VAXINIA (CF33 + hNIS) clinical trial

[Rock_Robster]

Hi all. So for those who follow these things - next week (19th) I will be starting the VAXINIA (CF33 + hNIS) clinical trial at St Vincent’s Hospital in Melbourne, Australia. This is a phase 1 trial of an oncolytic virus manufactured by Imugene and developed by Prof. Yuman Fong at City of Hope, who many of you may know through his reputation as a liver surgeon.

Although around 40 of the 100 phase 1 patients globally have been dosed, I am in the first cohort of the intratumoural delivery arm (i.e. direct injection of the virus into liver tumours), while the other cohort so far has all been IV. I will not be receiving pembrolizumab (Keytruda) - this is a different arm again (I am MSS, although this was randomised).

The only slight awkwardness is I live in another state (Queensland), so I’ll be doing a fair bit of travel. Fingers crossed for good results, and will update on how things go!

https://www.imugene.com/oncolytic-virus

https://clinicaltrials.gov/study/NCT05346484

[Markdale]

Hope the trial works out rob. The lead investigator in Australia is the surgeon who operated on me, he has a great reputation.

[Rock_Robster]

Hope the trial works out rob. The lead investigator in Australia is the surgeon who operated on me, he has a great reputation.

Thanks Markdale, that’s great! Is that Gavin Wright? If so I met him once and he seems like a great guy.

[skimom]

Prayers for a good results Rob! Please keep us updated on how it goes :)

[Dennyp]

Hi all. So for those who follow these things - next week (19th) I will be starting the VAXINIA (CF33 + hNIS) clinical trial at St Vincent’s Hospital in Melbourne, Australia. This is a phase 1 trial of an oncolytic virus manufactured by Imugene and developed by Prof. Yuman Fong at City of Hope, who many of you may know through his reputation as a liver surgeon.

Although around 40 of the 100 phase 1 patients globally have been dosed, I am in the first cohort of the intratumoural delivery arm (i.e. direct injection of the virus into liver tumours), while the other cohort so far has all been IV. I will not be receiving pembrolizumab (Keytruda) - this is a different arm again (I am MSS, although this was randomised).

The only slight awkwardness is I live in another state (Queensland), so I’ll be doing a fair bit of travel. Fingers crossed for good results, and will update on how things go!

https://www.imugene.com/oncolytic-virus

https://clinicaltrials.gov/study/NCT05346484

Best of luck to you!

[Rock_Robster]

Thanks all! First intratumoural dosing done and went fine - I feel a bit like you do after a vaccination (which makes perfect sense). Just quite tired really - I can nap most days . The sedation probably affected more than anything else. Also the liver biopsies are by far the most unpleasant part, but thankfully after next week they don’t happen again for a while. I also have a SPECT scan next week which is a first for me - interesting to see what that looks like.

Otherwise though it’s really just more swabbing, peeing, bleeding, questioning, scanning and other testing than I’ve ever experienced. Which is of course all fine and welcome compared to chemo!

Fingers crossed little CF33 is getting in there and doing its job now (along with my immune system!).

[Rock_Robster]

Just a very short update - had the 2nd dosing today, along with a lot more bloods, swabs etc plus a SPECT scan (which was new to me). The intratumoural delivery into the liver has been fine so far, but I have to say the flu-like side effects have been real! A decent fever on most days, serious fatigue, and some liver pain which is apparently to be expected. They seem happy to be seeing signs of a decent immune response, which hopefully will correlate with treatment effectiveness too.

[Digiapo]

Just wishing you all the best with this, I've been following this trial closely as Dad has various nodules and pnets on his liver. Unfortunately he doesn't qualify for the trial.

I'm keeping my fingers crossed for you and everybody else on the trial. please keep us updated. I'm really interested. Because if this works well or better than the standard of care. it could really a huge change in treatment protocols...

Digi

[mobrouser]

What is a SPECT scan? Different than a PET scan?

[Rock_Robster]

What is a SPECT scan? Different than a PET scan?

Yes similar concept but a bit different in practice - I understand they’re using it to track the movement of the virus via a radiotracer:

https://my.clevelandclinic.org/health/d ... spect-scan

[Maggie Nell]

All the best for your desired outcome, Rock.
Be sure to pack your moccies, extra sox and oodie when you come south of the border in Winter.

Maggie
in Ballaarat

[beach sunrise]

Hey R_R! Wow, you are in this trial.
I read about a virus that can kill cancer a few months back. I was impressed by it and seemed out of this world how they found this potential cancer killer virus.
Will be keeping an eye for more of your updates!
All the best,
B

[Rock_Robster]

Another week and another dosing done - that makes 2 intratumoural doses in total, plus two liver biopsies. I got a brief look at my pathology and my liver enzymes were very elevated - clearly it doesn’t enjoy frequent stabbing and injection with strange viruses! Thankfully bilirubin is still ok in spite of my Gilbert’s.

Also, it turns out SPECT scans suck! A bit like a CT scan, only MUCH longer (~45 mins), on a very hard table immobilised with a weird leather/lead wrap thing. Can’t say I enjoyed that very much. But, the things we do.

Back next week for another treatment, then we go to a 3-weekly treatment cycle. Interestingly I read the case report of the guy on the trial who had a complete response (bile duct cancer) - on his first set of imaging after treatment he had a +49% increase in tumour size, prior to the subsequent shrinkage to zero which has since remained NED for 420 days. That is some serious pseudoprogression, and explains why the trial doc was quick to clarify that we would likely continue even if I had progression on the first post-treatment imaging.

[Carmark]

Hi Rock
Are the elevated liver enzymes perhaps pseudo progression? Glad to hear you are still going strong despite the constant invasions! Sounds like you get a bit of a break now.
All strength to you.
CM

[rp1954]

after treatment he had a +49% increase in tumour size, prior to the subsequent shrinkage to zero .

We had a somewhat similar warning about potential "tumor swelling" from our endocrinologist, JJ Prendergast (dec'd), about immune responses after 50k-100k megavitamin D tx for cancer patients, partly based on modern research including CT series, all the way back to much earlier European work. As the cancer accumulated sacks of immune components they would finally initiate an attack and dissolve the cancer. Whatever the lesions in my wife's liver were, they had surprising enough breakup and shrinkage 4 months after her vitamin D immunochemo turboboost (and second surgery) that I know my shocked radiologist was talking about her reponse for a while.

With an actual infection, one can suspect the there might be even more swelling with the infected, inflamed tissues.
Hang in there, we all hope that you get that complete response miracle.