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I hold a similar view.In my mind the only way to get OnCARlytics...

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    I hold a similar view.

    In my mind the only way to get OnCARlytics into humans is with an approved CD19 targeted therapy. Although promising they couldn’t put OnCARlytics with any of the other preclinical candidates (Eureka, Cellularity, ALA) or even Azer-Cel for that matter. None of them would get an IND nod.

    So the name of the game is prove the concept. Let’s not forget that even the likes of Amgen haven’t been approved for Blyncyto on solid tumours, it’s not their focus. In the same way Precision wasnt trying to get solid tumour market share with Azer-Cell.

    BP eyes and ears will start pricking up when results start showing it works in humans, likely before us shareholders know. Until then it’s likely an “oh yea, that’s interesting” just like the 100s of other therapies in preclinical or phase I trials…

    In my mind, we must wait for:

    1. Clear confirmation CF33 is doing what it’s meant to do. Huge risk reduction if this occurs.
    2. Confirm OnCARlytics can effectively cause solid tumours to express CD19.
    3. Azer-Cell gets approved.

    If 1 occurs we can say CF33 is validated. If results are great, “same as we saw in mice” (I.e. CRs & PRs at RP2D) it’s a high value product on its own. Could be bought out/licensed as a stand alone therapy. If the results are good but not amazing, CF33 finds all tumours and replicates, and engages the bodies immunity but doesn’t eradicate the tumour in a meaningful way (CRs PRs) then we will need to rely more heavily OnCARlytics as that’s the “1-2 Punch” and potentially had more cancer killing ability. If CF33 is a duster then we all know what that means. On the other hand if it works well and OnCARlytics also works, the whole portfolio including Azer-Cell will have confirmed significant value (to BP not necessarily SP).

    It might seem obvious but if OnCARlytics works, it has the potential to open the doors to a lot more therapies, not just CD19 directed ones. Any therapy thats effective at killing/inhibiting any biological target becomes a potential partner for OnCARlytics. No need to test the patients cancers for HER-2, PD1, LAG targets, OnCARlytics can find the one that will get expressed by the most tumours once piggybacked onto CF33 and then use the appropriate target therapy (an oversimplification but that’s the gist).

    ADCs have gotten massive amount of investment because they aim to add monoclonal antibody targeting to chemotherapy. Arguably one of the best monoclonal antibodies Keytruda had an average response rate of 26% across 14 different trials (see ). ADCs offer a big movement in the right direction for treahttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6527794/ting cancer but if OnCARlytics is proved it’d blow right past ADCs in terms of scope, safety and efficacy. Possibly moving the dial from 26% RR to 60%+ RR with relatively little toxicity cannot be understated. It’s still a big IF but that’s the size of the opportunity IMU have.

    Still too early to call it, but the next few weeks will be the most significant ever for IMU. Although, I think we will still need to wait sometime to get results that will be reflective of CF33 capabilities, if they are eventually show it does what it’s designed to, I have no doubt in my mind a commercial ($$ signs) will soon be forthcoming.

    Cheers.

    Last edited by Jov88: 29/10/23
 
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