Good post bavarian, but a few questions:
The first trial was comparing Her vaxx combo with chemo to... Chemo alone.
So it seems that, the only outcome re- commercialisation was going to be with a Chemo company.
Perhaps there was interest as Steini has mentioned earlier and it was knocked back as not sufficient.
Merck (Keytruda) and others may even have been interested. Yet what data are they going to go off? Data with Chemo alone. So they ask, or it is inferred, we would really be interested to see in combo with our drug. So along comes new trials with Hervaxx in combo with chemo vs Hervaxx combo with Keytruda. These trials appear to be specifically designed to see the effect of a Merck combo.
Why do you think Merck would be interested now? Do you think they were waiting 8 years to see HER-Vaxx administered with chemo to 18 patients before deciding that it would be interesting to see what happens if its administered with Keytruda? And even if this is the case (ie the interest was stimulated by interim HER-Vaxx trial results) wouldn't you expect Merck to at lease part-fund a combination trial? Or provide free product? Or even wish IMU well in a joint press release?
So after these say another 12 months - perhaps IMU will be in a position to shop around with Merck.
Now in hindsight you could say, why do the combo with chemo in the first place? All very easy to say, but impossible to know. Even with the Merck combo - who knows what will happen.
Impossible to know? I can't be as forgiving. What's the point of recruiting execs from BP and paying them millions if they don't know what's the most likely path to commercialisation? Why didn't they have the conversations with the chemo companies before spending as long as they did on the trial? Why didn't they engage with Merck (assuming Merck is actually interested) years earlier? Biotech investors take the >90% risk that a drug won't make it through clinical trials. They are not really signing up for the risk that the drug makes it though, but still fails to be commercialised.
What I do know is that IMU has not suddenly changed the strategy toward combo, mid last year there is an integrity with how they have been progressing. Why does this matter? I don't think there is some really bad things they are hiding, or that Hervaxx is dead. Does it mean Hervaxx is a certainty re commercialisation at end? who knows? But it probably lies somewhere in between dead or certainty.
I'm not sure about the integrity. There has still never been an "ethical" reason presented for stopping the HER-Vaxx trial. As things stand, according to IMU, chemo + HER-Vaxx is better than chemo alone. However no cancer sufferer can now access this combination. Even if there was no one willing to fund further trials, completing the Phase II trial would have enabled another 18 patients to access this combination. Where are the ethics in denying even those patients?
I also can't see the integrity in Leslie's "dance cards full" comment and refusal to rectify. She presented a case that the HER-Vaxx trial was being ended early (on advice from the IDMC) because it would be unethical to continue. The implication was that the benefit of HER-Vaxx was so evident that there was no reason to continue with a Phase II trial, and that any second now, a dance partner would appear to buy / licence HER-Vaxx and take it through to a registrational trial. Even if that was her genuine belief at the time, why hasn't she come back to shareholders and admitted the mistake? "Sorry, I / the management team were of the belief that a BP deal for HER-Vaxx was imminent, but for reasons xxxxx it hasn't eventuated. As such, we are progressing with new clinical trials of combination therapies to see if we can garner the interest of other BPs". A very clear explanation about why this round of Phase II trials is likely to result in a better outcome is required. IMO, not doing this shows a lack of integrity.
The integrity issue is a big one. All fund managers / investment companies will list "quality of management team" at the top of their list of investment criteria. The capital raise shenanigans (Hopper), and Leslie's missteps in assessing the interest of BP (including the embarrassing supply agreement announcements from last May) have damaged IMU.
At sub-10c per share IMU should be a good gamble re: CHECKVacc + Vaxinia. The problem is, to advance these to and through Phase II will require more capital. You can see at CHM how difficult this is proving for essentially the same management team. Maybe they should be lowering the cashburn or focusing it on CHECKVacc and Vaxinia. Yet they continue to invest in HER-Vaxx without even an explanation about what happened after the shortened HER-Vaxx trial and why we should expect better outcomes with the current HER-Vaxx trials.
Really not having a go. Genuinely interested to understand how the supporters reconcile these issues ...
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