Arbutus Biopharma Advances cHBV Program with Imdusiran Phase 2b Trial Initiation Planned for 2025
• Arbutus Biopharma plans to initiate a Phase 2b clinical trial of imdusiran, combined with interferon and nucleos(t)ide analogue therapy, in the first half of 2025 for cHBV.
• The planned Phase 2b trial will enroll approximately 170 HBeAg-negative cHBV patients with baseline HBsAg levels ≤1000 IU/mL, pending regulatory approval.
• Arbutus's oral PD-L1 inhibitor, AB-101, is currently in Phase 1a/1b trials, with data from the 10 mg cohort expected in the first half of 2025.
• The company's financial update indicates a strong cash position, with resources sufficient to fund operations through Q1 2028, including the imdusiran Phase 2b trial.
Pfizer's Sasanlimab Shows Promise in Bladder Cancer Treatment
• Pfizer's sasanlimab, a PD-1 inhibitor, combined with standard therapy, significantly delayed death and disease complications in bladder cancer patients.
• The Phase 3 trial results position sasanlimab as a potential competitor to existing immunotherapies like Merck's Keytruda and Bristol Myers Squibb's Opdivo.
• Sasanlimab, if approved, could become the fourth subcutaneous PD-1 or PD-L1 inhibitor available, offering a convenient under-the-skin administration.
• Eli Lilly has licensed an experimental drug (MTX-463) for idiopathic pulmonary fibrosis from Mediar Therapeutics, with Phase 2 trials planned for later this year.
VRON-0200 Shows Promise in Phase 1b Trial for Chronic Hepatitis B Functional Cure
• Virion Therapeutics' Phase 1b trial of VRON-0200 has completed enrollment for the first two cohorts, involving 27 chronic hepatitis B patients on antiviral therapy.
• VRON-0200, a T cell-based immunotherapy, demonstrated safety, tolerability, and anti-HBV activity in early data, even in patients with impaired HBV immunity.
• Barinthus Bio's VTP-300, combined with low-dose nivolumab, shows encouraging results in Phase 2b trial, with 8 participants achieving HBsAg loss.
• VTP-300 is designed to stimulate the immune system and encourage the production of de novo, disease-specific T cells, enabling long-term viral control.
Biopharma Job Market Shows Signs of Recovery Despite Continued Layoffs in 2024
• Biopharma job postings declined 16% year-over-year in Q4 2024, with at least 24,000 industry professionals laid off throughout the year, including major cuts at Johnson & Johnson, Bristol Myers Squibb, and Bayer.
• Recent positive developments include venture investment reaching $26 billion across 416 rounds in 2024, up from $23.3 billion in 2023, breaking a two-year downward trend in venture capital spending.
• Early 2025 has seen significant deal activity at the J.P. Morgan Healthcare Conference, with Eli Lilly, GSK, Gilead, and Johnson & Johnson announcing deals potentially worth over $15 billion combined.
Barinthus Bio Completes Enrollment in Phase 2b HBV003 and Phase 1 PCA001 Trials
• Barinthus Bio has completed enrollment for the Phase 2b HBV003 trial evaluating VTP-300 in adults with chronic hepatitis B (CHB).
• The Phase 1 PCA001 trial, assessing VTP-850 in men with rising PSA after prostate cancer therapy, has also completed enrollment.
• Interim data from the HBV003 trial is expected in Q4 2024, while PCA001 data is anticipated in the first half of 2025.
© Copyright 2025. All Rights Reserved by MedPath