Laurus Labs, an India-based pharmaceutical manufacturer, has successfully produced its first batch of Race Oncology Ltd (ASX:RAC)’s active pharmaceutical ingredient (API) bisantrene dihydrochloride.
The 3.25-kilogram batch of the API was produced to a standard that meets the quality specified under the ‘Code of Good Manufacturing Practice’ (cGMP), using an improved process that is scalable to commercial quantities.
Upcoming clinical trials
The milestone paves the way for upcoming clinical trials and potentially unlocking new intellectual property avenues for Race.
Innovations incorporated into the manufacturing will support new Race patent applications, proving the API’s suitability for use in all regulatory jurisdictions, including Australia, the United States and the European Union.
In April 2022, Race Oncology opted for Laurus Labs as its API supplier to secure a scalable and quality supply of bisantrene for its flagship drug product, RC220.
This set off a transfer of technical knowledge from the previous manufacturer to Laurus Labs, which resulted in improved yield and purity.
The efficiencies that emerged throughout the manufacturing process delivered new intellectual property (IP) rights for the company.
Paves way for FDA approval
The process also fulfils manufacturing process impurity requirements, a critical factor for registering bisantrene-containing drug products under a US FDA New Drug Application (NDA).
Executive director Dr Pete Smith said: “Completion of the first batch of API at our new contract manufacturing organisation (CMO), Laurus Labs, and its certification of cGMP quality, is an important milestone for Race.
“Laurus Labs has performed very well during this first campaign and has the capabilities and capacity to provide our clinical development and commercial needs for API over the longer term.
“We have sufficient active pharmaceutical ingredient for our RC220 cGMP drug product manufacturing program and near-term clinical trials.
“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.”
Next steps
The cGMP-grade API will be transferred to Ardena in Belgium for manufacturing Race’s new sterile formulation, RC220.
Further studies for Phase 3 readiness and protection of newly developed IP assets are also in the pipeline.
With this successful synthesis, Race Oncology not only secures a high-quality supply of API but also minimises risks associated with chemistry, manufacturing, and controls (CMC), making it an attractive potential partner for larger pharmaceutical enterprises.