CELL AND GENE THERAPY CATAPULT

INmune Bio Partners with CGT Catapult to Scale CORDStrom Manufacturing for Rare Skin Disease Treatment

a month ago

• INmune Bio has partnered with Cell and Gene Therapy Catapult to establish commercial-scale manufacturing for CORDStrom, a promising therapy for recessive dystrophic epidermolysis bullosa that showed positive results in Phase 2 trials. • The collaboration leverages CGT Catapult's Stevenage Manufacturing Innovation Centre to scale production for approximately 4,000 children with intermediate to severe RDEB across the US, UK, and EU. • Following CORDStrom, INmune Bio plans to transition production of INKmune, its NK-priming cell medicine currently in Phase 2 trials for metastatic castration-resistant prostate cancer.

UK Sees 70% Surge in Phase I Advanced Therapy Clinical Trials

4 months ago

• The UK witnessed a 70% increase in Phase I advanced therapy medicinal product (ATMP) studies in 2024, according to new data. • Total ATMP trials in the UK reached 187 in 2024, a 7% increase from the previous year, solidifying the UK's position in global trials. • Oncology remains the leading sector in ATMP research, accounting for 38% of all UK trials, followed by metabolic and hematological indications. • The rise in ATMP trials signifies the UK's attractiveness for advanced therapy product development and improved patient access to innovative drugs.

Insmed's Brensocatib NDA Accepted by FDA with Priority Review; Anticipated Launch in Q3 2025

4 months ago

• The FDA has accepted Insmed's New Drug Application for brensocatib in bronchiectasis, granting Priority Review with a PDUFA target action date of August 12, 2025. • Insmed anticipates launching brensocatib in the U.S. in the third quarter of 2025, pending FDA approval, with regulatory submissions planned for the EU, UK, and Japan in 2025. • ARIKAYCE global revenue grew 19% in 2024, and Insmed projects 2025 revenues between $405 million and $425 million, representing double-digit growth. • A Phase 3 study of TPIP in pulmonary hypertension associated with interstitial lung disease is planned for the second half of 2025.