RE: Imminent9 Jul 2025 23:22
Greenshaw,
I think it depends entirely on whether they're aware of the reason and what it is. For example, it appears there have been some patients who have suffered from severe side effects following the first dose of the doublet CPI therapy, leading to a pause/delay before they go on to have their second dose. The treatment to manage CPI toxicity is steroids which of course are an immunosuppressant. These patients may not have had enough time/doses of SCIB1/iSCIB1+ to mount a strong enough memory T cell response before treatment with steroids and before they continue treatment. I'm not saying for one moment that this will cause a drop in ORR, but if it did, we know Scancell have adjusted the dosing schedule for cohort 4 and have introduced an accelerated iSCIB1+ dose to overcome this.
The whole point of clinical trials is to learn from early results, not just to discover whether the therapy merits further development, but also to establish the optimum setting, dosing, patient population etc. etc. before moving on to much more costly larger studies. They'll only get one shot at a registrational trial and they have to absolutely certain that they give themselves the very best chance of success. So if there is a known cause for a drop in ORR (backed up with data) and there is a solution, I really don't think it would be a massive issue, we'd just have to wait for results from cohort 4.