Hi there friend Taurean
Yes - exciting! They will have started on a much higher dose than the MAST trial started at. So far as I can recall, there has been nothing that tells us the specific starting dose for OnCARlytics. I'm guessing that the first Intra-Tumoural injection patient (Ovarian Cancer), back in late October, received 1 x 10
8 PFU because that's the dose they had reached with Vaxinia at that point.
We haven't had an announcement of dose escalation for the IT arm of the OnCARlytics OASIS trial - but they should be pretty much at dose escalation by now. It's quite possible they
have already dose escalated without making an Announcement though. The last dose escalation in the MAST trial was not announced until well after it happened. I picked it up from a slide in the JP Morgan presentation on 10 Jan (my post:
https://hotcopper.com.au/threads/ann-imugene-to-present-at-annual-jpmorgan-healthcare-conference.7752505/page-100?post_id=71808446 ) but they didn't actually make it an Announcement until 19 January. That's 9 days after my post and probably a few weeks after dose escalation actually happened.
Both monotherapy arms of the MAST trial are now at 3 x 10
8 so I suspect they are now at that level in the OASIS trial. The OnCARlytics virus is just another version of CF33, as is Vaxinia, and it would seem reasonable that safety in the MAST trial is acceptable evidence for dose escalation in the OASI trial.
This is just an educated guess on my part though.
The thing I find very interesting indeed is that patient 1 for the IV arm of OASIS is a Bile Duct cancer - (also called Cholangiocarcinoma). As you know - that is the cancer type for which Vaxinia now has "Fast Track" designation from the FDA. The OnCARlytics virus is of course not identical to Vaxinia - but they are both based on CF33 and the viral killing and immune system activation effect should be similar, so if they achieve stable disease or better for this patient, then it will be further evidence that CF33 works against Bile Duct cancer.
(Cautionary note: Prof Yuman Fong has emphasised in the past that editing the genes of a virus can reduce its potency, so it is possible that the OnCARlytics virus has a less potent cancer killing effect than Vaxinia, because OnCARlytics has been gene edited to cause expression of the CD19 protein on cancer cells, to make them a target for CD19 targeting CAR-T therapies. So any cancer controlling/killing effect by OnCARlytics as a
monotherapy will be all the more impressive. After all - OnCARlytics was designed specifically for use in combination with a CD-19 targeting CAR-T drug).
Bile Duct Cancer/Cholangiocarcinoma is relatively rare. Liver cancer of all types only comprise 5% of all cancers. (Source:
https://www.wcrf.org/cancer-trends/worldwide-cancer-data/ ) and Cholangiocarcinoma is only about 15% of all primary liver cancers (Source:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8299326/ )
So I don't think it is a coincidence at all that IMU has chosen a (relatively rare) Bile Duct/Cholangiocarcinoma patient to be "first in" for the IV monotherapy arm of the OnCARlytics trial.
Anyway - this is all more evidence that IMU is well organised and pushing hard.
2024 is going to be a fascinating ride,,,,,
Cheers
Dave
(20min delay)