Pharma Focus Asia

Biond Biologics Begins Phase 1 Clinical Trial, Administers First Dose of BND-35

Tuesday, June 25, 2024

Biond Biologics Ltd. ("Biond"), a clinical-stage biopharmaceutical company specializing in cancer immunotherapy, has initiated its first-in-human clinical trial of BND-35, a humanized ILT3/LILRB4 antagonist antibody. The trial commenced with the dosing of its first patient at the Institute of Oncology, Davidoff Center, Rabin Medical Center, Israel, one of six sites in Israel and the US participating in the study.

This phase 1, open-label, dose escalation study aims to assess the safety, tolerability, pharmacokinetics, and potential anti-tumor activity of BND-35 as both a standalone treatment and in combination with either a PD-1/PD-L1 inhibitor or the anti-EGFR drug cetuximab. The decision to combine BND-35 with cetuximab was based on supportive preclinical data and a thorough understanding of its mechanism of action. BND-35 enhances immune response through mechanisms such as antibody-dependent cellular phagocytosis and cytotoxicity, which are mediated by Fc receptors on immune cells.

Professor Salomon Stemmer, M.D., Head of Research, Development, and Innovation at the Davidoff Center, highlighted the trial's innovative approach in targeting the immunosuppressive tumor microenvironment (TME). He emphasized the need for novel therapies for cancers resistant to current treatments, underscoring BND-35's potential based on promising preclinical efficacy.

According to Tsuri Peretz, project manager for BND-35, the antibody blocks ILT3/LILRB4 receptors expressed on suppressive myeloid cells in the TME, thereby disrupting immunosuppression and enhancing the immune system's ability to combat tumors. In vitro and ex vivo studies support BND-35's role in promoting a pro-inflammatory environment within the TME, crucial for boosting anti-tumor responses.

BND-35's efficacy has been validated in patient-derived tumoroids and in vivo models, demonstrating reduced tumor growth and activation of tumor-resident immune cells when used alone or in combination therapy. Further details about the trial can be found at under trial identifier NCT06274437.



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