Ankündigung • 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. Ankündigung • 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. Ankündigung • 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. Ankündigung • Jul 01
Amplia Therapeutics Limited, Annual General Meeting, Aug 28, 2026 Amplia Therapeutics Limited, Annual General Meeting, Aug 28, 2026. Ankündigung • 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. Ankündigung • 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. Ankündigung • May 11
Amplia Therapeutics Limited And Australia New Zealand Gynaecological Oncology Group Announce Clinical Study Of Narmafotinib In Ovarian Cancer Amplia Therapeutics Limited and the Australia New Zealand Gynaecological Oncology Group announced that they have entered into an agreement to conduct a new clinical study investigating the Company’s lead drug narmafotinib in ovarian cancer. Narmafotinib is a best-in-class FAK inhibitor currently undergoing clinical development in pancreatic cancer where it is showing promising efficacy combined with good tolerability. The study is an investigator-initiated clinical trial led by Dr Gwo Yaw Ho of Monash Health and Monash University, and sponsored and coordinated through ANZGOG, an international cooperative clinical trials network spanning major hospitals across Australia and New Zealand. The study is expected to enroll approximately 15–20 patients with high-grade serous ovarian cancer (HGSOC) who demonstrate poor response to up-front standard-of-care platinum-based chemotherapy prior to planned interval debulking surgery. The trial, to be called the PRROSE trial, will evaluate the safety of narmafotinib in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) in this patient population. Approximately one in five ovarian cancer patients do not respond adequately to initial chemotherapy, limiting their ability to undergo surgery and contributing to poor clinical outcomes. This study is designed to address this significant unmet medical need. The study will therefore also explore whether the addition of narmafotinib can increase the proportion of patients eligible for successful surgical resection. Extensive tissue and blood biomarkers will be examined for insight into narmafotinib’s mechanism of action to further enrich data provided from the study. 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. Ankündigung • Apr 24
Amplia Therapeutics Limited Presents Mature Data from Accent Trial in Pancreatic Cancer Amplia Therapeutics Limited announced that an oral presentation highlighting mature data from the Company’s ACCENT trial in metastatic pancreatic cancer is being delivered at the annual meeting of the AACR. The presentation includes more detailed analysis of the recently reported data from the ACCENT study, which is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapy. The key points from the presentation are: Narmafotinib displays a manageable toxicity profile, with no significant tolerability burden over chemotherapy alone. Independent (central) reading of data identified 5 confirmed Complete Responses (CR’s) from 64 patients, an 8% CR rate compared to a 0.2% rate for chemotherapy alone. A response rate of 36% is observed (23 of 64 patients); 42% if unconfirmed responses included. A Disease Control Rate (DCR) of 70% was determined, compared to 50% for chemotherapy alone. Median overall survival (mOS) was found to be 11.1 months, while median progression-free survival (mPFS) was 7.7 months, both showing improvements of over two months compared to chemotherapy alone. A trend to improved Overall Survival is observed when comparing Stable Disease, Partial Response and Complete Response patients. The combined efficacy data is superior to chemotherapy alone across all measures despite the intermittent narmafotinib dosing schedule employed (12 days of each 28 day treatment cycle). Subsequent trials will employ a daily dosing regimen of narmafotinib given the tolerability observed to date, which may lead to improved responses. 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 already achieved its desired outcome in achieving a response rate of 31%, superior to chemotherapy alone and an interim PFS of 7.6 months has been reported. A second trial – AMPLICITY – has recently opened and 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. The ACCENT trial is entitled ‘A Phase 1b/2a, Multicenter, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’. The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b), completed in November 2023, determined an optimal dose of narmafotinib (AMP945) by assessing the safety, tolerability, pharmacokinetics and preliminary efficacy when dosed in combination with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The second stage (Phase 2a) of the trial is designed to assess efficacy in combination with gemcitabine and Abraxane. The primary endpoints are Objective Response Rate (ORR) and safety and tolerability, with secondary endpoints including Progression Free Survival (PFS) and Overall Survival (OS). The trial is being conducted at seven sites in Australia and five sites in South Korea. Ankündigung • Mar 10
Amplia Therapeutics Limited Demonstrates Combination Benefit Of Narmafotinib In Preclinical Kras-Mutated Cancer Models Amplia Therapeutics Limited announced that compelling data describing new clinical opportunities for its lead drug narmafotinib was presented at the AACR Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics in Los Angeles, California on March 6. The poster presentation discloses preclinical data demonstrating that the Company’s best-in-class FAK inhibitor narmafotinib enhances the activity of a new class of drugs called kRAS inhibitors in various models of cancer. In particular, the data indicates that narmafotinib blocks resistance pathways that can emerge with kRAS inhibitor treatment, thereby enhancing efficacy and durability of response. Data showing narmafotinib activity in preclinical models of pancreatic cancer, lung cancer and ovarian cancer are presented. The development of kRAS inhibitors for different types of solid tumors is currently an area of intense global activity. Inhibitors of mutant kRAS proteins are an exciting new class of drug in development for the treatment of lung, colon and pancreatic cancer, amongst others. There are currently over 50 different kRAS inhibitors undergoing clinical studies across the globe. Despite promising mid-stage clinical data, however, side-effects of these drugs can be significant and treatment-emergent resistance is commonplace. 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 already achieved its primary endpoint in achieving a confirmed response rate of 35%, superior to 23% reported in the benchmark MPACT study for gemcitabine and Abraxane alone. An interim median PFS of 7.7 months has also been reported. A second trial – AMPLICITY – has recently opened and is being run under an IND at sites in Australia and the US, investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients. Ankündigung • Feb 11
Amplia Therapeutics Announces Opening of US Sites for Amplicity Pancreatic Cancer Trial Amplia Therapeutics Limited announced that two (2) sites in the US have been initiated and will shortly be commencing recruitment activities for the AMPLICITY trial. The two sites - University of California, Irvine (Irvine, Calif.) and The Cleveland Clinic (Cleveland, Oh.) - join the two (2) sites already open in Australia as part of the Company's AMPLICITY trial, which is investigating Amplia's lead drug, narmafotinib, in advanced pancreatic cancer patients. An additional three (3) sites in the US will be initiated in the near future as recruitment to the trial continues. The AMPLICITY trial is investigating narmafotinib, the Company's best-in-class FAK inhibitor, in combination with the chemotherapy FOLFIRINOX in advanced pancreatic cancer. 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 being investigated in two clinical trials in pancreatic cancer. The most advanced clinical trial (ACCENT) investigates a combination with the chemotherapies gemcitabine and Abraxane®? in first-line patients with advanced pancreatic cancer. The trial has already achieved its primary endpoint in achieving a confirmed response rate of 35%, superior to 23% reported in the benchmark MPACT study for gemcitabine and Abraane alone. An interim median PFS of 7.7 months has also been reported. The AMPLICITY trial explores the safety, tolerability, efficacy and pharmacokinetics of the combination of narmafotinib with the chemotherapy regimen known as modified FOLFIRINOX in newly-diagnosed patients with advanced pancreatic cancer patients and is being conducted under an open IND from the US FDA. Designed as a single-arm, open-label study, the trial will proceed in two parts, incorporating the principles of the FDA's Project Optimus guidance for developing new oncology therapies. Part A will explore a range of oral daily doses of narmafotinib in combination with modified FOLFIRINOX (administered every 14 days), for safety, tolerability, and pharmacokinetics. Part B of the trial is designed to identify the optimal daily dose of narmafotinib for future studies, by comparing two (2) doses identified from Part A, for safety, tolerability and efficacy. The trial is being conducted initially at sites in Australia and the US. More information about the trial can be found at the Amplia Therapeutics website; ClinicalTrials.gov under the identifier NCT07026279; and atamplicity trial. The Company has previously presented data from preclinical studies demonstrating that the addition of narmafotinib to FOLFIRINOX significantly improves survival in animal survival in animal cancer. Ankündigung • Jan 22
Amplia Therapeutics Limited Announces Successful Completion of the First Large-Scale Manufactre of Narmafotinib Amplia Therapeutics Limited announced the successful completion of a large-scale manufacture campaign of narmafotinib to required purity and quality specifications. This milestone marks a significant step towards Phase 3 readiness and represents the culmination of months of process development, preparation and delivery as the Company has transitioned manufacturing from a research and development (R&D) facility to a commercial-ready environment. Amplia has collaborated closely with its contract development and manufacturing organisation (CDMO) partner to ensure a seamless transition to large-scale production. Importantly, the scale-up has led to production efficiencies and significant cost-savings. The next step will involve converting the approx. 13 kg of drug substance manufactured, known as active pharmaceutical ingredient (API), into oral capsules for use in ongoing and upcoming clinical trials. This newly manufactured API will support Amplia's pancreatic cancer trials as well as other potential studies currently in various stages of planning. Narmafotinib is manufactured under GMP (Good Manufacturing Practice), which is an internationally recognised system that ensures medicinal products are consistently produced and controlled according to quality standards. It covers all aspects of the manufacturing process, including hygiene, equipment, documentation, and staff training, providing confidence that the product meets strict safety and quality requirements. Ankündigung • Dec 12
Amplia Therapeutics Limited Announces Additional Confirmed Response Reported as Part of Amplia Investor Presentation Amplia Therapeutics Limited announced that an additional confirmed partial response (PR) has been recorded in the ongoing ACCENT trial in metastatic pancreatic cancer. The trial investigates the combination of the Company's best-in-class FAK inhibitor narmafotinib in combination with the chemotherapies gemcitabine and nab-paclitaxel (Abraxane®?). The additional PR brings the confirmed objective response rate (ORR) to 35% (19/55) which compares favourably to the ORR of 23% recorded for gemcitabine and nab the benchmark MPACT trial upon which ACCENT is based. Ankündigung • Dec 03
Amplia Therapeutics Limited Receives Key Narmafotinib Patent in the U.S Amplia Therapeutics Limited announced that it has received formal notification from the US Patent and Trademark Office (USPTO) that a key patent titled A salt and crystal form of a FAK Inhibitor has been granted. The Certificate of Grant follows on from the notification of allowance of the patent from the USPTO received in September1. This key patent protects the specific form of narmafotinib being developed clinically by the Company. The patent has already been granted in various important jurisdictions including Europe, Japan, India, Korea and Australia. Granting of this patent extends protection of narmafotinib out to a least 2040 in these jurisdictions. Protection in other regions is under review by the respective patent offices. Ankündigung • Sep 02
Amplia Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 25.000002 million. Amplia Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 25.000002 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 57,937,087
Price\Range: AUD 0.23
Discount Per Security: AUD 0.01265
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 38,867,267
Price\Range: AUD 0.23
Discount Per Security: AUD 0.01265
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 10,869,566
Price\Range: AUD 0.23
Discount Per Security: AUD 0.01265
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,021,740
Price\Range: AUD 0.23
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing Ankündigung • Jul 03
Amplia Therapeutics Limited, Annual General Meeting, Aug 27, 2025 Amplia Therapeutics Limited, Annual General Meeting, Aug 27, 2025. Ankündigung • Jun 18
Amplia Therapeutics Limited Announces Important New Data from Ongoing Accent Clinical Trial Amplia Therapeutics Limited announced important new data from ongoing ACCENT clinical trial in pancreatic cancer. The trial is investigating the Company's best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapies gemcitabine and Abraxane®? in patients with metastatic pancreatic cancer. A patient from the trial has now recorded a pathological complete response (pCR), an extremely rare observation in this patient population. During routine assessment of tumour burden for the patient in question, it was noted that there had been a significant reduction in the size and number of hepatic metastases (secondary tumours in the liver) and in the primary tumour in the pancreas. The medical team decided that this enabled them to change the treatment plan for this patient, and surgery was performed to remove both the secondary tumours in the liver and the primary tumour in the Pancreas. The surgically removed lesions were subjected to pathological examination and were determined to contain no live tumour tissue. This outcome is classified as a pCR. A pCR is very rarely reported in patients with advanced pancreatic cancer, where the disease has spread to other organs in the body. In patients with locally advanced (i.e. non-metastatic) pancreatic cancer, however, around 5% of patients do record a pCR in response to treatment with neoadjuvant chemotherapy (chemotherapy before surgery). In these earlier stage patients, a pCR is associated with improvements in overall survival. The ACCENT trial is entitled 'A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients'. The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b), completed in November 2023, determined an optimal dose of narmafotinib (AMP945) by assessing the safety, tolerability, pharmacokinetics and preliminary efficacy when dosed in combination with gemcitabine and Abraane in first-line patients with advanced pancreatic cancer. The second stage (Phase 2a) of the trial is designed to assess efficacy in combination with gemcitabines and Abraxane. The primary endpoints are Objective Response Rate (ORR) and Duration on Trial (DOT) with secondary endpoints being Progression Free Survival (PFS) and Overall Survival (OS). Safety and tolerability will continue to be assessed. The trial is being conducted at seven sites in Australia and five sites in South Korea. More information about the ACCENT trial can be found via the ACCENT trial site, the Amplia Therapeutics website, the Amplia Therape therape website, the Amplia Theraputics website. Ankündigung • Oct 30
Amplia Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 4.9 million. Amplia Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 4.9 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 15,652,174
Price\Range: AUD 0.115
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 26,956,522
Price\Range: AUD 0.115
Discount Per Security: AUD 0.0069
Security Features: Attached Options
Transaction Features: Rights Offering Ankündigung • Jul 04
Amplia Therapeutics Limited, Annual General Meeting, Aug 23, 2024 Amplia Therapeutics Limited, Annual General Meeting, Aug 23, 2024. Ankündigung • May 16
Amplia Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 4.27 million. Amplia Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 4.27 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 33,854,545
Price\Range: AUD 0.055
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 43,781,818
Price\Range: AUD 0.055
Transaction Features: Rights Offering Ankündigung • Apr 17
Amplia Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 4.27 million. Amplia Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 4.27 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 73,490,909
Price\Range: AUD 0.055
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 4,145,455
Price\Range: AUD 0.055
Transaction Features: Rights Offering Ankündigung • Jan 18
Amplia Therapeutics Limited Announces FDA Clearance of it's IND for Pancreatic Cancer Trial in US Amplia Therapeutics Limited announced 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. Ankündigung • Sep 25
Amplia Therapeutics Limited Announces Chief Financial Officer Changes Amplia Therapeutics Limited announced that Mr. Tim Luscombe will replace Mr. Hamish George as Chief Financial Officer (CFO) of the Company. Mr. Luscombe is a highly experienced Chartered Accountant who holds a Bachelor of Commerce from the University of Melbourne and a Certificate in Governance Practice from the Governance Institute of Australia. He is a Director at Bio101 Financial Advisory and has been working with Amplia in a senior accounting capacity over the last two years. Ankündigung • Jun 20
Amplia Therapeutics Limited, Annual General Meeting, Aug 24, 2023 Amplia Therapeutics Limited, Annual General Meeting, Aug 24, 2023. Ankündigung • May 22
Amplia Receives Grant to Collaborate with CSIRO Amplia Therapeutics Limited announced it has received grant funding to undertake a research collaboration with Australia's national science agency CSIRO to develop novel topical formulations of the Company's FAK inhibitors. Amplia will work with researchers at CSIRO to help develop formulations of its small molecule FAK inhibitors that could be applied topically (i.e. directly) to wounds and burns to aid healing and reduce scarring. Over-activity of Focal Adhesion Kinase (FAK) in fibroblast cells in wounds is believed to be responsible for laying down and cross-linking of collagen, resulting in the formation of scar tissue. Scarring limits the movement and pliability of skin as well as having cosmetic implications. The global wound healing market is estimated to be >USD 20 billion and the market for scar treatments is of similar size. The funding is being provided through Innovation Connections, a service under AusIndustry's Entrepreneurs' Programme that provided advice and grants to small and medium businesses to access knowledge and engage with researchers with specific capabilities. Ankündigung • Jan 12
Amplia Therapeutics Limited Announces Dose Escalation Approved in ACCENT Clinical Trial of AMP945 Amplia Therapeutics Limited announced that following a review of safety data collected to date, the ACCENT clinical trial's Safety Review Committee has approved dose escalation of AMP945 and recruitment of another patient cohort. The first stage of the ACCENT trial is designed to identify the most suitable dose of AMP945 to combine with gemcitabine/nab-paclitaxel chemotherapy in patients with advanced pancreatic cancer. Accordingly, ascending doses of AMP945 are given in combination with standard gemcitabine/nab- paclitaxel chemotherapy while safety, pharmacokinetics and pharmacodynamics are monitored. Dose escalation of AMP945 will continue until either a dose-limiting safety signal is identified or the pharmacodynamic effect of AMP945 reaches a plateau. The Company expects that up to four cohorts of three patients may be required to identify the most suitable dose of AMP945. Following completion of recruitment of the first cohort in late 2022, drug safety and tolerability was monitored for a minimum of one treatment cycle (28 days). The ACCENT trial's Safety Review Committee has now examined the available safety, pharmacokinetic and pharmacodynamic data and concluded that dose escalation to a further cohort is warranted.