On June 24, 2024 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, reported that the first patient has been dosed in a first-in-human clinical trial testing BND-35, a humanized ILT3/LILRB4 antagonist antibody (Press release, Biond Biologics, JUN 24, 2024, View Source [SID1234644517]).
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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 View Source;rank=1 (Trial Identifier: NCT06274437).