Road Ahead ......... What do we know ?5 Nov 2025 19:57
From what was said at the AGM, what do we know that we can be confident about ?
A ) GenMab are currently manufacturing a trial size batch of one of our Glycan Targets.
Plus there was confidence that a Ph1 Study will start in early 2026.
This will trigger a small milestone payment of between $2 and $4 million.
B ) SCOPE Trial : There are in depth regulatory discussions already underway with the FDA, MHRA and the EMA.
This is to pave the way for a well designed Registration Trial to start in 2026, the earlier the better.
A main priority for the trial will be Progression Free Survival (PFS). The FDA are focused on the PFS as a means to assess 'value for money' when awarding new drug approvals.
C ) With some high profile mRna Tailored trials being shelved or not reaching their Trial End Points, Scancell's "Off the Shelf" Vaccine should be attracting potential partners.
D ) ModiTope Trial : We know very little about how this trial is progressing in 2025. The delay could be down to Scancell wanting to achieve both, The highest number of Patients that have reached their 13 week scans, and Having the Maximum 'PFS' data possible. Which I would totally agree with.
The ModiTope Update is now time tabled for 'before the end of this year' and the way it was discussed with enthusiastic confidence it does reassure me that the results from RCC plus the double checkpoint, when released' will be very good or better.
Hopefully we will hear some new details from the SCOPE Trial at this weekends SITC Conference.