24 February 2022
Adelaide, Australia- Aucentra Therapeutics is pleased to announce that it has received regulatory approval to progress to a Phase 1a/b clinical trial of Auceliciclib (AU3-14) in combination with Temozolomide for recurrent/refractory GBM patients. Aucentra’s first-in-human clinical trial commenced in June 2021 and is currently enrolling participants at cohort 4 across three sites in Australia with the primary objective of evaluating the safety and tolerability of Auceliciclib as a monotherapy in patients with advanced solid tumours.
To date, the ongoing Phase 1a monotherapy arm has shown Auceliciclib to be well tolerated and safe at dose levels up to cohort 4 when administered orally once daily for 21 days per cycle. Based on the encouraging results, Aucentra obtained regulatory approval on 15th February 2022 to concurrently conduct a GBM patient arm, which involves dose escalation as a combination therapy of Auceliciclib together with standard of care Temozolomide therapy for relapsed and refractory GBM patients. This combination therapy escalation arm will then expand at the recommended Phase 2 dose level and further evaluate the potential efficacy of Auceliciclib in improving patient outcomes for this difficult to treat disease. The approval to proceed to the combination arm is based on the encouraging preliminary safety data from the monotherapy Phase 1a arm, and on the supporting preclinical data, which has revealed synergistic efficacy when used in combination with Temozolomide. This clinical trial has been designed specifically to provide an alternative treatment option for GBM patients where there is a large unmet need due to limited treatment options for this aggressive disease.
Aucentra would like to express sincere gratitude to the Principal Investigators at our clinical trial sites in Australia, Dr Ganessan Kichenadasse, Dr Hui Gan and Dr Adam Cooper who have supported us in achieving this significant milestone. Aucentra also recognises the contribution of the key team members Professor Shudong Wang, Dr Paul Wabnitz, Dr Jasmine Karanjia and Ms Charmaine Symons who have been instrumental in the conceptualization, design and successful execution of this trial. Aucentra would like to acknowledge Seed-Start funding from the Government of South Australia, Department for Innovation and Skills that supports the GBM component of this trial.