BND-35-001

BND-35-001 is the first-in-human clinical trial of BND-35. It is a Phase 1/2 multicenter, open label, dose escalation and expansion study enrolling advanced cancer patients with select solid tumor types. The study is evaluating the safety and tolerability, maximum tolerated dose/recommended Phase 2 dose (MTD/RP2D), pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of BND-35, administered alone and in combination with an anti-Programmed Cell Death Protein Ligand-1 (PDL-1) or with an anti-Epidermal Growth Factor Receptor (EGFR) antibody. Participants’ tumors and peripheral blood are sampled before treatment and during treatment, to identify and confirm predictive biomarkers to be used in further clinical development.

Following dose escalation and determination of BND-35 recommended Phase 2 dose, the study design allows for the expansion of patient cohorts to evaluate the anti-tumor activity of BND-35 in specific tumor types. The trial will be conducted at several clinical sites, initially enrolling patients in the US and Israel. For more information about the study including participating medical centers, please visit.

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 tumor microenvironment (such as APOE and fibronectin). In vitro and ex vivo studies have demonstrated that BND-35 enhances the pro-inflammatory activity of various myeloid cells and inhibits the immunosuppressive activity of suppressive myeloid cells, thus restoring T cells and NK cells activation as monotherapy and in combination with PD-1 pathway inhibitors as well as with anti-EGFR agents.
BND-35 enhanced immune activity was demonstrated in a unique system of patient-derived tumoroids In vivo, blocking ILT3 (LILRB4) activity with BND-35 resulted in decreased tumor growth and induced a pro-inflammatory phenotype in tumor resident T cells and myeloid cells populations as a single agent and in combination with anti PD-1 and anti-EGFR

BND-35 is an investigational drug, and it has not been approved for the treatment of any cancer types. Patients should contact their physician for information regarding any aspect of their treatment or involvement in clinical trials.

If you are a medical professional and require further information about Biond Biologics, our clinical research, or clinical trials, please send an email to natalia@biondbio.com.