Vir Biotechnology doses first patient in prostate cancer combo trial

SAN FRANCISCO - Vir Biotechnology, Inc. (NASDAQ:VIR), a biotechnology company with a market capitalization of approximately $842 million, announced on Thursday that it has dosed the first patient in Part 3 of its Phase 1 clinical trial evaluating VIR-5500 in combination with androgen receptor pathway inhibitors (ARPIs) for first-line pre-taxane metastatic castration-resistant prostate cancer (mCRPC). The company’s stock has shown resilience with a 6.9% gain over the past week, according to InvestingPro data.

VIR-5500 is an investigational dual-masked T-cell engager targeting prostate-specific membrane antigen (PSMA). According to the company, it is the only dual-masked PSMA-targeting T-cell engager currently in clinical trials. InvestingPro analysis reveals that while Vir maintains a strong balance sheet with more cash than debt and a healthy current ratio of 7.01, the company is currently experiencing rapid cash burn - a critical factor for investors following clinical-stage biotech companies. Get access to 8 more exclusive InvestingPro Tips and comprehensive financial analysis through the Pro Research Report.

The open-label, non-randomized study is designed to assess safety, pharmacokinetics, and preliminary anti-tumor activity of the combination therapy in patients with metastatic prostate cancer.

The trial expansion follows earlier phases of the same study where VIR-5500 was evaluated as a monotherapy in heavily pre-treated mCRPC patients. The company stated that the monotherapy demonstrated promising early anti-tumor activity and favorable safety profile in those patients.

"Opening Part 3 of the Phase 1 trial brings the potential benefits of the universal PRO-XTEN approach to patients earlier in their cancer journey," said Marianne De Backer, Chief Executive Officer of Vir Biotechnology, in the press release.

VIR-5500 incorporates a masking technology designed to selectively activate in the tumor microenvironment, which the company claims may reduce toxicity to healthy cells.

Prostate cancer remains the most diagnosed cancer in men, with metastatic forms representing a significant burden with limited treatment options, according to information provided in the company statement.

The company’s clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across solid tumor indications.

In other recent news, Vir Biotechnology is set to present the Week 48 endpoint results from its SOLSTICE Phase 2 clinical study at the upcoming American Association for the Study of Liver Diseases meeting. The study focuses on evaluating the treatment of chronic hepatitis delta, with previous data showing promising virologic suppression. In terms of analyst ratings, BofA Securities recently upgraded Vir Biotechnology from Neutral to Buy, raising the price target to $14.00, citing the significant potential of the company’s hepatitis delta virus treatment. This treatment could potentially generate over $1 billion in unadjusted peak sales, according to BofA’s projections. Meanwhile, H.C. Wainwright has reiterated its Buy rating with a $15.00 price target following discussions with Vir’s management. Evercore ISI also initiated coverage on the company with an Outperform rating, setting a price target of $12.00. These developments highlight a growing interest and optimism among analysts regarding Vir Biotechnology’s future prospects.

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