Race Strategic Update August 2023

SYDNEY, Aug. 9, 2023 /PRNewswire/ -- Race Oncology Limited ("Race") is pleased to provide a strategic update, including an overview of revisions to corporate strategy, designed to optimise use of existing resources, while driving bisantrene's commercial partnering and collaboration potential.

Evolving the corporate strategy

Race's new strategy has been designed to maximise the inherent value of bisantrene:

Anti-cancer + cardio-protection

Race's core focus is to impact cancer outcomes and address the challenges of chemotherapeutic cardiotoxicity. Studies will leverage the unique mechanisms of bisantrene in mBC and AML, both cancer patient populations with a high unmet need, paving the way to a host of future indications.

Metastatic breast cancer (mBC) 

The mBC patient population would strongly benefit from a therapeutic approach that could provide both anti-cancer and cardio-protection by allowing more doses to be delivered with an improved safety profile.

mBC has been identified as the lead indication for bisantrene as it provides Race with the opportunity to address this clear high unmet patient need and, with around 36,000 mBC patients in the US per annum, it represents a large commercial opportunity.

Race plans to take bisantrene RC220 into a Phase 1/2 clinical trial in combination with the anthracycline doxorubicin, the most widely used chemotherapy agent in mBC. This trial will be initiated once GMP RC220 is available, and after the completion of toxicology studies, ethics submission, and regulatory approvals. The expected timeframe for trial commencement is Q3 CY 2024.

Acute myeloid leukaemia (AML) 

The AML program remains a key part of Race's strategy as there remains a need for a new therapeutic which improves on current cancer treatment options, while limiting toxicity for the ~16,000 AML patients in the US each year who are considered unfit for other treatments.

Race plans to take bisantrene into a Phase 1b/2a clinical trial where it will be investigated in combination with oral decitabine/cedazuridine in dose escalation studies, followed by a triple combination with a standard of care treatment. The initial phase will provide a transition from the original RC110 (central vein administration) formulation to RC220. The trial is planned to start in late Q4 CY 2023, with transitional phases from RC110 to RC220 in 2024.

Race believes the AML program offers significant opportunities to enter into early commercial partnerships.

Discovery

Our discovery program is designed to further elucidate both cardio-protective mechanisms of action and the findings by City of Hope that bisantrene is the most potent inhibitor of FTO. This finding is suggestive of an option to deliver targeted therapy to the right patient, identified with an overexpression of FTO.

The discovery program will:

• Continue to build knowledge around the unique MOA of bisantrene that enables reduced cardiotoxicity and related cardio-protection in combination with anthracyclines
• Help to define the individual clinical benefits of anthracenes vs anthracyclines like doxorubicin
• Enhance exploration of FTO through the City of Hope alliance
• Further pursue the FTO inhibitor discovery program with Monash University
• Provide an understanding of the MOA within the m6A pathway
• Develop a biomarker assay that can be used in clinic

New bisantrene

Activities conducted under this program are designed to strengthen intellectual property for bisantrene and to develop the next generation of bisantrene to improve patient outcomes and experience. 

This program will:

• Build upon and leverage the foundations of RC110, bringing RC220 to clinic
• Develop the next generation bisantrene to expand treatment indications, strengthen IP and enhance partnering options with potential for increasing the overall lifecycle of bisantrene

Additional follow-on indications

Race's focus on mBC and AML has led the Company to categorise other investigated indications where it has produced promising data as "follow-on indications". These disease areas include melanoma, soft tissue sarcoma, renal cell small cell carcinoma and lung cancer.

Commercialisation strategy

Race is commercially prepared and positioned to engage in international biopharma dialogues, enabling partnership opportunities. Race believes its clinical program enhances and delivers a unique commercial opportunity that can now be realised by the appropriate in-market pharmaceutical company.

Race retains a solid cash reserve. Both the AML Phase 1b/2a study and committed preclinical programs are fully funded. Race is investigating a variety of avenues for funding the mBC study due to start in late 2024. 

The Strategic Update and Strategy Deck can be downloaded here.