Race Oncology Ltd (ASX:RAC, OTC:RAONF) has unveiled two new clinical programs for its lead asset RC220, expanding into acute myeloid leukaemia (AML) and EGFR-mutated non-small cell lung cancer (NSCLC) as the company looks to progress multiple late-stage opportunities in parallel.
The initiatives build on recent discoveries around RC220’s molecular mechanism and are designed to create a streamlined regulatory path while targeting major oncology markets where treatment resistance remains a critical challenge.
New lung cancer program advances
Race has moved quickly to translate October’s discovery that (E,E)-bisantrene — the active compound in RC220 — binds DNA/RNA G-quadruplexes into a clinical opportunity for mutated epidermal growth factor receptor (EGFRm)-driven NSCLC, a segment dominated by third-generation tyrosine kinase inhibitors (TKIs) such as AstraZeneca’s Tagrisso, which generated US$6.6 billion in sales last year.
While TKIs are effective, resistance is considered inevitable, often leaving patients with limited alternatives. Preclinical research conducted by Race indicates that RC220 may delay or prevent this resistance, creating a potential combination strategy aimed at prolonging TKI benefit.
Planning for the new NSCLC trial is well advanced. Key opinion leaders, principal investigators and five major clinical sites across Sydney, Melbourne and Brisbane have already been engaged and recruited, with clinical research organisation (CRO) contracts finalised. The full protocol was submitted to the Bellberry Human Research Ethics Committee on September 29, with Race lodging responses to follow-up queries on November 10.
Phase 3 AML pathway identified
Race has also outlined a rapid, lower-cost path towards potential regulatory approval in relapsed or refractory AML. A bridging and dose-optimisation stage will be used to demonstrate pharmacokinetic and pharmacodynamic equivalence between RC220 and the earlier RC110 formulation, while meeting US Food and Drug Administration requirements for Project Optimus.
This stage is expected to generate additional in vivo biomarker data, including MYC gene-silencing effects, and will support a future investigator-sponsored Phase 1b/2 trial to determine optimal combinations with standard-of-care AML treatments.
Cardioprotection program continues
The company reaffirmed its ongoing clinical focus on RC220 in combination with doxorubicin, aimed at providing both cardioprotection and enhanced anticancer activity. The Phase 1a/b trial remains under way with no changes to the current design.
Funding and outlook
Race CEO Dr Daniel Tillett said the expanded clinical program reflects the company’s rapid translation of mechanistic insights into new treatment avenues.
“The opportunity to use RC220 to delay, or even prevent, TKI resistance across a range of cancers is a compelling opportunity,” Tillett said. “I want to especially thank the Race Oncology preclinical and clinical teams for their extraordinary effort in moving from the initial discovery of the mechanism of action of (E,E)-bisantrene to a full clinical trial program in lung cancer in under nine months.”
Race held $11.3 million in cash at September 30 and says all currently running programs are funded through to mid-2027. Additional expenditure on the new trials will begin once further capital is available, with piggyback option conversions (expiring May 2026) expected to be a key source of funding.
Race will host an investor webinar on Tuesday, November 18, at 1 pm AEDT to discuss the expanded clinical program in detail. To register, click here.