- Patrys (PAB) shares are slumping on Friday after the company flagged delays over the phase one clinical trial of its PAT-DX1 compound
- PAB CEO and Managing Director James Campbell says it is “disappointing” to push back the trial for its cancer treatment
- Recent updates from PAB’s contract development manufacturing organisation (CDMO) confirm there is a “sporadic issue” relating to the cell line used to produce good-manufacturing-practice (GMP) PAT-DX1
- PAB says it’s investigating the issue but, for now, remains on track with the final non-clinical GLP toxicology studies of PAT-DX1, with results expected in May
- Shares in PAB are down almost 24 per cent and trading at 1.6 cents at 3:01 pm
Patrys (PAB) has flagged delays to the phase one clinical trial of its PAT-DX1 compound after a “sporadic issue” was raised by its contract development manufacturing organisation (CDMO).
Its first human clinical trial of PAT-DX1 was originally planned for mid-2023, but the company said this had now been pushed back to 2024.
The news wasn’t received well by investors, with the therapeutic antibody developer’s shares tumbling more than 23 per cent on Friday.
Patrys said the issue related to the cell line used to produce good manufacturing practice (GMP) PAT-DX1.
PAB is investigating the issue but, for now, remains focused on the final, non-clinical GLP toxicology studies of PAT-DX1, with results expected in May.
PAB CEO and Managing Director James Campbell said it was “disappointing” to delay the trial.
“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,” Dr Campbell said.
The company, however, urged that its focus remained on advancing PAT-DX1 to the clinic.
The company believes PAT-DX1 has clinical utility for treating primary and secondary brain cancers due to its ability to cross the blood-brain barrier.
PAB said it could also have utility for treating cancers with existing DNA damage response (DDR) deficiencies, or in collaboration with other DNA-damaging agents such as radiation and chemotherapy drugs.
Shares in PAB were down almost 23.8 per cent and trading at 1.6 cents at 3:01 pm.