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; 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.
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.
This newly manufactured API will support Amplia's pancreatic cancer trials as well as other potential studies currently in various stages of planning.
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."
Narmafotinib is manufactured under GMP (Good Manufacturing Practice), which is an internationally recognised system that ensures medicinal products are consistently produced and controlled according to quality standards. It covers all aspects of the manufacturing process, including hygiene, equipment, documentation, and staff training, providing confidence that the product meets strict safety and quality requirements.
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.
| Investor Contact: Dr Chris Burns Chief Executive Officer chris@ampliatx.com U.S. Contact: Robert Giordano rjgiordano@ggrouplifesciences.com +1 917 327 3938 | Media Contact: H^CK Director, Haley Chartres haley@hck.digital +61 423 139 163 U.S. Media: media@ampliatx.com |
About Amplia Therapeutics Limited
Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on X (@ampliatx) and LinkedIn.
About Narmafotinib
Narmafotinib (AMP945) is the company's best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumors. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. Narmafotinib is currently undergoing a clinical trial (the ACCENT trial) where it is dosed in combination with the chemotherapies gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial has already achieved its primary endpoint in achieving a confirmed response rate of 35%, superior to 23% reported in the benchmark MPACT study for gemcitabine and Abraxane alone. An interim median PFS of 7.6 months has also been reported. A second trial - AMPLICITY - has recently opened and is being run under an IND at sites in Australia and the US, investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients.
