Patrys Limited announce that its Contract Development Manufacturing Organisation has successfully completed a second engineering run which used an updated purification process to produce large scale quantities of clinical grade PAT-DX1. Subject to meeting specification, the manufactured PAT-DX1 antibody from this engineering run will provide sufficient PAT-DX1 for Patrys to complete the remaining pre-clinical toxicology studies in preparation for a proposed phase 1 clinical trial of PAT-DX1 in second half of CY2023. The engineering run consisted of two phases; a fermentation phase, in which cells were grown in culture to produce PAT-DX1, followed by a purification phase, in which the PAT-DX1 produced during the fermentation process was isolated and purified.

As announced by Patrys on 24 January 2022, the first engineering run for PAT-DX1 was unsuccessful due to low recoveries of drug product during the purification phase. Patrys and its CDMO subsequently developed a modified purification process that was used in this second engineering run. The initial yield from this commercial scale run exceeds what the Company was expecting based on previous, smaller-scale pilot runs.

In the coming weeks, the PAT-DX1 antibody product from this engineering run will be tested to ensure that it meets specification. As PAT-DX1 from all prior manufacturing runs to date has met specification, Patrys expects to complete pre-clinical GLP toxicology studies as planned from Fourth Quarter CY2022 to Second Quarter CY2023.