Scancell Holdings has commenced dosing patients in the fourth cohort of its Phase 2 SCOPE clinical trial, marking a significant milestone in the development of its iSCIB1+ immunotherapy for advanced unresectable melanoma. The AIM-traded company announced that the first eight patients have been safely dosed using intradermal administration with an accelerated dosing regimen, including participants recruited through the NHS Cancer Vaccine Launch Pad, with no significant adverse events observed.
Strong Early Efficacy Signals Drive Program Forward
The SCOPE trial has generated encouraging preliminary data that positions Scancell's immunotherapy approach as a potential improvement over current standard treatments. Initial results from 25 patients in cohort one, who received first-generation SCIB1 ImmunoBody in combination with checkpoint inhibitors ipilimumab and nivolumab, demonstrated an 84% disease control rate and 80% progression-free survival. The trial also achieved a 20% complete response rate and 72% overall response rate, representing what the company describes as significant improvements over standard of care treatment.
"The SCOPE data reported so far are highly encouraging, with SCIB1 immunotherapy showing excellent efficacy and long-term survival benefits that signal a meaningful improvement over standard of care," said Dr. Nermeen Varawalla, Scancell's Chief Medical Officer. "Initiation of cohort four is an important milestone for our iSCIB1+ programme to evaluate intradermal administration on our path towards randomised studies."
Multi-Cohort Trial Design Evaluates Next-Generation Approach
The SCOPE study (NCT04079166) is a Phase 2, multi-center open-label investigation of SCIB1/iSCIB1+ combined with checkpoint inhibitors in late-stage melanoma, designed to enroll over 140 patients across four cohorts. Cohort three, which evaluates next-generation iSCIB1+ in combination with ipilimumab and nivolumab, has now been completely enrolled.
The newly initiated cohort four specifically focuses on intradermal administration of iSCIB1+ Immunobody, described as a potent and targeted "off-the-shelf" active immunotherapy, utilizing accelerated dosing of priming immunizations. This alternative delivery method represents Scancell's effort to enhance patient outcomes through optimized administration protocols.
Technology Platform Drives Immunotherapy Innovation
SCIB1 represents the lead product from Scancell's ImmunoBody platform, which harnesses the body's immune system to identify, attack and destroy tumors. The next-generation iSCIB1+ is a modified version developed using the company's AvidiMab platform to enhance potency compared to the original SCIB1. The enhanced version also incorporates additional melanoma-specific epitopes, potentially enabling effectiveness across a broader patient population.
Clinical Timeline and Strategic Outlook
The company expects additional data from cohorts one through three in July 2025, while interim data from the newly initiated cohort four is anticipated around the end of 2025. Chief Executive Officer Phil L'Huillier emphasized the clinical potential of the program while highlighting broader strategic initiatives.
"The continued momentum in the SCOPE study highlights the clinical potential of SCIB1, and the next generation iSCIB1+, to address the unmet needs in melanoma," L'Huillier stated. "We are also progressing plans on our commitment to unlock the full potential of our innovative GlyMab platform by establishing GlyMab Therapeutics Ltd."
The SCOPE trial protocol involves participants receiving up to 10 doses of either SCIB1 or iSCIB1+ using PharmaJet Stratis or Tropis needle-free injection devices, with primary endpoints including efficacy and safety assessment. Additional endpoints encompass disease control rate, duration of response, progression-free survival, and overall survival measurements.
