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The CF33, Vaxinia and Oncarlytics Deal, page-20

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    Hi King

    Side effects, including toxicity, are a very important issue for most Immunotherapy. The T cell MAbs such as Keytruda, for example, or Herceptin, only work on a minority of patients and they do come with significant side effects. So do CAR-T drugs. For some people the side effects - especially Cytokine Release Syndrome - can require cessation of treatment. In a worst case they can be fatal.

    https://www.cancer.net/navigating-cancer-care/how-cancer-treated/immunotherapy-and-vaccines/side-effects-immunotherapy

    However - one incredibly powerful advantage of Imugene's B cell and CF-33 drugs is that they come with minimal to no serious side effects.

    Her-vaxx and PD1-vaxx induce the immune system to produce its own antibodies, instead of pumping the patient with artificially produced manufactured antibodies. Huge Advantages: Minimal to zero toxicity. Also far easier to administer (a quick injection instead of frequent long infusions). Far cheaper too. All we are waiting on is confirmation that they are also as effective - clinically - or more so, than the equivalent MaB's.

    CF-33 - so far at least - is also showing no toxicity, and minimal side effects. Note Yuman Fong's statement that in mice the CF-33 treatment started to become effective at a dose as low as 1,000 PFU (10 to the 3rd), but toxicity was not observed until they went as high as 1,000,0000,000 PFU (10 to the 9th). At the recent roadshow Yuman stated that he has never seen a drug with such a vast gap between the therapeutic dose and the toxic dose (6 orders of magnitude).

    What he is saying here is that CF-33 will kill cancers at a dose so much lower than the dose at which toxicity is seen, that toxicity just isn't an issue.

    Which really is remarkable.

    Of course any damage done by a tumour before it is shrunk or eradicated cannot be reversed by Imugene's treatments - but the treatments themselves will not make the patient more unwell, or cause damage.

    That really is a paradigm shift for Oncology. Which is why firm evidence of major clinical effectiveness will turn the Imugene products into front page news. ie. Once everyone can see that it really works and it's also safe.

    Note: OnCARlytics is a little different because it will be used in combo with an existing effective CAR-T drug. The Imugene OnCARlytics treatment will probably have zero side effects, but the CAR-T will have whatever side effects that CAR-T's can have.

    Of course, that's also why Imugene is partnering with Celularity and Arovella, because their CAR-T drugs (still in development) show the possibility of having fewer/milder side effects.

    Cheers

    Dave
 
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