BND-35 / Biond Biologics - LARVOL DELTA

BND-35-001: A Study of BND-35 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Terminated | Sponsor: Biond Biologics | N=280 ➔ 12 | Trial completion date: Nov 2027 ➔ Apr 2026 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2027 ➔ Apr 2026; Study terminated due to strategic considerations

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

BND-35, a novel anti-ILT3 antibody for remodulation of the tumor microenvironment (AACR 2024) - "BND-35 is an anti-ILT3 antagonist antibody that was shown to induce potent pro inflammatory activity of myeloid cells and enhance T cells activity inhibited by ILT3 expressing myeloid suppressive cells in multiple in vitro, ex vivo and in vivo models. By doing so, BND-35 can lead to TME remodelling from immunosuppressive to proinflammatory. Safety, tolerability, and anti-tumor activity of BND-35 will be explored in a first-in-human clinical trial in cancer patients with solid tumors."

Biomarker • First-in-human • Tumor microenvironment • Oncology • Solid Tumor • APOE • CD4 • CD8 • GLI2 • IL3 • LILRB4

Biond Biologics Announces Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany to Evaluate BND-35 in Combination with Cetuximab in a Phase 1 Clinical Study in Patients with Solid Tumors (PRNewswire) - "Biond is pleased to announce a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, to evaluate its immunotherapy agent BND-35 in combination with Merck KGaA, Darmstadt, Germany's anti-EGFR monoclonal antibody cetuximab (Erbitux) in a Phase 1 clinical trial (BND-35-001, NCT06274437) for the treatment of patients with unresectable or metastatic solid tumors. Under the terms of this agreement, Merck KGaA, Darmstadt, Germany will supply Biond Biologics with cetuximab to support Biond's Phase 1 clinical trial, aimed at evaluating the safety and efficacy of BND-35 in combination with cetuximab. Enrollment to the BND-35 dose-escalation monotherapy arm has already begun and several patients have already been dosed."

Commercial • Trial status • Oncology • Solid Tumor

BND-35-001: A Study of BND-35 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=280 | Recruiting | Sponsor: Biond Biologics | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor

Biond Biologics Announces First Patient Dosed with BND-35 in Phase 1 Clinical Trial (PRNewswire) - "Biond Biologics Ltd...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 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."

Trial status • Oncology • Solid Tumor

Biond Biologics Announces Presentation of BND-35, a Novel Anti-ILT3 Antibody for Remodeling the Tumor Microenvironment, at the American Association for Cancer Research (AACR) 2024 Annual Meeting (PRNewswire) - "BND-35 Receives IND Clearance, and First in Human Phase 1 Trial is Expected to Begin in April 2024....Biond Biologics Ltd...is excited to announce that our BND-35 program has been selected for presentation at the esteemed American Association for Cancer Research (AACR) Annual Meeting, scheduled for April 5 - 10, 2024, in San Diego Convention Center, San Diego, CA, USA....BND-35 phase 1 trial includes a unique clinical design, that will be presented in the ACCR, and is based on Biond's extensive pre-clinical work and the ability of BND-35 to block interactions with the various ligands of ILT3....The presentation will detail how BND-35, as a standalone therapy and in combination with anti-PD-1 and anti EGFR agents, has shown promising results in restoring T and NK cell activity and inducing a pro-inflammatory TME in various in vitro, ex vivo, and in vivo models."

Clinical protocol • IND • Preclinical • Oncology • Solid Tumor

A Study of BND-35 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=280 | Not yet recruiting | Sponsor: Biond Biologics

Combination therapy • Metastases • New P1 trial • Oncology • Solid Tumor

Biond Biologics to Present at the Raymond James LILRB/ILT Symposium (PRNewswire) - "Biond Biologics Ltd...announced that Tehila Ben Moshe, Ph.D., Co-Founder, and Chief Executive Officer and Ilana Mandel, Ph.D. and VP R&D, will be presenting therapeutics targeting ILTs (also known as LILRBs) at the LILRB/ILT Virtual Symposium....Biond will be presenting BND-22 (SAR444881), a multi-cell checkpoint inhibitor targeting the Immunoglobulin-like transcript receptor 2 or ILT2 (also known as Leukocyte Immunoglobulin Like Receptor B1 or LILRB1) that was partnered with Sanofi and is now in phase 1 for evaluating safety, tolerability, and anti-tumor activity in advanced cancer patients. Biond will also present BND-35 – an ILT3 (LILRB4( blocking antibody, that targets suppressive myeloid cells in the tumor microenvironment."

Clinical data • Oncology

Biond Biologics Announces Oral Presentation for BND-67, an Inhibitor of CD28 Shedding, a Potential Novel Resistance Mechanism to Anti PD-1 Therapy, at the American Association for Cancer Research (AACR) 2022 Annual Meeting (PRNewswire) - "Biond Biologics Ltd...announced...that the abstract on BND-67 was accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting...Soluble CD28 produced by this shedding mechanism was shown to counteract the efficacy of anti-PD-1 blocking antibodies in-vitro...Biond will present data demonstrating CD28-shedding process as a potential resistance mechanism to PD-1 therapies and will describe BND-67, an agent that can selectively and efficiently block this novel regulatory mechanism in cancer patients....In addition to Biond's BND-67 program, the company's Immuno-Oncology (I-O) pipeline also includes BND-35, an anti Ig-Like Transcript 3 (ILT3) antibody, an immune checkpoint inhibitor that inhibits the activity of suppressive myeloid cells."

Preclinical • Hematological Malignancies • Oncology