Amplia Therapeutics Ltd.

HIGHLIGHTS The US FDA has granted Fast Track Designation to Amplia's lead drug narmafotinib in advanced pancreatic cancer Fast Track Designation facilitates the development of investigational drugs and allows for expedited review MELBOURNE, Australia, Sept. 19, 2024 /PRNewswire/ -- Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), is pleased to announce that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to Amplia's Focal Adhesion Kinase inhibitor, narmafotinib, for the treatment of advanced pancreatic cancer. Continue Reading Fast Track Designation is available to drugs that may provide an advantage over current therapies in the treatment of serious conditions. It is designed to speed the development of these drugs to enable patients to receive them sooner. This Designation will grant the Company access to more frequent meetings, and written communication, with the FDA. In future, narmafotinib may be eligible for Accelerated Approval and Priority Review. The Company has previously received Orphan Drug Designation from the FDA for narmafotinib in pancreatic cancer. The Company's CEO and Managing Director, Dr Chris Burns, commented, "Fast Track Designation for narmafotinib is a significant milestone for the Company. With this designation, we can work more closely with the FDA to accelerate our clinical program and gather the most compelling evidence for regulatory approval in this devastating disease." Amplia's clinical trial in advanced pancreatic cancer, the ACCENT trial, is ongoing in Australia and South Korea. Earlier this year, the Company announced that the US FDA had cleared its IND[1] application for a trial of narmafotinib in pancreatic cancer in the US. This trial is in advanced planning stages. This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics. About Narmafotinib Narmafotinib (AMP945) is the company's best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic and other cancers, 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. The drug has successfully completed a healthy volunteer study and is currently in an open-label Phase 2a trial in pancreatic cancer where a combination of narmafotinib and the chemotherapies gemcitabine and Abraxane® is being assessed for safety, tolerability and efficacy. 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 Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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 Data from preclinical studies in ovarian cancer presented at premier international conference in Boston, USA. Results indicate that Amplia's proprietary FAK inhibitor narmafotinib (AMP945) performs better than standard-of-care in models of chemotherapy-resistant high-grade serous ovarian cancer Data from these studies support clinical study of narmafotinib in ovarian cancer – with plans now commencing with leading international cancer specialists MELBOURNE, Australia, Oct. 9, 2023 /PRNewswire/ -- Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company") is pleased to announce that a poster, detailing a series of preclinical studies in ovarian cancer models, was presented at the American Association for Cancer Research (AACR) Special Conference In Cancer Research: Ovarian Cancer meeting, held in Boston, USA over the weekend. The poster describes research with narmafotinib (AMP945) conducted by the company's collaborators at the University of California, San Diego (UCSD), and was presented by lead researcher Prof Dwayne Stupack. The data presented clearly demonstrates that narmafotinib is active in mouse models of chemotherapy-resistant ovarian cancer with improved tumour growth inhibition activity and tolerability compared to a PARP inhibitor (niraparib), the current standard-of-care agent for this chemotherapy-resistant patient population. Moreover, narmafotinib showed promising activity in a model where niraparib therapy is ineffective. These results build on previous research by Prof. Stupack and his collaborators showing that activity of the FAK enzyme is upregulated in chemotherapy-resistant ovarian cancer and that FAK inhibition resensitises the cancer to standard-of-care chemotherapy and immunotherapy as well. Lead researcher Prof Dwayne Stupack stated: "PARP inhibitors are now widely used in the treatment of high-grade serous ovarian cancer (HGSOC) and work well in a subset of patients with what's known as homologous recombinant deficient (HRD) HGSOC – at least until drug resistance occurs. We have shown in our preclinical models that narmafotinib (AMP945) has better activity across the non-HRD disease, and importantly works in PARP inhibitor-resistant disease as well. Moreover, it appears to be very well tolerated, which is important for a drug that will be taken daily." A copy of the presentation, entitled 'Maintenance therapy inhibition of ptk2 [FAK] yields decreased disease in preclinical models of HRP/HRD models of recurrent HGSOC' is available on the Company's website here. Amplia CEO and MD, Dr Chris Burns commented: "The research results presented today by Prof. Stupack are extremely exciting and clearly demonstrate that our best-in-class FAK inhibitor narmafotinib has significant potential in the treatment of ovarian cancer. Given that over 1000 women in Australia die each year of this disease, there is a clear need for better treatment, and plans are now underway to work with local and international ovarian cancer specialists to initiate a clinical trial of narmafotinib in ovarian cancer patients. "The clinical potential of FAK inhibition in ovarian cancer was demonstrated earlier this year with the first-generation FAK inhibitor defactinib showing promising activity in patients with low-grade serous ovarian cancer. Our preclinical results in models of high-grade disease, which represents over 90% of all ovarian cancer patients, further underscore the potential role of FAK inhibitors in treatment of this disease." This ASX announcement was approved and authorised for release by the Board. 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 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