Amplia Therapeutics Ltd (ASX:ATX) has doubled the batch scale of anti-cancer drug candidate AMP945 during its latest manufacturing run.
The Aussie pharmaceutical company has prepared a 2-kilogram batch of the drug substance during the good manufacturing process (GMP) run, which will support toxicology studies and phase two clinical trials in pancreatic cancer and lung fibrosis in 2022.
This batch was produced on time and within budget and represents a big step up from the 1-kilogram batch that’s been manufactured under GMP conditions previously.
During the recently completed manufacturing run, the company also implemented improvements to the manufacturing process for AMP945 that will support its future clinical and commercial development.
Of note, long-term stability testing data has shown that AMP945 can be stored for periods of more than 24 months without detectable deterioration — an outcome that further supports the commercial development of the anti-cancer drug candidate.
“Exceeded initial expectations”
Speaking to the latest manufacturing run, Amplia CEO Dr John Lambert said: “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.
“As well as providing material for our near-term development programs, these improvements lay a strong foundation for the AMP945 data package that will be required for future regulatory applications and its commercial development.
The phase two clinical trial of AMP945 in patients with pancreatic cancer remains on track to commence during the current quarter.
In addition, the extended (3-month) toxicology studies required to support the phase 2 clinical trial of AMP945 in patients with fibrotic lung disease are on schedule to commence in February 2022 as previously advised.
Shares have been as much as 15.65% higher this morning to A$0.185.
Entitlement offer to fund upcoming trials
Amplia is accelerating towards its phase two clinical trials following a fully underwritten entitlement offer it completed in mid-December.
The offer raised A$6.97 million for ATX’s coffers, with roughly 38.7 million new shares issued at A$0.18.
In addition, 12.9 million options were issued in connection with the offer, bearing a A$0.28 exercise price and due to expire on December 31, 2023.
Earlier in December, Amplia also snapped up a A$2.1 million Victorian Government research and development funding facility.
The funding runway stands to accelerate the company’s work on a second drug candidate, known as AMP886.
About Amplia Therapeutics
Amplia is advancing a pipeline of focal adhesion kinase (FAK) inhibitors to tackle diseases like cancer and fibrosis.
The pharmaceutical company is working on a suite of drug candidates that combat the FAK signalling protein, which is involved in many cancer defence mechanisms that ultimately reduce the effectiveness of cancer drugs.
By creating inhibitors that disrupt the FAK protein, Amplia hopes to remove the shield that protects cancerous cells and deliver a deadly blow to diseases like pancreatic cancer.
Outside of the oncology space, Amplia’s pipeline also has the potential to combat fibrosis conditions like idiopathic pulmonary fibrosis (IPF), which affects 3 million people worldwide.
With a view to build on past clinical momentum, Amplia heads into 2022 determined to develop its lead drug candidate, AMP945, in a series of phase two clinical studies.
