BND-35 is a
Novel and Unique Anti-ILT3/LILRB4 Antibody for Remodeling the Tumor
Microenvironment
BND-35-001 trial
includes unique combination arms with anti-EGFR (cetuximab) and
anti-PD-1/PD-L1, in selected indications
MISGAV, Israel, June 24,
2024 /PRNewswire/ -- Biond Biologics Ltd. ("Biond"
or the "Company"), a private clinical-stage biopharmaceutical
company developing novel immunotherapies for cancer and a platform
for the intracellular delivery of biologics, today announced that
the first patient has been dosed in a first-in-human clinical trial
testing BND-35, a humanized
ILT3/LILRB4 antagonist antibody.
The first patient was administered BND-35 as a monotherapy at the Institute of
Oncology, Davidoff Center, Rabin Medical Center, Israel, one of the six Israel and US trial study sites. The phase 1,
open-label, dose escalation study aims to explore the safety,
tolerability, anti-tumor activity, pharmacokinetics and exploratory
biomarkers for BND-35 as a
monotherapy and in combination with two approved drugs, a
PD-1/PD-L1 inhibitor or the anti-EGFR drug, cetuximab. The decision
to test the combination of BND-35
with cetuximab was driven by supportive pre-clinical data and a
deep understanding of the BND-35
mechanism of action. BND-35 augments
antibody-dependent cellular phagocytosis and antibody-dependent
cellular cytotoxicity, which are mediated by binding of Fc
receptors (FcR) on immune cells to antibodies as cetuximab and
additional tumor targeting antibodies. Each arm of the trial
includes the patient populations most likely to benefit from
ILT3/LILRB4 blockade based on translational research findings.
"The BND-35 trial design
introduces a novel combination
therapy that targets the immunosuppressive cell milieu within the
tumor microenvironment (TME)," commented Professor Salomon Stemmer, M.D., Head of Research,
Development and Innovation and Deputy Director of Davidoff Center
at the Rabin Medical Center, and a clinical investigator in the
trial. "There's a pressing need for innovative treatments for
cancers that are resistant to existing therapies. Given its
promising preclinical efficacy, we're eager to assess BND-35's
potential in overcoming ILT3/LILRB4-mediated
immunosuppression."
"ILT3 is a unique receptor expressed on various suppressive
myeloid cells within the TME and the binding of various ligands to
ILT3 maintains the TME in an immunosuppressive state. BND-35 has been demonstrated to effectively block
the interaction between ILT3 and its various ligands, thereby
enhancing the immune system's ability to fight tumors, resulting in
increased physiological anti-tumor responses and enhanced tumor
cell destruction by immune cells," stated Tsuri Peretz, project
manager for the BND-35 program.
About ILT3/LILRB4/LILRB4
BND-35 is a novel anti-ILT3/LILRB4 antagonist antibody developed
for the treatment of solid tumors. BND-35 binds ILT3/LILRB4 with high affinity and
blocks its interaction with ligands present in the TME In vitro and
ex vivo studies have demonstrated that BND-35 as monotherapy or in combination with
anti-PD-1/PD-L1 pathway inhibitors as well as with anti-EGFR
agents, enhances the pro-inflammatory activity of various myeloid
cells and inhibits the immunosuppressive activity of suppressive
myeloid cells, thereby restoring T cell and NK cell activity.
BND-35-induced immune activity
enhancement was demonstrated in a unique system of patient-derived
tumoroids. In vivo, blocking ILT3/LILRB4 activity with BND-35, as monotherapy or in combination therapy,
resulted in decreased tumor growth and induced a pro-inflammatory
phenotype in tumor-resident T cells and myeloid cell populations.
Further information about the trial is available in
https://www.clinicaltrials.gov/study/NCT06274437?term=BND-35&rank=1
(Trial Identifier: NCT06274437).
About Biond Biologics
Biond Biologics is at the forefront of developing cutting-edge
therapies targeting novel oncology pathways and enabling the
intracellular delivery of biologics. By exploring immunoregulatory
pathways and pioneering intracellular delivery platforms, Biond
Biologics aims to translate advanced science and innovative
technologies into transformative drugs for diseases with
significant unmet needs. The company fosters synergistic
collaborations with leading biopharmaceutical entities to formulate
groundbreaking medicines to patients worldwide.
In addition to BND-35, Biond
Biologics' programs include BND-22
(SAR444881), a multi-cell checkpoint
first-in-class ILT2 blocking antibody that was partnered with
Sanofi. In addition, it is developing BND-67, a novel agent for attenuation of CD28
shedding, an immune-evasion mechanism discovered by Biond's
scientists, which could overcome PD-1 pathway blockade resistance.
Biond Biologics is also developing INspire – an innovative
technological platform that enables the intracellular delivery of
protein therapeutics, such as antibodies, proteins or enzymes, into
cells.
This press release shall not constitute an offer to sell or
the solicitation of an offer to buy the securities described
herein, nor shall there be any sale of these securities in any
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to the registration or qualification under the
securities laws of any such jurisdiction.
Company contact:
Tal Sines
VP of Business Development
Biond Biologics Ltd.
+972-4 884 4337
tal.sines@biondbio.com
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SOURCE Biond Biologics Ltd.