Update from iSCIB1+ Clinical Advisory Meeting
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Scancell Provides Update from iSCIB1+ Clinical Advisory Meeting to Strengthen Plans for Phase 2/3 Registration Clinical Trial
A panel of international key opinion leaders in the treatment of Melanoma convened in Chicago to offer strategic guidance in the design of Scancell's Phase 2/3 seamless adaptive registration study.
The SCIB1 stage 1 clinical data poster was very well received at ASCO.
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, today announces that a group of leading medical oncologists in the field of melanoma treatment reviewed and strengthened Scancell's plan for a Phase 2/3 registration study following completion of the ongoing SCOPE study.
Scancell's plans to conduct an adaptive randomised controlled Phase 2/3 SCOPE-2 trial is supported by a panel of experts. The study is expected to have an early interim analysis of Overall Response Rate (ORR) based on a blinded independent centralised review of CT/MRI scans before advancing to the Phase 3 component where the primary endpoint of progression-free survival will be analysed at a predetermined landmark.
The panel comprised the following members:
| Name | Institution |
| Paul Chapman | Weill Cornell Medicine and NewYork-Presbyterian, New York, NY, USA |
| Pippa Corrie | Cambridge Cancer Centre, Addenbrooke's Hospital, Cambridge, UK |
| Alexander Eggermont | Princess Máxima Center for Pediatric Oncology, Utrecht, Netherlands. |
| Georgina Long | Melanoma Institute Australia, Sydney, Australia. |
| Sapna Patel | University of Colorado Cancer Center, USA |
| Michael Postow | Memorial Sloan Kettering Cancer Center, New York, NY, USA |
| Heather Shaw | University College Hospital, London, UK |
| Jeffrey Weber | Pelmutter Cancer Center, New York, NY, USA |
| Jedd Wolchok | Weill Cornell Medicine and NewYork-Presbyterian, New York, NY, USA |
A poster, presenting the first stage of the SCOPE study, was also very well received at ASCO with Prof Durrant, Dr Heather Shaw, Dr Robert Miller and Mr Fayaz Master discussing the results for three hours with oncologists, pharmaceutical companies and commercial enterprises.
Scancell continues to recruit to the SCOPE study, which includes patients treated with SCIB1 as well as iSCIB1+. 32/43 patients have been recruited into the SCIB1 cohort and 22/43 into the iSCIB1+ cohort, with clinical results expected in Q4 2024 and Q1 2025, respectively.
Prof Lindy Durrant, Chief Executive Officer, Scancell said: "We are very grateful to the esteemed panel for their interest in our SCOPE results and their input into our further clinical study. The panel felt that the data was compelling enough to proceed to the Phase 2/3 randomised registration study upon the completion of the SCOPE study. We were also overwhelmed by the interest in the poster, which is the most significant response I have seen in my career."
- Wolchok serves as an uncompensated consultant for Scancell Limited.
- Chapman serves as a compensated consultant for Scancell Limited.
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