Amplia Therapeutics Ltd (ASX:ATX) achieved multiple clinical and manufacturing milestones during the December quarter, setting the company up for a busy 2022 with Phase 2 clinical trials for AMP945 beginning imminently.
Amplia is developing new approaches for the treatment of cancer and fibrosis, engaged in progressing a pipeline of small molecule, focal adhesion kinase (FAK) inhibitor drugs which are becoming increasingly important in the field of cancer immunology.
2022 to be “watershed year”
“While 2021 was a challenging year for everyone, I am extremely proud of what our team at Amplia has been able to achieve,” Amplia Therapeutics CEO and managing director Dr John Lambert said.
“In the last quarter of 2021, we put in place all the elements to make 2022 a watershed year for the company.
“We have a robust package of data supporting our strategy as we initiate the first Phase 2 trials for AMP945 and we have successfully completed a 2-kilogram Good Manufacturing Practice (GMP) manufacturing run of AMP945 which provides sufficient drug material to complete two 3-month animal toxicology studies as well as take us deep into two Phase 2 clinical trials.
“And finally, through the much-appreciated support of our shareholders, we have raised the capital to support these important activities.”
Key quarter highlights
In October 2021 Amplia appointed pharmaceutical veteran José Iglesias MD to serve the company as an oncology clinical advisor, bringing extensive drug development experience – especially in pancreatic cancer – to the table.
Read: Amplia Therapeutics appoints pharmaceutical veteran as clinical advisor
In November, Amplia used supplementary data from a Phase 1 clinical trial to confirm the ability of AMP945 to inhibit its intended target (FAK) in the tissues of human subjects even when administered orally.
Read: Amplia Therapeutics' new data reveals inhibition of Focal Adhesion Kinase in humans
December marked the second jump in Amplia’s cash reserves, reported at A$16.2 million as of the end of December, generated from a successful placement of A$12.4 million and a research and development tax incentive from the Australian government.
By January 2022, the therapeutics company had doubled the batch scale of its GMP manufacturing run for AMP945, synthesising two kilograms of drug substance to support toxicology studies and phase two clinical trials in pancreatic cancer and lung fibrosis in 2022.
Read: Amplia Therapeutics completes AMP945 manufacturing run ahead of phase two clinical trials
Future activities
Amplia’s primary focus for 2022 will be on initiating Phase 2 clinical trials in pancreatic cancer and, in the second half of the year, lung fibrosis.
Clearance for these trials has not yet been secured and the Omicron-strain outbreak is having a significant impact on the resources and focus of the healthcare system.
In view of this, Amplia believes that it is likely that the initiation of recruitment for this trial may be delayed until early in the June quarter.
The company is continuing to refine the design of the Phase 2 clinical trial of AMP945 in lung fibrosis and, during the March quarter, Amplia will initiate two longer-term (3-month) animal toxicology studies to support the extended dosing of AMP945 that will be used in this clinical trial.
The company is also undertaking further non-clinical studies evaluating clinical opportunities for AMP886, Amplia’s second FAK inhibitor.