14 November 2019 – Race Oncology Limited (ASX: RAC) today revealed its new “5 Path” clinical strategy for its cancer drug, Bisantrene.
The strategy defines five paths for the clinical development of Bisantrene that greatly expands the addressable market for Bisantrene while reducing clinical development risk and targeting cancers beyond Acute Myeloid Leukaemia (AML). The new strategy builds on the value embedded in Bisantrene from its use in more than 40 prior human trials across a range of cancers.
Race Oncology will continue to prioritise the use of Bisantrene in treating AML, but will seek to introduce the drug earlier in the treatment pathway with the aim of improving patient survival and increasing Bisantrene’s commercial potential.
“Recent changes in the medical understanding of AML has opened up an exciting opportunity to use Bisantrene earlier in AML treatment to improve patient outcomes,” said Race’s new Chief Scientific Officer, Dr Daniel Tillett. “The residual cancer often left after chemotherapy – referred to as measurable residual disease or MRD – means many patients face a bleak survival outlook.”
New research suggests that Bisantrene could play an important and unique role in clearing this residual cancer before bone marrow transplantation. Race plans to conduct an AML MRD Phase II trial in the USA in partnership with a leading cancer centre.
“If successful, our MRD strategy could prove to be a breakthrough in the treatment of AML, greatly enhancing the value of Bisantrene to partners and potentially leading to an early approval by the FDA,” said Race CEO, Peter Molloy.
In addition to the MRD opportunity, new preclinical research by Race’s collaborators in the US has demonstrated that the clinical value of Bisantrene may be greatly enhanced by use in combination with other approved cancer drugs.
“The synergy between Bisantrene and other anti-cancer agents has been suggested by the historical data, but never confirmed using current research methodology, until now” said Dr Tillett. “We believe Bisantrene shows real promise when used in combination therapy for AML and other cancers.”
“The new combination positioning for Bisantrene will make it easier to attract clinical support for our trials and increase the attractiveness and value of Bisantrene to potential licensing partners,” said Mr Molloy.
To establish this in AML, the Company intends to run a Phase I/II combination trial in Australia for adult R/R AML. Conducting early stage trials in Australia (where suitable) will enable Race to lower trial costs and receive R&D tax credits, representing a 43.5% rebate on all eligible Australian R&D.
For paediatric AML, the Company is committed to running a registration trial in the United States with the goal of obtaining a Priority Review Voucher (PRV). Race’s plan is that this trial may involve sites in Australia as well.
PRVs are offered by the US FDA to incentivise companies to pursue rare diseases. In July 2018, the Company announced that paediatric AML has been designated as a ‘rare disease’ by the FDA, which means that Bisantrene currently qualifies for a PRV upon approval. The PRV is a highly valuable and saleable voucher with an active secondary market.
Race Oncology will also be actively pursuing proof-of-concept (Phase I/II) trials for Bisantrene in combination treatment for breast and ovarian cancers, where considerable historical data suggests Bisantrene has significant clinical benefit. The Company intends to conduct these clinical trials in Australia to take advantage of the R&D tax rebate, as well as the reduced cost of conducting clinical trials.
“Our new MRD and combination strategy opens up valuable new markets for Bisantrene,” said Mr Molloy. “Over the next months and years, we plan to see that value demonstrated in clinical trials and valuable partnerships.”
Read the full strategy here.