Melbourne, Australia, Feb. 11, 2026 (GLOBE NEWSWIRE) -- HIGHLIGHTS Two US-based sites have completed trial initiation activities for the AMPLICITY trial in pancreatic cancer These sites join the two Australian sites already open and recruiting patients Three additional US sites are expected to be open in the coming weeks Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the “Company”), announces that two (2) sites in the US have been initiated and will shortly be commencing recruitment activi ...

Core Insights - Amplia Therapeutics Limited is making significant progress in the clinical development of its FAK inhibitor, narmafotinib, particularly for metastatic pancreatic cancer, with promising results from ongoing trials [2][3][17] Clinical Trial Updates - The ACCENT trial, which combines narmafotinib with gemcitabine and Abraxane®, has reported an overall response rate of 35%, significantly higher than the 23% response rate for chemotherapy alone [3][17] - The mean duration on trial for patients was 219 days, with some patients remaining on the study for over 12 months, indicating the drug's potential to halt cancer progression [4] - The AMPLICITY trial has commenced, investigating narmafotinib in combination with FOLFIRINOX chemotherapy, with patient recruitment ongoing in Melbourne and Sydney [6][7] Regulatory and Commercial Developments - Positive feedback from the US FDA has been received regarding the dose optimization strategy for narmafotinib, which supports its planned Phase 2b/3 trial [8] - A key patent for narmafotinib has been granted, extending protection until at least 2040 in the US and other jurisdictions [9] - Amplia has successfully uplisted to the US-based OTCQB Venture Market, enhancing its visibility and investor reach [10] Preclinical Studies - The second phase of a research collaboration with Next & Bio has been initiated, focusing on evaluating narmafotinib against patient-derived pancreatic cancer cells with specific genetic mutations [11] Financial Update - Amplia reported a cash position of $31.5 million at the end of December 2025, with net operating cash inflows of $2.4 million during the quarter [13] - The company received $3.8 million from government grants and tax incentives, while outflows included $0.9 million for staff and administration costs, and $0.9 million for research and development [14]

Core Insights - Amplia Therapeutics has successfully completed the first large-scale manufacture of narmafotinib, producing approximately 13 kg of the drug, marking a significant step towards Phase 3 readiness [1] - The transition from R&D to commercial manufacturing has been achieved, ensuring sufficient drug supply for ongoing pancreatic cancer trials and other planned studies [1][3] Manufacturing and Production - The company collaborated closely with its contract development and manufacturing organization (CDMO) to ensure a seamless transition to large-scale production, resulting in production efficiencies and significant cost savings [2] - The next step involves converting the 13 kg of active pharmaceutical ingredient (API) into oral capsules for clinical trials [2] Clinical Development - The newly manufactured API will support Amplia's pancreatic cancer trials and other studies currently in planning stages [3] - Dr. Rhiannon Jones emphasized the importance of this large-scale API synthesis campaign in preparing for the next stages of clinical development [4] Quality Standards - Narmafotinib is manufactured under Good Manufacturing Practice (GMP), ensuring that the product meets strict safety and quality requirements [4] Drug Information - Narmafotinib (AMP945) is a best-in-class inhibitor of the protein FAK, which is over-expressed in pancreatic cancer and is a significant target in solid tumors [6] - The drug has shown promising results in preclinical studies and is currently undergoing clinical trials, including the ACCENT trial, which has achieved a confirmed response rate of 35% [7]

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 is set to present updated data from the ACCENT trial at the ASCO Gastrointestinal Cancers Symposium, focusing on the combination of Narmafotinib with gemcitabine and nab-paclitaxel for metastatic pancreatic cancer [1][2] Company Overview - Amplia Therapeutics Limited is an Australian pharmaceutical company specializing in Focal Adhesion Kinase (FAK) inhibitors aimed at treating cancer and fibrosis, with a focus on fibrotic cancers such as pancreatic and ovarian cancer [2] - FAK is recognized as a significant target in cancer treatment and is also involved in chronic diseases like idiopathic pulmonary fibrosis (IPF) [2] Drug Information - Narmafotinib (AMP945) is a potent and selective FAK inhibitor, currently in clinical trials, showing promising results in preclinical studies [3] - The ACCENT trial has achieved a confirmed response rate of 35%, surpassing the 23% response rate from the benchmark MPACT study for gemcitabine and Abraxane alone, with an interim median progression-free survival (PFS) of 7.6 months [3] - A second trial, AMPLICITY, is underway, investigating the combination of Narmafotinib with FOLFIRINOX in advanced pancreatic cancer patients [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].