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- Race Oncology (RAC) has fleshed out a three-pillar strategy for programs and activities involving its Bisantrene drug in 2021
- Under the first pillar, focused on the drug’s ability to inhibit fat mass and obesity associated protein which is understood to play a role in the proliferation of several cancers, the company intends to undertake pre-clinical studies for both melanoma and clear cell renal cell carcinoma
- The second focus is on developing Bisantrene to treat breast cancer and over the year Race Oncology will pursue an Australian Phase II trial and a European Phase IIb trial in different subtypes of the disease
- Under the third and final pillar, this quarter Race Oncology has secured in-principal support for two Phase I/II trials in acute myeloid leukaemia in Australia and Israel
- Shares have been trading 2.3 per cent lower at $3.75
Race Oncology (RAC) has fleshed out a three-pillar strategy for programs and activities involving its Bisantrene drug in 2021
Since first announcing the strategy in the November 2020 AGM, CEO Phillip Lynch and Chief Scientific Officer Dr Daniel Tillett said in a statement the company has been evaluating how best to derive the most value from Bisantrene.
“The 2021 program capitalises on Bisantrene’s significant FTO opportunity while also pursuing its differentiated chemotherapy profile. We propose that the strategy outlined today minimises risk while maximising commercial and therapeutic upside, particularly with respect to the potential we see in FTO.”
“The 2021 committed program is fully funded and will generate actionable data by year-end, so supporting an expanded 2022 clinical program thereafter.”
Pillar 1
The first pillar surrounds the drug’s ability to inhibit fat mass and obesity associated protein (FTO), which is understood to play a role in the proliferation of several cancers.
The company intends to undertake two pre-clinical studies — one to assess the use of Bisantrene as an FTO-directed treatment for melanoma and the second as a treatment for clear cell renal cell carcinoma.
Both of these preclinical studies are expected to support Phase II human trials, each scheduled to begin in Australia in 2022.
Pillar 2
The second pillar is focused on developing Bisantrene to treat breast cancer, and over the year Race Oncology will pursue a two-path clinical program.
This will include an Australian Phase II trial in patients with late-stage metastatic breast cancer. Final contracting for the trial is expected to be completed by mid-year and recruitment will begin in the second half of 2021.
The second component is a potential European Phase IIb trial in patients with anthracycline-naïve metastatic breast cancer. Race Oncology has engaged George Clinical to provide a detailed costed proposal which is expected within three months.
Pillar 3
Race Oncology’s final pillar spotlights the potential use of Bisantrene to treat acute myeloid leukaemia (AML). This quarter, the company has secured in-principal support for two Phase I/II trials in relapsed and refractory AML in Australia and Israel.
The trial in Israel has been granted ethics approval to test a combination of the drug with Clofarabine and Fludarabine and will enrol 29 patients. The first patient is expected to be treated in the second quarter of 2021 and the trial to run for up to 36 months.
The other trial will concentrate on the extramedullary form of AML and recruit up to 40 patients at 10 clinical site in Australia and New Zealand. Race Oncology is anticipating it will receive human ethics approval in the third quarter of 2021 and treat the first patient before the year’s end.
Shares have been trading 2.3 per cent lower at $3.75 at 1:27 pm AEDT.
