- Patrys’ (PAB) Contract Development Manufacturing Organisation (CDMO) has completed the second engineering run for its cancer antibody candidate, PAT-DX1
- The engineering run used an updated purification process to produce large-scale quantities of the antibody product
- Patrys says the manufactured PAT-DX1 will provide enough product to complete its remaining pre-clinical toxicology studies ahead of a planned phase one clinical trial in the second half of 2023
- Over the coming weeks, Patrys will test the antibody product from the latest engineering run to make sure it meets all specifications
- Shares in Patrys are up 14.3 per cent and trading at 2.4 cents at midday AEST
Biotech junior Patrys (PAB) has completed a second engineering run for its PAT-DX1 cancer antibody candidate through its Contract Development Manufacturing Organisation (CDMO).
The engineering run used an updated purification process to produce large-scale quantities of clinical-grade PAT-DX1.
Patrys said the manufactured PAT-DX1 antibody from the engineering run would provide enough product to complete its remaining pre-clinical toxicology studies in preparation for a planned phase one clinical trial in the second half of 2023.
The engineering run consisted of two phases: a fermentation phase, during which cells were grown in culture to produce PAT-DX1, and a purification process, in which the product produced during the fermentation process was isolated and purified.
In January, the first engineering run for PAT-DX1 was less successful due to low recoveries of the drug product during the purification phase. Patrys and its CDMO developed a modified purification process that was used in the second run.
Over the coming weeks, Patrys will test the antibody product from the latest run to make sure it meets all specifications.
Patrys CEO James Campbell said this was an “outstanding result” as it showed the close working relationship between the company and its CDMO.
“The commercial-scale manufacture of antibodies is a complex, multi-dimensional process. The efforts made to understand and remediate the issues with the first engineering run have been both extensive and exhaustive,” Dr Campbell said.
“We are delighted that this has delivered such a successful outcome, both addressing the issue with the original purification process and improving the overall yield. We are
now in a position to proceed with our plan to initiate the final GLP toxicology studies by the end of the year.”
Shares in Patrys were up 14.3 per cent and trading at 2.4 cents at midday AEST.