Therapy Areas: AIDS & HIV
First Patient Dosed in Phase I Clinical Trial of ITI-3000 pDNA Vaccine for the Treatment of Merkel Cell Carcinoma
21 July 2022 - - US-based clinical-stage biotechnology company Immunomic Therapeutics, Inc has dosed the first patient in the company's Phase 1 study evaluating ITI-3000, a plasmid DNA vaccine targeting patients with Merkel cell carcinoma, a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV), the company said.

The single-center study is being conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington and is being led by Drs. Paul Nghiem, Song Park and David M. Koelle.

The eight-patient, open label, first-in-humans study is designed to evaluate the safety, tolerability, and immunogenicity of 4 mg of ITI-3000 in patients with MCC who have undergone surgery.

The study's primary endpoints include the number of participants experiencing dose limiting toxicities, the number of occurrences of adverse events/serious adverse reactions, (AEs/SARs), as well as other standard clinical assessments and safety laboratory parameters.

ITI-3000 leverages the company's investigational UNiversal Intracellular Targeted Expression (UNITE) platform, powered by LAMP, which fuses sequences from the mutated form of the large T antigen of the MCPyV into the sequence of the LAMP-1 gene.

This lysosomal targeting technology has been shown to result in enhanced antigen presentation and a balanced immune response, including, of note, ITI-3000 activated antigen-specific CD4+ T cells in vivo.

Immunomic Therapeutics, Inc. is a privately held, clinical stage biotechnology company pioneering the development of vaccines through its proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the body's natural biochemistry to develop vaccines that generate broad immune responses.

UNITE has a history of applications in various therapeutic areas, including infectious diseases, oncology, allergy, and autoimmune diseases.

ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including antigen-derived antibodies as biologics.

The company has built a pipeline leveraging UNITE with programs in oncology, animal health, infectious disease, and allergy.

ITI maintains its headquarters in Rockville, Maryland.