Thank, friend @FibberUseful reference! I had not seen this. The...

Thank, friend @Fibber

Useful reference! I had not seen this. The FDA's only extra concerns for Allogeneic CAR-T were patient matching (to ensure compatibility) and monitoring go Graft vs Host problems. Azer-cel doesn't require the former, because they have successfully gene edited to avoid the latter. The FDA must be extremely impressed by that.

They have also released an Industry Guidance document for 'Human Gene Therapy Products Incorporating Human Genome Editing" - which definitely includes Azer-Cel.

Here it is:

https://www.fda.gov/media/156894/download

I have only had a skim read so far, but it includes Guidelines for the Gene Editing (in the case of Azer-Cel, that would be the ARCUS technology) and also for the delivery method. ie. How the Gene Edited components are actually delivered into the cells. That would be MaxCyte’s Flow Electroporation® technology recently licensed to IMU. https://fox5sandiego.com/business/press-releases/globenewswire/9022040/maxcyte-signs-strategic-platform-license-with-imugene-to-advance-their-cancer-immunotherapy-programs/

The good news though is that the Ph 1 and 2a studies already accomplished by Precision have demonstrated - particularly in the Ph 2a - that the technologies produce a very safe product. Certainly IMU seemed to have no problems getting its Ph 2 "confirmatory" clinical trial of Azer-Cel approved by the FDA - and that trial is now enrolling patients.

Thinking about it - I would expect that the Guidelines will also apply to the related research IMU is planning to do using NeoImmuneTech's technology to further improve the effectiveness of Azer-cel production: "The partnership will evaluate Imugene’s allogeneic CAR T, azer-cel, in combination with NIT’s proprietary immune T-cell amplifier “Fc-fused recombinant human interleukin-7”, NT-I7, for the treatment of cancer. Combining the two has the potential to increase the number of cancer-fighting properties in the body." Sources:
https://investorhub.imugene.com/announcements/5466179
https://themarketonline.com.au/imugene-and-neoimmunetech-team-up-to-improve-cancer-treatments-using-t-cell-therapy-2023-12-12/

More reading...

Lol

Dave