RE: Pharma jet .. why post now as bout covidity success21 Mar 2023 19:24
I suppose it could be all related to:
'Under the updated protocol the Company is now also testing the SCIB1 vaccine delivered via needle-free injection, using a PharmaJet® device. Prior to the amendment, SCIB1 had 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 (such as the PharmaJet® device) could provide enhanced patient acceptance and uptake. Eight sites are currently recruiting with a further six in the set-up stage. Although recruitment remains challenging, the recent protocol changes have resulted in an uplift in enrolment rates in the SCOPE study.
In addition, to further increase eligibility the Company has been developing iSCIB1+, an AvidiMab® modified version of SCIB1, which is expected to increase both the potency of SCIB1 and extend its patent life. This modification also includes multiple epitopes so it can be used to treat all patients rather than being limited to the 40% of patients who have the appropriate human leukocyte antigen (HLA) type for treatment with SCIB1. Given the significant potential improvements in potency, utility and patent life with iSCIB1+, the Company plans to transition the SCOPE trial to the iSCIB1+ product during 2023.
The current modifications to the SCOPE protocol have significantly increased the recruitment rate into the ongoing Phase 2 trial at the existing UK sites and the transition to iSCIB1+ during 2023 is also expected to further increase patient enrolment rates. As a result, the Company intends to withdraw the open Investigational New Drug (IND) application in the US for the SCIB1 product and focus its resources on continuing to expand recruitment in the UK for SCIB1 and transitioning the iSCIB1+ product into the existing SCOPE study.'