Following the Phase II faceoff between two of Scancell’s lead melanoma immunotherapy candidates, the biotech has selected iSCIB1+ for progression into Phase III clinical trials.
Also known as Immunobody, the iSCIB1+ monoclonal antibody (mAb) showed promise in treating advanced unresectable melanoma — a condition currently fraught with unmet medical needs.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
During the single-arm Phase II SCOPE trial (NCT04079166), the company compared the safety, efficacy and durability of DNA-active immunotherapies SCIB1 and iSCIB1+ in combination with checkpoint inhibitors, which are currently the standard of care (SoC) for this indication.
The study also looked at SCIB1 in combination with blockbuster PD-1 blocker Keytruda (pembrolizumab), though this arm of the study was halted due to changes in SoC protocol during the study period.
Interestingly, the cohort receiving iSCIB1+ intramuscularly alongside the SoC regimen exhibited an overall response rate of 68.6% — a notable improvement from the 50% rate observed in the Checkmate 067 study (NCT01844505) on Opdivo (nivolumab) and Yervoy (ipilimumab) alone.
Alongside its ability to improve treatment response, both immunotherapies demonstrated their capacity to improve progression-free survival (PFS), with 80.8% of the iSCIB1+ cohort remaining stable in their disease after 11 months.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThis compares with a PFS of 43.9% after 12 months following treatment with Opdivo and Yervoy.
Addressing unmet needs
According to GlobalData, the melanoma market was estimated to be worth $6.49bn in 2024, highlighting its lucrative potential.
GlobalData is the parent company of Clinical Trials Arena.
Currently, the SoC combination of Yervoy plus Opdivo has a market share of 65%-70% within this sector — though the regimen’s efficacy and durability of response (DoR) in this patient population is limited.
Notably, an estimate from the Melanoma Research Alliance estimates that 50% of patients receiving treatment for advanced melanoma will either not respond to treatment or experience disease progression, highlighting the need for effective new therapies which can improve patient outcomes.
Scancell CEO Dr Phil L’Huillier said: “By adding iSCIB1+ to the combination of Opdivo and Yervoy, we can produce a marked benefit for patients with this hard-to-treat cancer.”
According to the company’s CMO Dr Nermeen Varawalla, the treatment regimen “can demonstrate meaningful benefits in terms of responses, disease control, progression-free survival and immune responses”, offering a potentially “huge” improvement in patient outcomes.
Following the positive results of this Phase II trial, Scancell will prime iSCIB1+ for further development, with the CEO noting the company’s plans to initiate a global registrational study in an advanced melanoma patient population soon.
“We are also evaluating the potential of a second trial, which will explore iSCIB1+ in earlier lines of disease,” L’Huillier added.
