Further to this, I came across some interesting points from Leslie's presentation to the EGM (29/9/23) when I reviewed some old presentations from last year. Here are the key highlights related to Azer-Cel:
1. Imugene has referred to the Precision BioSciences trials as a Phase 1b, not "Phase 1/2a," as stated in the Official Title on the Clinical Trial website since its inception.
2. The Phase 1b expansion was mentioned to be in Q4 2023.
3. The timeline indicates that Phase 1b enrollment completion is expected in Q2, 2024, and an announcement along with Phase 1b readout should be anticipated in Q3.
4. Q4 FDA mentioned that the feedback on the registration study seems to be on track, as she highlighted it in the video.
If Imugene can transition the Azer-Cel from Phase 1b to a registrational trial approved by the FDA, this would be significant. This would suggest that the data must be compelling. Leslie has always been optimistic about the results of the Azer-Cel trials. In the previous video, she mentioned at the 5:09 minute mark, "and I have evidence that it's working..."
If they are on track with the Azer-Cel timeline from last year, then a positive update could catalyse a re-rate.
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