Vir Biotechnology Expands Strategy with Sanofi License for Clinical-Stage T-cell Engagers

Vir Biotechnology, Inc. has announced a significant global license agreement with Sanofi, granting Vir exclusive rights to three clinical-stage masked T-cell engagers (TCEs) and the protease-cleavable masking platform for oncology and infectious diseases. This innovative technology, originally developed by Amunix Pharmaceuticals and acquired by Sanofi, can activate drugs in tumor tissues by leveraging the high protease activity within the tumor microenvironment. This selective activation aims to enhance the therapeutic index (TI) and reduce the toxic effects associated with traditional TCEs.

The assets involved in this agreement are:
1. SAR446309 (AMX-818): A dual-masked HER2-targeted TCE currently in Phase 1 clinical trials. This study includes participants with metastatic treatment-resistant HER2+ tumors, such as breast and colorectal cancers. The advanced dual masking technology may allow this TCE to be used both as a monotherapy and in combination with checkpoint inhibitors.
2. SAR446329 (AMX-500): Another dual-masked TCE, this time targeting PSMA, also in Phase 1 clinical trials. It is being tested on participants with metastatic castration-resistant prostate cancer and could potentially be used as a monotherapy or in combination with other treatments.
3. SAR446368 (AMX-525): This is a dual-masked EGFR-targeted TCE, with an Investigational New Drug (IND) application already cleared. Enrollment for a Phase 1 clinical study is expected to start in the first quarter of 2025, involving patients with EGFR-expressing tumors across various cancer types, such as colorectal, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma.

Vir’s Chief Executive Officer, Marianne De Backer, emphasized the company's commitment to advancing transformative treatments for patients with severe diseases. She acknowledged that despite recent advances in cancer therapeutics, many patients still face poor prognoses and significant treatment-related toxicity. She believes these new TCEs could play a crucial role in addressing these issues and advancing Vir's mission of leveraging the immune system to improve patient lives.

As part of the strategic agreement, key Sanofi employees with extensive experience in TCE development and the masking platform technology will join Vir, pending Hart-Scott-Rodino (HSR) Act clearance. Jennifer Towne, Vir’s Executive Vice President and Chief Scientific Officer, highlighted that the integration of this new platform and expertise aligns with Vir’s focus on conditionally activated biologics. She noted that Vir's deep understanding of T-cell immunology, coupled with its infrastructure and machine learning and antibody engineering capabilities, would create synergies and foster innovative, patient-centric solutions.

Under the terms of the agreement, Sanofi will receive an upfront payment, along with potential future payments tied to development, regulatory, and commercial milestones, as well as tiered royalties on global net sales. This agreement still requires regulatory approval.

This strategic licensing transaction is a pivotal step for Vir in its quest to develop transformative therapeutics for severe diseases. Vir has outlined several upcoming milestones in its clinical pipeline:
- Tobevibart +/- Elebsiran: Phase 2 SOLSTICE 24-week treatment data for chronic hepatitis delta virus infection is anticipated in the fourth quarter of 2024.
- Tobevibart + Elebsiran +/- PEG-IFN-⍺: Phase 2 MARCH Part B 48-week end-of-treatment data for hepatitis B virus infection is also expected in the fourth quarter of 2024.
- SAR446309: Phase 1 monotherapy and combination study data are expected in the latter half of 2025.
- SAR446329: Phase 1 monotherapy study data are anticipated in the second half of 2025.
- SAR446368: Enrollment for the Phase 1 study is expected to begin in the first quarter of 2025 or sooner.

This agreement marks a significant milestone in Vir’s dedication to developing groundbreaking treatments for some of the most challenging diseases, reflecting its commitment to transforming patient care through innovative immunological solutions.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!