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- Race Oncology (ASX:RAC) produces its first batch of bisantrene dihydrochloride under cGMP standards with its partner Laurus Labs
- This achievement paves the way for Race’s flagship drug RC220
- RAC’s next steps include transferring the cGMP-grade bisantrene dihydrochloride to Ardena (Belgium) for use in RC220’s sterile formulation for patient infusion
- Additionally, the company plans to complete phase three readiness studies at Laurus Labs
- RAC shares are down 1.18 per cent, trading at 84 cents at 10:57 am AEST
Race Oncology (ASX:RAC) has produced its first batch of bisantrene dihydrochloride under cGMP standards through its partnership with Laurus Labs (India).
This achievement marks a key milestone for Race’s flagship drug, RC220, and lays the foundation for future clinical trials.
In Q2 2022, RAC made the strategic decision to appoint Laurus Labs as its new API manufacturer to ensure a consistent supply of high-quality bisantrene dihydrochloride API.
The transfer of process chemistry expertise from the previous manufacturer was seamless, resulting in improved yields and higher purity intermediates.
A significant development in the process was the qualification and quantification of manufacturing process impurities, a vital step for the eventual registration of bisantrene-containing drug products, including RC220, with regulatory agencies such as the US FDA.
”We have sufficient active pharmaceutical ingredients for our RC220 cGMP drug product manufacturing program and near-term clinical trials,” RAC Executive Director Dr Pete Smith said.
“As an unexpected bonus, there have been some discoveries made at Laurus during the manufacturing campaign that can add to our overall intellectual property position, we look forward to continuing our productive relationship with Laurus.”
The next steps for RAC include transferring the cGMP-grade bisantrene dihydrochloride to Ardena (Belgium) for use in RC220’s sterile formulation for patient infusion.
Additionally, the company plans to complete phase three readiness studies at Laurus Labs to safeguard the intellectual property assets developed during this partnership.
RAC shares were down 1.18 per cent, trading at 84 cents at 10:57 am AEST.
