Amplia teams up with big pharma for lung cancer trial

Melbourne-based ASX listed biotech Amplia Therapeutics has secured a major collaboration with pharmaceutical goliath Eli Lilly & Company to evaluate a new combination therapy aimed at tackling non-small cell lung cancer (NSCLC).

The two companies have signed a Clinical Trial Collaboration and Supply Agreement that will see Amplia’s investigational FAK blocker drug known as “narmafotinib” trialled in combination with Eli Lilly’s late-stage KRAS G12C inhibitor, “olomorasib”.

The Phase 1b/2b clinical trial will assess the safety and efficacy of the novel combination as a second-line treatment for patients with advanced-stage NSCLC.

Under the deal Amplia will conduct the study at sites across Australia and the US. Notably, Eli Lilly will provide its olomorasib drug for the trial at no cost.

′ The combination of FAK and KRAS inhibition can lead to improved outcomes.′

While the trial is slated to begin in late 2026, the two companies will now start collaborating to finalise the clinical study protocol and other associated documents, building on an advanced draft they have already developed together.

The collaboration is a significant step for Amplia, extending the clinical reach of its lead drug beyond its established programs in pancreatic and ovarian cancer into the lucrative NSCLC market. That market is currently valued at about US$31 billion (A$44 billion) and is forecast to grow to more than US$60 billion (A$86 billion) by 2033.

The trial will specifically target a patient subset with “KRAS G12C” mutations, which the company says occurs in about 13 per cent of NSCLC patients and between 1 and 3 per cent of those with other solid tumours.

FAK is a protein inside cells that acts like a control switch for movement, survival and attachment. It sits where cells anchor to their surrounding environment and helps tell them whether to grow, move or shut down.

In many cancers, FAK becomes overactive or over-produced, helping tumour cells survive, move and spread. That has made it a target for cancer-fighting drugs such as narmafotinib.

The company says the scientific theory underpinning the trial is that the FAK activation process is a key driver of resistance to KRAS G12C inhibitors, a class of drugs that has shown promise but often only sees short-lived benefits. By combining a FAK blocker like narmafotinib with a KRAS inhibitor, the companies are hoping to overcome this resistance and deliver a more durable and effective treatment.

Lilly’s confidence in its own drug, olomorasib, is evident, with the pharma giant already advancing it in two separate global Phase 3 trials.

Amplia chief executive officer and managing director Dr Chris Burns said: “This collaboration is an exciting new stage in the clinical progression of narmafotinib. We and others have shown that the combination of FAK and KRAS inhibition can lead to improved outcomes, and we are excited to advance with this clinical study to explore the combination potential with olomorasib, Eli Lilly’s leading KRAS G12C inhibitor currently undergoing two global Phase 3 studies in NSCLC.”

The collaboration with Lilly leverages narmafotinib’s growing base of clinical evidence. Amplia says the new study builds on promising clinical data from its “ACCENT” study in pancreatic cancer, which has shown that narmafotinib doesn’t cause any further side effects when added to chemotherapy and shows a range of compelling positive outcomes across patient responses and survival.

The company’s flagship ACCENT trial which tested narmafotinib with standard-of-care chemotherapy, has already delivered impressive data including a response rate of 36 per cent, a median overall survival of 11.1 months and an unprecedented complete response rate of 7.8 per cent.

In addition to the ACCENT study, Amplia is also running a second pancreatic cancer trial known as AMPLICITY and is planning a third trial in ovarian cancer, dubbed PRROSE, which is scheduled to begin recruiting later this year.

Impressively, Amplia has already secured significant regulatory milestones in the US, with the Food and Drug Administration granting narmafotinib Orphan Drug Designation for both pancreatic cancer and idiopathic pulmonary fibrosis, in addition to a Fast Track pathway for pancreatic cancer.

Backing up its clinical ambitions, the company recently completed its first large-scale manufacturing campaign, producing 13 kilograms of narmafotinib’s active pharmaceutical ingredient.

Amplia appears to have the right people in the room to navigate the high-stakes world of drug development too. Chief executive officer Dr Burns was a co-recipient of the 2024 Prime Minister’s Prize for Innovation and was involved in discovering the now-approved drug momelotinib.

Independent non-executive director Dr Robert Peach also co-founded biotech company Receptos, which was acquired by Celgene in 2015 for a staggering US$7.8 billion (A$11.1 billion).

With its lead drug now being tested in pancreatic cancer and set to enter a trial for lung cancer with a global pharmaceutical leader, Amplia appears to be building a compelling case for narmafotinib as a versatile combination agent. The latest deal with Eli Lilly might just be a pivotal moment for the company, potentially thrusting the Melbourne biotech into a much larger and more lucrative arena.

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