Race Oncology Ltd (ASX: RAC) shares burst out of the gates on Wednesday morning.
In early trade, the ASX healthcare stock was up as much as 15% to $1.96.
The clinical stage biopharmaceutical company's shares have eased back a touch since then. At the time of writing, they are up 7% to $1.83.
Image source: Getty Images
Why is this ASX healthcare stock surging?
The catalyst for this strong gain has been the release of a positive announcement relating to its RC220 bisantrene formulation.
The company is advancing RC220 to address the high unmet needs of patients across multiple oncology indications.
In October, Race Oncology contracted Attentive Science and Agilex Biolabs to undertake the regulatory-standard Good Laboratory Practice (GLP) non-clinical toxicology and safety pharmacology studies required to advance RC220 bisantrene into human clinical trials.
These studies aimed to demonstrate in two animal species that RC220 bisantrene is safe and amenable to administration via peripheral IV infusion in humans. In addition, they aimed to establish an acceptable starting dose for Phase I clinical studies.
According to the release, this GLP program has been delivered on time and on-budget.
More importantly, the GLP toxicology and safety pharmacology studies showed no unexpected or unacceptable toxicities. As a result, management notes that the completed data package supports the use of RC220 bisantrene in human clinical trials.
The company advised that three doses of RC220 bisantrene were administered via peripheral veins. These were low, medium and high doses, which reflect the expected dose-range in humans. Pleasingly, these doses showed similar systemic effects to those seen when using the historical bisantrene formulation administered via a central line.
Examination of the animals after a four-week post-dose recovery period showed that all observed toxicities were reversible. Importantly, there were no formulation-specific adverse macroscopic or histological findings at the sites of infusion.
What now?
Data from these studies will be used to support regulatory and ethics submissions for evaluation of RC220 bisantrene in human clinical trials. This includes the upcoming Phase 1a/1b trial in Australia, Hong Kong, and South Korea, an investigator-sponsored Phase 1/2 AML trial, and a US FDA Investigational New Drug (IND) application in 2025.
The ASX healthcare stock's CEO, Dr Daniel Tillett, described the news as "another major milestone" for the company. He commented:
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. I congratulate and thank the Race preclinical team, Attentive Science and Agilex Biolabs for completing these studies on time and on-budget.
Following today's gain, Race Oncology's shares are now up approximately 115% since the start of the year.
