Race Oncology Secures Breakthrough Composition of Matter IP for Bisantrene - An Anti-Cancer Story.
- Noel Ong
- Oct 3
- 6 min read
Announcement
Race Oncology Limited (ASX: RAC) has announced a major scientific breakthrough that could reshape its commercial and clinical trajectory. The Company has discovered that bisantrene – a clinically validated cancer drug – exists as three photoisomers, with only the (E,E)—bisantrene form possessing significant anticancer activity. This discovery has enabled Race to file three new patent applications, potentially providing composition of matter intellectual property (IP) protection until 2045—a highly valuable milestone for a company advancing toward pivotal Phase 3 trials.
Race Oncology CEO and Managing Director, Dr Daniel Tillett, commented:
“Being able to generate new composition of matter IP covering the active isomer of bisantrene fundamentally changes the commercial prospects of Race Oncology. We now expect to have 20 years of the strongest IP protection possible for the RC220 and RC110 formulations containing (E,E)-bisantrene. These discoveries highlight the commercial value of undertaking new preclinical research on clinically established pharmaceutical assets. I congratulate the entire Race preclinical team for their inspiration and extraordinary efforts in making this fundamental discovery and turning science into a valuable outcome for all our investors.” To avoid confusion in future announcements, the historical bisantrene isomer mixture developed by Lederle Laboratories will be referenced as ‘bisantrene’, while the all-trans isomer developed by Race will be referenced as either ‘(E,E)-bisantrene’ or by the code ‘RCDS1’.
Key Highlights - An Anti-Cancer Drug Story
Breakthrough Discovery: Bisantrene identified as a mixture of three photoisomers—(E,E), (E,Z), and (Z,Z)—which rapidly interconvert upon exposure to light (Figure 1). Only the (E,E) form has strong anticancer activity.
Controlled Manufacturing: Race has developed proprietary manufacturing and handling processes to ensure controlled infusion of pure (E,E)-bisantrene into patients.
Three Patent Filings: Filed on 12 September 2025, covering the chemical structure, manufacturing, formulation, storage, and uses of (E,E)-bisantrene. If granted, these patents extend protection until 2045, resetting the patent clock and strengthening commercial leverage for RC110 and RC220 formulations.
Clinical Relevance: All Race-sponsored trials to date—including two Phase 2 AML trials and the current Phase 1 solid tumour cardioprotection study—have exclusively used pure (E,E)-bisantrene. This ensures clinical consistency and removes dosing variability present in historical trials.
Commercial Impact: Strong IP position now opens pathways for pharma partnering, licensing, and progression of RC110 into a pivotal Phase 3 trial without compromising RC220’s value proposition.
Figure 1: Interconversion between the different bisantrene isomers by visible light or heat (source: RAC)
Background
1. Composition of Matter IP
Composition of matter patents are the strongest form of pharmaceutical intellectual property, protecting the chemical structure of a drug’s active ingredient (API). They grant at least 20 years of exclusivity, regardless of how the compound is made, formulated, or used, making them the most valuable patents for new drug products.
2. Isomers
Isomers are molecules with the same chemical formula but different three-dimensional arrangements of atoms, leading to distinct chemical, physical, and biological properties. They can be structural isomers (different bonding patterns) or stereoisomers (same bonds, different spatial arrangement). For molecules with double bonds (Figure 2), two forms exist: cis (atoms on the same side) and trans (atoms on opposite sides).
Figure 2: Example of double bond isomers: cis-1,2-difluoroethene (left) & trans-1,2-difluoroethene (right). (source: RAC)
Why This Matters
Composition of matter patents are the gold standard of pharmaceutical IP, offering the strongest form of exclusivity for new drugs (Figure 3). This discovery provides Race with:
Extended Exclusivity: Up to 20 years of patent protection, with potential extensions in key jurisdictions such as the USA.
Barrier to Generics: Prevents approval of any generic formulations with unknown levels of active API.
Improved Dosing Consistency: Ensures that patients receive only the active isomer, minimizing variability and optimizing safety.
Enhanced Deal-Making Position: Strengthens Race’s negotiating power with potential partners and acquirers, as long patent life is highly prized by the industry.
Figure 3: Examples of single-isomer drug patents – Lipitor®, Plavix®, Nexium® (source: RAC)
Samso Concluding Comments
Race Oncology’s announcement is how science and commercial strategy intersect in the biopharma sector. By isolating and patenting the (E,E)-bisantrene isomer, the Company has effectively reset its patent clock and built a powerful moat around its core asset. For investors, this provides confidence that Race’s key formulations – RC110 and RC220 – can be developed and commercialised without the looming risk of generic competition.
From a clinical development perspective, the ability to deliver a consistent and pure active drug addresses one of the lingering questions from historical bisantrene data. This could improve the predictability of patient outcomes, a factor that regulators and pharma partners alike will view favourably.
Commercially, this move strengthens Race’s hand in any future negotiations, whether for licensing, co-development partnerships, or even an outright acquisition. A composition of matter patent that stretches out to 2045 is the kind of asset that can transform a small-cap biotech into a globally relevant player.
As always, this is a reminder that the pathway for companies like RAC from discovery to shareholder value is never a simple journey. Patents, trials, and partnering discussions take time, but this announcement marks a major milestone. For long-term investors, it may be worth watching how quickly Race leverages this IP win into strategic deals that bring RC110 and RC220 closer to market. This is a long-term investment scenario.
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