Good question and definitely one for the webinar. Is it defined as a drug or a method? Either way, I doesn't sound like specific regulatory approvals are required per se. Today's release states: "CellPryme-A is now ready for clinical testing and can be incorporated into clinical studies of existing cell therapies."
It makes logical sense that CP-A will undergo the standard approval process in conjunction with the particular CarT therapy that is being partnered with our platform. Same applies with CP-M and OmniCAR, I should imagine. CP-A will form one cog in an overal clinical trial design submission.
This scenario doesn't preclude the licensing of our technology at this stage, though. Some people might think that our platform products are not monetisable until such time as they have done the rounds of umpteen trials. It could be a case that prospective collaborators may hold out for some clinical data first (from our own CarT trials) before committing... BUT when you think about it, we are dealing with biotechs all of the same ilk. They'd be keen to put it to the test as much as our crew based on how the pre-clinical data stacks up.
From what I have read, the difficult part in transitioning from lab to human trials is scaling. Getting the dosage volumes right is no mean feat. But, we have Bec and a number of experts on our SAB that have experience in the area. The other thing, of course, is when to administer it. It can be administered prior and/or post (for different reasons).... and in today's ann, it mentions "or alongside cellular immunotherapy". So, its super flexible - but that in itself will likely require planning and tweaking.
The main takeaway, of course, is its applicability to solid tumours and those quoted increases to CarT capabilities of 300% to 900% and 66% reduction in burdensome Treg cells. If they aren't impressing someone, then its time to shoot me!!! Over and out!
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Good question and definitely one for the webinar. Is it defined...
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