Amplia Therapeutics Sets Stage For Strong News Flow From Pancreatic Cancer Trial

Australian pharmaceutical company Amplia Therapeutics Ltd (ASX:ATX) is steadily 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.

Narmafotinib

Narmafotinib (AMP945) is the company’s best-in-class inhibitor of FAK and is 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.

Pancreatic cancer trial

Earlier this month, Amplia completed the recruitment of 26 patients in the Phase 2a stage of its ACCENT clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer.

Watch: Amplia Therapeutics CEO Talks To JustStocks Video About Recruitment Milestone for Phase2A Pancreatic Cancer Trial

The ACCENT trial explores the use of narmafotinib in combination with standard-of-care chemotherapy of gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer.

The Phase 1b stage of the trial, completed in November 2023, identified a 400 mg oral daily dose of narmafotinib, given in the days preceding regular chemotherapy infusion, as safe and well tolerated.

This dosing regimen is being employed in the Phase 2a trial where drug efficacy is being assessed.

Two-stage trial design

The Phase 2a trial is being conducted using the industry-standard Simon’s Two-Stage Trial design, wherein an interim analysis of efficacy is determined at a statistically defined number of patients.

In the ACCENT trial this is 26 patients.

An efficacy assessment showing six or more partial or complete responses out of the 26 patients will be sufficient to continue the trial, when an additional 24 patients will be enrolled, giving a total of 50 patients.

Interim analysis outcome in Q4 2024

Amplia CEO and MD Dr Chris Burns said: “The recruitment of our 26th patient is an important milestone for the company.

“With 26 patients enrolled, and based on experience to date, we believe that the outcome from the interim analysis will be reported around the beginning of Q4 2024.

“Imaging data for the first patients from this cohort is now being collated and efficacy signals to date mirror the positive data previously reported from the Phase 1b stage of the trial.”

The ACCENT trial is currently being conducted at 6 sites in Australia and 5 sites in South Korea.

Brief history

Amplia’s pipeline drugs were originally developed by the Cancer Therapeutics CRC (CTx), an Australian industry/academic collaboration that included leading cancer and drug discovery researchers at Australia’s top cancer research institutes.

The company was established to advance these promising drugs into clinical development and commercialisation.​

Headquartered in Melbourne, Amplia has a market capitalisation of about A$17.5 million.

It is well supported by Australian institutional shareholders including Platinum, Blueflag, Acorn Capital and Pengana Capital.

 

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