- IND application submitted for first-in-human study of AFM24, a
bispecific EGFR/CD16A innate cell engager for solid tumors
- FDA clearance of IND for first clinical study of a stable
complex of AFM13 pre-mixed with cord blood-derived allogeneic NK
cells in patients with relapsed/refractory CD30-positive lymphoid
malignancies
- Registration-directed Phase 2 study of AFM13 on track to start
this quarter, supported by data confirming single-agent activity of
AFM13 in CD30-positive lymphoma patients with an objective response
rate of 50%
Heidelberg, Germany, October 15, 2019 - Affimed
N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company
committed to giving patients back their innate ability to fight
cancer, today announced the submission of an Investigational New
Drug (IND) application to the U.S. Food and Drug Administration
(FDA) to initiate a first-in-human Phase 1/2a study of AFM24. The
initial goal of the study is to determine the maximum tolerated
dose and recommended Phase 2 dose of AFM24, as well as to evaluate
the safety, pharmacokinetics, pharmacodynamics, and preliminary
efficacy in patients with advanced cancers known to express the
epidermal growth factor receptor, EGFR. The second part of the
study will evaluate the preliminary efficacy of AFM24 in patients
with select solid tumor subtypes.
Affimed also announced that the FDA has cleared
an IND application for a Phase 1 study to evaluate a stable complex
of AFM13, its lead innate cell engager, pre-mixed with cord
blood-derived allogeneic NK cells (cbNK cells) as an
investigational treatment for patients with relapsed/refractory
CD30-positive lymphoid malignancies. In addition, the
registration-directed study of AFM13 as monotherapy in
relapsed/refractory peripheral T cell lymphoma (pTCL), where
patients have very few treatment options, is on track to initiate
this year.
AFM24: Potential to Address Current
Treatment Limitations in Solid Tumors
“Our goal at Affimed is to develop medicines
that activate the innate immune system, the body’s first line of
defense, as a powerful way to treat patients living with cancer,”
said Dr. Adi Hoess, Chief Executive Officer of Affimed. “The IND
filing is an important step toward the development of AFM24, our
innate cell engager designed to target EGFR-expressing cancers,
including those with resistance to existing EGFR-targeted
therapies.”
AFM24, a tetravalent, bispecific EGFR- and
CD16A-binding innate cell engager from Affimed’s fit-for-purpose
ROCK® platform, is designed to address limitations associated with
other EGFR-targeted therapies, such as toxicities or resistance, by
using a new mechanism of action to target EGFR-expressing solid
tumors through activation of innate immunity rather than inhibition
of EGFR-mediated signal transduction.
AFM24 has the potential to provide meaningful
benefit to patients with certain mutations that cannot be addressed
by existing EGFR-targeted therapies. According to internal market
research, leading clinical experts across multiple cancer
indications see a tremendous need for novel immuno-oncology
approaches for the treatment of solid tumors. Preclinical data
showed AFM24’s ability to bridge NK cells and macrophages to
EGFR-expressing tumor cell lines and induce cell lysis through
antibody-dependent cellular cytotoxicity (ADCC), independent of RAS
mutational status, and antibody-dependent cellular phagocytosis
(ADCP). In addition, AFM24 enhanced tumor infiltration of NK cells
and elicited dose-dependent anti-tumor efficacy in in vivo tumor
models. Treatment of cynomolgus monkeys with AFM24 showed a
favorable safety profile, even when the animals were treated at
high dose levels, demonstrating AFM24’s potential to have lower
toxicities in humans compared to other EGFR-targeted
therapeutics.
AFM13: Lead Innate Cell Engager,
Targeting CD30-positive Lymphomas
“We also continue to progress our lead innate
cell engager, AFM13,” said Dr. Hoess. “The clearance of the IND for
AFM13 pre-mixed with cord blood-derived NK cells is a significant
milestone in our overall clinical development plan. The planned
clinical study will investigate the potential for adoptive cellular
therapy together with our AFM13 innate cell engager to overcome a
patient’s dysfunctional immune system to treat cancer.”
AFM13 binds to CD16A on NK cells with high
affinity, which enables the formation of a stable complex of AFM13
and cbNK cells that results in pre-mixed AFM13 with cbNK cells.
This will be investigated in CD30-positive lymphoma patients and
the study will be conducted by The University of Texas MD Anderson
Cancer Center (MDACC) as an investigator-sponsored study. It builds
upon encouraging in vitro and in vivo data that showed a
significant enhancement of antitumor activity of pre-mixed AFM13
with cbNK cells versus cbNK cells alone.
Enrollment is ongoing for a Phase 1b/2a study of
AFM13 led by Columbia University, with 13 patients now recruited.
Previously reported data from this investigator-sponsored
translational study in patients with relapsed/refractory
CD30-positive lymphoma with cutaneous manifestation confirmed
single-agent activity of AFM13, with an objective response rate of
50% (5 out of 10 patients). Patients who responded showed increased
infiltration of NK cells, as well as NK cell-mediated killing in
the patients’ tumors. These encouraging data supported Affimed’s
rationale to study AFM13 in patients with relapsed/refractory
CD30-positive pTCL and the registration-directed Phase 2 study of
AFM13 is on track to enroll patients this quarter.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical stage
biopharmaceutical 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. 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 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, expectations regarding 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 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:Gregory Gin, Head of Investor RelationsE-Mail:
IR@affimed.com
Affimed Media Contact:Anca
Alexandru, Head of Communications, EU IRE-Mail:
media@affimed.com
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