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robvano79 122 posts  |  Last Activity: 5 hours ago Member since: Apr 1, 2012
  • Why is ONCS one of the safest, if not THE safest, FDA bet currently?

    Apart from it having the best in-class response rates out of 150 other clinical trials, the basic fact is that ONCS is not really testing a new "drug". It is merely testing a proven PLASMID applied with a proven delivery method. What is being tested is solely their conjunction (patented by ONCS); hence the ingenuity and risk-mitigated profile of this investment. If you don't realize the implications, I'll spell it out. We are not testing here a "new" drug with a mysterious mechanism of action, which would be impossible to guess efficacy. That's the thing with most biotech plays; we are, more or less, gambling here since most of us are not scientists/ don't have access to the continuing trials. If we have a new drug, we simply do not know if it will work. We might have some P1 results which have a lot of times proven to be terrible indicators for future results, and that's it. Can we say this for ONCS? No. The reason being that the Interleukin 12 plasmid has been PROVEN, for a few years now, in its cancer fighting immune boosting ability. The problem with it has been that systemic application leads to horrible side effects.
    Here comes $ONCS; with the patented OMS method of Immunopulse they have devised a way to apply the plasmid locally through electroporation ("locally" here means that they apply it directly into the tumor, as opposed to systemically where the drug is injected in a vein, for example, leading to the drug being distributed throughout the body) . Not only does this eliminate the side effect of the plasmid but it also boosts efficacy. So we have here a proven Plasmid + a proven delivery method.
    So what exactly is being tested, if they're both "proven"?
    What is being tested, as I said, is their conjunction. That's it.
    This logical deduction makes investing in ONCS, at least for me, an absolute no-brainer.
    (Keep in mind that my stating that we're "not testing a new drug" should be understood in the figurative sense, as supported by my argument above. Because after all, technically we are testing a new drug. Otherwise Oncosec's OMS method would not have its own patent and we wouldn't be going through FDA trials. This was only to point out the risk mitigated nature of basing a treatment around two independently proven components.)

    What is an added awesomeness about Immunopulse is that, despite a local administration of the IL 12 plasmid, evidence is pointing to a systemic result. This is HUGE. that means that not only is the tumor where the electroporation is applied disappearing; but also tumors throughout the body. If or when this is confirmed, the outcome will be highly lucrative...

    And this evidence was just reinforced on December the 16th:

    Importantly, 61.1% of patients (11/18) with evaluable lesions exhibited systemic antitumor immune responses, as evidenced by objective regression (30% reduction in size) in at least one untreated lesion.

    Now, keep in mind that IMMUNOPULSE was meant as a local treatment. It was meant to work on the tumors where it was applied. It already did this. But ON TOP OF THAT, for 61% of the patients, there was a systemic response as well. Meaning that not only did tumors where Immunopulse was applied shrink, but ALSO tumors where it was not applied. That's what a systemic response is, and to get a systemic response for a local treatment is huge.

    Some of you might now be saying, "well this is a phase two trial, how do you know the efficacy won't drop further down, how do you know Immunopulse is what's benefiting and not some kind of cherry picking of patients (as seen with the IMUC, for example)?"

    Let me tell you how this is different from IMUC. You might know that IMUC demonstrated 50% efficacy in their phase one, only to horribly disappoint with their phase 2, where they showed no statistical significance and lead to 70% bloodbath of a drop in PPS.

    Something to keep in in right off the bat is that, for obvious reasons, ONCOSEC and IMUC should not be compared at all. Their treatments are entirely different, one was a systemic cancer vaccine, the other is a local IL12 application via electroporation. So they are apples to oranges, or apples to lobster, rather. My only reason for bringing it up is to evaluate the general claim that efficacy might drop further down in trials, as is usually seen with many many biotech's. Some drop a little some drop totally like IMUC. So, this distinction is only one about general "trial structure".

    Now, there is a significant difference between the way Immunopulse trial is set up vs the way the IMUC trial was set up for example.
    ICT-107 was given on top of standard of care, after total or near total resection of tumor by surgery and after significant doses of TMZ and radiation, etc. At the time when ICT was applied there was virtually no tumor, it had been surgically removed, plus dosed with chemo radiation and the works. Thus, the longevity of some of these patients could have been merely attributed to the standard of care administered before IMUC (and age). Actually this was the case, since there is no other way to explain the total disaster seen in IMUCs phase 2 trial.
    Immunopulse, on the other hand, is dosed directly into the tumor, in patients with advanced stage tumors who might or might not have had prior treatments. And for those that might have had prior treatment, they still "must have PROGRESSIVE disease after therapy" and "a minimum of two eligible tumors and may have up to four eligible tumors treated with electroporation." all stage 3.

    So if we're seeing tumor shrinkage here and in some cases total systemic response, then necessarily Immunopulse is what's causing it, since we cannot attribute these effects to anything else, any other treatment. (not surgery, not chemo or radiation, since the patient must still have progressive disease and substantial tumors after treatment, ie. it is a condition that the previous treatment, IF THERE WAS ANY, must not have worked for them to be accepted into the immunopulse trial)

    With IMUC, on other hand, the standard of care treatment before ICT, in conjunction with age, could have very well been responsible for increase in survival seen in ph1.

    So we see that where the IMUC phase 1 trials looked good because of cherry picking, ONCOSECS phase two trials look good because Immunopulse is actually doing its job, as we cannot attribute success to any other factor here.

    Another thing to keep in mind is that Immunopulse is being tested in three separate phase 2 trials. One for melanoma, one for Merkel Cell (which is of orphan drug indication, thus highly lucrative and basically a shoo-in approval with FDA on the slightest benefit shown), one for Squamous Cell. So positive results on one of the trials serves as further validation for ALL the other trials, as the treatment is the SAME and they're all skin cancers.

    Going back to the ICT example again, you should know that another reason why ICT-107 failed, scratch that, why a lot of SYSTEMIC cancer vaccines fail is the antigen targeting system.
    I've been in a debate with NWBO longs over this very issue as they think the fuller antigen profile of D-Vax will make up for the horror seen in IMUC.
    I think that's a rather shaky bet.
    The moment you introduce such secondary mechanisms such as antigen systems, you're opening up the room for error. Tumors constantly adapt as there are thousands upon thousands of subtypes and the antigen profile recognized for one will not be recognized for the other (within the same person even). Or even if they are the correct antigens there is never a guarantee that the loading into the dendritic cells will lead to a proper structuring within the Tcells. Plainly put: you never know if the drug is even reaching the tumor. The moment you introduce antigen systems, you're opening up one other venue for error. ICT-107's synthetic antigen profile might have not been recognized by the tumors at all, as those antigens were probably never expressed within that specific tumor. ICT-107 probably never reached its target for most people..hence the disaster. people are saying that NWBO has a fuller antigen profile which will make up for this. This might be true. I'm just very skeptical and steering the f away from it.

    Why muddle up things with antigen systems?

    Here comes in the beauty of the LOCAL treatment of $ONCS IMMUNOPULSE. The IL-12 plasmid is being directly applied into the tumor's cells through electroporation. No need for anigen systems. No room for error. We know the drug is reaching its target because we are LITERALLY applying the DNA plasmid directly into the tumor's cells themselves.
    Simpler. Better. Stronger

    Info on burn rate: around 500 000$ a month (dare you to find a biotech with such a low burn rate, especially one with 3 phase 2 trials!), meaning we won't see dilutive financing for AT LEAST another full year. By that time, a partnership is a likely option/ other means of financing will be likely given continued success so we might not see dilution at all.

  • Reply to


    by robvano79 Mar 23, 2014 1:06 PM
    robvano79 robvano79 Jun 1, 2014 12:53 PM Flag

    bump for asco

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