Nice post, action
I particularly liked what you said here: "
The biggest stumbling block is TIME. it's not as if they can put another 20 scientist on the payroll to speed up the process. One thing that did impress me was that they have a very strong desire to get it right the first time. They would rather wait and get it right and nailed down before they go to the next step than do something that means they have to backtrack.'
This is exactly why Biotech requires patience (as well as patients). I am also heavily invested in a junior mining exploration outfit, which has made a huge discovery in battery related minerals/rare earths. To speed up their progress they have raised cash and brought in more drill rigs, as well as getting some dedicated analysis equipment at an assay lab. There are still delays with any results, because of pressure on the assay labs, but they are setting a blistering pace.
By contrast, Biotech results require you wait for
biological processesto take their course - and that cannot be rushed. For Her-vaxx - it's the time required for the patients to develop antibodies and for the antibodies to attack the cancer cells, while at the same time the cancer cells themselves are multiplying. It's like an agonisingly slow pursuit race in cycling. Which will be fastest - the cancer cell replication rate or the rate at which antibodies can be produced and destroy the cancer cells?
It's the same for the Checkvacc CF33 variant trial - and Yuman mentioned this in Sydney. The metastatic breast cancer patients are so unwell, with such advanced disease, that it's really really hard to beat the cancer cell replication rate - especially given the low low low dose of CF33 they were required to start with. The cancer cells have a massive head start on the virus, with each side replicating as fast as it can, but the virus starting with a very low population and the cancer cells starting with a huge one.
Going way back in time, there was an excellent video presentation by (I think) Dr Axel Hoos - former IMU Board member and (at the time) Senior VP for Immune-Oncology research at GSK. Earlier in his career, when he was working for Bristol-Myers Squibb, Dr H led the team which developed Yervoy (Ipilimumab), the first checkpoint inhibitor in Immuno-Oncology.
Axel's video - which I can't find right now - describes clearly how Immune-oncology treatments take time to "ramp up" and show impact on cancer. In the development of Yervoy, to the concern of the researchers, the patients continued to get more unwell after starting treatment. They thought the treatment was a failure. All patients showed as "Progressive Disease" against the standard measures.
And then - for some of them - that changed. The tumour size peaked, then it started to retreat......
This "delayed response" is a characteristic of immune related oncologic therapy - and it resulted in Axel and others developing a whole new set of response criteria for evaluating the effect of immuno-oncology drugs in clinical trials. You can read about it here:
https://www.longdom.org/open-access/immunerelated-response-criteria-78321.htmlThe original video is truly fascinating - but I can't find it. Of course memory is fallible - and it is possible that the video I'm thinking of is with a different person, talking about the early trial of Keytruda in Melanoma. It doesn't really matter though, because the principle remains the same; Immuno-oncology treatments take time to ramp up, and so the patients actually get
worsebefore they start to get better.
I would suggest that this is why Yuman, although still very positive, was more cautious in his comments during his previous presentation tour back in November. My interpretation of his extremely upbeat comments this time around is that some of the patients, in one or more of the Vaccinia and Check-vacc trials, have passed the point of "peak" tumour size and are starting to improve. That would be a reasonable explanation for Yuman's reported comments in Melbourne that we are now seeing in humans what we saw in the animal studies. (Note - in the tree clinical mouse studies most of the mice were literally
cured of cancer). And at the Sydney event I personally heard him say that "
we are already seeing unequivocal evidence that we are killing cancer in humans...by itself, without a second agent."
I really did literally get goosebumps when he said that. I have replayed my recording several times!
And sure - yes - until the results are peer reviewed and published, this is all speculative. It will also be early/preliminary data that Yuman is talking about publishing. The full story will take longer to play out because - as above - these are biological processes, of virus and cancer growth, of tumour cell death and - hopefully - of long and healthy life for at least some of the patients for whom this is their last chance....
I do think of them daily, and I send my very best wishes to readers who are fighting that battle, or loving and caring for someone who is.
Regards
Dave
(20min delay)
