Scancell’s Modi-1 Moditope® vaccine achieves early clinical validation in head and neck cancer
10 January 2025 - Modi-1 successfully achieved Simon stage 1 suggesting the combination of Modi-1 and checkpoint blockade is beneficial in HPV negative head and neck squamous cell carcinoma (SCCHN). This result supports the continuation of the study in this indication Moditope® patent granted by the US Patent and Trademark Office (USPTO).
Scancell, a clinical-stage biopharmaceutical company developing novel immunotherapies for cancer, has achieved significant clinical and commercial milestones in its ModiFY study. Modi-1, the lead vaccine from Scancell’s Moditope® platform, is being investigated in the open-label Phase 2a dose expansion ModiFY study.
This trial evaluates the safety, tolerability, and preliminary efficacy of Modi-1 in combination with checkpoint inhibitors (CPIs) in patients with renal and head and neck cancers.
The cohort investigating HPV negative head and neck squamous cell carcinoma (SCCHN) was designed to determine if the overall objective response rate (ORR) in patients could be improved by combining Modi-1 Moditope® in combination with standard of care single agent checkpoint inhibitor pembrolizumab.
Three of the seven evaluable patients that have received immunisation with Modi-1 Moditope® combined with a checkpoint inhibitor have demonstrated a partial response as determined by RECIST 1.1 tumour assessment at their 25-week scan.
This equates to an ORR of 43% compared to historical ORRs of 19% for Pembrolizumab and 13% for nivolumab.
In view of the significant improvement in response rate and the good safety and tolerability, this study is well positioned to continue enrolment into Simon stage 2.
These encouraging early results will be further verified upon completion of this HPV (-) SCCHN Modi-1 Moditope ® + CPI cohort, after a total of up to 21 patients have been vaccinated.
In addition, there is investigator interest to evaluate Modi-1Moditope® in the neoadjuvant setting for this indication. The commercial positioning of Modi-1 Moditope® has been further strengthened through approval by the U.S. Patent and Trademark Office (USPTO) for a patent for Moditope® and successful formulation development. The patent from the USPTO will add to the protection of the Company's pipeline of Moditope® vaccines for the treatment of cancer, which has already been granted by the European Patent Office, along with China, Japan and Australia.
Dr Nermeen Varawalla, Chief Medical Officer Scancell commented:
The promising early Simon stage 1 (non-futility) read-out from the (HPV negative) SCCHN cohort of the ModiFY Phase 2 clinical study sets the stage for Simon stage 2 and the further development of Modi-1 Moditope® in a cancer indication with poor outcomes following standard of care.
Chief Investigator Christian Ottensmeier, Professor of Immuno-Oncology at Head and Neck Institute, University of Liverpool, commented:
This positive preliminary clinical read-out validates the scientific rationale for Moditope® vaccines as a therapy with real potential to improve outcomes achievable with checkpoint inhibitors alone. Given its good safety profile and ease of use, I remain keen to continue using this vaccine as well as explore the application of Modi-1 Moditope® in the neoadjuvant setting.