Race Oncology races ahead in FY24 with key milestones

• Race Oncology hails significant FY24 with several key milestones achieved
• First batch of (cGMP) manufacturing and toxicology study successfully completed for Race’s new bisantrene formulation RC220
• Preclinical work in the past year has demonstrated the drug’s potent cancer killing effect

Special Report: Race Oncology said FY24 has been momentous for the company, which has made significant strides toward advancing its new bisantrene formulation RC220 into human clinical trials.

Race Oncology (ASX:RAC) has released its FY24 annual report and said progress included key milestones such as completing manufacturing, conducting toxicology and safety pharmacology studies, and appointing George Clinical International as its contract research organisation.

Additionally, RAC released a strong set of preclinical results demonstrating the anticancer and cardioprotective effects of bisantrene, both as a standalone treatment and in combination with existing thearaputics.

Bisantrene is an anthracene-based chemotherapy drug originally developed in the 1970s in France, which is known to reduce cardiotoxicity when used with anthracyclines.

Despite bisantrene’s efficacy in treating acute myeloid leukaemia (AML) in France, complex administration of the drug limited its success.

However, RAC has been able to overcome the administration obstacles and reformulated Bisantrene for easy infusion and is now exploring its anti-cancer and cardio-protective benefits.

Positive preclinical results

While RC220 bisantrene is being prepared for clinical studies in her annual report, Race Chair Mary Harney said impressive preclinical results have reinforced that the company has a unique drug asset in bisantrene, owing to its anticancer and cardioprotective properties.

“Preclinical work performed at Oncolines BV yielded results that showed bisantrene’s potent cancer-killing activity in 113 out of 143 human cancer cell lines, representing a broad cross-section of the most common haematological (blood/liquid) and solid organ cancers—an impressive outcome,” she said.

“When used in combination, bisantrene enhanced the cancer-killing activities of doxorubicin, an anthracycline chemotherapeutic, and one of the most widely used anticancer drugs, with more than 20 million doses provided to patients worldwide each year.”

She said further preclinical work with Oncolines BV, based in the Netherlands, demonstrated that bisantrene, when combined with decitabine, displayed enhanced cancer-killing activity across a broad panel of 143 cancer cell lines, representative of solid and blood cancers originating from more than 20 different human tissues.

Harney said preclinical work performed by Labcorp demonstrated that bisantrene, as a single-agent treatment, was effective against human multiple myeloma in a mouse model.

She said importantly the result supported further evaluation of bisantrene in combination with carfilzomib as a potentially more effective treatment for multiple myeloma.

Progress toward first human trial

The first planned Phase 1a/1b trial of RC220 is an ‘all-comers’ Bayesian dose escalation study in solid tumour patients where doxorubicin use is indicated as standard of care.

With support of its manufacturing partner and contract development and manufacturing organisation (CDMO) Ardena Holding NV, RAC completed its first current Good Manufacturing Practice (cGMP) batch of RC220.

The milestone showed that RC220 met the quality specifications required for intravenous drug product use in humans.

Additionally, Harney said working alongside its partners Attentive Science and Agilex Biolabs, RAC completed Good Laboratory Practice (GLP) toxicology and safety pharmacology studies on time and on budget.

“This program included valuable dose-finding data that will support regulatory and ethics submissions for the evaluation of RC220 bisantrene in human clinical trials,” she said.

The company appointed George Clinical as its clinical research organisation (CRO) to support the upcoming Phase 1a/1b trial of RC220 bisantrene, providing access to a supplementary network of key opinion leaders in clinical oncology.

AML trial meets endpoints

After the reporting period, RAC announced that the RC110 bisantrene Phase 1b/2 trial, had concluded successfully after meeting its endpoints.

The investigator-sponsored study was led by Professor Arnon Nagler at the Chaim Sheba Medical Centre in Israel.

Results showed that six of the 15 evaluable patients (40%) with relapsed or refractory AML in the Phase 2 efficacy stage responded to RC110 bisantrene in combination with clofarabine and fludarabine. There were five complete responses and one partial response.

“Although the study focused on the original RC110 formulation, the results have sparked further clinician interest in advancing the drug in new AML trials,” Harney said.

RAC is discussing plans with an Australian investigator in the AML field.

Highly skilled and knowledgeable team

Harney said RAC has a highly skilled and knowledgeable team that brings a diverse range of expertise to the company and continues to attract leading professionals in the field.

In November 2023, RAC announced its chief scientific officer and executive director Dr Daniel Tillett had been appointed CEO.

Further to his extensive experience with RAC and development of bisantrene, Tillett has more than 25 years’ experience in the biotech industry.

He is also the founder and CEO of Nucleics, an Australian biotechnology company focused on DNA sequencing and genomics.

Harney said the company has also garnered strong support from shareholders, which was displayed through its bonus options offer, which raised around 84% of its target.  The RAC share price is up ~93% YTD.

“This was an excellent result and gave us the confidence to proceed with the next investigator-sponsored trial in AML,” she said.

At the end of FY24, RAC held $17.19m in cash and cash equivalents, compared to $21.52 million at the end of FY23.

Harney said the changing balance was from the funding of RAC’s program, a significant manufacturing campaign, and ongoing operations.

She said the company was well-capitalised to complete its planned studies.

This article was developed in collaboration with Race Oncology,  a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.