Narmafotinib Large-Scale Manufacture Complete
Released
Released
Announcement PDF
ABN 16 165 160 841
+61 (0) 3 9123 1140 | info@ampliatx.com
Level 5, 90 William Street, Melbourne VIC 3000 Australia
www.ampliatx.com
22 JANUARY 2026
ASX RELEASE
NARMAFOTINIB LARGE-SCALE MANUFACTURE COMPLETE
HIGHLIGHTS
• 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: 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.
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