Inovio Pharmaceuticals Inc (INO)

[Lakers_w]

GBM 5401 Overall Survival at 24 Months
MGMT Unmethylated (Cohort A)
MGMT Methylated (Cohort B)
Combined
n Alive/N Total
7/32
11/20*
18/52

OS24% (95% CI)
21.9 (9.3 - 40)
55 (31.5 – 76.9)
34.6 (23.1 – 49.1)

https://s23.q4cdn.com/479936946/files/doc_presentations/INOVIO-Investor-Deck-Presentation_Nov2021.pdf

“results for GBM is on our website.
In terms of timing we are trying to be more conservative.”

4800 P3 interim result only needs 75 Covid-19 cases.

Previously, Dr Kim said INNOVATE Phase 3 interim data would be released in 1Q22, Now 1H22. Why?

“6 other country openings for our trial in last several weeks. But it really -- the clinical hold lift and authorization for Phase 3 in the U.S., it provides us additional validation, and it shows that we have met all of the concerns of the U.S. FDA satisfactorily. That being said, we're really pleased that -- to say that the dosing for INNOVATE Phase 3 trial has already begun and it's underway. And interim efficacy -- it's a case-driven study so magic number is around 150 lab-confirmed cases and of course, interim will be at the 50% of those cases. So faster re-enroll and the percent of attack rate in those countries or those regions will really impact when exactly where we will meet that 50% efficacy -- these are all blinded until we hit about 75 cases. So that's why we left that as a broadly first half 2022. So that's what we're looking for. And it's always been the same design from when we started the INNOVATE Phase 3 trial. “ JK 11/10/21