Immunomic Therapeutics has dosed the first subject in Phase I clinical trial of plasmid DNA (pDNA) vaccine, ITI-3000, for Merkel cell carcinoma (MCC) patients.
The vaccine leverages the investigational UNiversal Intracellular Targeted Expression (UNITE) platform of the company, powered by Lysosome Associated Membrane Protein (LAMP).
It combines sequences from the mutated form of the Merkel cell polyomavirus’ (MCPyV) large T antigen (LT) into the LAMP-1 gene sequence.
The single-centre, open-label, first-in-human trial will enrol eight patients to analyse the safety, tolerability and immunogenicity of a 4mg dose of ITI-3000 in MCC patients who have undergone surgical procedure.
It is being carried out at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington, US.
The number of subjects having dose-limiting toxicities and the number of incidences of adverse events/serious adverse reactions will be some of the trial’s primary endpoints.
Furthermore, various other standard clinical evaluations and safety laboratory parameters will be analysed as other primary endpoints.
The company anticipates top-line findings from the trial in the second half of next year.
Immunomic Therapeutics CEO Dr William Hearl said: “Despite recent advances in cancer immunotherapy, there remains a need for therapies to treat this rather rare, but aggressive form of skin cancer and we believe that our proprietary approach, utilising nucleic acid vaccines with the power to leverage the body’s natural biochemistry to develop a broad immune response, holds tremendous potential in this indication.
“We look forward to reporting top-line results from the Phase I trial in the second quarter of next year.”
A rare and aggressive skin cancer type, MCC is usually caused by MCPyV.
In February this year, the company announced a Phase I trial of ITI-3000 in MCC patients.