Narmafotinib

HIGHLIGHTS The US FDA has cleared Amplia's Investigational New Drug (IND) Application for a clinical trial of narmafotinib in the USA The proposed trial would explore the combination of narmafotinib and FOLFIRINOX in advanced pancreatic cancer patients in the USA MELBOURNE, Australia, Jan. 17, 2024 /PRNewswire/ -- Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), is pleased to announce that the US FDA have cleared Amplia's IND application for a trial of Amplia's best-in-class focal adhesion kinase (FAK) inhibitor narmafotinib in pancreatic cancer. The proposed trial will explore the safety, tolerability and efficacy of a combination of narmafotinib with the chemotherapy regime FOLFIRINOX. The company is currently undertaking a Phase 2a clinical trial of narmafotinib, in combination with two chemotherapy drugs, gemcitabine and Abraxane®, in advanced pancreatic patients in Australia and South Korea. In contrast, the IND application reviewed by the US Food and Drug Administration (FDA) supports the use of narmafotinib in combination with a different chemotherapy called FOLFIRINOX (a four drug regimen), which is widely employed in the US for the treatment of pancreatic cancer. The IND document is an extensive dossier that details all preclinical and clinical data amassed to date for narmafotinib, along with complete CMC (chemistry, manufacturing and controls) information. The final document comprised more than 10,000 pages and represented a major undertaking by the company over the previous months. Amplia CEO and MD Dr Chris Burns commented: "Clearance of the IND by the US FDA is a significant step forward for the Company. We will now start planning the combination trial of narmafotinib with FOLFIRINOX in the US, which expands the clinical opportunities for our best-in-class FAK inhibitor. FOLFIRINOX is the preferred treatment for pancreatic patients in the USA and most of Europe, and therefore this combination trial is highly relevant as we position narmafotinib as the preferred drug to enhance the effectiveness of existing chemotherapy combinations in pancreatic cancer." This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics. 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 and follow Amplia on Twitter (@ampliatx), Threads (@ampliatx) and LinkedIn. SOURCE Amplia Therapeutics

HIGHLIGHTS Amplia's highly selective FAK inhibitor AMP945, when used in combination with FOLFIRINOX, enhances survival in a preclinical model of pancreatic cancer FOLFIRINOX is the most widely used treatment for pancreatic cancer patients in the US, Canada and most European countries This new data supports clinical studies investigating the combination of AMP945 in a second major treatment regimen in pancreatic cancer Amplia has filed a patent to cover the use of FAK inhibitors in combination with FOLFIRINOX and related treatment regimes MELBOURNE, Australia, May 29, 2023 /PRNewswire/ -- Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") is pleased to announce new data showing the efficacy of its investigational FAK inhibitor, AMP945, in a preclinical model of pancreatic cancer, when used in combination with FOLFIRINOX treatment. FOLFIRINOX, a combination of four chemotherapies used in the treatment of pancreatic cancer patients, is currently a widely-used treatment in many major markets around the world including the US. New data from preclinical studies conducted in the laboratory of Prof. Paul Timpson at the Garvan Institute of Medical Research in Sydney, demonstrate that mice treated with AMP945 in addition to FOLFIRINOX show improved overall survival compared to those treated with FOLFIRINOX alone. The data, available in the Meeting Abstracts for the forthcoming American Society of Clinical Oncology meeting in Chicago, USA, (here)[1] describe studies in mice bearing pancreatic cancer tumours derived from a human patient. AMP945 was given in the days preceding FOLFIRINOX treatment (given on a 12-day cycle) resulting in a statistically significant increase in survival (up to 35% approx.) compared to FOLFIRINOX-only treated mice. Dr Chris Burns, Amplia's CEO and Managing Director commented: "The exciting results from this mouse study further indicate the potential of AMP945 in pancreatic cancer treatment when used in combination with standard-of-care therapies. In light of this data, we have filed a patent to cover the use of FAK inhibitors, and particularly AMP945, in combination with FOLFIRINOX and related treatment regimes." With this data, and the Company's previously reported preclinical data demonstrating the benefit of combining AMP945 with gemcitabine and nab-paclitaxel, AMP945 has shown promising activity in models of pancreatic cancer with the two most common first-line chemotherapy regimens for treatment of the disease. Prof. Nick Pavlakis, a medical oncologist at the Royal North Shore Hospital in Sydney, and an investigator in the current ACCENT trial, commented: "FOLFIRINOX is employed under certain conditions in Australia and more broadly in the USA and Europe, and the data from this study, coupled with the developing safety and tolerability data from Amplia's current ACCENT trial, provide strong support to undertake a future clinical study of AMP945 with FOLFIRINOX." This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics. About AMP945 AMP945 is an orally bioavailable small molecule FAK inhibitor with a best-in-class profile. The compound is currently undergoing a Phase 1b/2a trial in pancreatic cancer patients in combination with gemcitabine and nab-paclitaxel (the ACCENT trial) in Australia. More information about the ACCENT trial, including a list of participating sites, can be found via our website and at ClinicalTrials.gov under the identifier NCT05355298. About FOLFIRINOX FOLFIRINOX is combination chemotherapy consisting of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin used in the treatment of pancreatic cancer. In Australia, FOLFIRINOX is reserved for younger, fitter patients whereas in other countries (e.g. US, UK, Canada, France) it is standard-of-care therapy where it has been shown to result in a median overall survival of 11.1 months. Related chemotherapies such as FOLFOX and FOLFIRI are used to treat colorectal cancer and other gastric cancers. 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 immunology and Amplia has a particular development focus in fibrotic cancers such as pancreatic cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). For more information visit and follow Amplia on Twitter (@ampliatx) and LinkedIn. SOURCE Amplia Therapeutics