In a half-yearly update, Race Oncology Ltd (ASX:RAC) has outlined significant progress on its preclinical and clinical programs around its Phase 2/3 cancer drug, bisantrene, both in Australia and internationally.
During the half-year, the company has made advancements in the manufacturing of RC220, its new intravenous formulation of bisantrene.
The development of RC220 has presented therapeutic advantages related to the ease and safety of peripheral IV administration, thereby positioning it as a strong choice for multi-centre clinical studies.
The company's preclinical programs are making substantial strides, which include the cardioprotection program headed by Dr Brian Jensen, a cardio-oncologist at the University of North Carolina, USA, and in-house studies at the University of Wollongong.
Meanwhile, ongoing clinical programs include a Phase 2 AML clinical trial at Chaim Sheba, Israel, and a Phase 1b/2a clinical trial of bisantrene in AML and MDS patients with extramedullary disease.
Race has opted to shift the focus of its strategy towards its novel patent-protected formulation, RC220, which offers clear therapeutic advantages related to ease and safety of peripheral IV administration.
Manufacturing of RC220: a key advance in Oncology
The manufacture of RC220, Race's novel intravenous (IV) formulation of bisantrene suitable for administration into a peripheral vein, is advancing well, with an engineering batch completed in May.
The company anticipates receiving RC220 material from the engineering batch in the September quarter, which will be used in upcoming Good Laboratory Practice (GLP) safety pharmacology and toxicology studies as necessitated by regulatory authorities for clinical trial conduct.
The company has partnered with a newly selected European Contract Development and Manufacturing Organisation (CDMO) for the Good Manufacturing Practice (GMP) production of RC220, marking a milestone in ensuring the provision of quality drug products for future Phase 1/2 clinical trials across Australia, the US, and Europe.
Securing future supply of bisantrene
Race's bisantrene manufacturer, Laurus Laboratories, has delivered a significant project that boosts the value of the company's active pharmaceutical ingredient (API).
The optimisation of the process chemistry by Laurus has produced a substantial amount of bisantrene dihydrochloride API material that meets GMP standards, securing sufficient drugs to supply Race's projected preclinical and clinical programs.
Transition to RC220: a strategy focused on patient safety
Race has decided to cease the manufacturing of RC110, a bisantrene formulation that requires central venous access for administration due to its damaging effect on smaller peripheral veins.
The company will now focus its development efforts on the peripheral IV administered bisantrene formulation RC220, which offers clear therapeutic advantages related to the ease and safety of peripheral IV administration.
The new formulation, RC220, presents a more patient-centric approach with its superior and simplified route of administration.
This allows for increased recruitment for clinical trials, as peripheral IV dosing is increasingly standard in breast cancer and other solid tumour settings.
Moreover, the new RC220 formulation enhances bisantrene's franchise value by generating robust, novel intellectual property (IP) with associated claims.
Cardioprotection: a preclinical program moving forward
The company's preclinical program studying the cardioprotective properties of bisantrene, led by cardio-oncologist Dr Brian Jensen at the University of North Carolina, USA, is progressing well, with results expected in the September quarter.
This work, combined with in-house preclinical studies at the University of Wollongong, is building a comprehensive understanding of bisantrene's cardioprotective properties, anticipated to be published in conference proceedings and peer-reviewed journals over the coming year.
Exploring bisantrene's effect on multiple cancer cells
Studies commissioned at Oncolines (Netherlands) reveal bisantrene's potent cell-killing activity across a variety of human cancer types/indications.
These findings have prompted additional studies combining bisantrene with select cancer drugs in priority indications, with results expected to be disseminated following IP review and protection.
Updates from clinical trials
The Phase 2 AML clinical trial at Chaim Sheba, Israel, which applies the central venous administered bisantrene formulation RC110, is proceeding as planned under the guidance of principal investigator Professor Arnon Nagler.
The trial has recruited 20 heavily pre-treated patients with relapsed and refractory AML, requiring only two more patients to reach the first stage of the Simon two-stage decision point.
As Race transitions from RC110 to RC220, the final two patients will be recruited, and outcomes will be reported in the coming months.
Race also revealed changes to the BISECT (RAC-006) Phase 1b/2a clinical trial of bisantrene in AML and MDS patients with extramedullary disease
After extensive consultation, the company will amend the RAC-006 protocol to include a broader subset of AML patients, with an anticipated increase in recruitment and potential expansion of the commercial opportunity.
Meanwhile, the RAC-008 Phase, 1b/2 cardio-protection trial in breast cancer patients, remains on track.
However, the company has decided to terminate its non-interventional AC therapy protocol after further diligence and consultation with international experts. Race will reallocate the related capital to RC220-led programs.
Race's strategic focus on RC220 across clinical programs aims to deliver significant value for shareholders and is backed by data analysis and consultation with international experts. The company looks forward to sharing further information on all program elements in the coming strategic update.