Latest Manufacturing Transfer News

NeuroScientific Biopharmaceuticals has secured favourable US FDA feedback on its planned StemSmart Phase 2 trial for refractory Crohn’s disease, while appointing a clinical research partner and advancing manufacturing validation. The company enters the next phase with $3.91 million in cash and a targeted trial start by the end of 2026.

AdAlta is nearing two important development milestones for its EW-001 CAR-T therapy, with a US FDA pre-IND meeting scheduled for 4 November and Australian manufacturing runs expected before year-end. The progress comes with encouraging but early Chinese clinical data, while cash of A$0.65 million leaves limited room for delay.

AdAlta expects an additional R&D Tax Incentive refund of more than A$1 million after securing approval for specified overseas work on its EW-001 CAR-T therapy. The cash benefit arrives as the company prepares for a US FDA pre-IND meeting in November.

AdAlta and Shanghai Cell Therapy Group have approved the FDA briefing pack and manufacturing transfer plan for EW-001, bringing the mesothelioma CAR-T therapy closer to an Australian Phase 1 trial. The FDA meeting is scheduled for November, while two Chinese patients remain under follow-up, including a second complete responder.

AdAlta has secured a formal US FDA pre-IND meeting for EW-001, moving its mesothelioma CAR-T therapy into a critical regulatory review. The November meeting will test the company’s Australian manufacturing, remaining studies and proposed Phase 1 trial before the more expensive stages of development begin.

AdAlta’s partner SHcell has gained regulatory approval to provide the BZDS1901 CAR-T therapy to advanced mesothelioma patients in China’s Hainan Boao Lecheng special access zone, marking a key milestone in real-world data collection and treatment availability.

NeuroScientific Biopharmaceuticals posted a $4.69 million loss for FY2026, driven by R&D ramp-up and clinical progress with its StemSmart™ platform, while halting independent development of its glaucoma drug EmtinB to pursue licensing deals.

AdAlta Limited (ASX:1AD) has progressed its ‘East to West’ cellular immunotherapy strategy by securing its first CAR-T asset, advancing Australian manufacturing and US FDA regulatory engagement, while raising A$5.3 million in FY2026 and reporting a net loss of $4.68 million.

AdAlta’s lead CAR-T therapy EW-001 continues to demonstrate encouraging survival and response rates in its mesothelioma study, with all patients alive at the latest follow-up and stronger outcomes at higher doses supporting plans for an Australian Phase 1 trial.

AdAlta’s lead CAR-T therapy EW-001 has achieved a rare clinical milestone with one mesothelioma patient remaining cancer-free two years after treatment, and a second reaching one-year survival, underscoring the therapy’s potential durability in a notoriously difficult cancer.

AdAlta has completed a key US$1 million milestone payment securing rights to its lead CAR-T therapy EW-001 outside Greater China, progressed Australian manufacturing with first runs expected late 2026, and is preparing for a critical pre-IND meeting with the US FDA.

NeuroScientific Biopharmaceuticals achieved an 80% clinical response rate in fistulising Crohn’s disease patients treated under the TGA Special Access Scheme, advancing plans for Phase 2 trials and manufacturing scale-up.