Vir Biotechnology

Vir Biotechnology's VIR-5818 and VIR-5500, dual-masked T-cell engagers, demonstrate encouraging preliminary safety and efficacy in Phase 1 trials.

BlueSphere Bio has appointed Alan Korman, Ph.D., a veteran immunotherapy researcher with over 30 years of experience, as Chief Scientific Officer to advance its T cell-based therapy pipeline.

The U.S. FDA granted Breakthrough Therapy designation to brelovitug from Bluejay Therapeutics in January 2025, accelerating development for this investigational hepatitis D treatment.

Vir Biotechnology will present 24-week subgroup analysis data from its Phase 2 SOLSTICE trial in chronic hepatitis delta at the EASL Congress 2025 in Amsterdam, examining how baseline viral parameters and cirrhosis status affect treatment responses.

Over 50 pharmaceutical companies are actively developing 55+ pipeline therapies for chronic hepatitis B virus (HBV) infection, signaling a robust research landscape aimed at achieving functional cures beyond current suppressive treatments.

New data from Brii Bio's Phase 2 ENSURE study reveals that patients who responded to BRII-179 achieved a 55.6% HBsAg seroclearance rate, compared to just 10% in non-responders, supporting a novel patient enrichment strategy.

• Surrozen has discontinued development of its hepatitis drug candidate SZN-043 after Phase I trial results failed to demonstrate sufficient clinical activity to warrant further development. • The company is strategically pivoting its R&D efforts toward ophthalmology applications, leveraging its proprietary Wnt pathway modulation platform for potential treatments in retinal diseases. • This setback follows a broader trend of challenges in hepatitis drug development, including Vir Biotechnology's recent Phase II disappointment with its hepatitis B combination therapy.

• Alnylam anticipates FDA approval for vutrisiran to treat ATTR amyloidosis with cardiomyopathy by March 23, 2025, and aims for EU and Japan approvals later in the year. • A Phase 3 trial for nucresiran in ATTR amyloidosis with cardiomyopathy is set to begin in the first half of 2025, expanding Alnylam's focus on cardiac amyloidosis. • Alnylam's pipeline progresses with zilebesiran in hypertension, mivelsiran in Alzheimer's, and ALN-6400 in bleeding disorders, with key data readouts and trial initiations expected in 2025.

• Vir Biotechnology's VIR-5818 and VIR-5500 demonstrate encouraging safety and early clinical response in heavily pretreated cancer patients. • Phase 1 data reveals dose-dependent tumor shrinkage in HER2-positive tumors with VIR-5818 and a 58% PSA50 response rate in prostate cancer with VIR-5500. • Morgan Stanley upgrades Vir Biotechnology to Overweight, citing platform de-risking and potential for improved activity with continued dose escalation. • The dual-masking technology enhances tolerability and efficacy, potentially making these treatments suitable for earlier stages of cancer treatment.

• Vir Biotechnology's VIR-5818 and VIR-5500 T-cell engager (TCE) programs demonstrate encouraging safety and early efficacy in heavily pretreated solid tumor patients. • VIR-5818 showed notable tumor shrinkage in HER2 cancers, while VIR-5500 exhibited substantial PSA50 response in metastatic castration-resistant prostate cancer patients. • The dual-masking PRO-XTEN platform acquired by Vir aims to reduce off-tumor toxicity, potentially differentiating it in the immuno-oncology space. • Analysts have reiterated a Buy rating for Vir, citing the TCE programs' potential and strategic focus on capital preservation through partnerships.