Scancell Holdings plc announced positive Phase 2 SCOPE trial data for its SCIB1/iSCIB1+ Immunobody® DNA active immunotherapies combined with checkpoint inhibitors in advanced melanoma patients. The iSCIB1+ treatment demonstrated a 69% overall response rate in patients with the target HLA type (80% of the total patient population), significantly exceeding the 48-50% response rate observed with the current standard of care. Furthermore, 12-month progression-free survival improved by 20% compared to the standard of care.
This data is potentially transformative for the treatment of advanced melanoma. The significant improvement in overall response rate and progression-free survival suggests that iSCIB1+ could become a crucial component in the treatment landscape. The identification of a potential biomarker (HLA class I alleles) for predicting patient response adds further value, allowing for more personalized and effective treatment strategies. This advancement offers a tangible hope for improved outcomes in a patient population with limited effective options.
The combined overall response rate for patients receiving SCIB1 or iSCIB1+ with standard-of-care checkpoint inhibitors was 68.6%. The iSCIB1+ therapy showed a complete response rate of 17.9%. Importantly, the therapy did not introduce additional safety concerns beyond those typically associated with the standard-of-care checkpoint inhibitor combination. iSCIB1+ has been selected for continued development due to its efficacy in a broader patient population (80% compared to 40% for SCIB1). This decision is supported by the observation that all six epitopes in iSCIB1+ generated targeted T cell responses, and CD8 T cell responses were linked to an improved clinical response rate.
Scancell is accelerating plans for a global registrational study for advanced melanoma with iSCIB1+, and exploring a second trial for earlier stages of the disease. They plan to consult with the FDA on the trial design. The identification of a potential patient selection biomarker may significantly impact the design and efficiency of these future trials. This development positions iSCIB1+ as a potential game-changer in melanoma treatment, underscoring the potential of Scancell’s technology platforms for the ongoing refinement and improvement of immunotherapies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
