NEW YORK – Vir Biotechnology said Monday that it has closed a license agreement granting it exclusive worldwide rights to three clinical-stage T-cell engagers from Sanofi.
The assets in the deal include SAR446309, a HER2-targeted T-cell engager; SAR446329, a PSMA-targeted T-cell engager; and SAR446368, an EGFR targeted T-cell engager. Both the HER2-targeted T-cell engager SAR446309 and EGFR-targeted T-cell engager SAR446329 are in Phase I studies.
SAR446309, also dubbed AMX-818, is undergoing testing as a monotherapy and in combination with Merck's checkpoint inhibitor Keytruda (pembrolizumab) in patients with locally advanced or metastatic HER2-expressing cancers. Researchers are studying SAR446329, also known as AMX-500, in patients with metastatic castration-resistant prostate cancer.
Vir said the US Food and Drug Administration has cleared an investigational new drug application for SAR446368, enabling Phase I testing. The company expects to begin enrolling patients with EGFR-expressing tumors in this trial in Q1 2025.
In the deal, Vir also gained exclusive rights to use Sanofi's proprietary PRO-XTEN masking platform for oncology and infectious disease targets. The firm can use the platform to design drugs that are activated in the tumor microenvironment rather than in healthy tissues, in turn reducing the off-target activity and toxicity associated with systemic immune activation seen with traditional T-cell engagers. The platform was originally developed by Amunix, which was acquired by Sanofi in 2021.
Employees from Sanofi with scientific and development expertise in T-cell engagers and experience using the PRO-XTEN platform will join Vir under the agreement. The companies did not disclose the financial details of the deal, which they first announced in August.
In addition to the T-cell engagers acquired through this deal, San Francisco-based Vir is also developing treatments for hepatitis delta, hepatitis B, respiratory syncytial virus (RSV), and HIV.