RE: RNS!15 Jun 2022 08:12
RNS Number : 8802O
Scancell Holdings Plc
15 June 2022
15 June 2022
Scancell Holdings plc
("Scancell" or the "Company")
Phase 2 SCOPE trial of SCIB1 vaccine in metastatic melanoma patients expanded
Additional cohort to test SCIB1 vaccine in combination with checkpoint doublet therapy
Protocol amendment broadens patient population for inclusion in the trial and enables faster recruitment to remain on track to deliver initial efficacy data in 2022
SCIB1 to be delivered using PharmaJet Needle-free Injection System
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces an update to the Phase 2 SCOPE clinical trial being conducted at multiple centres in the UK. Following the approval of a protocol amendment by the Medicines and HealthCare products Regulatory Agency (MHRA), the trial will include a cohort of melanoma patients who will receive SCIB1 plus doublet therapy consisting of ipilimumab (Yervoy®) plus nivolumab (Opdivo®) in addition to the cohort who will receive SCIB1 with pembrolizumab (Keytruda®). The updated protocol also allows all patients to receive the SCIB1 vaccine as a needle-free injection.
SCIB1 is the lead product from the Company's ImmunoBody® immunotherapy platform, which uses the body's immune system to identify, attack and destroy tumours. In a Phase 1/2 clinical trial, 14 out of 16 resected patients (89%) survived for more than 5 years following vaccination with SCIB1. The original Phase 2 study was designed to assess whether the addition of SCIB1 treatment to pembrolizumab results in an improvement in patient outcomes for patients with metastatic disease. The primary objectives of the trial are tumour response rate, progression-free survival and overall survival in patients with advanced melanoma. The amendment to the SCOPE protocol follows changes in the treatment landscape where the current most common treatment for metastatic melanoma patients is a doublet therapy combining two checkpoint inhibitors, ipilimumab and nivolumab.
Under the updated protocol the company will also test the SCIB1 vaccine delivered via needle free injection. To date, SCIB1 has been delivered using electroporation to enhance the uptake and presentation of the DNA vaccine to the immune system and, although electroporation is a proven delivery method, the Company believes that needle-free injection could provide enhanced patient acceptance. The Company is currently using PharmaJet Needle-Free Injector Systems in its COVIDITY trial being carried out in South Africa.
Professor Lindy Durrant, Chief Executive Officer, Scancell, commented: "The approved amendments will expand the patient population eligible to receive SCIB1 and are therefore expected to increase recruitment rates, allowing the study to remain on track to deliver initial efficacy data in 2022. We believe that SCIB1 administrat
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