• 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

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 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.

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 gynecological 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 authorized for release by the Board of Amplia Therapeutics.