Business
NARMAFOTINIB Large-Scale Manufactre Complete
Successful completion of the first large-scale manufacture of narmafotinib which produced approx. 13 kg of drug Successful transition of process and production from an R&D facility to a commercial manufacturing environment - a key step in Phase-3 readiness Sufficient drug supply to support Amplia’s pancreatic cancer trials and other planned studies, supporting the Company's clinical development pipeline Melbourne, Australia, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Amplia Therapeutics Limited (ASX:ATX;
About this update from Amplia Therapeutics Ltd.
[{"type":"text","content":"Successful completion of the first large-scale manufacture of narmafotinib which produced approx. 13 kg of drug","length":111,"tagName":"p"},{"type":"text","content":"Successful transition of process and production from an R&D facility to a commercial manufacturing environment - a key step in Phase-3 readiness","length":148,"tagName":"p"},{"type":"text","content":"Sufficient drug supply to support Amplia’s pancreatic cancer trials and other planned studies, supporting the Company's clinical development pipeline","length":153,"tagName":"p"},{"type":"text","content":"Melbourne, Australia, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the “Company”), announces the successful completion of a large-scale manufacture campaign of narmafotinib to required purity and quality specifications. This milestone marks a significant step towards Phase 3 readiness and represents the culmination of months of process development, preparation and delivery as the Company has transitioned manufacturing from a research and development (R&D) facility to a commercial-ready environment.","length":561,"tagName":"p"},{"type":"text","content":"Amplia has collaborated closely with its contract development and manufacturing organisation (CDMO) partner to ensure a seamless transition to large-scale production. Importantly, the scale-up has led to production efficiencies and significant cost-savings. The next step will involve converting the approx. 13 kg of drug substance manufactured, known as active pharmaceutical ingredient (API), into oral capsules for use in ongoing and upcoming clinical trials.","length":462,"tagName":"p"},{"type":"text","content":"This newly manufactured API will support Amplia’s pancreatic cancer trials as well as other potential studies currently in various stages of planning.","length":150,"tagName":"p"},{"type":"text","content":"Dr Rhiannon Jones, Chief Operating Officer of Amplia, who has overseen the production campaign, commented, “Amplia continues to develop its manufacturing processes to meet phase-appropriate standards as we move towards a registrational study. This successful large-scale API synthesis campaign is an important step in ensuring we are prepared for the next stages of clinical development.”","length":388,"tagName":"p"},{"type":"text","content":"Narma...