Completion of the ModiFY Monotherapy Dose Finding Arm23 Feb 2023 14:07
I am confused by some of the wording in Monday’s RNS, it states (Capital letters are mine for emphasis):-
“Scancell Holdings plc ……………………….. today announces completion of the MONOTHERAPY DOSE FINDING ARM of the multicentre Phase 1/2 ModiFY clinical trial.”
“So far, initial clinical responses have been assessed in 14 patients reaching the first imaging evaluation timepoint at week 8. Of these patients, one has had a confirmed partial response and seven patients have stable disease, despite having progressive disease prior to enrolment in the study. As no dose limiting toxicities were observed in the monotherapy dose escalation cohorts, patients continue to be enrolled into both the ongoing monotherapy expansion cohorts and the CPI combination dose escalation cohorts during H1 2023. “
The 14 patients evaluated consist of 3 from cohort 1, 3 from cohort 2 and 8 from the monotherapy expansion cohort. The wording “Scancell……………….today announces completion of the MONOTHERAPY DOSE FINDING ARM” implies to me that Scancell were experimenting with dosing levels in the 8 in the monotherapy expansion cohort and that the best level of dosing has now been determinined. AIMO
However, the RNS appears to contradict itself, it also states:-
“Based on the safety data from Cohort 2, the ModiFY trial was expanded AT THIS RECOMMENDED PHASE 2 DOSE for Modi-1 monotherapy in all four tumour types.”