Media Thread, page-12317

Hi AlCp,

Do you think all the patients already dosed with CF33 and whose cancers have stopped growing will also be waiting for the end of Phase II to confirm efficacy? What about the patient who went through four prior lines of therapy and has now been cancer-free for over a year and a half?

I take your point that Phase II is generally related to efficacy, but you are omitting highly relevant context. Keep in mind, almost every approved or clinical stage therapy out there has significant side effects; even Keytruda has been knocked back on certain indications based on efficacy/side effects tradeoff not being great enough. But, when a therapy already has safety in spades, coupled with very early responses (efficacy), as IMU has with CF33, the Phase I expansion cohorts will likely be able to serve as Phase II/III equivalents. That is, the Bile Duct expansion trial and others that have yet to be announced have the potential to prove CF33 for approval earlier than Phase II/IIIs. Don't take my word for it though; see here for the FDA's stance on the use of expansion cohorts. It's a worthwhile read, but if you don't want to read it, all the title is telling: Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry.

I'm not saying there won't be a requirement for Phase II/III, but I am saying that if anyone is waiting for Phase 2 completion for a commercial deal here, they haven't done enough research or are ignoring key information IMU has presented.

Cheers.