Race Oncology Ltd (ASX:RAC) has delivered a detailed commercial assessment of the market potential for Zantrene® as a cardio-protective agent or dual cardio-protective and anti-cancer agent in breast, endometrial and ovarian cancers.
Independent analysis suggests there is a use case for Zantrene in nearly the entire identified target patient population as a cardio-protective oncology drug if anti-cancer benefits are demonstrated.
If anti-cancer efficacy is demonstrated, sales for Zantrene could represent an overall peak commercial value of roughly US$1.7 billion in breast cancer alone within the US, and around US$3.4 billion globally.
Revenue may extend from US$5 to 8 billion annually if expansion is achieved into additional identified cancer indications and further approvals are obtained in markets outside the US.
Zantrene as a cardio-protective agent Zantrene® (bisantrene dihydrochloride) is an anthracene-based anti-cancer agent that was originally developed as a less cardiotoxic alternative to commonly used anthracycline chemotherapeutics such as doxorubicin.
Protection of heart muscle cells
Through work carried out by collaborators at the University of Newcastle, Race discovered that Zantrene protects heart muscle cells from anthracycline-induced damage while also synergising with anthracyclines to better kill breast cancer cells.
Follow-up work demonstrated that Zantrene is able to protect the hearts of mice from anthracycline-induced damage without additional chemotoxicity and myelosuppression.
Additional preclinical studies are underway in cell and animal models exploring both the mechanism of action and optimal therapeutic usage of Zantrene.
Race announced in February that it had received human ethics approval from the Hunter New England Human Research Ethics Committee (NSW, Australia) for the observational stage of a planned Phase 1/2b clinical trial of Zantrene in breast cancer patients receiving doxorubicin and cyclophosphamide who have two or more cardiovascular risk factors.
Details of the trial design and intent were outlined in December, while key supportive contracts for the study were announced in March.
Triangle Insights research
Blinded primary market research, commissioned by Race and conducted by Triangle Insights, involved consolidating US epidemiology data to characterise relevant patient segments and associated anthracycline use. The strong clinical efficacy and survival benefit of anthracyclines was noted to have driven widespread and regular use across a variety of different tumour types.
Given cardiotoxicity associated with anthracycline use remains the largest single concern for oncologists, the research noted there is a large unmet need for cardio-protection or extra survival benefits.
Discussions with oncologists suggested Zantrene may be widely adopted for nearly the entire identified breast cancer target populations if anti-cancer benefits are demonstrated.
According to oncologists, Zantrene may be broadly leveraged as a cardio-protective therapy in the absence of anti-cancer data, assuming no impact on the anti-cancer effect of the underlying anthracycline regimen.
Cardio-protection market
CEO and managing director Damian Clarke-Bruce said: “It is pleasing to now be able to share this complete research report to further illustrate what the cardio-protection market potential may look like.
“This has been defined with three unique clinical scenarios, where Zantrene has demonstrated pre-clinical and historically, early phase therapeutic outcomes.
“Our thanks go to the Triangle team for taking the time to provide the additional colour on this important piece of research.
“It is clear that anthracycline-associated cardiotoxicity remains a major concern for oncologists, and one which can impact the physician’s approach to dosing, sequencing and overall treatment regime.
“We hope that our clinical program will be able to provide a therapeutic option to enable optimal treatment outcomes for cancer patients globally, receiving anthracycline therapy.”