Ann: Updated guidance for PAT-DX1 phase 1 clinical study, page-45

herapeutic antibody development specialist Patrys (ASXXB) crashed 21% this morning after saying that it now only expects to commence the Phase 1 clinical trial of PAT-DX1 in the calendar year 2024, as opposed to second half of 2023.

The decision came after recent updates from its Contract Development Manufacturing Organisation (CDMO) regarding the timing of availability of clinical-grade PAT-DX1.

Despite prior successful manufacting test runs, Patrys’ CDMO has reported a sporadic issue relating to the cell line used to produce Good Manufacturing Practice (GMP) PAT-DX1.

While this issue is actively being investigated and resolved, it will result in a delay in the availability of investigational drug material to be used for Patrys’ Phase 1 clinical trial of PAT-DX1.

“We are disappointed that the delay in availability of clinical grade material is going to push our Phase 1 clinical trial of PAT-DX1 into calendar year 2024,” said Patrys’ CEO, Dr James Campbell.

“Once the sporadic issue affecting GMP production is resolved, we are confident the manufacturing and purification process developed and tested for PAT-DX1 can provide the material required to initiate the first human clinical trial of a deoxymab antibody.”

In the meantime, the final, non-clinical GLP toxicology studies of PAT-DX1 remain on-track with initial results expected in May.

“Furthermore, work on our full-sized IgG deoxymab, PAT-DX3, is progressing well and we expect to provide an update on this program in coming weeks,” said Campbell.