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Frontier Biotechnologies and GSK Forge ~$1B Global Licensing Deal for siRNA Therapeutics

Shots: Frontier has entered into an exclusive licensing agreement with GSK for two Small Interfering RNA (siRNA) assets in immunology, incl. one IND-stage candidate & one preclinical program As per the deal, GSK will gain exclusive global rights to develop, manufacture, & commercialize two of Frontier’s siRNA candidates, while Frontier will receive $40M upfront, up…

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Shanghai Henlius Receives the US FDA IND Clearance for HLX18 (Biosimilar, Opdivo)  

Shots:  The US FDA has granted IND clearance to HLX18 (nivolumab), a biosimilar version of Opdivo, for the treatment of certain resected solid tumors   Novolumab is an mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma   HLX17 (pembrolizumab biosimilar) and HLX13 (ipilimumab biosimilar) have entered worldwide multicenter P-I…

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Regeneron and Tessera Therapeutics Enter ~$275M Collaboration to Advance TSRA-196 for Alpha-1 Antitrypsin Deficiency (AATD)

Shots: Regeneron has entered into a global collaboration with Tessera Therapeutics to develop & commercialize TSRA-196 as a one-time gene editing treatment of AATD As per the deal, Tessera & Regeneron will equally share global development costs & potential future profits for TSRA-196. Tessera will receive $150M in upfront & equity investment plus $125M in near…

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Ascletis Advances ASC37 as an Oral Triple Agonist for Metabolic Disease

Shots: Ascletis Pharma has selected ASC37 tablets (PO), a GLP-1R/GIPR/GCGR triple peptide agonist, as a clinical development candidate ASC37, utilizing Ascletis’ POTENT tech, showed an average of 4.2% absolute oral bioavailability, higher than semaglutide, tirzepatide, & retatrutide in oral SNAC formulations, & ~57-fold greater AUC vs retatrutide (PO) in NHP studies, with an observed t½ of…

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VectorY Therapeutics Collaborates with Shape Therapeutics to Develop Vectorized Antibodies for Neurodegenerative Diseases

Shots: VectorY has entered into an option & license deal with Shape to assess Shape’s SHP-DB1 (AAV capsid) for vectorized Abs payloads against 3 targets & may secure an exclusive license for their delivery if evaluation succeeds As per the deal, VectorY will handle development & commercialization of resulting therapies in exchange for an upfront…

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UTR Therapeutics

UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

Shots: The US FDA has received the IND application for UTRxM1-18, a novel therapy targeting c-MYC-driven cancers, to initiate P-I trial in 2026 pending approval, focusing on c-MYC driven tumors incl. triple-negative breast, pancreatic, colorectal, & ovarian cancer UTRxM1-18 has demonstrated strong, dose-dependent efficacy against human-derived tumors from multiple cancer subtypes, with no dose-limiting toxicities…

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