Amplia is an ASX-listed drug development company headquartered in Melbourne, Australia. Its lead asset, narmafotinib (AMP945), a potent and selective small molecule inhibitor of FAK, is presently undergoing a phase 2 clinical trial (ACCENT) for advanced pancreatic cancer in Australia and Korea. Recent results from the ACCENT trial, evaluating narmafotinib in combination with the chemotherapies gemcitabine and nab-paclitaxel (GnP), have been reported as follows:

• Five complete responses recorded among 64 patients
• Median overall survival reached 11.1 months, representing a two-month improvement over GnP alone
• No additional safety burden was noted compared to chemotherapy alone.

Notably, narmafotinib’s potential extends beyond pancreatic cancer. Preclinical studies have demonstrated activity in ovarian and lung cancer models, including benefits when combined with KRAS inhibitors. There is strong scientific rationale to suggest that these advantages could be realised in combination with other targeted agents such as ADCs, antibodies, CAR-T therapies, and additional small molecule inhibitors.

Amplia is preparing to initiate a clinical study in patients with ovarian cancer, as well as a follow-up to the ACCENT study - a registration-enabling trial in combination with GnP.

An open IND exists for narmafotinib for a pancreatic cancer trial in the United States. In addition, narmafotinib has received Orphan Drug Designation from the US FDA for the treatment of pancreatic cancer and idiopathic pulmonary fibrosis (IPF), as well as Fast-track Designation for pancreatic cancer.

Amplia is actively seeking collaborative partnerships and co-development opportunities in solid tumour indications, with particular interest in enhancing the efficacy of targeted therapeutics, including small molecules, antibodies, ADCs, and cell therapies. We are also open to discussing regional licensing opportunities.