Ann: Phase 1 CF33-hNIS Study Update - Positive Early Signals, page-59

Hi @Jase99 , Reply function down.

Thanks so much for posting your summary, much appreciated! Like @davybabyk a very trusted & knowledgeable long time poster here to me.

We do know that these patients are from lower to mid dosing range & importantly there were correlations between immunological changes & response to treatment. You have pretty much said everything, but a few more I was thinking of:

Day 42 scan results just blows me away, and we are seeing efficacy in monotherapy & Combo with Keytruda. That’s not even 2 months, & when you look at the trial information on clinical trials website, in the IV combo arm, CF33-hNIS is administered on day 1 of each cycle & Keytruda on day 2, so every 3 weeks.

https://clinicaltrials.gov/study/NCT05346484?term=Imugene&checkSpell=false&rank=3

So those scans at day 42 would have been done on that trial visit (Day 42), not really even any time to see any efficacy yet on continuation of treatment following the 3rd dose. The next lot of data release will be interesting.

I think that now they know that pseudo-progression is a known phenomenon with CF33, that can be discussed with patients on screening & consent for the Vaxinia trial, not to give up too early, but I guess that biomarkers indicating immune response will also be helpful with that in regards to how to interpret this (ie progression vs pseudo progression?).

I agree with others, that potentially when patients hit later cycles in treatment those PRs & SDs, those numbers could be more promising again as time goes on. Especially interesting in GI cancers & melanomas.

But of course as Dr Seuss said, we need to wait but have fun doing so. This has made my day actually & we have got a snapshot here only in what will come out in a poster later this week. We got a little update for JPM 24, but you can’t compromise your Research poster for the sake of putting out extensive data, when the people (Oncologists & Industry) & their patients are going to be the ones benefiting from this with updates on Vaxinia trial.

Have a great day folks