Clinical-stage biopharmaceutical company Scancell has signed a strategic partnership agreement with PharmaJet for the supply of PharmaJet's needle-free Stratis delivery system for the delivery of Scancell's advanced melanoma vaccine for both clinical development and commercial use.
The Stratis Intramuscular (IM) Needlefree Injection System has received U.S. Food and Drug Administration (FDA) 510(k) marketing clearance, the European Union's CE Mark, and World Health Organization (WHO) prequalification to deliver medications and vaccines either intramuscularly or subcutaneously. Under the terms of the agreement, the Stratis system will be used to deliver Scancell's Immunobody SCIB1/iSCIB1+ DNA vaccine.
The intramuscular delivery of the SCIB1/iSCIB1+ vaccine has demonstrated effective uptake of the DNA vaccine, Scancell said in a statement, with the potential to provide clinical benefit to patients with advanced and metastatic melanoma through allowing native cellular machinery to express the target antigen and induce a potent antitumor response.
"We are pleased that PharmaJet's delivery system works effectively with our SCIB1/iSCIB1+ therapeutic cancer vaccines and offers a well-received immunization for patients," Lindy Durrant, CEO of Scancell, said. "Our ultimate goal for Scancell is to deliver an off the shelf, safe, tolerable, effective therapy that can provide potent and durable anti-tumor responses for unresectable stage IV melanoma which currently has a five-year survival of 35%, according to the SEER database, and we believe this agreement will bring us another step closer to achieving this goal."
The agreement has been completed in preparation for the phase II/III trial planned in 2025. Scancell said it hopes to build on the previous exceptional data from the first 13 patients who received SCIB1 in the ongoing SCOPE trial, a multicenter, open-label, umbrella study of SCIB1 and iSCIB1+ in patients with advanced unresectable melanoma receiving nivolumab with ipilimumab or SCIB1 with pembrolizumab.
Clinical data are expected from SCIB1 and iSCIB1+ at the end of 2024 and the beginning of 2025, respectively.
