GC Biopharma Corp.
🇰🇷South Korea
WHO Member States Reach Historic Draft Pandemic Agreement After Three Years of Negotiations
• WHO member states have finalized a draft pandemic agreement aimed at strengthening global collaboration on prevention, preparedness, and response to future health emergencies.
• The agreement includes provisions for knowledge-sharing systems, geographically diverse research capacities, a trained global health emergency workforce, and a coordinated supply chain network.
• The draft explicitly preserves national sovereignty, clarifying that WHO cannot mandate specific actions like lockdowns or vaccination requirements, and will be considered for formal approval at the May World Health Assembly.
OST-HER2 Shows Promise in Preventing Recurrence of Lung Metastatic Osteosarcoma
• OST-HER2 demonstrated a statistically significant 12-month event-free survival (EFS) rate of 33.3% compared to 20% in historical controls for recurrent, fully resected osteosarcoma with lung metastases.
• Interim overall survival (OS) analysis showed a favorable trend for OST-HER2, with 1-year OS at 91% versus 80% in historical controls, and all patients achieving 12-month EFS remaining alive.
• The Phase 2b trial's positive results support OS Therapies' plans to engage with the FDA for accelerated approval of OST-HER2 in this challenging indication with no currently approved therapies.
• OST-HER2, a HER2-targeted immunotherapy, exhibited a strong safety profile in the study, further supporting its potential use in patients with recurrent lung metastatic osteosarcoma.
Repare Therapeutics' Gynecological Cancer Trial Shows Mixed Results, Beigene Inks $1.5B Deal for MAT2A Inhibitor
• Repare Therapeutics' phase I trial of lunresertib and camonsertib in gynecological cancers with specific biomarkers showed mixed results, impacting stock prices.
• Beigene secured a global licensing agreement with CSPC for SYH-2039, a phase I MAT2A inhibitor targeting solid tumors, for up to $1.5 billion.
• A new study identifies inceptor as a novel insulin receptor that degrades insulin, potentially opening new avenues for diabetes therapeutics.
• GC Biopharma will acquire Abo Holdings for $96.28 million to enhance its U.S. plasma business and accelerate the entry of Alyglo (IVIG-SN 10%).
GC Biopharma and Novel Pharma Initiate Phase I Trial of GC1130A for Sanfilippo Syndrome Type A
• GC Biopharma and Novel Pharma have dosed the first patient in a multinational Phase I clinical trial of GC1130A for Sanfilippo syndrome type A (MPS IIIA).
• The Phase I trial will assess the safety, tolerability, and efficacy of GC1130A in children aged 2-6 years with MPS IIIA over a two-year period.
• GC1130A is a first-in-class treatment using GC Biopharma’s platform to deliver concentrated recombinant protein via intracerebroventricular (ICV) injection.
• The trial will be conducted across multiple sites in the US, Korea, and Japan, addressing a critical unmet need for this devastating genetic disorder.
GC Biopharma and Hanmi Pharmaceutical's Fabry Disease Treatment LA-GLA Receives FDA IND Clearance
• GC Biopharma and Hanmi Pharmaceutical received FDA IND clearance for Phase 1/2 clinical trial of LA-GLA (GC1134A/HM15421), a novel Fabry disease treatment.
• LA-GLA is designed as a once-monthly subcutaneous injection, offering improved convenience compared to current bi-weekly intravenous enzyme replacement therapies.
• Preclinical studies suggest LA-GLA enhances kidney function and shows superior efficacy in managing vascular and peripheral nerve disorders related to Fabry disease.
• LA-GLA has been granted Orphan Drug Designation by the U.S. FDA, highlighting its potential to address unmet needs in Fabry disease treatment.
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