Patrys Ltd (ASX:PAB) is a step closer to a clinical trial of the tumour-targeting PAT-DX1 after a successful second engineering run produced large-scale quantities of the antibody.
The therapeutic antibody development company’s contract development manufacturing organisation (CDMO) wrapped up the engineering run using an updated purification process to produce clinical-grade PAT-DX1.
Subject to the batch meeting specifications, the manufactured PAT-DX1 antibody should supply sufficient PAT-DX1 for Patrys to conduct final pre-clinical toxicology studies in preparation for a proposed Phase 1 clinical trial in the second half of next year.
Two-phase engineering run
The engineering run consisted of two phases:
- a fermentation phase, in which cells were grown in culture to produce PAT-DX1; and
- a purification phase, in which the PAT-DX1 produced during the fermentation process was isolated and purified.
In late January the company reported that 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 specifications.
As product from all prior manufacturing runs to date has met specifications, Patrys expects to complete pre-clinical GLP toxicology studies as planned between the last quarter of this year and the second quarter of next.
“Outstanding result”
Patrys 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.”