On March 3, 2025 Biond Biologics Ltd. ("Biond" or the "Company"), a private clinical-stage biopharmaceutical company developing novel therapies for cancer, reported that it would regain full rights to BND-22 (SAR444881) from Sanofi (Press release, Biond Biologics, MAR 3, 2025, View Source [SID1234650851]). Sanofi is returning the rights of BND-22 as part of their broader R&D prioritization to focus on programs that support the company’s strategy. Biond and Sanofi, are working together to complete full transfer of the BND-22 program to Biond.
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In January 2021, Biond entered into an exclusive worldwide license agreement with Sanofi for the development and commercialization of BND-22. As part of the agreement, Biond collaborated with Sanofi to initiate a first-in-human Phase 1 study (BND-22-001, NCT04717375), designed to evaluate the safety and tolerability of BND-22, both as a monotherapy and in combination with the approved cancer therapies cetuximab and pembrolizumab. The Phase 1 dose-escalation study was successfully completed and demonstrated a favorable safety profile across all patient groups. More specifically, data showed that BND-22 was well-tolerated and exhibited anti-tumor activity in heavily pretreated patients. Consistent with preclinical findings, a dose-dependent upregulation of activation markers was observed in monocytes and ILT2-expressing T and natural killer (NK) cell subsets. Notably, several confirmed clinical responses to both monotherapy and combination therapies regimens, were reported during the dose-escalation phase. These findings highlight the potential of BND-22 to address critical unmet needs in oncology.
Building on these encouraging results, Sanofi initiated enrollment for a Phase 2 dose-optimization and expansion study (BND-22-001, NCT04717375). The study was designed to evaluate BND-22 as monotherapy for patients with cholangiocarcinoma and in combination with cetuximab for patients with non-small cell lung cancer (NSCLC) or colorectal cancer (CRC). For more information about the trial, please visit View Source (Trial Identifier: NCT04717375).
"As part of the agreement between Biond and Sanofi, Biond will regain full rights to BND-22, including access to the clinical data generated by Sanofi," said Dr. Tehila Ben Moshe, Biond’s CEO and co-founder. "Sanofi has been an outstanding partner, and together, we have made remarkable progress in advancing the clinical development of BND-22. We remain committed to the continued development of BND-22 program, whether independently or in partnership with strategic collaborators".
"We are encouraged by the data demonstrated so far for BND-22 in the dose-escalation and dose-expansion study", said Dr. Natalia Ashtamker, Biond’s VP of Clinical Development. "We intend to continue treating patients who are benefiting from BND-22 treatment in the BND-22-001 study and are looking forward to the initiation of a Phase 2 biomarker study of BND-22 in combination with anti-PD-1 therapy".
About BND-22
BND-22 is a humanized IgG4 antagonist antibody targeting the ILT2 receptor, developed for the treatment of solid tumors. ILT2 is an inhibitory immuno-modulating receptor expressed on both innate and adaptive immune cells. It binds to major histocompatibility complex (MHC) class I molecules, including HLA-G, an immunosuppressive protein expressed by various tumor types.
Preclinical studies have demonstrated that BND-22 exerts broad anti-tumor effects by disrupting ILT2-mediated "do not eat me" signals in macrophages and activating NK and CD8+ lymphocytes.
BND-22-001, a Phase 1/2 multicenter, open-label, dose-escalation, dose-expansion and dose optimization study enrolled patients with advanced solid tumors known to express HLA-G. The study included evaluations of BND-22 as monotherapy in cholangiocarcinoma and in combination with cetuximab in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Additionally, a future Phase 2 biomarker trial will explore BND-22 in combination with an anti-PD-1 agent in NSCLC, CRC and ovarian cancers.