Funding Hurdles Ahead as Race Oncology Expands Clinical Programs for RC220
Race Oncology has announced pivotal new clinical trials for its lead asset RC220, aiming to accelerate regulatory approval in Acute Myeloid Leukemia and tackle resistance in Non-Small Cell Lung Cancer.
- Initiation of Phase 3 AML trial bridging RC110 to RC220
- Launch of Phase 1a/b NSCLC trial targeting EGFR mutation resistance
- RC220’s novel G4-binding mechanism underpins new lung cancer strategy
- Funding linked to shareholder exercise of piggyback options
- Ongoing cardioprotection and anticancer trials with doxorubicin continue
Expanding Clinical Horizons
Race Oncology has taken a significant step forward by announcing two new clinical programs for its proprietary drug RC220, targeting two critical cancer markets – Acute Myeloid Leukemia (AML) and Non-Small Cell Lung Cancer (NSCLC). These developments mark a strategic expansion designed to leverage RC220’s unique mechanism of action and address pressing unmet needs in oncology.
The company’s Phase 3 AML trial is particularly notable for its innovative design, which includes a bridging study to establish pharmacokinetic and pharmacodynamic equivalence between the new RC220 formulation and its predecessor, RC110. This approach aims to streamline regulatory approval by satisfying the US FDA’s Project Optimus requirements, potentially accelerating patient access to this therapy.
Targeting Resistance in Lung Cancer
In NSCLC, Race Oncology is advancing a Phase 1a/b trial focused on patients with EGFR-mutated tumors, a subgroup that currently faces inevitable resistance to tyrosine kinase inhibitors (TKIs) such as AstraZeneca’s Tagrisso®. The discovery that (E,E)-bisantrene, the active compound in RC220, binds to DNA/RNA G-quadruplex structures offers a novel mechanism to delay or prevent this resistance by silencing oncogenes like MYC and inhibiting multiple resistance pathways simultaneously.
This trial, named HARNESS-1, is well advanced in planning stages, with clinical sites and research organizations engaged across Sydney, Melbourne, and Brisbane. The study will assess safety, optimal dosing, and efficacy signals, including progression-free survival and circulating tumor DNA dynamics, aiming to fill a significant gap in lung cancer treatment where resistance limits long-term outcomes.
Sustained Focus on Cardioprotection
Alongside these new initiatives, Race Oncology continues its Phase 1a/b trial investigating RC220’s cardioprotective and anticancer effects when combined with doxorubicin, a widely used chemotherapy agent. This ongoing program underscores the company’s commitment to enhancing both efficacy and safety profiles in cancer treatment.
Funding and Future Outlook
Financially, Race Oncology is positioned to support its existing trials through mid-2027, with $11.3 million in cash reserves as of September 2025. The expansion into AML and NSCLC trials will be funded primarily through the exercise of piggyback options held by shareholders, including a significant stake held by CEO Dr Daniel Tillett. Approximately 18% of these options have already been converted, signaling shareholder confidence in the company’s clinical trajectory.
Race Oncology’s CEO, Dr Daniel Tillett, highlighted the rapid progress from mechanistic discovery to clinical trial readiness in under nine months, emphasizing the potential to transform treatment paradigms for cancers with high unmet needs and substantial market opportunities.
Bottom Line?
Race Oncology’s dual trial launch sets the stage for pivotal data that could redefine treatment for AML and resistant lung cancer.
Questions in the middle?
- How quickly will Race Oncology secure full funding to commence these trials?
- What early clinical signals might emerge from the NSCLC trial regarding resistance delay?
- Could RC220’s MYC silencing mechanism unlock broader applications beyond AML and NSCLC?
