 trial in
combination with cord blood-derived allogeneic NK cells in patients
with recurrent or refractory CD30-positive lymphomas. The study is
a dose-escalation trial of precomplexed NK cells, with patients
receiving 1x106 NK cells/kg in Cohort 1, 1x107 NK cells/kg in
Cohort 2, and 1x108 NK cells/kg in Cohort 3. The trial is designed
to explore safety and activity and determine the recommended Phase
2 dose. In each cohort, the dose of the precomplexed NK cells with
AFM13 is to be followed by weekly doses of 200 mg AFM13
monotherapy for three weeks, with each patient evaluated for
dose-limiting toxicities and responses on day 28.
MD Anderson has an institutional financial conflict of interest
with Affimed related to this research and has therefore implemented
an Institutional Conflict of Interest Management and Monitoring
Plan.
Additional information about the study can be found at
www.clinicaltrials.gov (NCT04074746). 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, New York, 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 STATEMENTSThis
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, including
with cbNK cells, 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 ContactAlexander
FudukidisDirector, Head of Investor
Relationsa.fudukidis@affimed.comTel.: +1 (917) 436-8102
Media ContactMary Beth SandinVice President,
Marketing and Communicationsm.sandin@affimed.comTel: +1 (484)
888-8195
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