Clinical Trial News
NextCell Pharma Strengthens Commercial Strategy with Appointment of MSC Therapy Expert Dr. Eric Strati
• NextCell Pharma has appointed Dr. Eric Strati, former executive at Takeda, Mesoblast, and Novartis, to its Board of Advisors to advance commercial strategy for ProTrans, its type 1 diabetes cell therapy.
• Dr. Strati brings critical expertise from launching two approved MSC-based therapies (Alofisel and Ryoncil), strengthening NextCell's capabilities as it prepares for pivotal trials and partnership opportunities.
• Recent analysis from the ProTrans-Young study shows promising trends in preserving insulin production in patients aged 12-21 years, with full trial results expected in the second half of 2026.
Lexicon's SONATA-HCM Phase 3 Trial Design Unveiled at European Cardiology Congress
• Lexicon Pharmaceuticals has launched SONATA-HCM, the only ongoing Phase 3 trial evaluating sotagliflozin in both obstructive and non-obstructive hypertrophic cardiomyopathy, with enrollment active across 20 countries.
• The randomized, double-blind study will enroll 500 patients globally and measure improvement in symptoms using the Kansas City Cardiomyopathy Questionnaire, addressing a significant unmet need particularly for non-obstructive HCM patients.
• Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor with established efficacy in heart failure, could potentially become the first approved therapy for non-obstructive HCM if trial results support a supplemental new drug application.
Eli Lilly Considers $5.9 Billion Biomanufacturing Facility in Houston
• Pharmaceutical giant Eli Lilly is exploring a $5.9 billion biomanufacturing plant at McCord Development's Generation Park in Northeast Houston, potentially creating 600 permanent jobs and 2,000 construction positions.
• The proposed 236-acre facility would be part of Eli Lilly's broader $50 billion U.S. manufacturing expansion since 2020, aimed at increasing production capacity for medicines including Mounjaro and Zepbound.
• If approved, the project would deliver an estimated $2.5 billion economic impact over 10 years and strengthen Houston's emerging life sciences sector, supported by local biotech workforce development initiatives.
Oligo Factory Expands Capabilities with New Low-Scale Synthesis Platform for Therapeutic and Diagnostic Development
• Oligo Factory has launched a new low-scale oligonucleotide synthesis capability, enabling researchers to order custom DNA and RNA oligos in volumes as small as 50 nmol while maintaining high quality standards.
• The company has appointed Luke Dannenberg as CEO and Baiju Parikh as VP of Commercial to drive expansion, while unveiling three specialized product portfolios: FactorTx™, FactorDx™, and FactorLS™ for therapeutics, diagnostics, and life science applications.
• With a new 13,000-square-foot facility in Holliston, Massachusetts, Oligo Factory has increased synthesis capacity 12-fold and purification capabilities 10-fold, positioning itself as an agile alternative to larger suppliers for specialized oligonucleotide needs.
CRISPR Therapeutics Expands into siRNA Therapies with $95M Sirius Partnership for Thromboembolic Disorders
• CRISPR Therapeutics is diversifying beyond gene editing through a strategic $95 million partnership with Sirius Therapeutics to develop SRSD107, a long-acting siRNA therapy targeting Factor XI for thromboembolic disorders.
• In Phase 1 trials, SRSD107 demonstrated impressive efficacy with over 93% reduction in Factor XI levels and doubled blood clotting time, with effects lasting up to six months from a single dose.
• The collaboration includes a 50-50 cost and profit-sharing structure for SRSD107 development, with CRISPR leading U.S. commercialization and retaining rights to license two additional siRNA targets.
Persist AI Raises $12M Series A, Launches Cloud Lab to Revolutionize Pharmaceutical Formulation Development
• Persist AI has secured $12 million in Series A funding to expand its AI-driven robotics platform that reduces drug formulation development time from years to months.
• The company's Cloud Lab platform enables pharmaceutical companies to remotely develop formulations using robotic laboratory facilities, testing 700 formulations in two months compared to the industry standard of 10-15 per month.
• Persist AI's technology miniaturizes testing processes, requiring just 1 mL of liquid and a few milligrams of material compared to traditional methods that need 1000 mL and several grams.
Breakthrough in Platelet Engineering Opens New Avenues for Targeted Drug Delivery
• University of Illinois researchers have successfully applied metabolic glycan labeling to platelets for the first time, overcoming the challenge of engineering these nucleus-free cell fragments.
• The novel chemical approach allows scientists to attach tags to platelet surfaces within hours, both in laboratory settings and living organisms, creating potential vehicles for targeted drug delivery.
• This breakthrough could revolutionize treatment for cancer, immune diseases, and blood clotting disorders, with the added benefit that platelets' short half-life ensures drugs clear from the body within days.
Federal Circuit Ruling Opens New Patent Challenge Avenue for Life Sciences Companies
• The U.S. Court of Appeals for the Federal Circuit's decision in Xencor Inc. case provides drugmakers with a new strategy to challenge patents by focusing on inadequate written descriptions in Jepson claims.
• The ruling establishes that Jepson claim preambles are limiting and require sufficient written description support, particularly important for complex biological inventions like antibodies.
• Following the 2023 Supreme Court Amgen v. Sanofi decision, this ruling creates a higher bar for patent protection of biologic products, requiring detailed descriptions and practical applications beyond theoretical utility.
Taiwan to Expand National Health Insurance Coverage for Cancer Immunotherapies and Targeted Drugs
• Taiwan's National Health Insurance Administration will expand coverage to include three types of cancer immunotherapies for lung, colorectal, and breast cancers, benefiting up to 3,400 patients starting June 2025.
• The expansion will also cover two PARP inhibitors (olaparib and niraparib) for treating five cancer types, including ovarian, fallopian tube, peritoneal, breast, and prostate cancers, helping approximately 775 additional patients.
• Patients could save between NT$1.71 million to NT$2.47 million annually in medical expenses, with the government allocating NT$3.295 billion from a dedicated cancer fund for immunotherapies.
Persist AI Secures $12M Series A Funding to Revolutionize Pharmaceutical Formulation Development
• Persist AI has raised $12 million in Series A funding led by Spero Ventures to expand its AI-driven robotic laboratory for pharmaceutical formulation development.
• The company's newly launched Cloud Lab platform enables pharmaceutical companies to remotely develop and test drug formulations, reducing traditional timelines from a year to just two months.
• Persist AI's technology supports various drug modalities including peptides, small molecules, and antibodies, with plans to build a GMP manufacturing system for long-acting injectables in collaboration with Nivagen Pharmaceuticals.