Therapy Areas: AIDS & HIV
Immunomic Therapeutics Receives FDA Fast Track Designation for ITI-3000, a pDNA Vaccine, in Development for the Treatment of Merkel Cell Carcinoma
10 November 2022 - - The US Food and Drug Administration has granted Fast Track Designation to the ITI-3000 program for the treatment of patients with Merkel cell carcinoma, US-based clinical-stage biotechnology company Immunomic Therapeutics, Inc said.

The company is currently enrolling a 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).

ITI-3000 leverages the company's investigational UNiversal Intracellular Targeted Expression (UNITE) platform, powered by LAMP (Lysosome Associated Membrane Protein), 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.

Fast Track Designation is designed to facilitate the development and expedite the FDA review of drugs to treat serious conditions and fulfill unmet medical needs, enabling drugs to reach patients earlier. Clinical programs with Fast Track Designation benefit from early and frequent communication with the FDA throughout the regulatory review process.

These clinical programs may also be eligible to apply for accelerated approval and breakthrough designation review by the FDA if relevant criteria are met.

ITI's UNITE platform leverages the ability to engineer chimeric proteins, directing antigen presenting cells to present antigens to the immune system through a targeted pathway and driving a robust immune response.

UNITE vaccines are distinct in that they combine two components: nucleic acid constructs that encode a specific antigen and an endogenous Lysosomal Associated Membrane Protein (LAMP-1) sequence.

The UNITE platform harnesses LAMP-1 as a means of presenting the vaccine target to the immune system, resulting in antibody production, inflammatory cytokine release, and establishing critical immunological memory, something that other vaccine approaches commonly lack.

This approach could put UNITE technology at the crossroads of immunotherapies in multiple indications, including cancer, human allergy, animal health, and infectious disease.

Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses in tumor types that otherwise do not provoke an immune response.

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

ITI is primarily focused on applying the UNITE platform to oncology indications, where it could potentially have broad applications, including development of antigen-derived antibodies as biologics in a number of cancers.

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.