Gary,
Good question, and the short answer is it does not apply, but for a reason worth understanding.
DCVax-L is a dendritic cell product. Dendritic cells are adherent. They grow attached to surfaces during manufacture. Ori's IRO handles only suspension cells (CAR-T, TIL, NK). Ori cannot manufacture DCVax-L and would not be used to improve it. They are incompatible product types at the manufacturing level. DCVax-L is under MHRA review right now based on the Phase III data generated with the existing manufacturing process, and Linda Powers has been clear that the laser focus is on finishing that process and getting the first approval.
Where Ori could potentially play a role, and this is a theory not a confirmed plan, is in a different product class entirely: the T cell adoptive cell therapy product that Kalinski's alphaDC1 platform is designed to produce. In that workflow, NWBO's EDEN bioreactor would handle the DC-T cell co-culture (the instruction event where DCs educate T cells), and a suspension bioreactor like Ori's IRO could handle the subsequent T cell expansion step. That T cell product would go through its own separate clinical development, its own IND, its own trials. It would not touch the DCVax-L approval pathway at all.
So to answer directly: no, Ori would not trigger a new trial for DCVax-L, because Ori has nothing to do with DCVax-L. The two product classes are manufactured differently, regulated differently, and would go through separate clinical programs. DCVax-L's regulatory path is its own, and it is already well advanced.
Hope that helps.
Market Data 
Markets 
AI
