Biond Biologics and Merck KGaA Partner on Phase 1 Trial of BND-35 with Cetuximab for Solid Tumors

MISGAV, Israel, Oct. 29, 2024 – Biond Biologics Ltd., a private clinical-stage biopharmaceutical company committed to pioneering novel immunotherapies for cancer and developing innovative platforms for the intracellular delivery of biologics, has announced a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany. This partnership aims to evaluate Biond’s immunotherapy agent BND-35 in conjunction with Merck's anti-EGFR monoclonal antibody cetuximab (Erbitux®) in a Phase 1 clinical trial for patients with unresectable or metastatic solid tumors.

According to the agreement, Merck KGaA, Darmstadt, Germany will provide cetuximab to support Biond’s Phase 1 trial, focusing on the safety and efficacy of combining BND-35 with cetuximab. The trial's dose-escalation monotherapy arm for BND-35 has already begun, with several patients having received doses.

BND-35 is an innovative anti-ILT3 (LILRB4) antibody that blocks the interaction between ILT3 and extracellular matrix ligands such as fibronectin, critical components of many tumor microenvironments (TME). ILT3 is present on myeloid suppressive cells, contributing to a TME that supports tumor growth. It also diminishes the effectiveness of antibody therapies that depend on antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), crucial mechanisms for targeting tumor cells. BND-35 modifies the suppressive microenvironment to a more pro-inflammatory state and counteracts ILT3's inhibitory effects on ADCC and ADCP.

Tal Sines, VP of Business Development at Biond, expressed enthusiasm about the collaboration with Merck KGaA, Darmstadt, Germany. He highlighted preclinical data suggesting that BND-35 can work synergistically with cetuximab and other therapies that enhance ADCC and ADCP activities, potentially offering a new treatment option for patients with solid tumors.

On the subject of BND-35, this innovative anti-ILT3/LILRB4 antibody is currently under evaluation as a monotherapy in a Phase 1 clinical trial. This trial aims to assess the safety, tolerability, and potential anti-tumor activity of BND-35. Additionally, BND-35 is being tested in combination with anti-EGFR (cetuximab) and PD-L1 therapies for various indications.

Biond Biologics is at the forefront of developing advanced therapies targeting new oncology pathways and enabling the intracellular delivery of biologics. The company's mission is to transform cutting-edge science and groundbreaking technologies into drugs that address diseases with high unmet medical needs. Biond is actively pursuing collaborative efforts with leading biopharmaceutical companies to introduce novel medicines to patients globally.

The company’s extensive pipeline includes BND-22 (SAR444881), a pioneering ILT2-blocking antibody developed in partnership with Sanofi, and BND-67, which targets CD28 shedding, a newly identified immune evasion mechanism. Biond is also progressing with INspire, a revolutionary platform designed for the intracellular delivery of protein therapeutics, including antibodies, proteins, or enzymes into cells.