Tillkännagivande • Jul 09
Amplia Therapeutics Limited Announces Publication Of New Patent Application For Chemically Novel FAK Inhibitors Amplia Therapeutics Limited announced publication of a new patent application describing chemically novel inhibitors of focal adhesion kinase (FAK) discovered by the Company. The patent application further expands Amplia’s FAK intellectual property portfolio and, if granted, would provide protection for the novel molecules described, and their use, out to 2046. Amplia’s patent portfolio covers its lead drug narmafotinib, currently in clinical trials for pancreatic and ovarian cancer, and a second drug candidate (AMP886) being investigated in preclinical studies. The new patent application describes additional chemical compounds closely related to narmafotinib that also demonstrate potent and selective activity against FAK. These molecules broaden Amplia’s development pipeline and may provide future opportunities for evaluation across additional indications. The patent application adds depth to the Company’s existing intellectual property estate around its FAK inhibitor program and supports the long-term commercial value of its development assets. 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 tumours. 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 achieved its desired outcome in achieving a response rate of 36%, including 5 Complete Responses and a pathological Complete Response, across 64 patients. A second trial – AMPLICITY – is being run at sites in Australia investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients. Tillkännagivande • Jul 07
Amplia Therapeutics Limited Announces Appointment of Brett Carter to Board, Effective July 6, 2026 Amplia Therapeutics Limited announced the appointment of Mr. Brett Carter to the Board of Directors as non-executive director, effective from July 6, 2026. Mr. Carter is an experienced biopharmaceutical executive with more than 25 years’ global experience across oncology drug development, corporate strategy and business development. Mr. Carter spent 11 years with GSK in London, including as a director in the company’s global corporate transactions team, where he led and supported major licensing, acquisition, investment and divestment transactions across Europe, Asia and the United States. Mr. Carter was subsequently CEO of the Cancer Therapeutics Cooperative Research Centre, where Amplia’s drug assets were discovered, and while there was involved in the licensing of an oncology program to Pfizer in a deal valued up to $670 million. Mr. Carter holds an MBA from London Business School and a BSc from RMIT University and is a graduate of the Australian Institute of Company Directors. He is currently COO of Melbourne-based Medicines Development for Global Health, a director of privately-held biotech Greywolf Therapeutics Australia, and strategic adviser to various Australian life science companies. Tillkännagivande • Jul 06
Amplia Therapeutics Limited Announces Board Changes, Effective June 30, 2026 Amplia Therapeutics Limited announced that Dr Warwick Tong will retire as Board Chairman on 30 June 2026 and remain as a Non-Executive Director (NED) of the Company. Dr Tong has been a Director of Amplia since 4 May 2018 following the acquisition of Amplia Therapeutics Pty Ltd. in April 2018. He was elected Chairman of the Board in August 2018. Ms Jane Bell AM was unanimously appointed Board Chair effective 30 June 2026 immediately following Dr Tong’s retirement. Ms Bell was appointed as an Independent Non-Executive Director of the Company on 12 April 2021 and is currently Chair of the Audit and Risk Committee. She has over two decades of experience as a Director with a particular focus in the Medical and Life Sciences sector as well as extensive banking and finance legal experience. Tillkännagivande • Jul 01
Amplia Therapeutics Limited, Annual General Meeting, Aug 28, 2026 Amplia Therapeutics Limited, Annual General Meeting, Aug 28, 2026. Tillkännagivande • Jun 23
Amplia Therapeutics Limited Provides Update on Narmafotinib Clinical Progress and Combination Potential with KRAS Inhibitors in Pancreatic Cancer Amplia Therapeutics Limited provided a letter outlining the potential for the company’s best-in-class FAK inhibitor narmafotinib in combination with the emerging KRAS inhibitor class following new data presented at the American Society of Clinical Oncology Annual Meeting. At the 2026 American Society of Clinical Oncology Annual Meeting, investigators presented pivotal Phase 3 data showing that daraxonrasib, an oral KRAS-targeted therapy from Revolution Medicines, roughly doubled overall survival against chemotherapy in previously treated metastatic pancreatic cancer. In March, Amplia Therapeutics Limited presented preclinical data at the AACR Special Conference on RAS Oncogenesis showing that narmafotinib enhances the activity of KRAS inhibitors in preclinical models of pancreatic and lung cancer, and that it blocks the resistance pathways that limit them. Narmafotinib targets the weakness standing between today's KRAS inhibitors and their full potential. FAK sits at a convergence point for the adaptive signaling that lets tumors escape RAS-pathway blockade, while also driving fibrosis around the tumor limiting any therapy's reach. Adding a FAK inhibitor to a KRAS-targeted backbone can extend both the depth and the durability of response. Both drugs are oral and once-daily. Narmafotinib was built for exactly that strategic space. Narmafotinib, a potent and selective inhibitor of focal adhesion kinase, attacks both the dense, fibrotic and immune-suppressed microenvironment around the tumor and the ability to adapt to, and resist, drug treatment. FAK drives the survival, proliferation and chemoresistance of pancreatic tumor cells, and it builds the fibrotic, immunosuppressive barrier that protects them. By inhibiting FAK, narmafotinib breaks down that shield and restores the tumor's sensitivity to chemotherapy. Narmafotinib does not depend on a tumor's mutational profile. In the ACCENT trial, narmafotinib combined with gemcitabine and nab-paclitaxel (Abraxane®) at their standard dose and schedule, in first-line advanced pancreatic cancer delivered a confirmed response rate of 35%, well above the 23% that chemotherapy alone achieved in the benchmark MPACT study, alongside an interim median progression-free survival of 7.7 months and median overall survival of 11.1 months. Five patients recorded confirmed complete responses giving a CR rate of 7.8%; with an additional patient achieving a pathological complete response. Patients have tolerated the oral, once-daily regimen well alongside chemotherapy. The U.S. Food and Drug Administration granted narmafotinib both Fast Track and Orphan Drug designation. Amplia Therapeutics Limited launched the first stage of a registration-enabling Phase 2b study, advancing a new daily-dosing regimen and laying the groundwork for a Phase 3 program. Amplia Therapeutics Limited entered an agreement with the Australia New Zealand Gynaecological Oncology Group to study narmafotinib in ovarian cancer. 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 desired outcome in achieving a response rate of 35%, superior to chemotherapy alone and an interim PFS of 7.7 months has been reported. A second trial – AMPLICITY – is being run under an IND at two sites in Australia, investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients. Tillkännagivande • May 21
Amplia Therapeutics Limited Initiates Phase 2B Study of Narmafotinib in Pancreatic Cancer Amplia Therapeutics Limited announced that it is initiating a Phase 2b study of narmafotinib in pancreatic cancer exploring a new dosing regimen. Designed in alignment with FDA feedback, the study will form the basis – and first stage – of a registrational study in this indication given the high existing unmet need for innovative treatments. Narmafotinib is a best-in-class FAK inhibitor that has received orphan drug designation and fast track designation from the U.S. FDA as a potential treatment in pancreatic cancer. The study will investigate, for the first time, a daily dosing schedule for narmafotinib, at two dosing levels, with the chemotherapies gemcitabine and Abraxane in newly diagnosed advanced pancreatic cancer patients. In this first stage, each dosing cohort will have 6 patients (12 patients in total), which will be combined with gemcitabine and Abraxane given on their conventional schedule. In addition to safety and tolerability, pharmacokinetics (PK) and efficacy will be assessed. Exploratory endpoints will include effects on disease biomarkers as well as effects on fibrosis, a key indicator of FAK activity. The study will enroll patients across 3-4 sites in Australia. The Company anticipates patient enrolment will begin by the fourth quarter of this year with the safety, tolerability and PK assessment for the 12 patients completed in the second quarter of 2027. 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 achieved its desired outcome in achieving a response rate of 36%, superior to chemotherapy alone, and a mOS of 11.1 months has been reported. A second trial – AMPLICITY – is being run at sites in Australia investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients. 
