Vir Biotechnology expands strategy of powering the immune system through exclusive worldwide license agreement with Sanofi for multiple potential best-in-class clinical-stage T-cell engagers.
Vir Biotechnology, Inc. announced that it has entered into an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers (TCEs) and exclusive use of the protease-cleavable masking platform for oncology and infectious diseases, which were acquired by Sanofi from Amunix Pharmaceuticals.
The clinical-stage assets include i. SAR 446309 (AMX-818), a dual-masked HER2-targeted TCE; ii.SAR 446329 (AMX-500), a dual-masked PSMA-targeted TCE; and iii.SAR 446368 (AMX-525), a dual-masked EGFR-targeted TCE. Sanofi’s proprietary masking platform can be applied to TCEs, cytokines, and other molecules by exploiting the intrinsically high protease activity of the tumor microenvironment to specifically activate drugs in tumor tissues. The selective activation of the molecules in the tumor microenvironment potentially increases the therapeutic index (TI) and mitigates toxicities associated with the systemic immune activation seen with traditional TCEs,
This deal announcement coincides with the Company’s statement on its strategic restructuring initiatives to prioritize its clinical-stage pipeline opportunities.
Sanofi’s masking platform has yielded three promising clinical-stage TCE programs : i. SAR 446309 is a dual-masked HER2xCD3 TCE in Phase 1 clinical study including participants with metastatic treatment resistant HER2+ tumors such as breast and colorectal cancers. Increasing the TI through this proprietary dual masking may allow for both monotherapy and combinations with checkpoint inhibitors. ii. SAR 446329 is a dual-masked PSMAxCD3 TCE in Phase 1 clinical study including participants with metastatic castration-resistant prostate cancer. Increasing the TI through this proprietary dual masking may allow for both monotherapy and combinations. iii. SAR 446368 is a dual-masked EGFRxCD3 TCE with a cleared IND. Phase 1 clinical study, which is expected to begin enrollment in the first quarter of 2025 or sooner, will include participants with EGFR-expressing tumors of various types such as colorectal, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma.
As part of the strategic agreement with Sanofi, key employees with extensive scientific and development expertise in TCEs, and in-depth experience using the masking platform technology, will join Vir upon receipt of Hart-Scott-Rodino (HSR) Act clearance.
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