Immunomic Therapeutics has announced the Phase I trial of ITI-3000 in individuals with Merkel cell carcinoma (MCC), a rare form of skin cancer.

MCC is usually caused by the Merkel cell polyomavirus (MCPyV). 

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The open-label, single-centre trial will be carried out at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington.

It will analyse the safety, tolerability and immunogenicity of a 4mg dose of ITI-3000 administered to MCPyV-positive MCC patients who underwent a surgical procedure. 

Dose-limiting toxicities (DLTs), adverse events/serious adverse reactions (AEs/SARs), standard clinical analyses and safety laboratory parameters will be included as the primary endpoints of the trial.

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Immunomic Therapeutics CEO Dr William Hearl said: “This Phase I clinical trial of ITI-3000 in MCC is an important milestone, as it expands the reach of our immuno-oncology program beyond our ongoing Phase II study of ITI-1000 (Umitrelimorgene autodencel) in glioblastoma multiforme, to a second potential indication. 

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“Based on the strength of our UNITE platform and strong pre-clinical data generated, to date, we believe ITI-3000 has the potential to address the urgent unmet medical need for therapies to treat this aggressive form of skin cancer.”

The clinical-stage biotechnology company advances the study of lysosome-associated membrane protein (LAMP)-mediated nucleic acid-based immunotherapy.

ITI-3000 uses the investigational UNiversal Intracellular Targeted Expression (UNITE) platform of the company, powered by LAMP.

LAMP combines a mutated form of the MCPγV’s large T antigen with LAMP1. 

ITI-3000 was found to activate antigen-specific CD4+ T cells in vivo, showing that the lysosomal targeting technology offered improved antigen presentation as well as a balanced immune response. 

Using the Stratis needle-free injection system of PharmaJet, the plasmid deoxyribonucleic acid (DNA) vaccine is administered intramuscularly.