Patrys says PAT-DX1 engineering run successfully completed

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Therapeutic antibody development company Patrys (ASX:PAB) has announced that its contract development manufacturing organisation (CDMO) has successfully completed a second engineering run that used an updated purification process to produce large-scale quantities of clinical-grade PAT-DX1.

The company said that subject to meeting specifications, the manufactured PAT-DX1 antibody from the engineering run will provide sufficient PAT-DX1 for it to complete the remaining pre-clinical toxicology studies in preparation for a proposed phase 1 clinical trial of PAT-DX1 in the first half of the calendar year 2023.

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 said it subsequently worked with its CDMO to develop a modified purification process that was used in the second engineering run.

CEO and managing director Dr James Campbell said, “This is an outstanding result, and a tribute to the close working relationship between Patrys and our 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.

"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, to support our target of initiating a phase 1 clinical study of PAT-DX1 in H2 CY2023.”