The CF33, Vaxinia and Oncarlytics Deal, page-876

Hi Harry, great post.

Like yourself I’ve been eagerly awaiting an update on the current patients enrolled in the Checkvacc trial. From memory the cutoff date for late breaking abstracts at ESMO is September 14^th so I’m only expecting to see data on the patients enrolled in cohorts 1-3 as cohort 4 was only started August 7^th…...but who knows.

I know Leslie mentioned that they were not going to provide individual patient updates until they could present them on the world stage, well that time is here and I’m hoping they revert to presenting the data like they did in the first Checkvacc update. We need to see both tumour reduction presented in mm’s and the objective response rates of patients from cohorts 1-3 (PD/SD/PR/CR). As much as its great to see the hNIS travelling around the body the market needs to see hard data which demonstrates the product is working as we’ve been told.

What we know?

Checkvacc is effective at the lowest dose of 10^5 and has shown no DLT’s through the first 3 cohorts.

What do we know about patients?

Patient 1 (COH-001) – Had a 40% reduction in baseline lesion size and achieved an SD at last known transmission. (almost a PR)

Patient 4 (COH-004) – Showed significant enhancement of injected lymph node, notable PD-L1 and increased CD8

Patient 8 (COH-008) – Received 10^6PFU which demonstrated necrosis on clinical exam after ONLY 9 DAYS!!! That’s right at 1,000,000PFU and after 9 days of the first cycle the lesion started to die.

https://www.imugene.com/s/21094-SABCS-2022-11-11-22.pdf

https://www.imugene.com/s/AACR-2023-FINAL-4-6-2023.pdf

Whats a pass mark?

I’m hoping IMU present data on all 9 patients but I think it might be wishful thinking, if we were to achieve SD,PR or CR’s on 7/9 patients that would be unbelievable. The only reason for this is I believe that two of the patients in the first cohort may have left the trial due to progression and the low dose not being able to replicate at the same time as the virus was (not confirmed but just hearsay). This is also inline with what Yuman Fong was saying at one of the roadshows in that he didn’t realise just how sick some of the patients were that they were admitting. Having said that the lowest dose was never designed to be effective and not the intended “sweet spot”.

Note: I’d really love to know what went wrong in cohort 3 and why it took the best part of a year to be completed, that really has been a speed bump in the trial progression.

Anyway I guess will know more in a few weeks time.