Hi Tooch
Thanks! You are most welcome.
Look - it's a very good question. I think the short answer is "Yes." Both drugs are the CF33 Oncolytic virus, and it is reasonable to assume that the cancer killing ability of the virus is the same in both drugs.
A longer version:
The difference is that CHECKvacc has been genetically modified to include PD-L1 genes which should give it a dual action. The virus will replicate within cancer cells and destroy them - and the PD-L1 genes should give the same effect as a PD-L1 Checkpoint Inhibitor drug like Pembrolizumab/Keytruda. ie it will restore the ability of the patients Immune system to recognise the cancer cells as dangerous and attack them.
This is very handy in patients with a cancer which expresses PD-L1. My understanding is that around 20% of TNBC patients are in that category, so Keytruda has become the "go to" immune therapy for those patients. CHECK-vacc should also be able to help the other 80% though, simply through the cancer destroying ability of the CF33 virus.
The trial is for patients with Metastatic TNBC - ie TNBC which has spread to other parts of the body. Metastatic TNBC is a VERY hard disease to treat, with generally dismal outcomes. I believe the 5 year survival rate is around 12%. Dreadful....
So if there are signs of real clinical success in the CHECKvacc TNBC trial - stopping tumour growth/spread and hopefully reducing tumours - that will be electrifying news.
The Vaxinia trial - using the original CF33 virus - will be across a wide range of different solid tumours. If it helps in any - that will be very big news. If it helps in a range of tumour types - that will be massive news.
The other big hope is that C F33 will have an effect not just on a primary tumour site - but also on secondary tumours elsewhere in the body. The "abscopal" effect. Because it is a virus - it should in theory travel around the body and "find" any additional cancer cells - then attack and destroy them. Evidence of a systemic effect would be incredible.
Another super smart thing: Both versions of the virus also include the Human Sodium-Iodide Symporter (hNIS) gene. The hNIS gene makes the virus location visible in PET scans. Why is that good? Well - it means that researchers can "track" the virus through the body. They can actually "see" where the virus is replicating and working. If that location coincides with a tumour, and the tumour then shrinks or disappears - that right there is huge evidence of success.
Even better - a concentration of the virus in an unexpected area could allow the medical team to identify the presence of a tumour they had not previously detected. The presence of the hNIS on PET scans can also be used to guide much better targeted radiation therapy - another massive bonus.
I suppose it would be possible for the CHECKvacc trial to show no or minimal effect - just because TNBC is such a hard disease to beat - while still having success in the Vaxinia trial. The difference would just be that some cancers are harder to treat than others. That would seem unlikely though. The preclinical trials indicate that CF33 is a very powerful Oncolytic virus.
On the other hand, if the CHECKvacc trial really IS a success, then we would have very very good reason to expect success in the Vaxinia trial. The questions then would be around:
- Which cancers
- Degree of effect
- Variability in effect between cancer types
- Evidence of systemic effect
- Use of the hNIS for tracking and for guiding radiotherapy
Also, of course, which Big Pharma player proves to have the biggest chequebook.
It will take time, but we should already be close to dose escalation for the CHECKvacc trial. First patient dosing was 20 October. Second patient dosing was 7 December. We do not know - but third patient dosing would have been early Feb if they kept to the same rate (though it does depend on having patients who meet the selection criteria). If dose escalation happens soon - by mid year maybe we could potentially have an interim report on effectiveness to date, as was done with Cohorts 1 and 2 in the PD1-vaxx trial.
I can live with slippage on all that - because it does depend on availability of patients who meet the selection criteria - but it is an indicative timeline.
In any case, IMU has so much happening now that we can expect a lot of exciting news this year. Every single one of their products is a potential company maker. Sure - one or more of them could surprise to the downside and prove to be relative duds. But for ALL of them to fizz? Given the preclinical and clinical data to date, that seems seriously unlikely to me.
Her-vaxx; PD1-vaxx; CHECKvacc; Vaxinia; OnCARlytics.... (And I'm still not writing off B-vaxx, and I'm also expecting more B cell products from the Mimotope platform, and Prof Kaumaya is also working on several more).
IMU is the TARDIS of Biotech. Small on the outside - enormous on the inside.
Unlike the TARDIS, they can't jump forward in time, and neither can we. We just have to be patient.
I kind of wish I COULD go back to 2018 or earlier and but a few million more at 1 cent or less, but I also have a feeling that in a year or so people will be saying that about 2022 and IMU at 28 cents.
Personal view only - not to be taken as advice.
Cheers
Dave
(20min delay)