Faron Pharmaceuticals Appoints Ralph Hughes as Chief Business Officer to Advance Immunotherapy Pipeline
• Faron Pharmaceuticals has appointed Ralph Hughes as Chief Business Officer, bringing extensive experience in commercial strategy and market access from his previous roles at PharmaVentures, Mundipharma, and Pfizer.
• Hughes joins Faron at a critical time as the company advances its lead immunotherapy candidate bexmarilimab, currently in Phase I/II trials for acute myeloid leukemia and myelodysplastic syndrome.
• Bexmarilimab targets the Clever-1 receptor on macrophages, potentially overcoming cancer treatment resistance by reprogramming the tumor microenvironment and enhancing immune system response against cancer cells.
Tango Therapeutics' PRMT5 Inhibitor TNG462 Shows Promise in Early Trials, Combination Studies Planned
• Tango Therapeutics' TNG462 demonstrates clinical activity in NSCLC and pancreatic cancer, with a 43% ORR in cholangiocarcinoma, showcasing a favorable safety profile.
• Tango plans to initiate combination trials of TNG462 with RAS(ON) inhibitors from Revolution Medicines, osimertinib, and pembrolizumab in 1H 2025.
• TNG908 shows clinical activity in non-CNS cancers, particularly pancreatic cancer, but development is deprioritized in favor of TNG462 due to its superior profile.
• Tango's next-generation brain-penetrant PRMT5 inhibitor, TNG456, is set to begin phase 1/2 trials in 1H 2025, targeting glioblastoma and brain metastases.
Cidara Therapeutics Regains CD388 for Universal Flu Prevention, Initiates Phase 2b Trial
• Cidara Therapeutics reacquired CD388, a long-acting antiviral drug, from Janssen after Janssen exited infectious disease development.
• CD388 combines a virus-targeting small molecule (zanamivir) with the Fc portion of a human antibody for universal flu prevention.
• Cidara initiated a Phase 2b clinical trial in September 2024, enrolling 5,000 unvaccinated subjects in the U.S. and U.K. to study CD388's safety and efficacy.
• The trial will test three different single-doses of CD388 (plus placebo) as a pre-exposure prophylaxis of influenza during the current flu season.
Cidara Therapeutics Cuts Workforce to Prioritize CD388 Influenza Prevention Program
• Cidara Therapeutics is reducing its workforce by 30%, impacting 20 positions, to focus on the clinical development of CD388, an influenza prevention therapy.
• The company plans to initiate a Phase IIb trial of CD388 for influenza A and B prevention in the Northern Hemisphere's upcoming flu season.
• Cidara reacquired rights to CD388 from Johnson & Johnson for $85 million and is now responsible for its development and marketing, with potential milestone payments to J&J.
• Despite promising Phase IIa data showing a numerical decrease in influenza virus replication, the reduction was not statistically significant.
Celltrion Pursues Novel Multi-Brand Strategy for Rituximab Biosimilar in EU Market
• Celltrion has received European regulatory approval to market its rituximab biosimilar under four different brand names - Truxima, Tuxella, Ritemvia, and Blitzima - in a unique market strategy.
• The company's approach aims to maximize market share through potential partnerships with multiple distributors, building on their successful dual-brand strategy with their infliximab biosimilar.
• Strategic differences in marketing authorizations include specific indications, with Ritemvia approved for chronic lymphocytic leukemia while Blitzima and Tuxella exclude this indication.
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