Stylus Medicine Emerges with $85M to Revolutionize In Vivo Genetic Medicines
• Stylus Medicine has emerged from stealth with $85 million in financing to develop its platform combining sequence-specific genome integration with cell-targeted lipid nanoparticle delivery.
• The company's technology aims to overcome limitations of ex vivo cell therapy manufacturing by enabling durable, flexible, and scalable in vivo cell engineering, with initial focus on CAR-T therapies.
• Led by industry veterans Emile Nuwaysir (CEO) and Jason Fontenot (CSO), Stylus has secured backing from prominent investors including RA Capital Management, Khosla Ventures, Chugai Venture Fund, Eli Lilly, and Johnson & Johnson Innovation.
Intrepid Labs Emerges from Stealth with AI-Powered Platform to Revolutionize Drug Formulation
• Intrepid Labs has launched its Valiant platform, an AI-driven robotic system that reduces drug formulation development time from months to days, potentially improving clinical success rates.
• The Toronto-based biotechnology company has secured $11 million in funding, including a recent $7 million seed round led by AVANT BIO, to expand its team and accelerate development of proprietary delivery technologies.
• Founded in 2023 as a University of Toronto spin-out, Intrepid Labs has already established partnerships with major pharmaceutical companies to optimize formulations and is developing licensable oral and long-acting injectable delivery technologies.
PAQ Therapeutics Secures $39M Series B Funding and Launches Phase 1 Trial for Novel KRAS G12D Degrader
• PAQ Therapeutics has raised $39 million in Series B financing co-led by MRL Ventures Fund and Bayland Capital, with participation from several other investors including Johnson & Johnson Innovation.
• The company has initiated a Phase 1 clinical trial for PT0253, its lead candidate that selectively degrades KRAS G12D mutations, a known driver for various solid tumors with high unmet medical needs.
• Preclinical data suggests PT0253 has best-in-class potential compared to existing agents targeting the same KRAS mutant, potentially offering more effective and durable treatment options for patients with lethal cancers.
MeiraGTx's AAV2-hAQP1 Receives FDA RMAT Designation for Radiation-Induced Xerostomia
• MeiraGTx's AAV2-hAQP1 gene therapy has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA for grade 2/3 radiation-induced xerostomia (RIX).
• The RMAT designation includes benefits like Fast Track and Breakthrough Therapy designations, facilitating closer collaboration with the FDA and potentially accelerating approval.
• Phase 1 trial data showed significant improvements in patient-reported outcomes and saliva production with AAV2-hAQP1, supporting the RMAT designation for this debilitating condition.
• The ongoing Phase 2 AQUAx2 trial is designed as a pivotal study, potentially leading to a Biologics License Application (BLA) filing based on MeiraGTx's proprietary manufacturing process.
Citryll Secures €85 Million in Series B Funding to Advance NET-Targeting Antibody CIT-013
• Citryll BV raised €85 million in a Series B funding round co-led by Johnson & Johnson Innovation, Forbion, and Novartis Venture Fund to advance clinical development of CIT-013.
• CIT-013, a first-in-class monoclonal antibody, targets Neutrophil Extracellular Traps (NETs) by binding to Histone 2A and Histone 4, addressing the source of autoantigens in immune-mediated disorders.
• Phase IIa trials are planned for rheumatoid arthritis (RA) and hidradenitis suppurativa (HS) to establish CIT-013’s dual mechanism of action in clearing existing NETs and inhibiting new NET formation.
• The funding will support further clinical studies of CIT-013, which has potential applications across a wide range of immune-mediated inflammatory diseases beyond RA and HS.
Metsera Secures $215 Million to Advance Weight Loss Drug Pipeline
• Metsera raised $215 million in a Series B funding round to advance its portfolio of GLP-1 receptor agonists for weight loss, bringing its total funding to over $500 million.
• The lead asset, MET-097i, a long-acting injectable GLP-1RA, showed a 7.5% reduction in body weight over 36 days in Phase I trials, with Phase II data expected in H1 2025.
• Metsera is also advancing MET-233i, an ultra-long-acting injectable, and MET-002, an oral GLP-1RA, with plans to explore combination therapies for enhanced efficacy.
• The company has partnered with Amneal to establish manufacturing facilities in India, ensuring large-scale supply of its weight loss medicines.
Wales Launches £100 Million Life Sciences Hub to Boost Innovation and Investment
• Wales establishes a major life sciences initiative with a £100 million investment fund, representing the largest sector-specific investment in the country's history.
• Life Sciences Hub Wales secures Johnson & Johnson Innovation and GE Healthcare as anchor tenants, creating a collaborative ecosystem for academia, business, and healthcare sectors.
• The initiative has already invested £20 million in strategic projects, including Simbec Research's expansion and ReNeuron's relocation of cell manufacturing operations to Wales.
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