Ann: Patrys Successfully Establishes PAT-DX1 Stable Cell Line, page-2

FANTASTIC NEWS.


Patrys Establishes Stable Cell Line for Production of PAT-DX1
Melbourne, Australia; 10 February 2021: Patrys Limited (ASX: PAB, “Patrys” or the Company), a
therapeutic antibody development company, is pleased to announce it has selected an optimised
stable cell line for its lead asset PAT-DX1. This important step allows the company to establish largescale production of PAT-DX1 deoxymab for final preclinical studies, first-in-man studies, and
partnering activities.
Patrys Chief Executive Officer and Managing Director, Dr. James Campbell said: “Establishing a
stable, high-yield cell line suitable for commercial production of clinical-grade material is one of the
critical steps of any antibody development program. Today’s announcement marks a major de-risking
step for the Company as it moves towards an anticipated first-in-man study of PAT-DX1 in H1 2022.”
The establishment of a stable, PAT-DX1-producing cell line by Patrys is the culmination of a
manufacturing development and optimisation program that was initiated in mid-2019. The
development program included modification of PAT-DX1’s protein back-bone to improve its
properties for use in human therapeutic applications. Cell lines expressing the modified PAT-DX1 were
developed and an extensive selection processes was conducted to identify single, clonal cell lines that
produced high yields of high quality PAT-DX1. The final step was to ensure that the cell line was stable
and able to deliver reproducible and consistent production of PAT-DX1 protein over time. Over the
past months Patrys evaluated six different optimised cell lines and has selected a best performer from
these studies. The cell line that has been selected will be stored as a Master Cell Bank (MCB) which
will form the basis for all future production of PAT-DX1.
Patrys Chief Executive Officer and Managing Director, Dr. James Campbell said: “Now that we have
a stable cell line and resultant Master Cell Bank in hand, Patrys’ is focused on completing the final two
milestones required for us to initiate first-in-man studies for PAT-DX1, namely; scaling-up the
production of PAT-DX1 in large fermenters (H1, 2021), and initiating GLP toxicology studies (H2, 2021).
I’d like to pay credit to the Patrys team, and to our international CRO, who have worked tirelessly on
developing this key reagent for us.”
The selection of a stable cell line for producing PAT-DX1 means that all future studies undertaken by
either Patrys or its partners and collaborators can be based on suitably qualified product, including
supporting ongoing research effort being conducted around the globe on this technology. Having a
consistent and qualified product means that data can potentially be leveraged from a broad range of
studies covering applications such as therapeutics, nanoparticle drug delivery, antibody-drug
conjugation and diagnostic imaging agents.