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Re: Lykiri post# 609125

Wednesday, 07/19/2023 10:11:55 AM

Wednesday, July 19, 2023 10:11:55 AM

Post# of 700371
Thanks Lykiri, yes interesting article, even if some of it went over my head. :)

It’s a good reminder though, of the complexity, and all the pioneering work that’s necessary to bring a novel cell therapy to market. After reading that, it’s encouraging to know that Dr. Lowdell apparently helped with, at least some of Northwest Bio’s proof of the “mechanism of action,” for the assay that was revealed at ASCO last year. I think that’s why, in this year’s ASCO presentation, the slide entitled “Induction of CTL Activity” based on work done by Daphne Franz and Dr. Lowdell, (which demonstrated that DC’s loaded with tumor lysate induce T cells to kill the target cancer cells) was dated 2022.

The length of time that milestone took to achieve, goes to show how complex the MOA work is, since it still wasn’t completed until the first quarter of this year. It also shows an understanding and recognition by Northwest Bio, of its importance in the regulatory agency’s view, and their requirement for a thorough analysis of the mechanisms of action in the marketing application for ATMP’s. I think that may have been the 6th workstream that was added months after the initial 5 workstreams were drafted last spring, possibly after discussions with their consultants, like Dr. Lowdell, or regulators.
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