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- INmune Bio has successfully completed the first commercial-ready umbilical cord tissue processing at the CGT Catapult Manufacturing Innovation Centre in Stevenage, UK, under its agreement with Anthony Nolan Cord Blood Bank. - The manufacturing milestone supports a planned Phase 3 confirmation trial for Ebstrocel™ and future commercial supply, with processes now meeting MHRA, EMA, and FDA standards. - The company's regulatory strategy aligns with the MHRA's draft rare disease therapies regulatory framework, which emphasizes flexible evidence generation and patient-centered outcomes. - With commercial manufacturing, pediatric strategy, and regulatory alignment completed, INmune Bio believes Ebstrocel™ has entered the final stage before planned UK commercialization.
- Minaris, a global cell and gene therapy CDMO, will relocate its viral vector innovation center to CGT Catapult's London laboratories to enhance lentiviral assay development. - The collaboration aims to improve productivity, safety, and performance of viral vector platforms while reducing manufacturing costs for gene therapies. - CGT Catapult will expand its lentiviral capabilities through access to Minaris' proprietary platforms and 25+ years of expertise in cell and gene therapy development. - The partnership strengthens support for therapy developers requiring both lentiviral and adeno-associated virus platform capabilities across multiple disease areas.
- INmune Bio successfully completed its first commercial pilot-scale manufacturing run of CORDStrom™, an umbilical cord-derived mesenchymal stromal cell therapy for treating Recessive Dystrophic Epidermolysis Bullosa (RDEB). - The manufacturing milestone at the Cell and Gene Therapy Catapult facility in the UK keeps the company on track for regulatory submissions, with plans to file a Marketing Authorization Application in the UK during the first half of 2026. - CORDStrom™ demonstrated promising results in a blinded-randomized Phase 2 Mission EB trial, showing improvements in itch, pain, wound scores, and quality of life for RDEB patients. - The successful manufacturing run confirms the scalability and consistency of CORDStrom™ production using a proprietary GMP-compliant process for this off-the-shelf allogeneic therapy.
- Mytos has launched its first automated contract development and manufacturing organization (CDMO) facility within the Cell and Gene Therapy Catapult's Stevenage Manufacturing Innovation Centre, targeting clinical readiness by September 2026. - The facility, powered by Mytos' iDEM™ automation technology, aims to deliver up to 1,500 autologous doses or 25,000 allogeneic doses annually, addressing scalability and cost barriers in regenerative medicine manufacturing. - The company has secured partnerships with three biotechnology companies including StemSight, Rinri Therapeutics, and Novadip to integrate its automated platform into clinical trials for therapies targeting blindness, hearing loss, and bone regeneration. - Mytos has strengthened its leadership team with key industry veterans including David DiGiusto as advisor and Barry Oliver as interim Head of Quality to accelerate its CDMO strategy.
- The UK has enacted world-first legislation allowing personalized medicines to be manufactured at hospitals, clinics, and near patients' homes, reducing treatment delivery times from months to days. - The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 covers cell and gene therapies, tissue-engineered treatments, 3D-printed products, blood products, and medicinal gases. - The framework supports mobile manufacturing units and enables final manufacturing steps at the point of care, potentially preventing patients from becoming too unwell to receive CAR-T therapies due to extended wait times. - This legislation represents a significant advancement toward truly personalized medicine and is part of the NHS 10-year plan announced by the UK government.
- The Cell and Gene Therapy Catapult made its first investment through the Cross-Catapult Investment Pilot in Spliceor, a Cambridge University spinout developing trans-splicing gene therapy for liver cancer. - Spliceor's platform targets hepatocellular carcinoma, which has a five-year survival rate of just 13.4% and affects approximately 6,500 new patients annually in the UK. - The funding will support pre-clinical development and team expansion as Spliceor advances its precise gene repair technology toward clinical trials. - This investment represents a new UK initiative supported by Innovate UK to strengthen the advanced therapies pipeline through targeted seed investments in early-stage companies.
- 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.
• Political changes in the UK and Europe may negatively impact university-based gene therapy research, while established pharmaceutical companies are expected to face minimal disruption in 2025. • Bio/pharmaceutical companies are increasingly expanding operations to the United States and considering growth in Asian markets, partly in response to regulatory developments like the BIOSECURE Act. • The UK government is anticipated to increase support through initiatives like Catapult to boost the cell and gene therapy industry, presenting an opportunity for the UK to reestablish itself as a leader in advanced therapeutics.
- 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.
