Race Oncology Expands Clinical Programs into AML and EGFRm NSCLC - All About An Oncology Business
- Noel Ong
- Dec 5, 2025
- 6 min read
Announcement
Race Clinical Program Update 17 November 2025 (click here to view the announcement)
Race Oncology Limited (ASX: RAC) has announced the expansion of its clinical strategy with two new programs centred on Acute Myeloid Leukaemia (AML) and EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) (Figure 1).
Figure 1: EGFR-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) (source: RAC)
These programs build directly on the newly characterised mechanism of action of (E,E)-bisantrene (Figure 2) and position RC220 for accelerated clinical validation across major oncology markets.
Figure 2: The Science Behind (E,E)-bisantrene (source: RAC)
The Business of the Company: Focus – Projects
Race Oncology is a Phase 3 clinical biopharmaceutical company focused on advancing its proprietary formulation RC220, a next-generation delivery form of (E,E)-bisantrene. The company aims to address high-value oncology areas through:
Phase 3 AML bridging program to align RC110 and RC220
Phase 1a/b EGFRm NSCLC program targeting TKI resistance
Phase 1a/b RC220 + doxorubicin cardioprotection program
Pipeline expansion opportunities via MYC silencing and G4 stabilisation biology
Highlights – Expansion of Clinical Programs in AML and EGFRm NSCLC
1. New Phase 3 AML Trial: Bridging RC110 to RC220
Race has established a cost-efficient pathway to potential regulatory approval through a two-part Phase 3 design incorporating (Figure 3):
A PK/PD bridging stage to demonstrate clinical equivalence between RC110 and RC220
Biomarker generation assessing MYC gene silencing
Alignment with US FDA Project Optimus
Figure 3: Phase 3 Pathway to Approve RC220 in r/r AML (source: RAC)
2. New EGFRm NSCLC Trial Targeting TKI Resistance
A Phase 1a/b program (HARNESS-1) will evaluate RC220 + osimertinib in patients with detectable ctDNA to delay or prevent resistance (Figure 4). Key points:
All preclinical data, KOL engagement, protocols, and CRO contracts completed
Ethics submission made to Bellberry HREC (29 Sept 2025)
Five major Australian oncology sites secured
Figure 4: HARNESS-1 Phase 1a/b Trial Overview (source: RAC)
3. Cardioprotection & Solid Tumour Opportunity
Race continues its ongoing Phase 1a/b trial of RC220 in combination with doxorubicin to explore dual benefits:
Mitigation of doxorubicin cardiotoxicity
Enhanced anticancer activity
4. Program Funding & Readiness
Planning is highly advanced across all programs
Execution timing tied to conversion of $1.25 piggyback options (expiry May 2026)
Cash position: $11.3m as of 30 Sept 2025
Leadership Commentary
Race Oncology CEO and Managing Director, Dr Daniel Tillett, commented,
“It is an exciting milestone for Race Oncology to translate the mechanism of action of (E,E)-bisantrene into tangible clinical programs. The opportunity to use RC220 to delay, or even prevent, TKI resistance across a range of cancers is a compelling opportunity. The scale of the opportunity is enormous, with more than US$10 billion of EGFRm TKIs sold every year for lung cancer alone.
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 9 months.”
About the Project
While Race Oncology’s programs operate nationally, the broader portfolio reflects collaborations across leading research institutes in Australia and international cancer centres.RC220’s development leverages preclinical work conducted in partnership with institutions such as:
University of Wollongong
University of Newcastle
UNC School of Medicine
Sheba City of Health (Israel)
The Company is also actively exploring partnerships, licence agreements, or commercial mergers and acquisitions to accelerate access to RC220 for patients with cancer worldwide.
Near-term Milestones to Watch
Q1 2026: First patient recruited in HARNESS-1 Phase 1a/b NSCLC trial
2026: AML Phase 3 bridging stage initiation (pending funding)
Completion of ctDNA screening across multiple sites
Regulatory interactions and responses from Bellberry HREC
Ongoing MYC biomarker data development
Further conversion of piggyback options to support program roll-out
How Samso Understands the Investment Memo for Race Oncology
Samso’s interpretation is that Race Oncology is positioning RC220 as a highly differentiated oncology asset capable of influencing major cancer treatment markets. The Company’s focus on TKI resistance, MYC gene targeting, and biomarker-led clinical design suggests a strategy grounded in science, commercial relevance, and regulatory alignment. The dual AML and NSCLC programs collectively offer pathways that could support accelerated value creation if clinical outcomes validate the mechanism.
Samso Concluding Comments
Race Oncology’s strategic expansion arrives at a key junction for precision oncology. The industry has been grappling with therapy resistance, particularly in EGFRm NSCLC, where, despite billions in annual TKI sales, real-world outcomes remain constrained by subclone emergence and bypass signaling. RC220’s mechanistic positioning — targeting G-quadruplex structures and MYC silencing — could mark a substantial shift in how resistance biology is approached clinically.
The AML pivotal trial pathway is equally notable, leveraging regulatory precedents and orphan drug frameworks. By bridging RC110’s historical clinical data with RC220’s modern formulation under a Project Optimus-aligned design, Race is pursuing an approval strategy that is both pragmatic and scientifically grounded. This reduces uncertainty associated with dosing, variability, and historical comparator alignment.
The integration of ctDNA as a patient selection and response metric is also an important direction for modern oncology trials. It provides measurable, early indicators of therapeutic effect and allows for more efficient trial conduct. This position aims to generate data that is directly relevant to clinicians and regulators who are increasingly seeking biomarker-anchored trial designs.
Overall, Race Oncology appears to be shaping a pipeline that leverages deep molecular insight, commercially significant disease settings, and realistic pathways to regulatory approval. The next 12–24 months will be critical as these programs move from planning into execution.
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