Vir Biotechnology has concluded an exclusive worldwide licence agreement with Sanofi, enabling access to multiple clinical-stage T-cell engagers (TCEs) and the PRO-XTEN masking platform.
The deal, initially announced on 1 August 2024, has been finalised following the expiration of the waiting period stipulated by the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Vir has gained sole global rights to three clinical-stage TCEs, which have shown promise for treating a variety of cancers.
The company will also have exclusive rights to utilise the PRO-XTEN masking technology in the fields of oncology and infectious disease.
Sanofi’s key employees, who possess significant scientific and development expertise in TCEs and experience with the PRO-XTEN platform, will be joining Vir’s team.
The TCEs included in the licence are SAR446309, SAR446329 and SAR446368, each targeting distinct cancer markers and currently in Phase I clinical studies or preparing for trial commencement.
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SAR446309 is a dual-masked HER2-targeted TCE being studied for metastatic treatment-resistant HER2+ tumours, including breast and colorectal cancers.
SAR446329 targets PSMA and is being investigated for metastatic castration-resistant prostate cancer.
An EGFR-targeted TCE, SAR446368 has active IND [investigational new drug status] and is expected to begin enrolling participants in Phase I trials in the first quarter of 2025 for EGFR-expressing tumours.
The PRO-XTEN technology, which Vir has exclusively licensed, is designed to enhance the therapeutic index of drug candidates by leveraging the high protease activity within the tumour microenvironment (TME).
This selective activation mechanism aims to reduce off-target effects and toxicity, a common issue with traditional TCEs, by preferentially releasing the active molecule in the TME.
Vir Biotechnology CEO Marianne De Backer stated: “The closing of this strategic agreement with Sanofi is a pivotal moment for Vir and a significant opportunity to help address patient unmet needs. We are excited to further advance the masked T-cell engagers in clinical development, bolstering our clinical pipeline and adding near-term value-creation opportunities.
“Our proven expertise in antibody engineering and clinical development combined with the innovative PRO-XTEN masking platform offers a unique opportunity to discover and develop therapies in oncology and infectious disease.”
In conjunction with the Sanofi deal, Vir Biotechnology began strategic restructuring in August 2024, which includes a workforce reduction of 25% and the discontinuation of its influenza and Covid-19 programmes.
Vir will also phase out its T cell-based viral vector platform.
