Amplia Therapeutics Ltd (ASX:ATX) has built a strong foundation for the year ahead as it advances 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.
Amplia’s drug development pipeline.
“Poised for growth in year ahead”
Looking back on the year that was in an investor newsletter, Amplia CEO and managing director Dr John Lambert said 2021 had been a transformative year for the company.
“Eighteen months ago, we were standing at the starting line for our clinical trial program, having just announced plans for our phase one clinical trial of our FAK inhibitor, AMP945.
“Today, I am proud to say that we are now poised for growth as we look to the year ahead.
“Our priorities for 2022 are clear – our goal will be to build on the solid foundations of the last 12 months and maintain this momentum as we move towards two phase-two trials in the new year.
“Our plans to initiate our first phase two clinical trial in pancreatic cancer of AMP945 in first-line pancreatic cancer patients are well underway.
“Planning for a second phase two trial of AMP945 in pulmonary fibrosis, slated to take place in the second half of the year, is also in progress.
“I look forward to sharing the progress of both of these trials and other developments with our shareholders throughout the year."
Amplia's target indications.
Targeting the shield, delivering the blow
By combatting the FAK inhibitors and targeting the shield, Amplia is able to deliver a more effective blow to diseases like cancer and fibrosis.
Some of the development opportunities linked to FAK inhibitors.
In mid-November, Amplia released results from a phase one clinical trial of AMP945.
The study commenced in October 2020 and recruited 56 health volunteers in Melbourne between 18 and 65. It concluded in May this year.
Speaking to the data at the time, Dr Lambert said: “Putting all the elements of this trial together, we are now able to declare it as a resounding success.
“Not only have we found that AMP945 has excellent pharmaceutical properties and appears to be suitable for once-daily oral dosing, we also know that it has a suitable safety profile for further development and, moreover, hits the intended target.
“Taking all this information together reinforces our confidence that we are on a solid foundation for phase two trials of AMP945 in patients with pancreatic cancer and pulmonary fibrosis.”
How an FAK inhibitor targets cancer’s defence mechanisms.
Echoing his comments, Amplia’s chief scientific officer Dr Mark Devlin said: “We are very encouraged by the way all the data is lining up as we prepare to start our first Phase 2 clinical trial of AMP945.
“Being able to observe inhibition of FAK in human volunteers is an important piece of the jigsaw.
“We have observed inhibition of FAK by AMP945 in animal models and this has been associated with anti-tumour and anti-fibrotic activity.
“Getting such clear and compelling FAK inhibition data in our Phase 1 trial is very pleasing and provides additional comfort as we start trialling AMP945 in patients.
“Furthermore, we now have an assay for monitoring the effects of AMP945 that can be used to guide dosing in our upcoming Phase 2 trials in pancreatic cancers and other fibrotic diseases.”
What’s on the cards in 2022?
Amplia has a number of key objectives in mind for the new year:
- Recruit patients for two phase-two clinical trials of its lead candidate, AMP945;
- Report early results from its pancreatic cancer and pulmonary fibrosis studies;
- Expand its clinical pipeline by progressing its AMP886 candidate into early development; and
- Continue to build momentum by hitting key development and corporate milestones.
Much of Amplia’s growth plans revolve around the upcoming phase two trials in pancreatic cancer and pulmonary fibrosis.
Upcoming trials in the new year.
The former study, set to kick off dosing in the first quarter of the new year, has been funded through the company’s latest capital raise, which brought in just under $12.4 million from a placement and entitlement offer.
Meanwhile, recruitment for Amplia’s pulmonary fibrosis trial is pencilled in for the second half of next year, while clinical design work is at an advanced stage.
The bottom line
Dr Lambert believes his company can build on its recent results and growth foundation in the year ahead.
“Our hard-working team at Amplia is primed to take the company to the next level, and there will be plenty of news to share with our supporters as we embrace our planned milestones over the next 12 months,” he concluded.