Race Oncology completes cGMP manufacturing for bisantrene formulation RC220

Race Oncology Limited (ASX: $RAC) has achieved a significant milestone with the completion of the current Good Manufacturing Practice (cGMP) manufacturing for its proprietary bisantrene formulation, RC220. The Certificate of Analysis (CoA) issued by Ardena confirms that RC220 meets the quality specifications required for human use, marking a major step forward in the progress of RC220 for use in human clinical trials.

Executive Commentary on RC220 Development

CEO, Dr Daniel Tillett comments, 'Reaching this point in the development of bisantrene is a major milestone and accomplishment. It is a testament to the dedication and skill of the Race team that we were able to accomplish what Lederle could not. I, along with the entire team at Race, are looking forward to completing the GLP toxicology testing of RC220 in the coming months and beginning the clinical program that will give patients access to bisantrene in a format that is both easier and safer to use.' CMO, Dr Michelle Rashford comments, 'This is a major milestone to have reached and means we have manufactured RC220 to a standard suitable to start our Phase 1 clinical trial here in Australia.'

Summary of RC220 Development and Future Outlook

Race Oncology has successfully completed the cGMP manufacturing for its bisantrene formulation, RC220, meeting the quality specifications required for human use. The company's CEO, Dr Daniel Tillett, emphasized the significance of this achievement and expressed optimism about the upcoming GLP toxicology testing and the commencement of the clinical program. With 2600 vials of RC220 manufactured, the company is well-positioned to meet the requirements of all planned human clinical trials over the next several years. The completion of GLP toxicology and safety pharmacology studies is on track for late Q2 CY2024, paving the way for human clinical trials to commence in H2 2024. Race Oncology's dedication to addressing unmet needs in cancer care through the development of RC220 underscores its commitment to advancing innovative treatment options for patients with cancer.