Race Oncology says non-clinical toxicology and safety studies of lead drug RC220 Bisantrene successfully completed
RC220 demonstrated excellent safety profile, including safe administration via peripheral IV infusion
Studies support start of human clinical trials in H2 2024 and a US FDA IND application in 2025
Special Report: Race Oncology is on track to start human trials after successful completion of Good Laboratory Practice toxicology and safety pharmacology studies for RC220, the company’s flagship formulation of bisantrene for peripheral intravenous infusion.
Bisantrene is an anthracene-based chemotherapy drug developed by Lederle Laboratories in the 1970s and 1980s.
It is known for reducing cardiotoxicity and providing cardio-protection when used with anthracyclines, a class of cancer treatment drugs.
Although effective and approved for treating acute myeloid leukaemia in France, its complex administration hindered commercial success.
RAC has reformulated Bisantrene for easy clinical use through standard infusion via arm or leg veins, and is exploring its anticancer and cardio-protective properties.
Race Oncology (ASX:RAC) says no unexpected or unacceptable toxicities were observed in the GLP toxicology and safety pharmacology studies with the completed data package supporting use of RC220 bisantrene in human clinical trials.
GLP testing shows positive results
In October 2023, RAC contracted Attentive Science (USA) and Agilex Biolabs (Australia) to undertake the regulatory-standard GLP non-clinical toxicology and safety pharmacology studies required to advance RC220 bisantrene into human clinical trials.
The studies had two aims including:
To demonstrate in two animal species that RC220 bisantrene is safe and amenable to administration via peripheral IV infusion in humans
To establish an acceptable starting dose for Phase I clinical studies.
In the GLP toxicology studies, which RAC says were delivered on time and budget, three doses of RC220 bisantrene were administered via peripheral veins and showed similar systemic effects to those seen when using the historical bisantrene formulation administered via a central line.
The doses of low, medium, and high reflected the expected dose range in humans.
RAC says examination of the animals after a four-week post-dose recovery period showed that all observed toxicities were reversible.
Importantly, there were no RC220 formulation-specific adverse macroscopic or histological findings at the sites of infusion.
RAC says the findings confirmed that, unlike the historical bisantrene formulation, peripheral IV administration of RC220 bisantrene was devoid of adverse infusion site or vein reactions.
Furthermore, the safety pharmacology studies also confirmed that at all three dose levels evaluated, RC220 bisantrene had an acceptable respiratory and cardiovascular safety profile.
Data to support submission for human trials
Data from the GLP toxicology and safety pharmacology studies will support regulatory and ethics submissions for evaluation of RC220 bisantrene in human clinical trials.
The human trials include an upcoming Phase 1a/1b trial in Australia, Hong Kong, and South Korea, an investigator-sponsored Phase 1/2 acute myeloid leukemia trial, and a US FDA Investigational New Drug application in 2025.
The first 1a Phase will study ascending doses of RC220 bisantrene to determine safety, tolerability, pharmacokinetics, m6A RNA effects, and the maximum tolerated dose alone and in combination with standard-of-care chemotherapy drug doxorubicin.
In the second 1b Phase the optimal dosage of RC220 bisantrene in combination with doxorubicin will be assessed for additional safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals in patients with advanced solid tumours.
RAC recently announced it had appointed contract research organisation George Clinical International to support development of RC220 bisantrene.
The CRO will assist RAC in the refinement and efficient execution of the proposed Phase Ia/1b study.
The final trial protocol and start of the trial is subject to human ethics and institutional approvals. RAC says first patient recruitment is forecast for late Q4 CY2024.
RAC also recently announced the US FDA had extended Rare Paediatric Disease Designation to RC220 to treat AML in children.
RAC is in talks to undertake a sponsored or investigator-initiated trial of RC220 bisantrene as a salvage treatment for paediatric AML patients.
‘Major milestone’
CEO Dr Daniel Tillett says RAC has achieved another key milestone in its bid to get its reformulated bisantrene to market.
“Receiving clear confirmation of the safety of RC220 bisantrene in these studies and identifying a suitable starting dose for our upcoming trial is another major milestone in bringing our new drug product to cancer patients,” Tillett says.
“I congratulate and thank the Race preclinical team, Attentive Science, and Agilex Biolabs for completing these studies on time and on budget.”
This article was developed in collaboration with Race Oncology, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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