Race Oncology Ltd (ASX:RAC) has continued to make significant preclinical and clinical progress across Australia and internationally in 2022.
On the preclinical front, the development and transfer to manufacturing of the new peripheral Zantrene formulation RC220 have provided the company with the opportunity to explore the preclinical programs in greater depth and breadth.
The clinical Phase 2 expansion stage of Zantrene in combination with fludarabine and clofarabine to treat relapsed/refractory (R/R) acute myeloid leukaemia is progressing to expectation and is continuing to recruit patients.
Meanwhile, the extramedullary AML-focused trial (RAC-006) is advancing with the support of the contract research organisation (CRO), Parexel.
What’s more, Race initiated two FTO-focused biomarker development projects in late 2021.
Preclinical programs
Additional preclinical studies are underway in cell culture and animal models exploring both the mechanism of action and optimal therapeutic usage of Zantrene as a cardioprotective agent.
Cell and animal studies exploring the optimal combination of Zantrene with the standard-of-care drugs doxorubicin and cyclophosphamide were begun in during the second half of 2022
Also during this half-yearly period, dose-ranging studies of Zantrene and a kinase inhibitor were performed in a rat model of clear cell renal cell carcinoma (kidney cancer).
Zantrene was found to protect heart muscle cells from the known cardiotoxic multiple myeloma drug carfilzomib. Both dose-ranging and cardioprotection studies were initiated in mouse models of multiple myeloma and cardioprotection.
Furthermore, a human-derived mouse model of AML study was undertaken to explore the optimal combination of decitabine and Zantrene as a low-toxicity treatment for AML.
Clinical programs
The Phase 2 R/R AML combination trial completed the Phase 1b dose escalation stage with three of the six patients successfully bridged to a stem cell transplant.
In the Phase 1/2 EMD AML trials, three patients have been screened for EMD AML, however, no patient has been identified who is eligible for treatment in either stratum of this trial.
Race intends to modify the design of the trial in the January quarter to improve recruitment and commence expansion to additional sites in Australia and Europe.
While good progress has been made to date at the FTO biomarker projects, Race is not in a position to update the market on details without compromising valuable IP.