Biond Biologics announced today that it will regain complete rights to its promising cancer immunotherapy drug BND-22 (SAR444881) from pharmaceutical giant Sanofi. The transfer comes as part of Sanofi's broader research and development reorganization, marking a significant milestone in the development of this novel immune checkpoint inhibitor.
The drug, which targets the ILT2 receptor, has shown encouraging results in clinical trials. The Phase 1 dose-escalation study (BND-22-001, NCT04717375) demonstrated a favorable safety profile and meaningful anti-tumor activity across multiple patient groups. Notably, researchers observed dose-dependent activation of immune cells, including monocytes and ILT2-expressing T and natural killer (NK) cells.
Clinical Trial Results and Ongoing Development
The Phase 1 trial evaluated BND-22 both as a monotherapy and in combination with established cancer treatments cetuximab and pembrolizumab. Several confirmed clinical responses were documented during the dose-escalation phase, providing strong evidence for the drug's potential in addressing unmet needs in oncology.
Building on these positive outcomes, the development program has advanced to Phase 2 studies. Current trials are investigating BND-22 as a standalone treatment for cholangiocarcinoma patients and in combination with cetuximab for those with non-small cell lung cancer (NSCLC) or colorectal cancer (CRC).
Mechanism of Action and Scientific Innovation
BND-22 represents a novel approach to cancer immunotherapy as a humanized IgG4 antagonist antibody. It works by targeting the ILT2 receptor, an inhibitory immune-modulating receptor present on both innate and adaptive immune cells. The drug disrupts ILT2-mediated "do not eat me" signals in macrophages while activating NK and CD8+ lymphocytes, as demonstrated in preclinical studies.
Future Development Plans
Dr. Tehila Ben Moshe, CEO and co-founder of Biond, expressed commitment to the program's continued development: "We remain dedicated to advancing BND-22, whether independently or through strategic collaborations." The company plans to maintain treatment for patients currently benefiting from BND-22 in the ongoing study.
Dr. Natalia Ashtamker, VP of Clinical Development at Biond, announced plans for a Phase 2 biomarker study combining BND-22 with anti-PD-1 therapy, highlighting the company's confidence in the drug's potential.
Strategic Implications
The return of BND-22 rights to Biond includes access to all clinical data generated during Sanofi's involvement, providing a strong foundation for future development. This transition represents a significant opportunity for Biond to advance its innovative cancer treatment platform while maintaining the momentum established through its collaboration with Sanofi.
