AMPLIA THERAPEUTICS AND AUSTRALIA NEW ZEALAND GYNAECOLOGICAL ONCOLOGY GROUP (ANZGOG) ANNOUNCE OVARIAN CANCER STUDY

Media Release – 8 May 2026

Highlights

  • Amplia and ANZGOG enter into agreement to conduct a clinical study in ovarian cancer evaluating narmafotinib in combination with standard-of-care chemotherapy
  • Ovarian cancer represents a major target for FAK inhibition therapy based on typically higher levels of FAK expression and fibrous nature of tumour
  • The study to enrol patients with high-grade serous ovarian cancer (HGSOC) who have not responded to platinum-based chemotherapy prior to surgery
  • Study focus is safety and exploring potential to improve post-surgical outcomes; biomarker collection will further characterize mechanism of action of narmafotinib

Melbourne, Australia: Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the “Company”), and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) announces 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 enrol 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.

Dr Chris Burns, CEO and Managing Director of Amplia, commented: “We are very pleased to be collaborating with ANZGOG and Dr Ho on this promising study. Based on the compelling biological rationale for the potential of FAK inhibitors in ovarian cancer, a clinical program in this indication is clearly warranted. Patients with ovarian cancer who do not respond to initial chemotherapy have very limited treatment options and this study will provide an opportunity to assess whether narmafotinib can improve outcomes for these patients. This trial also represents an important step in broadening the clinical utility of our FAK inhibitor program.”

Dr Gwo Yaw Ho, Lead Investigator, said: “This study reflects the strength of ANZGOG’s collaborative clinical trials network and its ability to bring together leading clinical investigators to address areas of high unmet need in gynaecological cancers. This trial builds on ANZGOG’s established capability to design and deliver rigorous, potentially practice-changing clinical research across Australia and New Zealand. The study is underpinned by a commitment to translating promising scientific approaches, such as Amplia’s, into well-conducted clinical trials that can generate meaningful evidence to inform future treatment options for women with ovarian cancer.”

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

Contact and Further Information

About the Australia New Zealand Gynaecological Oncology Group (ANZGOG)

ANZGOG is the peak national gynaecological cancer research organisation in Australia and New Zealand. It’s more than 1650 members work in hospitals, research institutions, universities, government, the non-profit sector, and industry. Members include surgeons, physicians, radiation oncologists, psychologists, social workers, nurses, trial coordinators, pure researchers, allied health professionals and cancer consumers who are based in all states of Australia and regions in New Zealand. ANZGOG’s vision is Advancing research, saving lives and its mission is to improve outcomes and quality of life for everyone with a lived experience of gynaecological cancer by conducting and promoting clinical trials and multidisciplinary research. For more information, visit www.anzgog.org.au and follow ANZGOG on LinkedIn.

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 www.ampliatx.com and follow Amplia on X (@ampliatx) and LinkedIn.

About Narmafotinib

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 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 – is being run under at sites in Australia investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients.

The study is an investigator-initiated clinical trial led by Dr Gwo Yaw Ho of Monash Health and Monash University.

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