HIGHLIGHTS
- Amplia has executed a Clinical Trial Collaboration & Supply Agreement (CTCSA) with Eli Lilly & Company, to evaluate the Company’s investigational FAK inhibitor narmafotinib in combination with Lilly’s late‑stage investigational next generation KRAS inhibitor olomorasib
- The collaboration is underpinned by narmafotinib’s growing base of clinical evidence and a strong scientific rationale that FAK activation is a key driver of resistance to KRAS G12C inhibitors
- The collaboration further extends narmafotinib beyond pancreatic and ovarian cancer into NSCLC, broadening Amplia’s clinical footprint and addressable opportunity
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.
- Leverages narmafotinib’s growing clinical evidence base. This study builds on the promising clinical data from Amplia’s ACCENT study, which has shown that narmafotinib has no significant tolerability burden over chemotherapy alone, together with a range of compelling efficacy signals across responses and survival1.
- Expansion into major new indication. The study extends narmafotinib’s clinical development from pancreatic cancer into NSCLC, materially broadening Amplia’s addressable opportunity. The NSCLC market is currently valued at approx. US$31 B and estimated to grow to over US$60 B by 20332. KRAS G12C mutations occur in 13% of patients with NSCLC and 1-3% of patients with other solid tumors.
- Capital-efficient growth and enhanced clinical strategy. Lilly’s in-kind supply of olomorasib gives Amplia the ability to efficiently pursue this new program in a high-value indication.
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.
- Next generation KRAS G12C inhibitor. In studies to date, olomorasib has demonstrated an efficacy and safety profile that has supported later stage clinical development, with Lilly now advancing olomorasib in two separate, global Phase 3 registrational trials.
- FAK as a central mediator of resistance to KRAS G12C. A growing body of preclinical and translational research has identified Focal Adhesion Kinase (FAK) as a central mediator of adaptive resistance to KRAS G12C inhibition. This adaptive FAK activation supports tumor cell survival and proliferation, driving resistance through several interconnected mechanisms including FAK-YAP signaling, along with FAK-driven fibrogenesis and remodeling of the tumor microenvironment.
This ASX announcement was approved and authorized for release by the Board of Amplia Therapeutics and Lilly.
| Investor Contact: Dr Chris Burns Chief Executive Officer chris@ampliatx.com U.S. Contact: |
Media Contact: H^CK Director, Haley Chartres haley@hck.digital +61 411 235 692 U.S. Media: |
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
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