Positive data from Phase 2 SCOPE trial with SCIB1

Scancell announces further positive data from the ongoing SCOPE trial of SCIB1 with double CPIs for Advanced Melanoma

80% Progression Free Survival in 25 patients at 6 months

20% (5) patients have shown a complete response following treatment

Disease Control Rate of 84% and an Objective Response Rate of 72%

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, announces today that 25 patients in cohort 1, receiving SCIB1 in combination with ipilimumab and nivolumab, have reached the 25-week landmark point of the SCOPE trial. These patients are showing progression free survival (PFS) of 80% at 6 months, with 5 (20%) complete responders (CR). 21 of 25 patients (84%) have shown disease control (stable disease or tumour regression, DCR). 18 out of 25 patients have shown a clinical response which is an objective response rate (ORR) of 72%, with many patients continuing to show tumour shrinkage over time. These responses have been verified in all patients with further scans at 19 and 25 weeks.

These results compare favourably with reported outcomes from the double checkpoints alone, namely PFS of 65%, CR of 16%, DCR of 58% and ORR of 48%, respectively. The PFS and accumulating number of complete responders indicates that the combination of SCIB1 with double checkpoints gives sustained and durable responses which are improved when compared to double checkpoints alone. To date, cohort 1 of the SCOPE trial has recruited 42/43 patients, and it is anticipated that all of these patients will reach week 25 during H1 2025.

Dr Heather Shaw, Medical Oncologist, University College Hospital, London, UK commented: "Based upon the emergent striking PFS, DCR and ORR results from cohort 1 so far and the lack of toxicity relating to the agent itself, SCIB1 is a promising product that would be a significant addition to ipilimumab and nivolumab and would be an important step forward in improving first line therapy for advanced melanoma patients. "

Cohort 2, investigating SCIB1 in combination with pembrolizumab, has recruited 9/43 patients and cohort 3, investigating the next generation, iSCIB1+ in combination with ipilimumab and nivolumab has recruited 33/43 patients. The iSCIB1+ cohort has predominantly recruited the non-HLA.A2 matched patients as these patients are being enrolled in cohort 1. Once recruitment in cohort 1 is complete, HLA.A2 patients will be recruited to complete cohort 3 to give a representative sample of the advanced melanoma patient population. It is anticipated that all cohort 3 patients will reach week 25 during H2 2025. This will allow us to select the best vaccine for our planned phase 2/3 randomised, adapted registration trial.

Prof Lindy Durrant, Chief Scientific Officer, Scancell, commented: "The SCOPE study continues to yield excellent results with a PFS of 80% and five patients now achieving a complete response. We are particularly impressed with the progression free survival data as this will be the primary endpoint of the next trial, a phase 2/3 randomised, adapted trial, and the key outcome for product registration. We look forward to providing further updates on our progress given the extremely positive results to date."

About SCIB1/iSCIB1+

SCIB1 is the lead product from the Company's ImmunoBody® DNA Vaccine platform, which uses the body's immune system to identify, attack and destroy tumours. SCIB1 is restricted to HLA.A2 matched patients. iSCIB1+ is a modified version of SCIB1 developed using Scancell's AvidiMab® platform to enhance its potency compared to SCIB1. iSCIB1+ also includes additional melanoma-specific epitopes so it has the potential to be effective in a broader patient population beyond the 30% of HLA.A2 matched patients with the tissue type treatable with SCIB1, where treatment is human leukocyte antigen (HLA) dependent.

About the SCOPE Study

The SCOPE Study (NCT04079166) is a Phase 2, Multicentre, Open-Label, Umbrella Study of SCIB1 and iSCIB1+ in Patients With Advanced Unresectable Melanoma Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab to determine the response rate and safety and tolerability of intramuscular SCIB1 or iSCIB1+ when added to nivolumab (Opdivo) with ipilimumab (Yervoy) or SCIB1 with pembrolizumab (Keytruda). Conducted across approximately 16 participating sites in the United Kingdom, this multi-site trial aims to demonstrate durable and potent anti-tumour activity and ORR of SCIB1/Iscib1+ in addition to standard of care checkpoint inhibitors. Additional endpoints include duration of response (DOR), progression free survival (PFS), overall survival (OS), safety, and tolerability. Participants receive up to 10 doses of either SCIB1 or iSCIB1+ using PharmaJet Stratis® Intramuscular Needle-free Injection System in the upper arm or upper leg, up to 85 weeks, in combination with nivolumab with ipilimumab or SCIB1 with pembrolizumab. More information on this trial can be found at clinicaltrials.gov or www.clinicaltrialsregister.eu.