Tegoprubart to be Used as Immunosuppressive Agent in Cohort C of Sernova’s Phase 1/2 Cell Pouch Bio-hybrid Organ Clinical Trial in Patients with Type 1 DiabetesLONDON, Ontario, July 09, 2025 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics (“Sernova”) (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH) today announced a Collaborative Research Agreement with Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) to evaluate Eledon’s immunosuppressive agent tegoprubart (AT-1501) in Sernova’s ongoing Phase 1/2 clinical tria ...

Core Insights - Arbutus Biopharma Corporation has reacquired the rights to its lead compound, imdusiran, from Qilu Pharmaceutical, concluding their strategic partnership for the development and commercialization of imdusiran in Greater China [1][2] - The decision to terminate the partnership was influenced by Qilu's pipeline reprioritization and Arbutus' focus on advancing its pipeline efficiently [2] - Imdusiran has shown promising results, achieving functional cure in eight patients during Phase 2a trials [2][3] Company Overview - Arbutus Biopharma is a clinical-stage biopharmaceutical company focused on infectious diseases, particularly chronic hepatitis B virus (cHBV) [7] - The company is also developing an oral PD-1 inhibitor (AB-101) for cHBV treatment and is involved in legal actions to protect its intellectual property related to its patented LNP technology [7] Product Details - Imdusiran is designed to reduce all HBV viral proteins and antigens, which is essential for reawakening the immune system to control the virus [5] - The treatment has been reported to be generally safe and well-tolerated, with significant reductions in hepatitis B surface antigen (HBsAg) and HBV DNA [5] Scientific Advisory Board - Arbutus has established a new Scientific Advisory Board consisting of experts in chronic hepatitis B treatment to guide its strategic evaluation of the cHBV pipeline [2]

Core Insights - Arbutus Biopharma has reported that imdusiran combination therapy has functionally cured eight patients with chronic hepatitis B (cHBV), including two patients who did not receive interferon [1][2] - The company has a strong financial position with cash, cash equivalents, and marketable securities totaling $113 million as of March 31, 2025 [1][9] - Andrew J. Sung has joined Arbutus as General Counsel, bringing over $28 billion in life sciences deal experience [1][8] Clinical Developments - Imdusiran (AB-729) has shown promising results, with eight patients achieving functional cure, particularly notable as two did not receive interferon [2][6] - The oral PD-L1 inhibitor AB-101 demonstrated 100% receptor occupancy in 11 of 13 evaluable healthy volunteers during Phase 1a/1b trials, indicating its safety and tolerability [3][10] - Data presented at the EASL Congress 2025 highlighted that patients with baseline HBsAg <1000 IU/mL had a significant chance of achieving functional cure when treated with imdusiran and low-dose nivolumab [6][22] Financial Performance - For Q1 2025, total revenue was $1.8 million, an increase from $1.5 million in Q1 2024, attributed to revenue recognition from a collaboration with Qilu [10][11] - Operating expenses for Q1 2025 were $27.5 million, with research and development expenses decreasing to $9.0 million from $15.4 million in the same period last year [12][15] - The net loss for Q1 2025 was $24.5 million, compared to a net loss of $17.9 million in Q1 2024, reflecting increased restructuring costs [15][20] Corporate Updates - The company is actively involved in litigation regarding its patented LNP technology against Moderna and Pfizer/BioNTech, seeking fair compensation for their use of this technology [9][10] - Andrew J. Sung's appointment as General Counsel is expected to enhance the company's legal strategy and corporate governance [4][8] - Arbutus continues to streamline its operations, focusing on advancing clinical development while reducing workforce and operational costs [12][14]

Core Insights - Arbutus Biopharma Corporation presented promising data on imdusiran and AB-101 at the EASL Congress 2025, indicating potential for functional cure in chronic hepatitis B patients [1][5] Group 1: Imdusiran and Clinical Trials - Imdusiran, when combined with VTP-300 and low-dose nivolumab, has shown to achieve functional cure in chronic hepatitis B (cHBV) patients [1] - In the Phase 2a clinical trial (IM-PROVE II), patients receiving imdusiran (60mg every 8 weeks) demonstrated significant reductions in HBsAg levels, with 25% of patients in the group receiving nivolumab achieving functional cure [2][7] - A total of 8 patients across all Phase 2a trials have been reported to achieve functional cure, with 7 of these having baseline HBsAg levels below 1000 IU/mL [3] Group 2: AB-101 and Safety Profile - AB-101, an oral PD-L1 inhibitor, has been shown to be generally safe and well-tolerated in a Phase 1a/1b clinical trial, with no liver dysfunction reported in cHBV patients [1][4] - Data from the first cohort of cHBV patients indicated that daily dosing of 10mg of AB-101 for 28 days was well tolerated, with no immune-related adverse events reported [4][10] Group 3: Background on Hepatitis B and Arbutus - Chronic hepatitis B infection represents a significant unmet medical need, affecting over 250 million people globally, with approximately 1.1 million deaths annually from related complications [11] - Arbutus Biopharma is focused on developing innovative therapies for infectious diseases, particularly chronic HBV infection, and is also involved in legal actions to protect its intellectual property [12]

Core Insights - Arbutus Biopharma Corporation announced the acceptance of five abstracts for presentation at the EASL Congress 2025, including one late-breaker, highlighting the company's ongoing research in hepatitis B treatments [2][9]. Group 1: Abstract Presentations - Five abstracts will be presented in the Viral Hepatitis B and D session on May 8, 2025, showcasing new therapies and strategies [3]. - The late-breaker abstract will focus on the antiviral efficacy and safety of imdusiran followed by VTP-300 in chronic hepatitis B subjects [9]. Group 2: Key Findings from Abstracts - Abstract 1768 discusses the factors associated with functional cure in chronic hepatitis B subjects, indicating that baseline HBsAg levels are significant [4]. - Abstract 2043 reveals that rapid HBV RNA decline during treatment with imdusiran and interferon is linked to HBsAg seroclearance [6]. - Abstract 1990 presents the pharmacokinetics and pharmacodynamics of AB-101, showing it to be safe and well-tolerated with dose-responsive increases in PD-L1 receptor occupancy [7]. - Abstract 1978 indicates that AB-101 is well-tolerated in both healthy and chronic hepatitis B subjects, with ongoing dosing studies [8]. Group 3: Product Information - Imdusiran is an RNAi therapeutic designed to reduce HBV viral proteins, showing promising results in Phase 2a trials for achieving functional cure rates [10]. - AB-101 is an oral PD-L1 inhibitor currently in Phase 1a/1b trials, aimed at reactivating exhausted HBV-specific T-cells [11]. Group 4: Industry Context - Chronic hepatitis B infection affects over 250 million people globally, representing a significant unmet medical need, with approximately 1.1 million deaths annually from related complications [12].