Race Oncology (ASX: RAC) has signed contracts with Attentive Science (USA) and Agilex Biolabs (Australia) to complete a package of Good Laboratory Practice (GLP) toxicology and safety pharmacology studies.
The studies are required to support human clinical trials of Race’s flagship bisantrene formulation for peripheral infusion, RC220.
Extensive historical and modern clinical data has been collected around the safety and efficacy of bisantrene in humans. RC220 is a patentable new formulation of bisantrene that will enable safer and more patient friendly peripheral infusions and while it contains the same active pharmaceutical ingredient (API) as previous formulations, RC220 is considered a new ‘drug product’.
All new drug products must pass a panel of toxicology and safety pharmacology preclinical studies to: (i) show that they are safe for use in humans and (ii) establish a safe starting dose for Phase I dose-escalation studies. The data for RC220 will be used in all regulatory submissions requesting approval for its use in clinical trials, including US FDA Investigational New Drug (IND) applications.
Attentive Science was chosen as the most suitable contractor for the toxicology and safety pharmacology studies. An important component of the work is quantification of the bisantrene present in various biological samples.
Agilex Biolabs, a partner of Attentive Science and Australia’s largest provider of GLP- compliant bioanalytical services, was selected to complete this important aspect. Race has previously engaged Agilex Biolabs to develop validated GLP assays that meet global regulatory standards to quantify bisantrene levels in human/patient samples from Race clinical trials.
Work will commence immediately, with final reporting expected end Q2, CY2024. The total cost is A$2.74 million, with most expenses expected to be eligible for the Australian Taxation Office (ATO) research and development (R&D) tax incentive (43.5%).
These critical studies represent a significant milestone for Race and the clinical and commercial development of RC220 by establishing bisantrene’s known safety profile in its new formulation. Attentive Science and Agilex Biolabs are impressive and complementary organisations, each specialising in the different aspects of the required work. We are confident that in executing these studies they will meet our high expectations in terms of time, cost and quality,” Race’s Executive Director, Dr Pete Smith, said.
