Arovella Therapeutics has released a second clinical batch of its off-the-shelf CAR-iNKT therapy ALA-101, with material expected to support dose escalation and the start of dose expansion in blood cancers. The company is also adding hospital sites ahead of anticipated first-patient dosing in late October.
- Second ALA-101 clinical batch released for patient use
- Material expected to support dose escalation and initial dose expansion
- Third batch targeted for release by the end of December
- Epworth Hospital activated, with Sydney and Brisbane sites expected soon
- No efficacy or safety data disclosed in the announcement
Second batch supports ALA-101 trial expansion
Arovella Therapeutics Ltd (ASX:ALA) has cleared another operational hurdle in its push into the clinic, releasing a second batch of ALA-101 for immediate patient use. The company says the available material is sufficient to complete dose escalation and begin dose expansion in its Phase 1 trial for blood cancers.
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Bottom Line?
The next value-bearing milestones are execution milestones: first-patient dosing, dose-escalation findings, recruitment and the release of the third batch.
Questions in the middle?
- Will first-patient dosing occur on the late-October timetable indicated by the company?
- How quickly can the expanded hospital network recruit eligible patients across the 46-person Phase 1 trial?
- What safety and early clinical activity will emerge as ALA-101 moves from dose escalation into dose expansion?