RE: RNS17 Sep 2024 07:22
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, today announces that it has signed a strategic partnership with PharmaJet for supply of the Stratis® Intramuscular (IM) Needle-free Injection System for delivery of Scancell's Immunobody® SCIB1/iSCIB1+ DNA vaccine for both clinical development and commercial use.
Delivering SCIB1/iSCIB1+ intramuscularly via Stratis® has shown effective uptake of the DNA vaccine and has the potential to provide clinical benefit to patients with advanced/metastatic melanoma by allowing native cellular machinery to express the target antigen and induce a potent anti-tumour response. To date, 60 patients across 15 clinical sites have successfully received a total of 171 doses of SCIB1/iSCIB1+ via Stratis®.
Stratis® has U.S. FDA 510(k) marketing clearance, CE Mark, and World Health Organization Prequalification to deliver medications and vaccines either intramuscularly or subcutaneously and has been widely accepted and favoured by patients and clinicians throughout the SCOPE Study.
The license agreement has been completed in preparation for the Phase 2/3 adaptive registrational trial planned for 2025, building on the previously announced exceptional data from the first 13 patients receiving SCIB1 in the ongoing SCOPE trial. Clinical data is expected from SCIB1 and iSCIB1+ in Q4 2024 and Q1 2025, respectively. The delivery of SCIB1/ iSCIB1+ vaccine with Stratis® offers patients speed of treatment as an off the shelf therapeutic cancer vaccine with the convenience of needle-free delivery that enhances the patient experience.
Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "Securing long term supply for the PharmaJet Stratis® Intramuscular Needle-free Injection System is an important step in allowing the clinical and commercial development of SCIB1/iSCIB1+. We are pleased that PharmaJet's delivery system works effectively with our SCIB1/iSCIB1+ therapeutic cancer vaccines and offers a well-received immunisation for patients. Our ultimate goal for Scancell is to deliver an off the shelf, safe, tolerable, effective therapy that can provide potent and durable anti-tumour responses for unresectable stage IV melanoma which currently has a 5-year survival of 35%, according to the SEER database, and we believe this agreement will bring us another step closer to achieving this goal."
Dr Heather Shaw, Consultant Medical Oncologist, Mount Vernon Cancer Centre and the UCLH, commented: "The convenience of an off-the-shelf vaccine for patients, clinicians and the healthcare system is further optimised with the ease of delivery of SCIB1/iSCIB1+ with the Stratis® Needle-free Injection System. Our patients on the SCOPE study are very comfortable with the delivery system and our research team benefit from the convenience of delivering the SCIB1/iSCIB1+ via Stratis®."