Race Oncology (ASX: RAC) has commenced a strategic collaboration with Emory University to study its lead candidate (E,E)-bisantrene (RC220) in osimertinib-resistant epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Preliminary data from the collaboration has demonstrated significant synergy between osimertinib and RC220 in the established HCC827/AR osimertinib resistance lung cancer mouse model, with p-value < 0.01.
The collaboration provides Race Oncology with access to Emory’s unique osimertinib-resistant cell and mouse models, whilst directly supporting the company’s ongoing HARNESS-1 clinical trial. Osimertinib (Tagrisso®) is the current standard of care for EGFRm NSCLC, with global sales of greater than US$7 billion in 2025 and projected to reach US$13.9 billion by 2029.
Race Oncology Partners with World-Leading Emory University to Tackle Lung Cancer Drug Resistance
The Race Oncology Emory University collaboration is led by Professor Shi-Yong Sun, the David A. Cole Family Professor and GRA Distinguished Cancer Scientist at the Winship Cancer Institute, Emory University (Atlanta, USA). Professor Sun has published extensively on the molecular mechanisms driving resistance to osimertinib in EGFRm NSCLC, establishing him as a recognised authority in the field.
His research team has deep knowledge on acquired EGFRm TKI resistance in NSCLC and has published several key papers on the critical importance of MYC, hTERT/telomerase, and topoisomerase IIα in the development of acquired osimertinib resistance. These resistance pathways are known targets of (E,E)-bisantrene, according to Race Oncology’s previous disclosure on 2 October 2025.
The collaboration aims to strengthen Race Oncology’s scientific foundation for ongoing and future discussions with key opinion leaders, regulators, and pharmaceutical partners. Additional mechanistic insights gained from the partnership are expected to support the company’s HARNESS-1 trial, which assesses RC220 in combination with osimertinib in patients with emerging therapy resistance.
Management Commentary
“Racura is very fortunate to be collaborating with Prof. Sun and his group at Emory. Their expertise is invaluable for deeply understanding the biology that explains the impressive efficacy we see when (E,E)-bisantrene is combined with osimertinib in EGFRm NSCLC,” said Professor Michael Kelso, Vice President of Research at Racura Oncology.
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What Does the Emory University Collaboration Mean for Race Oncology Shareholders?
The Emory University partnership provides several material advantages that strengthen Race Oncology’s commercial positioning and scientific credibility. The collaboration grants access to unique cell and mouse models specifically designed to study osimertinib resistance, capabilities that would be prohibitively expensive and time-consuming to develop internally.
Independent validation from a globally recognised cancer research institution significantly enhances the data package supporting RC220. Pharmaceutical partners evaluating potential licensing agreements or collaborations typically place substantial weight on third-party validation from prestigious academic centres, as it de-risks the scientific rationale and mechanism of action.
The collaboration is expected to run for more than 12 months, with data intended for publication in high-impact, peer-reviewed journals. Whilst public disclosure may be limited until publication, Race Oncology stated it will be able to share the full data package confidentially with potential pharmaceutical partners.
Key Shareholder Benefits:
- Enhanced Scientific Credibility: Independent validation from a world-leading institution strengthens regulatory submissions and pharma partnership discussions
- Clinical Trial Optimisation: Mechanistic insights can inform dosing regimens and patient selection strategies for HARNESS-1
- Accelerated Partnership Timeline: High-quality preclinical data from a recognised authority addresses key due diligence requirements for pharmaceutical partners
- Strengthened IP Position: Deeper mechanistic understanding supports potential additional patent filings around combination therapy strategies
Racura Oncology stated it is actively exploring partnerships, licence agreements, or a commercial merger to accelerate patient access to RC220. The Emory collaboration positions the company more favourably in these discussions by addressing scientific and development risk concerns that large pharmaceutical companies typically scrutinise during due diligence.
Early Data Demonstrates Significant Tumour Control in Resistant Lung Cancer
Preliminary results from the Emory collaboration showed significant synergy when RC220 was combined with osimertinib in the HCC827/AR mouse model, an established preclinical model of osimertinib-resistant EGFRm NSCLC. The combination therapy demonstrated superior efficacy compared to either agent alone, with a p-value < 0.01 indicating strong statistical significance.
The HCC827/AR model is widely used in preclinical research because it accurately replicates the resistance mechanisms observed in patients who initially respond to osimertinib but later develop progressive disease. The model provides a scientifically rigorous platform for evaluating combination strategies aimed at overcoming or delaying resistance emergence.
| Treatment Group | Tumour Response | Statistical Significance |
|---|---|---|
| Vehicle Control | Progressive growth | Baseline |
| Osimertinib Alone | Limited control | Not specified |
| RC220 Alone | Limited control | Not specified |
| RC220 + Osimertinib | Significant control | p < 0.01 |
The synergy observed in this resistance model provides strong preclinical rationale for the HARNESS-1 trial design, which aims to extend progression-free and overall survival by targeting osimertinib-resistant sub-clones soon after emergence rather than waiting for widespread treatment failure.
Professor Shi-Yong Sun stated: “I am very happy to be undertaking this collaboration with the team from Racura Oncology. Bisantrene appears to offer a unique opportunity to target osimertinib resistance sub-clones before they lead to treatment failure.”
Understanding Osimertinib Resistance in Lung Cancer
Epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer affects a specific subset of lung cancer patients whose tumours carry mutations in the EGFR gene. Osimertinib (Tagrisso®), developed by AstraZeneca, is a third-generation tyrosine kinase inhibitor that targets these mutations and is the current standard of care for this patient population.
Whilst osimertinib is effective at improving overall survival of EGFRm NSCLC patients, acquired resistance emerges in nearly all patients after a period of treatment. This resistance occurs because small populations of cancer cells develop genetic or molecular changes that allow them to survive despite continued osimertinib therapy.
Over time, these resistant sub-clones expand and eventually cause disease progression.
Research conducted by Professor Sun and others has identified three key molecular pathways that cancer cells activate to escape osimertinib:
- MYC overexpression: MYC is a protein that drives cancer cell growth and survival
- hTERT/telomerase activation: Telomerase allows cancer cells to divide indefinitely by maintaining chromosome ends
- Topoisomerase IIα upregulation: This enzyme helps cancer cells manage DNA replication stress
RC220 (E,E-bisantrene) targets all three of these resistance mechanisms through its primary mechanism of action: binding to G4-DNA and RNA structures, which leads to MYC inhibition and downstream effects on telomerase and topoisomerase IIα. The rationale for combining RC220 with osimertinib is to suppress these resistance pathways before they become dominant, potentially extending the duration of clinical benefit.
The global market opportunity is substantial. Osimertinib generated greater than US$7 billion in sales during 2025 and is projected to reach US$13.9 billion by 2029.
A combination therapy that meaningfully extends progression-free or overall survival in this patient population could capture significant market share, either through direct sales or through partnership with a major pharmaceutical company.
How Does Bisantrene Overcome Osimertinib Resistance in Lung Cancer?
RC220 (E,E-bisantrene) functions through a distinct mechanism compared to traditional chemotherapy agents. The molecule binds to G-quadruplex (G4) structures in DNA and RNA, which are specific three-dimensional formations that occur in gene regulatory regions.
By binding to these structures, RC220 disrupts the expression of genes critical for cancer cell survival and proliferation.
The primary downstream effect of G4 binding is potent inhibition of MYC, a master regulator of cancer cell growth that is frequently overexpressed in resistant tumours. MYC controls hundreds of genes involved in cell division, metabolism, and survival.
Suppressing MYC activity creates a metabolic crisis in cancer cells that have become dependent on high MYC levels to maintain their growth advantage.
Additionally, RC220’s mechanism affects two other validated resistance pathways identified in Professor Sun’s published research:
- Telomerase inhibition: By suppressing hTERT expression (the catalytic subunit of telomerase), RC220 limits cancer cells’ ability to maintain telomere length, eventually triggering cell death
- Topoisomerase IIα targeting: RC220 interferes with this enzyme’s function, preventing cancer cells from properly managing DNA replication stress
- Multi-pathway disruption: The simultaneous targeting of MYC, telomerase, and topoisomerase IIα creates multiple barriers to resistance development
This multi-pathway approach differentiates RC220 from single-target therapies that cancer cells can more easily circumvent through alternative survival mechanisms. Professor Sun’s prior publications established the critical importance of these pathways in osimertinib resistance, providing strong scientific rationale for the combination strategy being tested in HARNESS-1.
Scientific Validation
“Bisantrene appears to offer a unique opportunity to target osimertinib resistance sub-clones before they lead to treatment failure,” stated Professor Shi-Yong Sun, David A. Cole Family Professor at Emory University’s Winship Cancer Institute.
What is the HARNESS-1 Clinical Trial Targeting in EGFR Mutated NSCLC?
The HARNESS-1 trial is a Phase 1a/b clinical study evaluating the safety, tolerability, pharmacokinetics, and efficacy of RC220 in combination with osimertinib (Tagrisso®) in patients with EGFRm NSCLC who are developing resistance to osimertinib therapy. Race Oncology announced the trial on 26 November 2025.
The trial’s patient population comprises individuals whose tumours initially responded to osimertinib but are now showing signs of emerging resistance, such as slowly rising tumour markers or small increases in tumour size on imaging. This timing is crucial: rather than waiting until resistance is widespread and patients have exhausted treatment options, HARNESS-1 aims to intervene whilst resistant sub-clones are still relatively small.
Trial Design Elements:
- Phase 1a component: Dose escalation to determine optimal RC220 dosing when combined with standard osimertinib
- Phase 1b component: Expansion cohort to assess preliminary efficacy signals and further characterise safety
- Primary endpoints: Safety, tolerability, and pharmacokinetic parameters
- Secondary endpoints: Tumour response rates, progression-free survival, overall survival
The Emory collaboration directly supports HARNESS-1 by providing mechanistic insights that can inform dosing strategies and patient selection criteria. Data generated from Professor Sun’s models will help optimise the clinical programme design, potentially improving the probability of demonstrating meaningful clinical benefit.
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Strategic Pathway to Pharmaceutical Partnerships
High-quality preclinical data from a globally recognised institution addresses several key requirements that pharmaceutical partners typically evaluate when considering licensing agreements or collaborations. The Emory collaboration positions Race Oncology more favourably in these commercial discussions by providing independent scientific validation from a recognised authority in osimertinib resistance biology.
Pharmaceutical companies conducting due diligence on potential partnership opportunities scrutinise the scientific rationale, mechanism of action clarity, and development risk profile. Data generated by Professor Sun’s team provides credible answers to these questions from a source without financial stake in Race Oncology’s success, making it more persuasive than company-generated data alone.
The collaboration is expected to run for more than 12 months, with results intended for publication in high-impact, peer-reviewed journals. Race Oncology stated that whilst public disclosure may be limited until publication, the full data package will be available confidentially to potential pharmaceutical partners during partnership discussions.
What Makes This Data Package Attractive to Pharmaceutical Partners:
- Independent validation from world-leading research institution
- Mechanistic clarity explaining observed clinical synergy
- Publication-quality data meeting rigorous peer review standards
- De-risked scientific rationale for combination therapy approach
Racura Oncology confirmed it is actively exploring partnerships, licence agreements, or a commercial merger to accelerate patient access to RC220. The timing of the Emory collaboration aligns with these commercial objectives, as high-quality preclinical data strengthens the company’s negotiating position by addressing scientific questions that partners would otherwise need to investigate during their own due diligence process.
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