– Astellas and Vir Biotechnology to co-develop and co-commercialize VIR-5500 through a sharing of expenses and revenues –
– Astellas to lead commercialization of VIR-5500 in the U.S. with Vir Biotechnology retaining option to co-promote, and Astellas will obtain exclusive rights to commercialize VIR-5500 ex-U.S. –
– Vir Biotechnology will receive $335M in upfront and near-term milestone payments, will split U.S. profit/loss equally with Astellas (50/50), and is eligible to receive up to an additional $1.37B in development, regulatory and sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales –
– Vir Biotechnology to host conference call today at 2:30 p.m. PT / 5:30 p.m. ET –
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced they have entered into a global strategic collaboration to advance VIR-5500, an investigational PRO-XTEN® dual-masked CD3 T-cell engager (TCE) targeting PSMA for the treatment of prostate cancer. The collaboration aims to accelerate the development of VIR-5500 and further strengthen Astellas’ oncology pipeline and prostate cancer leadership.
Adam Pearson, Chief Strategy Officer, Astellas
“Astellas is proud to have helped 1.5 million patients with prostate cancer, and we are dedicated to expanding our impact as part of our R&D strategy. Our deep expertise in this disease area, combined with a growing immuno-oncology (IO) pipeline of biologics, including T-cell engagers, uniquely positions us to help advance VIR-5500, a potentially best-in-class T-cell engager for prostate cancer. This strategic collaboration allows Astellas and Vir Biotechnology to combine our expertise and reaffirms our commitment to improving the lives of people with prostate cancer.”
Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology
“Astellas is an ideal collaborator for the VIR-5500 program given the company’s successful track record advancing therapies across the treatment continuum, building blockbuster franchises and delivering value to patients through strategic development alliances with other biotech partners. This collaboration will enable more rapid advancement of VIR-5500 to potentially benefit more people living with prostate cancer. We believe this collaboration reflects confidence in our PRO-XTEN® platform, which has broad potential across multiple solid tumor indications.”
Despite recent advances in treatment, prostate cancer, especially metastatic castration-resistant prostate cancer (mCRPC), remains an aggressive and difficult cancer to treat; mCRPC has a 5-year survival rate of approximately 30%.i Patients who progress to mCRPC develop therapeutic resistance and currently have limited treatment options.
VIR-5500 is a potential best-in-class dual-masked Prostate-Specific Membrane Antigen (PSMA)-targeting TCE and is currently in Phase 1 development for people with advanced, metastatic prostate cancer (NCT05997615). VIR-5500 combines a bispecific PSMA and CD3 binding TCE with the PRO-XTEN® masking technology, which is designed to keep the TCEs masked (or inactive) until they reach the tumor microenvironment, reducing off-target effects and improving the therapeutic index.
Under the terms of the agreement, Vir Biotechnology will receive $335 million in upfront and near-term payments, including $240 million in cash, $75 million in equity investment at a 50% premium,ii and a near-term $20 million milestone. Global development costs for VIR-5500 will be shared, with Astellas responsible for 60% and Vir Biotechnology responsible for 40% of all costs. Vir Biotechnology will continue the ongoing Phase 1 trial, until responsibility is transitioned to Astellas, after which Astellas will be responsible for all development activities. In the U.S., Vir Biotechnology will have the option to co-promote VIR-5500 with Astellas, and profit/loss will be shared equally. Outside the U.S., Astellas will be exclusively responsible for commercialization of VIR-5500. In addition, Vir Biotechnology is eligible to receive up to $1.37 billion in development, regulatory and sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales. Under the terms of Vir Biotechnology’s licensing agreement with Sanofi, a portion of certain collaboration proceeds will be shared with Sanofi.
Lazard acted as Vir Biotechnology’s exclusive financial advisor. Closing of the transaction is contingent on customary closing conditions, including clearance under the Hart-Scott-Rodino (HSR) Act.
Vir Biotechnology Conference Call
Vir Biotechnology will host its fourth quarter and full year 2025 financial results conference call at 2:30 p.m. PT / 5:30 p.m. ET today, when members of the executive team and Dr. de Bono will share the updated VIR-5500 Phase 1 data that is also being presented at the 2026 ASCO Genitourinary Cancers Symposium on February 26. A live webcast will be available at https://investors.vir.bio and will be archived for 30 days.
