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Ann: Phase 1 CF33-hNIS Study Update - Positive Early Signals, page-124

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    Good morning @fungus123

    I am deeply sorry to hear about your partner's illness. Everyone here will feel the same - including some good people who maybe reacted a little sharply to your comments yesterday.

    A lot of posters here on the IMU forum are either living with cancer themselves, or helping a family member or friend who is fighting that fight. Many others have been through that experience. I suspect, across all those categories, a strong majority of IMU investors would be included. So there will be a lot of sympathy and support out there.

    I have been following Imugene for 10 years now, so at times that numbs me a bit to the understandable impatience we all feel for better treatments for cancer. Your post reminds me that the need is urgent, and far more urgent for some than for others.

    First up - I sincerely hope your partner does not fail their third line of treatment. I send every best wish and hope for a complete response and an ongoing remission. It does happen.

    You are correct when you say that there was not a lot of "new news" yesterday. In a recent post in the midst of everyone speculating about this weeks Conference presentation I made the comment that - if I was running Imugene - I would be inclined to leave a longer gap between data cuts just so that the next Announcement, when it comes, would be a truly major update. Although I do also appreciate that they want to get exposure for Vaxinia at major cancer conferences, and you have to take those opportunities as they come.

    Yesterday's update only included results for 6 additional patients, and they have only given a few select stats in the Announcement and in the Abstract. I was delighted by what I did see - because it appears to continue the encouraging trend we have seen to date, but for sure we do not yet have advanced data. I am hoping for more detail in the actual poster that will be presented. An update of the very informative chart that appeared on Slide 17 of the recent JP Morgan presentation would be good. I would also love to see a chart which shows results by cancer type as well as treatment arm. Duration of response would be good too. However, you can't fit a whole lot of info on a single poster, so we probably won't see those extra details at this event.

    The reason we only have data for 6 extra patients after a gap of 3 months is mainly due to the slow rate of enrolment ion the study. We have heard that they have Oncologists "lining up" to get their patients enrolled - which may be a bit of hyperbole on the part of LC but I'm sure they do have plenty of candidates. The delay is because the FDA imposed a very strict and cautious staged enrolment regime on the trial - which requires them to leave a gap of at least 3 weeks (the Dose Limiting Toxicity period) in between dose escalations on the Mono therapy arms, and 6 weeks between dose escalation cohorts on the Combo arm. And then after dose escalation each new patient has to wait 7 weeks for their first scan - without which there is no data.

    There are only 3 patients per arm cohort - so patient numbers through this dose escalation phase will always be small.

    We don't know if they have reached OBD yet in any of the trial arms. The Review Committee has to consider safety data for each cohort after the last patient in that cohort has waited out the DLT period. Then - and only then - can the Review Committee recommend either a dose escalation (if they think it is worth going higher), or a dose de-escalation (if they think they have overshot and the current highest dosage produced no meaningful extra benefit). You can see the detail near the end of this Ann from back on 13 Dec 2021.

    Once they do determine OBD for each cohort (and it may end up being different for each cohort) then enrolments should speed up. They are also holding off on the expansion group in Bile Duct Cancer until OBD has been determined.

    I do hope your partner never needs Vaxinia, or any other additional treatment.

    Very best wishes

    Dave




    Last edited by davybabyk: 18/01/24
 
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