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Azercel / PBCAR0191 toxicitySadly this forum has become so toxic...

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    Azercel / PBCAR0191 toxicity

    Sadly this forum has become so toxic and the vomit that has been present for the last few months is absurd. The speculation is ridiculous - but it follows the age old pattern. In the absence of news, rumours abound and the wolves have their play of the field. I don't expect this to change, it is human emotion that drives the market and those drivers are what create the best opportunities. Be greedy when others are fearful and fearful when others are greedy. The general sentiment of the Imugene investment community here at HC is certainly one of fear, and so those who have learned to buy in these 'uncertain times' are the ones who will benefit in the long run. While we have had little in the way of updates, we have not had any negative news. No news is not negative, it is just no news. The news we have had has all been positive. For the record, I am comfortable with my holding - I have not sold any, and should the price continue to drop I may consider taking advantage of the leverage and buying more.

    Why have I said that we've had positive news, even in the current cycle of the toxicity updates for Azercel? Let's recap:
    • We licensed Azercel at an absolute steal. The cost to Imugene was negligible for the product we got, so even if azercel turns out to be a non event, the punt had been worth it.
    • This data on the toxicity is not new to Imugene. Anyone who thinks Imugene was not aware of this at the time of signing the license doesn't have a clue about due diligence. The data reflects the patient numbers and %'s that been known for ages. Just because the toxicity is new to us, doesn't mean it's new to Imugene.
    Geta grip people.

    I've ceased posting on HC because of all the crap, and only read now and then. Out of respect for the professor I've been asked to post his reply.

    Hi Zior,

    ****** forwarded me your email about your concerns about Azer Cel toxicity. What people are referring to is a talk given at a CAR-T conference a few months ago. Here's a link to the conference:


    Look for Bijal Shah's presentation: "Updates for allo CAR-T PBCAR0191".

    Bijal Shah is basically presenting a developmental history of Azer Cel. He talks about the different trials they ran using various lymphodepletion (chemotherapy) and dosing combinations. In the video presentation he walks you through the various trials and discusses the results.

    In summary, they found out that certain combinations produced powerful results (100% CRs)...but with serious grade 5 side effects (including death). Their goal was to produce a "good" CAR-T drug with minimal side effect. So they chose the combination that had virtually no side effects with "good" levels of efficacy. Not the "best" efficacy.

    IMU is selecting patients that have failed of autologous CAR-T drugs.The trial data showed that this patient cohort had even better results. This group should provide an additional "bump" in the efficacy numbers with excellent overall safety.

    All CAR-T drugs require lymphodepletion. This basically wipes out the patient's immune system. This can leave a patient vulnerable to infections, much like with AIDs. This step is necessary to give the CAR-T cells the best chance at survival. So the key is to come up with the best "cocktail". Balancing CAR-T killing power with patient safety.

    So yes, Leslie and company certainly knew the developmental history of Azer Cel. They certainly knew the parameter boundaries that shape patient outcomes--in terms of efficacy and safety. The balance.

    My understanding is that the current Azer Cel expansión study is using the "sweet spot", in terms of dosing and lymphodepletion. So there should be no worries about toxicity.

    The professor
    Last edited by Zior: 03/07/24
 
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