Amplia Therapeutics (ASX: ATX) is a step closer to phase 2 clinical trials in pancreatic cancer and lung fibrosis after completing a manufacturing run of its lead focal adhesion kinase (FAK) inhibitor drug AMP945.
The company’s contractor has completed a 2 kilogram good manufacturing practice (GMP) run of AMP945 within budget and on time.
Amplia noted the previous batch size was 1kg – meaning the manufacturing scale has been doubled, while adhering to GMP conditions.
“The successful doubling of our manufacturing capacity for clinical-grade AMP945 and the implementation of manufacturing improvements are outstanding outcomes, which have exceeded our initial expectations,” Amplia chief executive officer Dr John Lambert said.
“As well as providing material for our near-term development programs, these improvements lay a strong foundation for the APM945 data package that will be required for future regulatory applications and its commercial development,” he added.
According to Amplia, FAK is involved in many cancer defence mechanisms that reduce the impact of anti-cancer treatments.
High FAK levels in cancers are typically associated with poor outcomes.
Amplia developed AMP945, which is a FAK inhibitor to disrupt cancer defences and make the disease more responsive to chemotherapy and other drug treatments.
Phase 2 trials to begin this quarter
Amplia will use AMP945 in its phase 2 clinical trial to treat patients with pancreatic cancer. The trial is due to begin in the current quarter.
In this upcoming trial, AMP945 will be combined with chemotherapy agents – gemcitabine and Abraxane. Gemcitabine and Abraxane are the current standard of care in newly diagnosed pancreatic cancer patients.
Pancreatic cancer is one of the deadliest malignancies and has a 5-10% five year survival rate.
In addition to the pancreatic cancer trial, Amplia will also begin a AMP945 study in patients with fibrotic lung disease.
The company will begin the extended three-month toxicology studies next month, which will be used to support the trial.