Amplia Signs Collaboration Agreement With Lilly, Evaluating Narmafotinib Plus Lilly’s Kras G12C Inhibitor, Olomorasib, in Non-small Cell Lung Cancer

HIGHLIGHTS

Melbourne, Australia, Aug. 04, 2026 (GLOBE NEWSWIRE) -- Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the “Company”), announces that it has entered into a Clinical Trial Collaboration and Supply Agreement (“CTCSA”) with Eli Lilly & Company (“Lilly”), to evaluate the combination of Amplia’s investigational FAK inhibitor, narmafotinib, with Lilly’s investigational KRAS G12C inhibitor, olomorasib. The Phase 1b/2b clinical trial will evaluate the safety and efficacy of this novel targeted therapy combination as a second line treatment in patients with advanced stage non-small cell lung cancer (NSCLC).

Under the terms of the CTCSA, Amplia will conduct the study, which is planned to begin in late 2026, at sites in Australia and the USA. Prior to signing the CTCSA, Lilly and Amplia have worked together to finalize an advanced draft clinical study protocol and will now collaborate to finalize both the protocol and other associated clinical study documents.

Dr Chris Burns, Amplia CEO and Managing Director commented, “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, Lilly’s leading KRAS G12C inhibitor currently undergoing two global Phase 3 studies in NSCLC.”

Strategic significance

The collaboration with Lilly supports and enhances Amplia’s strategy to position narmafotinib as a versatile oncology combination agent with the potential to enhance existing and investigational therapies across several high-value indications.

Scientific rationale

Approved KRAS G12C inhibitors such as sotorasib and adagrasib have advanced the treatment of KRAS G12C-mutant NSCLC and are approved for use after prior therapy. However, the clinical benefit of these drugs as single agents is frequently short-lived: response rates are modest and the majority of patients develop resistance, with reported median progression-free survival of only several months. There is therefore a clear and urgent need for strategies that deepen and prolong the benefit of KRAS G12C blockade.

This study combines the potential of Lilly’s potent and highly selective next-generation KRAS G12C inhibitor, olomorasib, with narmafotinib’s role as a suppressor of resistance mechanisms via inhibition of FAK.

This ASX announcement was approved and authorized for release by the Board of Amplia Therapeutics and Lilly.

About Amplia Therapeutics Limited

Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on X (@ampliatx) and LinkedIn.

About Narmafotinib

Narmafotinib (AMP945) is the company’s best-in-class inhibitor of FAK, a protein over-expressed in multiple cancers and a drug target gaining increasing attention for its role in solid tumors. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. Narmafotinib is currently being investigated in the ACCENT trial in advanced pancreatic cancer where it is dosed in combination with the chemotherapies gemcitabine and nab-paclitaxel (Abraxane ®) in first-line patients. The trial has achieved its desired outcome in achieving a response rate of 36%, superior to chemotherapy alone as reported for the benchmark MPACT study. A median Overall Survival (mOS) of 11.1 months has been reported along with an unprecedented complete response rate of 7.8%. A second trial (AMPLICITY) is being run at sites in Australia investigating the combination of narmafotinib with the chemotherapy mFOLFIRINOX in advanced pancreatic cancer patients, and a third trial in ovarian cancer (the PRROSE trial) is scheduled to begin recruiting later this year.

1 ASX Announcement 23 Mar 2026

2 https://www.coherentmarketinsights.com/market-insight/non-small-cell-lung-cancer-market-241