Race Oncology Limited (ASX: RAC)
Race Oncology Limited (ASX: RAC) recently made significant progress with their RC220 bisantrene formulation. On December 5, 2024, they announced the submission of their human ethics and regulatory package to the Bellberry Human Research Ethics Committee (HREC) for approval to begin a Phase 1 clinical trial for RC220 in solid tumour patients. The trial, to be conducted at the Southside Cancer Care Centre in New South Wales, will study RC220 both alone and in combination with the chemotherapy drug doxorubicin. Recruitment is expected to start in Q1 2025, with additional trial sites planned for Hong Kong, South Korea, and other locations. The trial will assess the safety, tolerability, and optimal dosage of RC220, with potential for future Phase 2 studies in multiple regions.
The RC220 Phase 1 trial will be conducted in two stages. Stage 1 will focus on determining the safety and tolerability of increasing doses of RC220 alone and with doxorubicin. The goal is to find the maximum tolerated combination dose, examine RC220’s pharmacokinetics, and explore its effects on biomarkers and cardiovascular health. Stage 2 will treat patients with solid tumours who have not previously received doxorubicin, using the optimal dose determined in Stage 1. This study will gather more data on the safety, efficacy, and cardioprotective effects of RC220, which could lead to larger international studies in the future.
In addition to preparing RC220 for clinical trials, Race Oncology has made substantial strides in preclinical research. Their work showed that bisantrene, the active component of RC220, has potent cancer-killing activity in a wide range of human cancer cell lines. When used with doxorubicin, bisantrene enhances the drug’s effectiveness. Preclinical studies also demonstrated its potential in treating multiple myeloma, both as a standalone treatment and in combination with other drugs. Moreover, a Phase 1b/2 trial in acute myeloid leukaemia (AML) showed promising results with a 40% response rate in patients treated with RC110 bisantrene.
Race Oncology has made impressive progress with RC220, completing necessary toxicology studies and selecting a contract research organization to support their upcoming trials. The company’s achievements also include securing manufacturing at GMP standards and ensuring the ability to submit data to support an Investigational New Drug application in the U.S. Although Race’s cash reserves declined slightly from $21.52 million in FY2023 to $17.19 million in FY2024, they remain well-positioned for future developments. The company continues to focus on advancing RC220’s clinical program, with the aim of addressing the significant health problem caused by chemotherapy-related accelerated aging and cardiotoxicity, while also tapping into the large market of anthracycline-based treatments.
Source: Company’s Report
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