VIR News & Events

"Vir Bio delivered incredible momentum during the first quarter with positive, new VIR-5500 Phase 1 data and execution of a global agreement with Astellas in prostate cancer. The closing of our collaboration with Astellas in April has ignited the next stage of development work, bolstering our ability to move faster and think bigger together," said Marianne De Backer, Chief Executive Officer of Vir Biotechnology. "We also announced promising updated Phase 2 data on our combination regimen in CHD and will be presenting complete Week 96 data at the EASL Congress later this month. CHD is the most severe form of hepatitis. We believe our well-tolerated combination regimen is uniquely positioned to change the standard of care, bringing together robust efficacy with the potential for self-administration at home with once monthly subcutaneous dosing."

Vir Biotechnology (VIR) announced that its global collaboration and licensing agreement with Astellas (ALPMY) announced on February 23 has closed following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The collaboration aims to accelerate the development of VIR-5500, a prostate-specific membrane antigen-targeted, PRO-XTEN dual-masked T-cell engager for metastatic prostate cancer. Upon closing, Vir Biotechnology receives a $240M upfront payment and a $75M equity investment at a price of $10.36 per share. The Company will also receive a near-term $20M milestone payment, will split U.S. profit/loss equally with Astellas, 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. Under the terms of Vir Biotechnology's licensing agreement with Sanofi (SNY), a portion of certain collaboration proceeds will be shared with Sanofi.

Vir Biotechnology announced that the first patient has been dosed in one of three expansion cohorts in the Phase 1 trial evaluating VIR-5500, a prostate-specific membrane antigen-targeted, PRO-XTEN dual-masked T-cell engager, TCE, for metastatic prostate cancer. The Phase 1 trial is measuring the safety and efficacy of VIR-5500 monotherapy in late-line mCRPC, and of VIR-5500 in combination with an androgen receptor pathway inhibitor, ARPI, in early-line mCRPC and mHSPC. "The initiation of the VIR-5500 expansion cohorts underscores the significant momentum behind this program and the enthusiasm we are seeing across the clinical community," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "We are encouraged by the promising anti-tumor activity shown in the Phase 1 data announced earlier this year and look forward to collaborating with Astellas after closing of the transaction to explore VIR-5500's potential to make a meaningful difference across the spectrum of metastatic prostate cancer."