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Wednesday, September 02, 2020 9:02:22 AM
You don't get much for up-front cash of £1.65m these days. But LP knows a potential bargain when she sees one (witness real estate), so let's hope this turns out to be 'a pennies on the dollar' deal, as time goes by.
The 'technical team' that has joined NWBO is probably quite a small team as teams go. Somewhere between 1 and 2 (and probably nearer the former..).
The technicalities are largely beyond me. I don't know whether the micro-Den cartridge system was dropped by Murthy or just dropped by Corning, so Murthy decided to take it elsewhere. I don't know whether the bioreactor replaces perfusion-based micro-Den or employs it.
Is it a niche application? Of course. But it's a niche that's only going to get bigger. The whole CGT field is a burgeoning one.
But having this proprietary process and its technical specialist on board and in-house now, can only be seen as a massive plus in my book.
LP is no doubt acutely aware of the costly limitations of the largely manual DC isolation / maturation process that bedevilled Provenge, so is taking the necessary steps to reduce manufacturing unit cost, improve reproducibility, and reduce human error. And ultimately reduce the therapy price tag. This will all help down the line when HTA's, (notably NICE) look at accrued patient benefit in terms of QALY's in their cost / benefit analyses.
If one is looking for a multi-billion buyout to occur in the next few weeks, then this development has little relevance.
But for long-haul investors (such as myself), it's a very positive development, and is another demonstration of LP being ahead of (or at least up with) the game. She knows that all of this is an essential plank that has to be in place for approval..
(UK first??)
Here's a link to discussion about CGT process development coming out Phacilitate 2020, which just happens to feature both Mark Lowdell and Shashi Murthy :-
https://bioprocessintl.com/manufacturing/cell-therapies/discussions-at-phacilitate-2020-on-cell-and-gene-therapy-products/
And here is a link to grant-based seed-funding that Flaskworks has received in the last couple of years, which obviously contributed greatly to their process development.
From which:-
This project will address this major unmet need by leveraging advanced concepts in engineering and biology to design an integrated system for cost-effective dendritic cell therapy manufacturing. Given the large number of personalized cell-based therapies currently in clinical trials and recently approved, such a system is expected to address a major societal need and have significant commercial potential. This SBIR Phase II project will advance to commercialization an advanced bioreactor system for closed-system manufacturing of autologous dendritic cell therapies. Multiple technological challenges must be overcome to automate and integrate the unit operations associated with the manufacturing of these therapies. Because of their low abundance in blood and tissue, dendritic cells are typically generated from leukapheresis-derived monocytes. Adherent monocytes must first be converted into nonadherent immature dendritic cells via incubation inIL4 and GM-CSF, prior to maturation and stimulation with tumor specific antigens. In order to achieve automation and integration of these steps on a single platform, the proposed system will build on successful Phase I work in perfusion-based dendritic cell culture that enables reduction of process steps associated with cytokine infusion and achievement of perfusion in a simple and cost-effective single-use bioreactor design. In addition, an agile product development methodology will be utilized in conjunction with computational modeling to rapidly and iteratively create prototypes and test them in the hands of potential customers.
https://www.sbir.gov/sbirsearch/detail/1644527
And congrats to Lykiri and Hyperopia for giving LP the heads-up on Flaskworks!
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