US Market News
2月前
Vir Biotechnology Announces First Patient Dosed in Phase 1 Dose-expansion Cohorts Evaluating PSMA-targeted, PRO-XTEN® Dual-masked T-cell Engager VIR-5500 in Patients with Metastatic Prostate CancerApril 13, 2026 8:05 AM
Business Wire
Phase 1 trial designed to assess the safety, pharmacokinetics and preliminary efficacy of VIR-5500 in both early and late-line metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC)
Dose-expansion builds on promising Phase 1 monotherapy dose-escalation data in mCRPC presented in February 2026
Vir Biotechnology, Inc. (Nasdaq: VIR) today 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 (PSMA)-targeted, PRO-XTEN® dual-masked T-cell engager (TCE) for metastatic prostate cancer (NCT05997615). 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.”
The monotherapy expansion cohort in late-line mCRPC is the first to begin enrollment based on the monotherapy dose-escalation data that showed VIR-5500 has a favorable safety profile and promising anti-tumor activity in mCRPC. These safety and efficacy data were presented at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in February. Based on these data, the selected dose regimen to be evaluated in this monotherapy expansion cohort is Q3W 800/2000/3500 µg/kg step-up dosing. This expansion cohort will measure safety and efficacy, including Prostate-Specific Antigen (PSA) response rate and Objective Response Rate (ORR) in patients with mCRPC who are refractory following treatment with multiple prior lines of therapy including at least one second-generation ARPI and one taxane regimen in addition to standard-of-care radioligand-based therapy.
“Building on the encouraging Phase 1 dose-escalation monotherapy data, this milestone represents an important step in further evaluating VIR-5500’s best-in-class potential,” said Anthony Jarkowski, Primary Focus Lead, Immuno-oncology, Astellas. “We look forward to starting our collaboration with Vir Biotechnology to potentially benefit more people living with prostate cancer, where there remains a significant unmet medical need.”
Dose-escalation of VIR-5500 in combination with enzalutamide continues in early-line mCRPC patients. The Company anticipates dosing of first patients in the combination dose-expansion cohorts in both early-line mCRPC and mHSPC over the coming months, followed by pivotal Phase 3 trials in 2027.
About Advanced Prostate Cancer
Prostate cancer remains a significant global health burden, representing the second leading cause of cancer-related mortality in men behind lung cancer.1 While diagnostic and therapeutic advances like androgen-directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).2 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. The majority of these patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC).3 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately 30%.4 There is a critical need for safer, more effective, and precisely targeted therapies capable of improving long term disease control and quality of life across the prostate cancer continuum.
About VIR-5500
T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. VIR-5500 is an investigational PRO-XTEN® dual-masked TCE currently being evaluated in an open-label, non-randomized Phase 1 clinical trial (NCT05997615) designed to assess the safety, pharmacokinetics and preliminary efficacy in participants with metastatic castration-resistant prostate cancer (mCRPC). VIR-5500 is the only dual-masked PSMA-targeting TCE in clinical evaluation.
VIR-5500 combines a bispecific PSMA and CD3 binding TCE with the PRO-XTEN® masking technology. The PRO-XTEN® masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with unmasked TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing for less frequent dosing regimens.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website.
Footnotes and references:
1 Kratzer TB, et. al. “Prostate cancer statistics, 2025.” CA Cancer J Clin. vol. 75 no. 6 (2025): 485-497. doi:10.3322/caac.70028.
2 Bernard-Terrier A & Beltran H. “Exploring the biology of metastatic hormone-sensitive prostate cancer: on the road to precision medicine.” J Clin Invest. vol. 136 no. 3 (2026):e200920. doi: 10.1172/JCI200920.
3 Leith A, et. al. “Real-World Treatment Patterns in Metastatic Castration-Resistant Prostate Cancer Across Europe (France, Germany, Italy, Spain, and the United Kingdom) and Japan.” Adv Ther. vol. 39 (2022): 2236-2255. doi: 10.1007/s12325-022-02073-w.
4 Huo, X et al. “Predicting Survival in Metastatic Castration-Resistant Prostate Cancer Patients: Development of a Prognostic Nomogram.” Studies in health technology and informatics vol. 323 (2025): 164-168. doi:10.3233/SHTI250070.
Vir Biotechnology Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of VIR-5500, both as a monotherapy and in combination with enzalutamide, to be a best-in-class treatment for advanced mCRPC (including in early-line) and other indications across the spectrum of prostate cancer and make a meaningful difference for these patients, where there remains a significant unmet medical need; Vir Biotechnology’s clinical development plans and expectations for VIR-5500, including protocols for and enrollment into ongoing and planned clinical trials (including combination dose-expansion cohorts in both early-line mCRPC and mHSPC over the coming months, followed by pivotal Phase 3 trials in 2027), target endpoints and data readouts; the timing of the anticipated closing of the transaction with Astellas, including receipt of any necessary regulatory clearances; Vir Biotechnology’s strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology’s planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology’s competitors, as well as changes in expected or existing competition; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Vir Biotechnology retains exclusive rights to the PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260413500942/en/
Media Contact
Caren Scannell
Director, Communications
cscannell@vir.bio
Investor Contact
Kiki Patel, PharmD
Head of Investor Relations
kpatel@vir.bio
Original: Vir Biotechnology Announces First Patient Dosed in Phase 1 Dose-expansion Cohorts Evaluating PSMA-targeted, PRO-XTEN® Dual-masked T-cell Engager VIR-5500 in Patients with Metastatic Prostate Cancer
US Market News
3月前
Vir Biotechnology Announces Proposed Public Offering of Common StockFebruary 24, 2026 4:05 PM
Business Wire
Vir Biotechnology, Inc. (Nasdaq: VIR), a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer, today announced that it intends to offer $200,000,000 of shares of its common stock in an underwritten public offering. In addition, Vir Biotechnology intends to grant the underwriters a 30-day option to purchase up to an additional $30,000,000 of shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares in the proposed offering will be offered by Vir Biotechnology. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Goldman Sachs & Co. LLC, Leerink Partners, Evercore ISI and Barclays are acting as book-running managers for the offering.
The shares described above are being offered pursuant to an automatically effective shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission, or the SEC, on November 3, 2023. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and may be obtained, when available, by contacting: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; Leerink Partners LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; Evercore Group L.L.C., Attn: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200 or by email at ecm.prospectus@evercore.com; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847, or by email at Barclaysprospectus@broadridge.com; or by accessing the SEC’s website at www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a portfolio of preclinical programs across a range of infectious diseases and oncologic malignancies.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the anticipated size and terms of the offering, the ability to complete the offering, whether or not the underwriters ultimately purchase any additional shares; risks and uncertainties related to the market and other conditions; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation, market and other conditions, including as may be impacted by geopolitical changes and other external factors that are beyond Vir Biotechnology’s or the underwriters’ control; the ability to complete the offering; and the satisfaction of the customary closing conditions related to the offering. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the section titled “Risk Factors” of Vir Biotechnology’s Annual Report on Form 10-K, filed with the SEC on February 23, 2026, and in the preliminary prospectus supplement relating to the proposed offering. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260224282771/en/
Media
Caren Scannell
Director, Communications
cscannell@vir.bio
Investors
Kiki Patel, PharmD
Head of Investor Relations
kpatel@vir.bio
Original: Vir Biotechnology Announces Proposed Public Offering of Common Stock
US Market News
3月前
Astellas and Vir Biotechnology Announce Global Strategic Collaboration to Advance PSMA-targeting PRO-XTEN® Dual-masked T-Cell Engager VIR-5500 for the Treatment of Prostate CancerFebruary 23, 2026 5:00 PM
PR Newswire (US)
- 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 -TOKYO and SAN FRANCISCO, Feb. 23, 2026 /PRNewswire/ -- 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.About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagersiii across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. Footnotes:
iHuo, Xingyue et al. "Predicting Survival in Metastatic Castration-Resistant Prostate Cancer Patients: Development of a Prognostic Nomogram." Studies in health technology and informatics vol. 323 (2025): 164-168. doi:10.3233/SHTI250070
ii50% premium to the 30 day volume weighted average share price as of February 19, 2026
iiiVir Biotechnology retains exclusive rights to the PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.Vir Biotechnology Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "should," "could," "may," "might," "will," "plan," "potential," "aim," "expect," "anticipate," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of the combination of VIR-5500 to treat prostate cancer (including mCRPC) and Vir Biotechnology's belief that it can be a best-in-class PSMA-targeting TCE; Vir Biotechnology's clinical development plans and expectations for VIR-5500, including protocols for and enrollment into ongoing and planned clinical studies, target endpoints and data readouts; Vir Biotechnology's immediate and potential future financial and other obligations under the agreement and collaboration with Astellas, as well as Vir Biotechnology's ability to realize the benefits; Vir Biotechnology's belief that Astellas is an ideal collaborator (given Astellas' successful track record advancing therapies across the treatment continuum, building blockbuster franchises and delivering value through strategic development alliances) and that the agreement will enable faster and broader advancement of VIR-5500 to potentially benefit more people living with prostate cancer; the timing of the anticipated closing of the transaction with Astellas, including receipt of any necessary regulatory clearances; Vir Biotechnology's strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies, some of whom may be competitors of Vir Biotechnology or otherwise have divergent interests, and uncertainty as to whether the benefits of Vir Biotechnology's various collaborations can ultimately be achieved; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology's planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology's competitors, as well as changes in expected or existing competition; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology's available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
View original content to download multimedia:https://www.prnewswire.com/news-releases/astellas-and-vir-biotechnology-announce-global-strategic-collaboration-to-advance-psma-targeting-pro-xten-dual-masked-t-cell-engager-vir-5500-for-the-treatment-of-prostate-cancer-302694866.htmlSOURCE Astellas Pharma Inc.
Original: Astellas and Vir Biotechnology Announce Global Strategic Collaboration to Advance PSMA-targeting PRO-XTEN® Dual-masked T-Cell Engager VIR-5500 for the Treatment of Prostate Cancer
US Market News
3月前
Vir Biotechnology Reports Positive Updated Phase 1 Results for PSMA-targeting, PRO-XTEN® Dual-masked T-Cell Engager VIR-5500 in Patients with Metastatic Prostate CancerFebruary 23, 2026 5:02 PM
Business Wire
– Updated Phase 1 dose-escalation data (n=58) show VIR-5500 monotherapy has a favorable safety profile and was well tolerated with no dose-limiting toxicities observed to date
– Dose-dependent anti-tumor activity was observed, with 82% PSA50 and 53% PSA90 declines and RECIST-evaluable objective responses (45% ORR in 5/11 patients) in ≥3,000 µg/kg Q3W dosing cohorts
– Vir Biotechnology to host conference call today at 5:30 p.m. ET / 2:30 p.m. PT
– Data will be presented at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium on February 26 (Oral Abstract #17)
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new data from the ongoing Phase 1 clinical trial of VIR-5500, a prostate-specific membrane antigen (PSMA)-targeting, PRO-XTEN® dual-masked T-cell engager (TCE) being evaluated in patients with advanced metastatic castration-resistant prostate cancer (mCRPC) who have progressed after multiple lines of therapy (NCT05997615). These data suggest that VIR-5500 monotherapy is well tolerated and exhibits promising anti-tumor activity. Data will be presented in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium on February 26 in San Francisco, CA (Oral Abstract #17).
"We are encouraged by VIR-5500's safety and tolerability profile and the early signals of durable anti-tumor activity in a heavily pre-treated population, which validate our PRO-XTEN® masking strategy aimed at achieving a differentiated therapeutic index," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "Based on these data, we are advancing dose-expansion cohorts and plan to initiate our registrational trial in 2027. We want to thank the patients in our Phase 1 program and their families for participating in the development of VIR-5500.”
Data across all patients receiving VIR-5500 monotherapy in the Phase 1 trial (n=58) show that VIR-5500 was generally well tolerated with no dose-limiting toxicities (DLTs) observed to date. Grade ≥3 treatment-related adverse events occurred in 12% (7/58) of patients and were manageable. Limited cytokine release syndrome (CRS) was observed in 50% (29/58) of patients, with events generally restricted to Grade 1 (fever only). Prophylactic steroids were not required and were only explored in a small cohort of three patients. Enrolled patients were heavily pre-treated (median of four prior lines) and a substantial proportion presented with high tumor burden, including nearly one half with visceral metastases.
Dose-dependent activity was observed across the entire treatment group as measured by both prostate-specific antigen (PSA) declines and radiographic responses. Efficacy data were reported in the highest dose cohorts (≥3,000 µg/kg Q3W; n=22/58) as of the January 9, 2026 data cut-off. In these cohorts, PSA50 declines occurred in 82% (14/17) and PSA90 declines in 53% (9/17) of PSA-evaluable patients. Among RECIST (Response Evaluation Criteria in Solid Tumors)-evaluable patients, objective responses were seen in 45% (5/11). Of the five responders, four achieved confirmed responses with one patient pending confirmation. Reductions on PSMA-PET (positron emission tomography) affirm PSA declines and radiographic responses, with tumor shrinkage observed across multiple lesions, including visceral metastases. These findings support proof-of-concept and further evaluation in expansion cohorts.
“It is remarkable to see these early signs of profound anti-tumor activity in heavily pre-treated mCRPC patients, and the favorable tolerability with minimal CRS to date means VIR-5500 could play a role in treating earlier disease,” said Dr. Johann de Bono, Principal Investigator and Director of the Drug Development Unit and Head of Prostate Cancer Targeted Therapy Group at the Institute of Cancer Research. “For patients with metastatic prostate cancer who have long faced limited treatment choices, VIR-5500 may offer a renewed sense of hope and a potential path to better outcomes.”
Vir Biotechnology has concluded QW and Q3W monotherapy dose-escalation in late-line mCRPC and has defined a preliminary go-forward dose and regimen recommendation for expansion. In parallel, dose-escalation of VIR-5500 in combination with enzalutamide continues in early-line mCRPC patients. The Company anticipates initiating monotherapy dose-expansion cohorts in late-line mCRPC and combination dose-expansion cohorts in both early-line mCRPC and metastatic hormone-sensitive prostate cancer (mHSPC) in the second quarter of 2026 followed by pivotal Phase 3 trials in 2027.
Conference Call
Vir Biotechnology will host its fourth quarter and full year 2025 financial results conference call at 5:30 p.m. ET / 2:30 p.m. PT 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.
About Advanced Prostate Cancer
Prostate cancer remains a significant global health burden, representing the most common cancer diagnosis in men and the second leading cause of cancer-related mortality in men behind lung cancer.1 Despite diagnostic and therapeutic advances, patients with prostate cancer continue to face substantial unmet medical need. While androgen directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).2 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. While androgen-directed therapies have improved outcomes in mHSPC settings, the majority of these patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC).3 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately 30%.4 There is a critical need for safer, more effective, and precisely targeted therapies capable of improving long term disease control and quality of life across the prostate cancer continuum.
About VIR-5500
T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. VIR-5500 is an investigational PRO-XTEN® dual-masked TCE currently being evaluated in an open-label, non-randomized Phase 1 clinical trial (NCT05997615) designed to assess the safety, pharmacokinetics and preliminary efficacy in participants with metastatic castration-resistant prostate cancer (mCRPC). VIR-5500 is the only dual-masked PSMA-targeting TCE in clinical evaluation.
VIR-5500 combines a bispecific PSMA and CD3 binding TCE with the PRO-XTEN® masking technology. The PRO-XTEN® masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with unmasked TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing for less frequent dosing regimens.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website.
Footnotes and references:
1 Kratzer TB, et. al. “Prostate cancer statistics, 2025.” CA Cancer J Clin. vol. 75 no. 6 (2025): 485-497. doi:10.3322/caac.70028.
2 Bernard-Terrier A & Beltran H. “Exploring the biology of metastatic hormone-sensitive prostate cancer: on the road to precision medicine.” J Clin Invest. vol. 136 no. 3 (2026):e200920. doi: 10.1172/JCI200920.
3 Leith A, et. al. “Real-World Treatment Patterns in Metastatic Castration-Resistant Prostate Cancer Across Europe (France, Germany, Italy, Spain, and the United Kingdom) and Japan.” Adv Ther. vol. 39 (2022): 2236-2255. doi: 10.1007/s12325-022-02073-w.
4 Huo, X et al. “Predicting Survival in Metastatic Castration-Resistant Prostate Cancer Patients: Development of a Prognostic Nomogram.” Studies in health technology and informatics vol. 323 (2025): 164-168. doi:10.3233/SHTI250070.
Vir Biotechnology Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of VIR-5500, both as a monotherapy and in combination with enzalutamide, to treat advanced mCRPC and other forms of prostate cancer (including in earlier disease) and offer patients a path to better outcomes; Vir Biotechnology’s clinical development plans and expectations for VIR-5500, including protocols for and enrollment into ongoing and planned clinical trials (including monotherapy dose-expansion cohorts in late-line mCRPC and combination dose-expansion cohorts in both early-line mCRPC and mHSPC in the second quarter of 2026, followed by pivotal Phase 3 trials in 2027), target endpoints and data readouts; Vir Biotechnology’s strategy and plans (including its PRO-XTEN® masking strategy aimed at achieving a differentiated therapeutic index); and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology’s planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology’s competitors, as well as changes in expected or existing competition; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Vir Biotechnology retains exclusive rights to the PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260223892941/en/
Contacts for inquiries or additional information:
Media Contact
Caren Scannell
Director, Communications
cscannell@vir.bio
Investor Contact
Kiki Patel, PharmD
Head of Investor Relations
kpatel@vir.bio
Original: Vir Biotechnology Reports Positive Updated Phase 1 Results for PSMA-targeting, PRO-XTEN® Dual-masked T-Cell Engager VIR-5500 in Patients with Metastatic Prostate Cancer
US Market News
3月前
Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial ResultsFebruary 23, 2026 5:14 PM
Business Wire
– Announces global strategic collaboration with Astellas to advance PSMA-targeted PRO-XTEN® dual-masked T-cell engager (TCE) VIR-5500 for the treatment of prostate cancer
– Reports updated VIR-5500 Phase 1 dose-escalation data supporting a favorable safety profile and promising anti-tumor activity
– Strong financial position with $781.6 million in cash and investments as of December 31, 2025
– Conference call scheduled for February 23, 2026, at 5:30 p.m. ET / 2:30 p.m. PT
Vir Biotechnology, Inc. (Nasdaq: VIR), today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2025.
“This is a seminal moment for Vir Biotechnology, marked by key high-potential partnerships on two of our programs showcasing the strength of our pipeline and technology platforms. Today, we announced a global strategic collaboration with Astellas and compelling new Phase 1 data for VIR-5500, demonstrating the potential for our PRO-XTEN® masked TCEs to play a transformative role in oncology and impact the lives of people living with hard-to-treat cancers,” said Marianne De Backer, Chief Executive Officer, Vir Biotechnology. “Additionally, our licensing agreement with Norgine signed in December 2025, for the combination of tobevibart and elebsiran for the treatment of hepatitis delta, positions us to reach patients worldwide who face hepatitis delta, the most severe form of chronic viral hepatitis. Together, these milestones reflect how we are unlocking meaningful value in our pipeline and expanding the reach of our potential therapies.”
Pipeline Programs
Chronic Hepatitis Delta (CHD)
To support global commercialization of the combination of tobevibart, an investigational neutralizing monoclonal antibody (mAb), and elebsiran, an investigational small interfering RNA (siRNA), for the treatment of CHD, the Company granted Norgine Pharma UK Limited (Norgine) an exclusive commercial license in Europe, Australia and New Zealand.
Phase 2 SOLSTICE data presented at the 44?? Annual J.P. Morgan Healthcare Conference in January 2026 showed the combination of tobevibart and elebsiran is well tolerated and achieved undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) in 88% (21/24) of participants with CHD evaluable at Week 96 of treatment.
Previous positive Phase 2 SOLSTICE data at Week 48 were presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025 and simultaneously published in the New England Journal of Medicine.1
Topline data from the ECLIPSE 1 trial are expected in the fourth quarter of 2026. Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027.
Solid Tumors
VIR-5500
The Company executed a global strategic collaboration with Astellas2 to advance PSMA-targeted PRO-XTEN® dual-masked TCE VIR-5500, currently in development for metastatic castration-resistant prostate cancer (mCRPC).
Positive updated Phase 1 data for VIR-5500 monotherapy showed dose-dependent anti-tumor activity and a well-tolerated safety profile to date in patients with mCRPC. The data will be shared during the Company’s fourth quarter and full year conference call today and in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium on February 26 (Oral Abstract #17). The oral presentation will be delivered by Dr. Johann de Bono, Principal Investigator and Director of the Drug Development Unit and Head of Prostate Cancer Targeted Therapy Group at the Institute of Cancer Research.
Phase 1 monotherapy dose-escalation of weekly and once every three weeks dosing of VIR-5500 is complete, and the Company has defined a preliminary go-forward dose and regimen recommendation for expansion. In parallel, dose-escalation of VIR-5500 in combination with enzalutamide continues in early-line mCRPC patients.
The Company anticipates initiating monotherapy dose-expansion cohorts in late-line mCRPC and combination dose-expansion cohorts in both early-line mCRPC and metastatic hormone-sensitive prostate cancer (mHSPC) in the second quarter of 2026 followed by pivotal Phase 3 trials in 2027.
VIR-5818
Phase 1 dose-escalation of VIR-5818, a HER2-targeted PRO-XTEN® dual-masked TCE, in combination with pembrolizumab continues, with response data expected in the second half of 2026.
VIR-5525
The Phase 1 study of VIR-5525, an EGFR-targeted PRO-XTEN® dual-masked TCE, continues enrollment as expected.
Preclinical Pipeline Candidates
The Company is currently progressing a number of PRO-XTEN® masked TCEs in preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors, including lung, colorectal and bladder.
Fourth Quarter and Full Year 2025 Financial Results
Cash, Cash Equivalents and Investments: As of December 31, 2025, the Company had approximately $781.6 million in cash, cash equivalents and investments, representing a decline of approximately $29.1 million during the fourth quarter of 2025. For the full year of 2025, cash, cash equivalents and investments declined approximately $313.8 million. During the fourth quarter, the Company received a $64.3 million initial cost reimbursement payment upon signing the license agreement with Norgine.
Revenue: Revenue for the fourth quarter of 2025 was $64.1 million compared to $12.4 million for the same period in 2024. Revenue for the full year of 2025 was $68.6 million compared to $74.2 million in 2024. The increase in the fourth quarter was primarily driven by the recognition of $64.3 million license revenue related to the initial cost reimbursement payment received under the license agreement with Norgine. The decrease in the full year was primarily due to lower license and collaboration revenue from GSK and lower grant revenue, partially offset by the license revenue recognized under the license agreement with Norgine.
Cost of Revenue: The change in cost of revenue for the fourth quarter and full year of 2025 compared to the same periods in 2024 was nominal.
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2025 were $88.3 million, which included $5.6 million of non-cash stock-based compensation expense, compared to $106.1 million for the same period in 2024, which included $8.3 million of non-cash stock-based compensation expense. R&D expenses for the full year of 2025 were $456.0 million, which included $25.1 million of non-cash stock-based compensation expense, compared to $506.5 million in 2024, which included $43.9 million of non-cash stock-based compensation expense. The decrease in both the fourth quarter and full year was primarily due to cost savings from previously announced restructuring initiatives as well as lower expenses from contingent consideration liability revaluation, partially offset by higher clinical cost due to the initiation of our Phase 3 ECLIPSE registrational program and progression of our oncology programs.
The full year of 2025 R&D expenses include a $75.0 million milestone payment made upon VIR-5525 achieving first-in-human dosing, the $30.0 million expense in connection with amending the Company’s license agreement with Alnylam Pharmaceuticals, Inc., and milestone payments due upon initiation of the ECLIPSE Phase 3 registrational program. These 2025 license-related expenses were substantially offset by the $102.8 million upfront license payment made to Sanofi in 2024.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2025 were $23.6 million, which included $5.6 million of non-cash stock-based compensation expense, compared to $26.7 million for the same period in 2024, which included $7.5 million of non-cash stock-based compensation expense. SG&A expenses for the full year of 2025 were $92.1 million, which included $24.0 million of non-cash stock-based compensation expense, compared to $119.0 million in 2024, which included $34.5 million of non-cash stock-based compensation expense. The decrease in both the fourth quarter and the full year was primarily due to efficiencies and cost savings from previously announced restructuring initiatives.
Restructuring, Long-Lived Assets Impairment and Related Charges: The decrease in restructuring, long-lived assets impairment and related charges for the fourth quarter and full year of 2025 was due to the fact that our restructuring initiatives implemented in prior years were substantially completed by the end of 2024.
Other Income: The decrease in other income for the fourth quarter and full year of 2025 was primarily driven by lower interest income. Additionally, the decrease in the full year was partially offset by lower unrealized loss from the Company’s equity investment.
Benefit from (Provision for) Income Taxes: The change in benefit from (provision for) income taxes for the fourth quarter and the full year of 2025 was nominal.
Net Loss: Net loss attributable to Vir Biotechnology for the fourth quarter of 2025 was $(42.9) million, or $(0.31) per share, basic and diluted, compared to a net loss of $(104.6) million, or $(0.76) per share, basic and diluted, for the same period in 2024. Net loss attributable to Vir Biotechnology for the year of 2025 was $(438.0) million, or $(3.16) per share, basic and diluted, compared to a net loss of $(522.0) million, or $(3.83) per share, basic and diluted, in 2024.
2026 Financial Guidance
Based on current operating plans, including the expected net effects of the Astellas global collaboration and the Astellas equity investment,2 the Company expects its cash, cash equivalents and investments to fund operations into the second quarter of 2028.
Conference Call
Vir Biotechnology will host its fourth quarter and full year 2025 financial results conference call at 5:30 p.m. ET / 2:30 p.m. PT 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.
About the ECLIPSE Registrational Program
ECLIPSE is a registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 (NCT06903338) is a Phase 3 trial evaluating the safety and efficacy of tobevibart in combination with elebsiran compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 (NCT07128550) is a Phase 3 trial evaluating the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies. ECLIPSE 3 (NCT07142811) is a Phase 2b head-to-head trial evaluating combination tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients, and is designed to provide important supportive data to help establish access and reimbursement in key markets.
About Tobevibart and Elebsiran
Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary mAb discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously and is currently in clinical development for the treatment of patients with chronic hepatitis delta (CHD).
Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) licensed from Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of HBsAg. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously and is currently in clinical development for the treatment of patients with CHD.
About Chronic Hepatitis Delta (CHD)
CHD is the most severe form of chronic viral hepatitis3 and was recently classified as carcinogenic by the International Agency for Research on Cancer.4 People living with the disease rapidly progress to cirrhosis, liver failure5 and liver-related death.3 There are currently no approved treatments in the U.S., and options are limited in the European Union and globally.
About VIR-5500, VIR-5818 and VIR-5525
VIR-5500, VIR-5818 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the universal PRO-XTEN® masking technology and target PSMA, HER2 and EGFR, respectively.
TCEs are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The universal PRO-XTEN® masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians.
About Advanced Prostate Cancer
Prostate cancer remains a significant global health burden, representing the most common cancer diagnosis in men and the second leading cause of cancer-related mortality in men behind lung cancer.6 Despite diagnostic and therapeutic advances, patients with prostate cancer continue to face substantial unmet medical need. While androgen directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).7 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. While androgen-directed therapies have improved outcomes in mHSPC settings, the majority of these patients still eventually progress to metastatic castration-resistant prostate cancer (mCRPC).8 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately 30%.9 There is a critical need for safer, more effective and precisely targeted therapies capable of improving long-term disease control and quality of life across the prostate cancer continuum.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a portfolio of preclinical programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website.
Footnotes and references:
1 Asselah T, Chattergoon MA, Jucov A, et al. “A Phase 2 Trial of Tobevibart plus Elebsiran in Hepatitis D” N Engl J Med. vol. 394, no. 4 (2026), 343-353, doi:10.1056/NEJMoa2508827.
2 Closing of the Astellas global collaboration and Astellas equity investment is contingent on customary closing conditions, including clearance under the Hart-Scott-Rodino (HSR) Act. Under the terms of Vir Biotechnology's licensing agreement with Sanofi, we will share with Sanofi 20% of certain future collaboration proceeds from the Astellas collaboration agreement.
3 National Institute of Diabetes and Digestive and Kidney Diseases. Hepatitis D. NIDDK. Published November 2024. Accessed September 2025. Hepatitis D - NIDDK (nih.gov).
4 Karagas, Margaret R et al., “Carcinogenicity of hepatitis D virus, human cytomegalovirus, and Merkel cell polyomavirus” The Lancet Oncology, vol. 26, no. 8 (2025): 994 – 995. doi: 10.1016/S1470-2045(25)00403-6.
5 Center for Disease Control and Prevention. Hepatitis D FAQs. CDC. Published March 2020. Accessed September 2025. What is Hepatitis D - FAQ | CDC.
6 Kratzer TB, et al. “Prostate cancer statistics, 2025.” CA Cancer J Clin. vol. 75 no. 6 (2025): 485-497. doi:10.3322/caac.70028.
7 Bernard-Terrier A & Beltran H. “Exploring the biology of metastatic hormone-sensitive prostate cancer: on the road to precision medicine.” J Clin Invest. vol. 136 no. 3 (2026):e200920. doi: 10.1172/JCI200920.
8 Leith A, et al. “Real-World Treatment Patterns in Metastatic Castration-Resistant Prostate Cancer Across Europe (France, Germany, Italy, Spain, and the United Kingdom) and Japan.” Adv Ther. vol. 39 (2022): 2236-2255. doi: 10.1007/s12325-022-02073-w.
9 Huo, X et al. “Predicting Survival in Metastatic Castration-Resistant Prostate Cancer Patients: Development of a Prognostic Nomogram.” Studies in health technology and informatics vol. 323 (2025): 164-168. doi:10.3233/SHTI250070.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: Vir Biotechnology’s cash balance and anticipated runway; Vir Biotechnology’s collaboration with Astellas, including potential payments to be made to Vir Biotechnology under such collaboration; Vir Biotechnology’s future financial and operating results and its expectations related thereto, including Vir Biotechnology’s financial guidance; the therapeutic and commercial potential of Vir Biotechnology's chronic hepatitis delta program, as well as Vir Biotechnology's strategy, plans and expectations related thereto; the therapeutic and commercial potential of VIR-5500 and the other assets in Vir Biotechnology's oncology solid tumor portfolio, preclinical pipeline and PRO-XTEN® masking technology, as well as Vir Biotechnology's strategy, plans and expectations related thereto; the potential of and Vir Biotechnology’s expectations for its other pipeline programs; Vir Biotechnology’s plans and expectations for its clinical development programs, including protocols for and enrollment into ongoing and planned clinical studies, potential partnering opportunities, and data readouts and presentations, as well as anticipated timelines; the potential benefits, safety and efficacy of Vir Biotechnology’s investigational therapies; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; the timing and amount of Vir Biotechnology’s actual operating expenses, as determined in accordance with U.S. Generally Accepted Accounting Principles; difficulties in collaborating with other companies, some of whom may be competitors of Vir Biotechnology or otherwise have divergent interests, and uncertainty as to whether the benefits of Vir Biotechnology’s various collaborations can ultimately be achieved in the amounts and on the timeline Vir Biotechnology expects, including risks affecting the anticipated closing of the transaction with Astellas, including delays and the satisfaction of closing conditions that are outside Vir Biotechnology’s control; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology’s planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology’s competitors, as well as changes in expected or existing competition; Vir Biotechnology’s use of AI and machine learning in its efforts to engineer next-generation proteins and in other research and development efforts; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later-stage or larger-scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
VIR BIOTECHNOLOGY, INC.
Consolidated Balance Sheets
(in thousands, except share and per share data)
(unaudited)
December 31,
2025
2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
232,185
$
222,947
Short-term investments
228,753
678,051
Restricted cash and cash equivalents, current
1,922
89,385
Equity investments
6,077
4,350
Prepaid expenses and other current assets
45,143
47,725
Total current assets
514,080
1,042,458
Intangible assets, net
7,850
8,120
Goodwill
16,937
16,937
Property and equipment, net
55,620
63,183
Operating right-of-use assets
62,099
59,680
Restricted cash and cash equivalents, noncurrent
6,963
6,363
Long-term investments
314,575
190,015
Other assets
24,699
12,057
TOTAL ASSETS
$
1,002,823
$
1,398,813
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable
$
9,803
$
5,081
Accrued and other liabilities
83,012
98,521
Contingent consideration obligation, current
—
16,060
Total current liabilities
92,815
119,662
Operating lease liabilities, noncurrent
89,054
90,139
Contingent consideration obligation, noncurrent
34,100
24,050
Other long-term liabilities
21,578
14,577
TOTAL LIABILITIES
237,547
248,428
Commitments and contingencies
STOCKHOLDERS’ EQUITY:
Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of December 31, 2025 and 2024, respectively; no shares issued and outstanding as of December 31, 2025 and 2024
—
—
Common stock, $0.0001 par value; 300,000,000 shares authorized as of December 31, 2025 and 2024, respectively; 139,474,954 and 136,959,446 shares issued and outstanding as of December 31, 2025 and 2024, respectively
14
14
Additional paid-in capital
1,965,090
1,911,872
Accumulated other comprehensive loss
(2,057
)
(1,717
)
Accumulated deficit
(1,197,771
)
(759,784
)
TOTAL STOCKHOLDERS’ EQUITY
765,276
1,150,385
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
1,002,823
$
1,398,813
VIR BIOTECHNOLOGY, INC.
Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)
Three Months Ended
December 31,
Year Ended
December 31,
2025
2024
2025
2024
Revenues:
License and collaboration revenue
$
63,760
$
10,589
$
63,130
$
61,370
Grant revenue
310
1,096
2,036
10,493
Other revenue
—
689
3,390
2,342
Total revenues
64,070
12,374
68,556
74,205
Operating expenses:
Cost of revenue
26
684
26
845
Research and development
88,349
106,083
455,966
506,499
Selling, general and administrative
23,616
26,701
92,074
119,031
Restructuring, long-lived assets impairment and related charges, net
—
(3,944
)
(182
)
34,995
Total operating expenses
111,991
129,524
547,884
661,370
Loss from operations
(47,921
)
(117,150
)
(479,328
)
(587,165
)
Other income:
Change in fair value of equity investments
(2,606
)
(1,172
)
1,729
(5,528
)
Interest income
7,802
14,153
40,238
71,809
Other expense, net
(335
)
(506
)
(409
)
(2,221
)
Total other income
4,861
12,475
41,558
64,060
Loss before benefit from (provision for) income taxes
(43,060
)
(104,675
)
(437,770
)
(523,105
)
Benefit from (Provision for) income taxes
137
86
(217
)
1,145
Net loss
$
(42,923
)
$
(104,589
)
$
(437,987
)
$
(521,960
)
Net loss per share, basic and diluted
$
(0.31
)
$
(0.76
)
$
(3.16
)
$
(3.83
)
Weighted-average shares outstanding, basic and diluted
139,232,143
136,808,690
138,520,419
136,246,865
View source version on businesswire.com: https://www.businesswire.com/news/home/20260222469334/en/
Media Contact
Caren Scannell
Director, Communications
cscannell@vir.bio
Investor Contact
Kiki Patel, PharmD
Head of Investor Relations
kpatel@vir.bio
Original: Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial Results
US Market News
4月前
Registration-Ready: How 2026's Clinical Leaders Are Beating Cancer BenchmarksJanuary 27, 2026 3:50 PM
PR Newswire (Canada)
Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, Jan. 27, 2026 /CNW/ -- Equity-Insider.com News Commentary – The global oncology therapy market is charging toward a massive $668 billion valuation by 2034, as a ruthless capital rotation finally rewards execution-ready platforms over the "hopes and dreams" of speculative discovery assets[1]. With the FDA's accelerated approval pathway delivering survival wins across 65% of solid tumor indications, the 2026 regulatory landscape is demanding a new breed of registration-directed study designs that prioritize raw objective response rates and durability[2]. This structural shift creates an asymmetric investment window for Oncolytics Biotech Inc. (NASDAQ: ONCY), Moderna (NASDAQ: MRNA), Merck (NYSE: MRK), Vir Biotechnology (NASDAQ: VIR), and Coherus Oncology (NASDAQ: CHRS) at the intersection of pivotal execution readiness and combination immunotherapy innovation in high-unmet-need gastrointestinal and respiratory cancer markets.
As pharmaceutical giants face a staggering patent cliff, they are aggressively hunting for late-stage assets with clear, high-signal registration pathways[3]. In 2026, the market isn't buying "promise"—it's buying the disciplined execution of pivotal trials and the mechanistic clarity that determines valuation floors[4].Oncolytics Biotech Inc. (NASDAQ: ONCY) is strengthening its operational and clinical leadership as it advances pelareorep toward multiple registration-directed programs in gastrointestinal cancers.The company recently announced the appointments of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, bringing deep expertise in late-stage oncology trial execution and regulatory strategy. McAdory joins from CG Oncology, where he served as Vice President of Clinical Operations leading late-stage development programs for oncolytic virus therapies. Wu arrives from Morphic Therapeutic, where he headed Biostatistics through the company's acquisition by Eli Lilly, and previously led statistical strategy for multiple Phase 3 oncology programs at Takeda. Both executives bring direct experience navigating complex registration trials and global regulatory interactions."John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment."These appointments complete a transformative executive team buildout following Kelly's promotion to CEO last year and the addition of Chief Business Officer Andrew Aromando. They were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. Oncolytics also recently expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, positioning the company for accelerated clinical development across multiple indications.The company recently announced breakthrough efficacy data showing pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy. This triples the historical 6-11% response rate for chemotherapy alone in this difficult-to-treat patient population.The company is also advancing pelareorep toward potential accelerated approval in anal cancer after reporting third-line data that achieved a 29% objective response rate, nearly tripling historical benchmarks in a setting with no FDA-approved treatment options. The median duration of response reached approximately 17 months.Second-line or later results were equally compelling, with pelareorep achieving a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response of 15.5 months compared to 9.5 months for standard care demonstrates pelareorep's ability to deliver durable clinical benefit in patients with limited treatment options.Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease. This regulatory milestone clears the path for initiating a pivotal study in one of oncology's most challenging therapeutic areas.CONTINUED… Read this and more news for Oncolytics Biotech at: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other recent industry developments and happenings in the market include:Moderna (NASDAQ: MRNA) and Merck (NYSE: MRK) announced median five-year follow-up data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, demonstrating that adjuvant treatment with intismeran autogene in combination with KEYTRUDA reduced the risk of recurrence or death by 49% compared to KEYTRUDA alone in patients with high-risk stage III/IV melanoma following complete resection."Now with five years of follow-up data, today's results highlight the potential of a prolonged benefit of the intismeran autogene and KEYTRUDA combination in patients with resected high-risk melanoma," said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Oncology and Therapeutics. "We continue to invest in our platform in oncology because of encouraging outcomes like these, which illustrate mRNA's potential in cancer care."The companies have eight Phase 2 and Phase 3 clinical trials underway across multiple tumor types, including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma. Moderna and Merck plan to present further data from follow-up analyses of the study's primary and secondary endpoints at an upcoming medical meeting, with the Phase 3 INTerpath-001 trial for adjuvant melanoma fully enrolled.Vir Biotechnology (NASDAQ: VIR) provided updates on its oncology solid tumor portfolio, including new Phase 1 data from its PSMA-targeted PRO-XTEN dual-masked T-cell engager VIR-5500 in prostate cancer to be presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium in February. VIR-5500 is currently being evaluated as monotherapy and in combination with androgen receptor pathway inhibitors for the first-line treatment of metastatic castration-resistant prostate cancer, with the Phase 1 trial successfully clearing the second dose cohort.The Company is also currently enrolling patients in its Phase 1 dose escalation trials for VIR-5818 in HER2-expressing solid tumors and VIR-5525 in EGFR-expressing solid tumors, with Phase 1 dose escalation response data for VIR-5818 expected in the second half of 2026. Vir Biotechnology is progressing additional PRO-XTEN masked T-cell engagers in preclinical studies directed at clinically validated targets with potential applications across lung, colorectal and bladder cancers, all discovered using the Company's proprietary antibody and T-cell engager discovery platform including dAIsY, a proprietary artificial intelligence engine, and the universal PRO-XTEN masking technology.Coherus Oncology (NASDAQ: CHRS) announced publication in Molecular Cancer Therapeutics highlighting the strong pharmacology of investigational CCR8 antibody tagmokitug, demonstrating picomolar binding affinity with no off-target binding. The publication provides important scientific evidence showing tagmokitug selectively eliminates CCR8+ T regulatory cells without affecting other immune cells, with proof-of-mechanism established in first-in-human clinical studies showing selective reductions in CCR8+ Tregs."This publication presents the robust pharmacology of tagmokitug in preclinical and clinical studies, and with a selectivity profile and potent binding and killing of CCR8+ T regulatory cells and not other immune cells. These data provide evidence that tagmokitug has the potential for a differentiated profile," said Theresa LaVallee, Ph.D., Chief Scientific and Development Officer at Coherus. "The data show a high abundance of CCR8 target expression in a broad range of solid tumors suggesting the promise of the tagmokitug program."Coherus Oncology is currently evaluating tagmokitug in Phase 1b/2a clinical trials in patients with solid tumors, including head and neck, colorectal, gastric, and esophageal cancer. The company's immunotherapy pipeline focuses on enhancing innate and adaptive immune responses to enable robust antitumor activity in combination with the approved PD-1 inhibitor LOQTORZI.Source: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:Equity Insider
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.globenewswire.com/news-release/2025/12/02/3198196/0/en/Oncology-Market-Size-Worth-USD-668-26-Billion-by-2034.htmlhttps://www.oncologynurseadvisor.com/news/fda-accelerated-approval-oncology-drugs-improved-patient-survival/https://www.biospace.com/drug-development/biotech-investors-bet-on-a-2026-rebound-as-deal-activity-accelerateshttps://blog.crownbio.com/the-oncology-drug-development-landscapeLogo - https://mma.prnewswire.com/media/2840019/5737560/Equity_Insider_Logo.jpg
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Original: Registration-Ready: How 2026's Clinical Leaders Are Beating Cancer Benchmarks
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