Core Insights - Amplia Therapeutics Limited announced mature data from the ACCENT clinical trial for advanced pancreatic cancer, showing a median overall survival of 11.1 months and five complete responses recorded to date [2][9]. Clinical Trial Data - The ACCENT trial has reported a confirmed complete response (CR) rate of 7.8% (5 out of 64 patients) for those receiving a 400 mg dose of narmafotinib, which is unprecedented for this indication [3][9]. - An updated Objective Response Rate (ORR) of 35.9% (23 out of 64 patients) has been established, with one patient nearing 24 months on the trial [4][9]. - The median overall survival (mOS) of 11.1 months represents a two-month improvement compared to the standard gemcitabine-Abraxane chemotherapy [6][9]. Comparative Analysis - The ACCENT trial data compares favorably to historical data from the MPACT and NAPOLI 3 trials, with the mOS of 11.1 months being identical to that of the NALIRIFOX regimen, which received FDA approval [7][8]. - The complete response rate of 7.8% in the ACCENT trial significantly exceeds the rates of 0.2% and 0.3% reported in the MPACT and NAPOLI 3 trials, respectively [8]. Safety and Tolerability - Narmafotinib has been well tolerated by patients, with the adverse effect profile similar to that of chemotherapy alone [8][9]. Upcoming Presentations - The company has been selected to present trial data at the American Association of Cancer Research (AACR) annual meeting in April 2026 [10][11].

Core Insights - Amplia Therapeutics Limited presented compelling preclinical data on its lead drug narmafotinib at the AACR Special Conference, highlighting its potential to enhance the efficacy of kRAS inhibitors in cancer treatment [2][3]. Company Overview - Amplia Therapeutics Limited is an Australian pharmaceutical company focused on developing Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis, with a particular emphasis on fibrotic cancers such as pancreatic and ovarian cancer [6]. - The company’s lead drug, narmafotinib, is a highly potent and selective FAK inhibitor that has shown promising results in preclinical studies [7]. Clinical Data - Preclinical data indicates that narmafotinib enhances the activity of kRAS inhibitors by blocking resistance pathways, thereby improving treatment efficacy and durability [3]. - Narmafotinib is currently involved in the ACCENT clinical trial, which has achieved a confirmed response rate of 35%, surpassing the 23% benchmark from the MPACT study for gemcitabine and Abraxane alone [8]. - An interim median progression-free survival (PFS) of 7.7 months has been reported in the ACCENT trial [8]. Industry Context - The kRAS inhibitors represent a new class of drugs in development for treating various cancers, with over 50 different kRAS inhibitors currently undergoing clinical studies globally [4]. - Despite the promising mid-stage clinical data for kRAS inhibitors, significant side effects and treatment-emergent resistance are common challenges faced in this area [4].

Company Overview - Amplia Therapeutics Limited is an Australian pharmaceutical company focused on developing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis, particularly in fibrotic cancers such as pancreatic and ovarian cancer [5] - Narmafotinib (AMP945) is the company's leading drug, recognized as a best-in-class FAK inhibitor, which is over-expressed in pancreatic cancer and is gaining attention as a drug target for solid tumors [6] AMPLICITY Trial Details - The AMPLICITY trial is investigating the safety, tolerability, efficacy, and pharmacokinetics of narmafotinib in combination with modified FOLFIRINOX in newly diagnosed patients with advanced pancreatic cancer [8] - The trial is designed as a single-arm, open-label study, proceeding in two parts to identify the optimal daily dose of narmafotinib [9][10] - Currently, the trial has initiated two sites in the US (University of California, Irvine and The Cleveland Clinic) and has two sites open in Australia, with three additional US sites expected to open soon [2][3][6] Clinical Trial Progress - The AMPLICITY trial aims to expand the potential patient base significantly, enhancing the company's presence in the US from both clinical and investor perspectives [3] - The trial is being conducted under an open IND from the US FDA, and further information can be found on the trial's website [8][10] - Previous preclinical studies have shown that the addition of narmafotinib to FOLFIRINOX significantly improves survival in animal models of pancreatic cancer compared to FOLFIRINOX alone [11]

Core Insights - Amplia Therapeutics Limited presented interim data from the ACCENT trial for metastatic pancreatic cancer at the ASCO GI symposium, showcasing the efficacy of narmafotinib in combination with standard chemotherapy [1][3] Group 1: Clinical Trial Data - The ACCENT trial is assessing narmafotinib, a FAK inhibitor, in combination with gemcitabine and Abraxane for advanced pancreatic cancer patients [1][5] - Updated progression-free survival (PFS) for the narmafotinib combination is reported at 7.7 months, compared to 5.5 months for gemcitabine and Abraxane alone [6] - The overall response rate (ORR) for the narmafotinib combination is 35%, increasing to 42% when including unconfirmed responses [6][7] - The trial has achieved a confirmed response rate of 35%, superior to the 23% reported in the benchmark MPACT study for gemcitabine and Abraxane alone [7] Group 2: Company Overview - Amplia Therapeutics is focused on developing a pipeline of FAK inhibitors for cancer and fibrosis, with a particular emphasis on fibrotic cancers such as pancreatic and ovarian cancer [4][5] - Narmafotinib (AMP945) is highlighted as a best-in-class FAK inhibitor, showing promising preclinical data and currently undergoing clinical trials [5][6] - The company is positioned among leading biotechnology firms, emphasizing its progress in developing narmafotinib for pancreatic cancer [3]

Core Insights - Amplia Therapeutics Limited has reported an additional confirmed partial response in the ongoing ACCENT trial for metastatic pancreatic cancer, indicating progress in their clinical research [1][6] - The confirmed objective response rate (ORR) has reached 35% (19 out of 55 patients), which is significantly higher than the 23% ORR observed in the benchmark MPACT trial for gemcitabine and nab-paclitaxel alone [2][5] Company Overview - Amplia Therapeutics Limited is an Australian pharmaceutical company focused on developing a pipeline of Focal Adhesion Kinase (FAK) inhibitors targeting cancer and fibrosis, particularly in fibrotic cancers like pancreatic and ovarian cancer [4] - The company is advancing its lead candidate, narmafotinib, which is a potent and selective FAK inhibitor, currently being tested in the ACCENT trial in combination with gemcitabine and Abraxane for advanced pancreatic cancer [5] Clinical Trial Details - The ACCENT trial has achieved its primary endpoint with a confirmed response rate of 35%, surpassing the benchmark of 23% from the MPACT study [5] - An interim median progression-free survival (PFS) of 7.6 months has also been reported in the trial [5] - A second trial, AMPLICITY, is underway, investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients [5]

Company Overview - Amplia Therapeutics Limited is an Australian pharmaceutical company focused on developing therapies for hard-to-treat cancers, particularly through Focal Adhesion Kinase (FAK) inhibitors [5] - The company is targeting fibrotic cancers such as pancreatic and ovarian cancer, as well as chronic diseases like idiopathic pulmonary fibrosis (IPF) [5] Recent Developments - Dr. Chris Burns, CEO and Managing Director, will present at the Life Sciences Virtual Investor Forum on December 11, 2025 [1] - The company is available for one-on-one meetings on December 11, 15, and 16, after 3 PM ET [2] - Top-line data from the ACCENT pancreatic cancer trial indicates that narmafotinib, when dosed in combination with chemotherapy, shows superior efficacy compared to chemotherapy alone [8] - The AMPLICITY Phase 1b pancreatic cancer trial commenced dosing in September 2025 [8] - The company has received Fast Track Designation and Orphan Drug Designation for its pancreatic cancer treatment [8] - Promising preclinical data suggests potential expansion opportunities in pancreatic cancer when combined with kRAS inhibitors [8] - Positive preclinical data has also been reported in ovarian cancer, indicating an additional therapeutic opportunity [8] Event Information - The Life Sciences Virtual Investor Forum will be an interactive online event allowing real-time questions from investors [2][3] - Investors are encouraged to pre-register and conduct an online system check to facilitate participation [3] Investor Engagement - Virtual Investor Conferences (VIC) provides a platform for publicly traded companies to present directly to investors, enhancing investor access and engagement [6][7]

Core Viewpoint - Amplia Therapeutics Limited has received a key patent grant for narmafotinib, enhancing its intellectual property protection and extending it to at least 2040 in several jurisdictions [1][2][5]. Group 1: Patent and Intellectual Property - The US Patent and Trademark Office has granted a patent for a specific form of narmafotinib, which is crucial for the company's clinical development [1][2]. - The patent has also been granted in significant markets including Europe, Japan, India, Korea, and Australia, with ongoing reviews in other regions [2]. Group 2: Product Development - Narmafotinib (AMP945) is a potent FAK inhibitor targeting pancreatic cancer, showing promising results in preclinical studies [4]. - The drug is currently in the ACCENT clinical trial, demonstrating a confirmed response rate of 33%, which is higher than the 23% benchmark from the MPACT study [4]. - An interim median progression-free survival (PFS) of 7.6 months has been reported in the ACCENT trial [4]. - A second trial, AMPLICITY, is underway, investigating narmafotinib in combination with FOLFIRINOX for advanced pancreatic cancer patients [4]. Group 3: Company Overview - Amplia Therapeutics is focused on developing FAK inhibitors for cancer and fibrosis, with a particular emphasis on fibrotic cancers like pancreatic and ovarian cancer [3].