VAXINIA (CF33 + hNIS) clinical trial

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Rock_Robster
Posts: 1028
Joined: Thu Oct 25, 2018 5:27 am
Location: Brisbane, Australia

VAXINIA (CF33 + hNIS) clinical trial

Postby Rock_Robster » Sat Mar 16, 2024 2:48 am

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
41M Australia
2018 Dx RC
G2 EMVI LVI, 4 liver mets
pT3N1aM1a Stage IVa MSS NRAS G13R
CEA 14>2>32>16>19>30>140>70
11/18 FOLFOX
3/19 Liver resection
5/19 Pelvic IMRT
7/19 ULAR
8/19 Liver met
8/19 FOLFOX, FOLFOXIRI, FOLFIRI
12/19 Liver resection
NED 2 years
11/21 Liver met, PALN, lung nodules
3/22 PVE, lymphadenectomy, liver SBRT
10/22 PALN SBRT
11/22 Liver mets, peri nodule. Xeloda+Bev
4/23 XELIRI+Bev
9/23 ATRIUM trial
12/23 Modified FOLFIRI+Bev
3/24 VAXINIA (CF33 + hNIS) trial

Markdale
Posts: 108
Joined: Wed Dec 02, 2020 4:45 pm

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby Markdale » Sun Mar 17, 2024 7:18 am

Hope the trial works out rob. The lead investigator in Australia is the surgeon who operated on me, he has a great reputation.
09/20:Diagnosed colonoscopy
10/20: LAR tumour t3n2m1 4/24 lymph nodes.
11/20: pet scan confirmed Mets
11/20: folfoxiri - 10/6/21. 12 rounds in total
1/1/21 thoracotomy 1 met removed
2/2022 sabr to 2 lung nodule
09/22 PET scan progression of sabr’d nodules
10/22 phase 1 trial bispecific antibody
9/23 added pd1 blocker
12/23 bilateral VATS all visible (7) lesions removed
3/24 radiation to acromion bone met + chest lymph nodex2

Rock_Robster
Posts: 1028
Joined: Thu Oct 25, 2018 5:27 am
Location: Brisbane, Australia

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby Rock_Robster » Sun Mar 17, 2024 9:05 am

Markdale wrote: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.
41M Australia
2018 Dx RC
G2 EMVI LVI, 4 liver mets
pT3N1aM1a Stage IVa MSS NRAS G13R
CEA 14>2>32>16>19>30>140>70
11/18 FOLFOX
3/19 Liver resection
5/19 Pelvic IMRT
7/19 ULAR
8/19 Liver met
8/19 FOLFOX, FOLFOXIRI, FOLFIRI
12/19 Liver resection
NED 2 years
11/21 Liver met, PALN, lung nodules
3/22 PVE, lymphadenectomy, liver SBRT
10/22 PALN SBRT
11/22 Liver mets, peri nodule. Xeloda+Bev
4/23 XELIRI+Bev
9/23 ATRIUM trial
12/23 Modified FOLFIRI+Bev
3/24 VAXINIA (CF33 + hNIS) trial

skimom
Posts: 78
Joined: Fri Mar 17, 2023 12:24 pm
Location: Oregon USA

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby skimom » Sun Mar 17, 2024 10:39 am

Prayers for a good results Rob! Please keep us updated on how it goes :)
47yo F at DX
DX 12/11/22 Stage IV (liver & lung mets) KRAS PIK3CA
12/15/22 Primary tumor removed from Transverse Colon (4.3x4.0x0.6cm G2 3/15 lymph nodes. Clear margins)
01/06/23 started Folfox (10 cycles)
Initial CEA 5608
CEA after 4 rounds 1319
CEA after 6 rounds 427
CEA after 9 rounds 95
HAI pump installed 06/20/23
Start FOLFIRI and FUDR 07/05/23
CEA down to 37
31
21
18
9/2023 Switch back to FOLFOX due to new lung nodules
11/23 FOLFOX fail CEA up to 62

Dennyp
Posts: 84
Joined: Thu Oct 29, 2020 9:28 pm

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby Dennyp » Fri Mar 22, 2024 7:13 pm

Rock_Robster wrote: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!
5/19 IIIC sigmoid cancer 2/25 lymph nodes positive
5/19 surgery
7/19 FOLFOX 6 months
9/20 recurrence to single lymph node
10/20 FOLFIRI 5 rounds
1/21 surgery to remove lymph node
4/21 CT NED
8/21 CT NED
11/21 CT NED
2/22 CT NED
5/22 CT NED
8/22 PET NED
11/22 CT NED
3/23 PET lesion on liver
3/23 MRI confirmed lesion
4/23 liver surgery aborted lesion found on diaphragm
5/23 chemo started
7/23 CT shows shrinkage of lesion, consult scheduled with surgeon

Rock_Robster
Posts: 1028
Joined: Thu Oct 25, 2018 5:27 am
Location: Brisbane, Australia

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby Rock_Robster » Fri Mar 22, 2024 8:57 pm

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!).
41M Australia
2018 Dx RC
G2 EMVI LVI, 4 liver mets
pT3N1aM1a Stage IVa MSS NRAS G13R
CEA 14>2>32>16>19>30>140>70
11/18 FOLFOX
3/19 Liver resection
5/19 Pelvic IMRT
7/19 ULAR
8/19 Liver met
8/19 FOLFOX, FOLFOXIRI, FOLFIRI
12/19 Liver resection
NED 2 years
11/21 Liver met, PALN, lung nodules
3/22 PVE, lymphadenectomy, liver SBRT
10/22 PALN SBRT
11/22 Liver mets, peri nodule. Xeloda+Bev
4/23 XELIRI+Bev
9/23 ATRIUM trial
12/23 Modified FOLFIRI+Bev
3/24 VAXINIA (CF33 + hNIS) trial

Rock_Robster
Posts: 1028
Joined: Thu Oct 25, 2018 5:27 am
Location: Brisbane, Australia

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby Rock_Robster » Tue Mar 26, 2024 9:02 am

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.
41M Australia
2018 Dx RC
G2 EMVI LVI, 4 liver mets
pT3N1aM1a Stage IVa MSS NRAS G13R
CEA 14>2>32>16>19>30>140>70
11/18 FOLFOX
3/19 Liver resection
5/19 Pelvic IMRT
7/19 ULAR
8/19 Liver met
8/19 FOLFOX, FOLFOXIRI, FOLFIRI
12/19 Liver resection
NED 2 years
11/21 Liver met, PALN, lung nodules
3/22 PVE, lymphadenectomy, liver SBRT
10/22 PALN SBRT
11/22 Liver mets, peri nodule. Xeloda+Bev
4/23 XELIRI+Bev
9/23 ATRIUM trial
12/23 Modified FOLFIRI+Bev
3/24 VAXINIA (CF33 + hNIS) trial

Digiapo
Posts: 1
Joined: Sun Mar 24, 2024 8:57 pm
Facebook Username: Brendon.smith

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby Digiapo » Tue Mar 26, 2024 9:15 pm

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

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mobrouser
Posts: 174
Joined: Wed Apr 11, 2018 1:44 pm
Location: Ontario

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby mobrouser » Wed Mar 27, 2024 8:17 pm

What is a SPECT scan? Different than a PET scan?
CC Dx 102017 age 58
Lap. right hemi-colectomy Dec 2017
Adenocarcinoma ascending colon – 6cm x 6cm x 2cm, Low Grade, penetrates to peritoneum
T4a N2a M0, Stage IIIC
lymph nodes 6 positive out of 18
FOLFOX start Jan/18 end Aug/8 (felt like a year)
CEA - 01/15/18-2.8; 07/29/18-5.3; 09/19-2.4; 03/20-2.7; 09/20-2.9
CT scan 08/18 - Clear; 10/19 - Clear; * 10/20 - 8mm & 6mm nodules in liver
PET scan 09/18 (thought about bringing the cat :wink: ) - Clear
Colonoscopy Dec 7 2018 - Clear - Next in 3 years?

Rock_Robster
Posts: 1028
Joined: Thu Oct 25, 2018 5:27 am
Location: Brisbane, Australia

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby Rock_Robster » Wed Mar 27, 2024 11:37 pm

mobrouser wrote: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
41M Australia
2018 Dx RC
G2 EMVI LVI, 4 liver mets
pT3N1aM1a Stage IVa MSS NRAS G13R
CEA 14>2>32>16>19>30>140>70
11/18 FOLFOX
3/19 Liver resection
5/19 Pelvic IMRT
7/19 ULAR
8/19 Liver met
8/19 FOLFOX, FOLFOXIRI, FOLFIRI
12/19 Liver resection
NED 2 years
11/21 Liver met, PALN, lung nodules
3/22 PVE, lymphadenectomy, liver SBRT
10/22 PALN SBRT
11/22 Liver mets, peri nodule. Xeloda+Bev
4/23 XELIRI+Bev
9/23 ATRIUM trial
12/23 Modified FOLFIRI+Bev
3/24 VAXINIA (CF33 + hNIS) trial

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Maggie Nell
Posts: 1151
Joined: Wed May 27, 2015 1:57 am
Location: Central Highlands, Victoria, Oz

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby Maggie Nell » Thu Mar 28, 2024 7:19 am

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. :D

Maggie
in Ballaarat
DX April 2015, @ 54
35mm poorly diff. tumour, incidental finding following emergency R. hemicolectomy
for ileo-colic intussusception.
Lymph nodes: 0/22
T3 N0 MX
Stage II CRC, no adjuvant chemo required.

User avatar
beach sunrise
Posts: 1041
Joined: Thu Mar 05, 2020 7:14 pm

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby beach sunrise » Thu Mar 28, 2024 11:21 am

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
8/19 RC CEA 82.6 T3N0M0
5FU/rad 6 wk
IVC 75g 1 1/2 wks before surgery. Continue 2x a week
Surg 1/20 -margins T4bN1a IIIC G2 MSI- 1/20 LN+ LVI+ PNI-
pre cea 24 post 5.9
FOLFOX
7 rds 6-10 CEA 11.4 No more
CEA
7/20 11.1 8.8
8/20 7.8
9/20 8.8, 9, 8.6
10/20 8.1
11/20 8s
12/20 8s-9s
ADAPT++++ chrono
CEA
10/23/22 26.x
12/23/22 22.x
2023
1/5 17.1
1/20 15.9
3/30 14.9
6/12 13.3
8/1 2.1
Nodule RML SUV 1.3 5mm
Rolles 3 of 4 lung nodules cancer
KRAS
Chem-sens test failed Not enough ca cells to test

Rock_Robster
Posts: 1028
Joined: Thu Oct 25, 2018 5:27 am
Location: Brisbane, Australia

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby Rock_Robster » Tue Apr 02, 2024 11:49 pm

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.
41M Australia
2018 Dx RC
G2 EMVI LVI, 4 liver mets
pT3N1aM1a Stage IVa MSS NRAS G13R
CEA 14>2>32>16>19>30>140>70
11/18 FOLFOX
3/19 Liver resection
5/19 Pelvic IMRT
7/19 ULAR
8/19 Liver met
8/19 FOLFOX, FOLFOXIRI, FOLFIRI
12/19 Liver resection
NED 2 years
11/21 Liver met, PALN, lung nodules
3/22 PVE, lymphadenectomy, liver SBRT
10/22 PALN SBRT
11/22 Liver mets, peri nodule. Xeloda+Bev
4/23 XELIRI+Bev
9/23 ATRIUM trial
12/23 Modified FOLFIRI+Bev
3/24 VAXINIA (CF33 + hNIS) trial

Carmark
Posts: 1
Joined: Wed Mar 27, 2024 5:12 pm

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby Carmark » Wed Apr 03, 2024 12:04 am

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
Posts: 1855
Joined: Mon Jun 13, 2011 1:13 am

Re: VAXINIA (CF33 + hNIS) clinical trial

Postby rp1954 » Wed Apr 03, 2024 1:53 am

Rock_Robster wrote: 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.
watchful, active researcher and caregiver for stage IVb/c CC. surgeries 4/10 sigmoid etc & 5/11 para-aortic LN cluster; 8 yrs immuno-Chemo for mCRC; now no chemo
most of 2010 Life Extension recommendations and possibilities + more, some (much) higher, peaking ~2011-12, taper chemo to almost nothing mid 2018, IV C-->2021. Now supplements


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