Race Initiates Extramedullary AML Preclinical Study

• Race enters a collaborative preclinical research program with The University of Newcastle to support the use of Bisantrene in the treatment of extramedullary acute myeloid leukaemia (AML)
• Research designed to support the use of Bisantrene to treat this form of AML with substantial unmet clinical needs
• The work will aid the clinical progress of Bisantrene under Pillar 3 of Race’s Three Pillar strategy

Race Oncology Limited (“Race”) is pleased to announce that it has entered into a new collaborative preclinical research program with The University of Newcastle. This work will be led by the eminent cancer researcher, Associate Professor Nikki Verrills, who successfully ran Race’s preclinical breast and ovarian program (ASX announcements: 24 November 2020, 23 February 2021, 9 March 2021).

The aim of this project is to support the clinical use of Bisantrene as a novel treatment for extramedullary AML, a difficult to treat form of AML, using an extramedullary mouse model developed by A/Prof Verrills’ team. Extramedullary AML occurs when the leukaemia spreads from the bone marrow and forms solid tumours in tissues such as the skin, breast, kidney, brain, or other organs1. A 2020 prospective positron imaging trial identified that up to 22% of AML patients have extramedullary AML2.

In a recent Sheba Medical Centre Phase II clinical trial conducted in relapsed and refractory (R/R) AML patients (ASX announcement: 16 June 2020), Bisantrene was observed to be highly effective in patients with extramedullary AML, with all patients with this subtype (4/4) showing a clinical response3. Patients with extramedullary AML currently have limited treatment choices with no approved, and very limited experimental treatment options4.
Race is pursuing Bisantrene therapies targeting AML, as part of its Three Pillar strategy (ASX announcement: 30 Nov 2020). This new program could lead to AML treatments with improved safety and efficacy for patients with extramedullary AML.

In addition, this study will be used to provide supportive data for a pivotal (Phase II/III) trial of Bisantrene in extramedullary AML patients with the aim of providing a rapid path to FDA approval for Bisantrene as an orphan drug under the 505(b)(2) track. Orphan drug designation provides for seven years post approval marketing exclusivity in the USA and 10 years in the EU/UK, as well as other tax and regulatory benefits.

“This is a key project for Race using Associate Professor Verrills’ extramedullary AML mouse model. Recent clinical evidence has identified Bisantrene as an effective treatment option for patients with the difficult-to-treat extramedullary form of AML. We believe that we have identified a low-risk pathway to rapid approval of Bisantrene via this indication that offers significant upside for Race in a crowded clinical space.”

Chief Scientific Officer, Dr Daniel Tillett

This project is to start immediately with the pre-clinical results expected to be reported over the coming 12 months.

About Associate Professor Verrills

Since completing her PhD in 2005 on chemotherapy resistance in childhood leukaemia, Associate Professor Verrills was awarded a Peter Doherty Postdoctoral Fellowship from the National Health and Medical Research Council in 2006. In the same year she was the inaugural recipient of a Hunter Medical Research Foundation grant for young cancer researchers. Since then she has established an innovative research lab at the University of Newcastle studying the differences between cancer cells that respond well to drug treatments and those that do not.

Prof Verrills is currently supported by a fellowship from the Australian Research Council and project funding from the National Health and Medical Research Council. She has published over 60 journal articles with an H-index of 24.