Biond Biologics Reclaims Full Rights to ILT2-Targeting BND-22 Immunotherapy

Biond Biologics Ltd., a biopharmaceutical company based in Misgav, Israel, has announced a significant development in its pursuit of innovative cancer treatments. The company is regaining full rights to its drug candidate, BND-22 (SAR444881), from Sanofi. This transition follows Sanofi's decision to return the rights as part of a strategic reallocation of their research and development priorities. Biond and Sanofi will collaborate to ensure a smooth transfer of the BND-22 program back to Biond.

Initially, in January 2021, Biond had formed a worldwide exclusive licensing agreement with Sanofi for the development and commercialization of BND-22. This collaboration led to a Phase 1 clinical study, assessing the safety and tolerability of BND-22. Conducted on patients with advanced solid tumors, the study evaluated BND-22 both as a standalone treatment and in combination with established therapies like cetuximab and pembrolizumab. The trial concluded with encouraging results, demonstrating BND-22’s favorable safety profile across diverse patient groups. The data indicated that BND-22 was well-tolerated and showed anti-tumor activity, even in patients who had undergone extensive previous treatments. Notably, the study revealed a dose-dependent activation in immune markers, with several patients experiencing clinical responses to the treatment regimen, underscoring BND-22's potential in tackling unmet needs in oncology.

Building on the success of the initial trial, Sanofi initiated a Phase 2 study to further explore BND-22. This trial aims to optimize dosage and expand the investigation to include its use as a monotherapy for cholangiocarcinoma and in combination with cetuximab for non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Biond, with regained rights, plans to continue advancing the clinical development of BND-22.

Dr. Tehila Ben Moshe, Biond's CEO and co-founder, expressed optimism about the future of BND-22, acknowledging Sanofi's crucial role in its development thus far. She emphasized Biond's commitment to advancing the BND-22 program, whether independently or with new strategic partners. Dr. Natalia Ashtamker, Biond’s VP of Clinical Development, also conveyed enthusiasm for the drug’s potential. She highlighted the ongoing patient treatments and upcoming plans for a Phase 2 biomarker study, which will explore BND-22 in combination with anti-PD-1 therapy.

BND-22 is a humanized IgG4 antibody that targets the ILT2 receptor, offering a promising therapeutic approach for treating solid tumors. Its mechanism involves modifying immune responses by disrupting inhibitory signals in immune cells, thereby enhancing anti-tumor activity. Preclinical studies demonstrated BND-22’s effectiveness in promoting immune cell activation and counteracting tumor growth mechanisms.

In addition to BND-22, Biond's pipeline showcases other promising candidates, such as BND-35 and BND-67, which target different pathways in cancer treatment. BND-35, targeting ILT3, aims to alter the tumor microenvironment, while BND-67 focuses on sustaining T cell activation by preventing CD28 shedding. Both represent Biond’s innovative approaches in addressing cancer treatment resistance and improving therapeutic outcomes.

Biond, established in 2016 by Dr. Tehila Ben Moshe and a team of Israeli biopharmaceutical experts, continues its mission to develop groundbreaking therapies for cancer, leveraging insights from immunoregulation research. The company remains at the forefront of oncology research, committed to pioneering new treatments that address critical challenges in cancer therapy.