BND-35 Receives IND Clearance, and First in Human Phase 1 Trial is Expected to Begin in April 2024

MISGAV, Israel I March 26, 2024 I Biond Biologics Ltd., a pioneering clinical-stage biopharmaceutical company, developing innovative immunotherapies for cancer and a transformative platform for the intracellular delivery of biologics, 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 is distinguished as a humanized IgG4, ILT3 (LILRB4) antagonist antibody, designed to modulate the tumor microenvironment (TME) from immunosuppressive to pro-inflammatory, thereby counteracting tumor growth. 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, titled “BND-35, a novel anti-ILT3 antibody for remodulation of the tumor microenvironment”, will be part of the session on “Immune Targets and Therapies.” It is scheduled for Monday, Apr 8th, 2024, at 4:05 PM. The session will highlight Biond Biologics’ comprehensive preclinical characterization of BND-35, emphasizing its potential as a transformative treatment for solid tumors.

BND-35 Oral Presentation Highlights at 2024 AACR Annual Meeting

Biond Biologics’ pivotal research on BND-35 demonstrates its specificity in binding ILT3 with high affinity, without affecting other ILT-family receptors. The specific blocking of ILT3’s interaction with key ligands significantly enhances the pro-inflammatory activity of myeloid cells and effectively reverses ILT3-mediated immune suppression of T cells. 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.

“ILT3 is a clinically validated target that in the past several years have been the focus of several clinical programs. The findings we’re presenting at AACR 2024 represent the unique features of BND-35 and why we believe it has the potential to surpass other ILT3 targeting agents,” said Motti Hakim, Ph.D., VP R&D at Biond Biologics. “BND-35’s ability to remodel the immunosuppressive environment into a pro-inflammatory one, opens new doors for treating solid tumors and our research in this field brings a significant leap forward in our understanding of immune regulation within the TME,” Tsuri Peretz, BND-35 project manager at Biond Biologics, added, “We are eager to share our latest advancements with the scientific community. BND-35’s compelling preclinical results pave the way for its upcoming first-in-human clinical trial, marking a pivotal step in our quest to provide innovative solutions for patients with solid tumors.”

In addition to the spotlight on BND-35, Biond Biologics continues to advance its Immuno-Oncology pipeline, including the pre-clinical-stage BND-67 program, and the innovative INspire platform for intracellular delivery of biologics. The presentation will underscore Biond’s commitment to groundbreaking research and development, aiming to unlock new pathways for cancer treatment.

About Biond Biologics

Biond Biologics is at the forefront of developing cutting-edge therapies targeting novel oncology pathways and enabling the intracellular delivery of biologics. By exploring immunoregulatory pathways and pioneering technological platforms, Biond aims to translate advanced science and innovative thinking into transformative drugs for diseases with significant unmet needs.

Biond’s programs include BND-22 that was partnered with Sanofi, a multi-cell checkpoint first in class ILT2 blocking antibody, and BND-67, a novel agent developed for attenuating CD28 shedding, overcoming PD-1 blockade resistance; an immune evasion mechanism discovered by Biond’s scientists. The company is also developing BND-35 – an ILT3 blocking antibody, that targets suppressive myeloid cells in the tumor microenvironment.

In addition to its pipeline of immunotherapy agents, Biond is developing INspire – an innovative technological platform that enables the intracellular delivery of protein therapeutics, such as antibodies, proteins or enzymes, into cells. Using INspire, Biond targets, for example, the RAS-RAF signaling pathway, which is a driver in many cancers.

SOURCE: Biond Biologics