Immunomic Therapeutics, Inc. (ITI), a privately-held clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the ITI-3000 programme for the treatment of patients with Merkel cell carcinoma. The company is currently enrolling a phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV).
“The FDA’s decision to grant FTD underscores the potential for the ITI-3000 program to address a serious unmet need and serve as a meaningful therapeutic option for patients with Merkel cell carcinoma,” stated Dr. William Hearl, chief executive officer of ITI. “We are committed to unlocking the full potential of ITI-3000 in patients with this aggressive form of skin cancer. We expect to report top-line data from our ongoing phase 1 trial of ITI-3000 in MCC patients next year and look forward to working closely with the FDA on a potential next phase clinical study design, while simultaneously continuing dialogue with possible partners.”
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 (LT) 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 programmes with Fast Track Designation benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programmes 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 tumour types and be used to create immune responses in tumour types that otherwise do not provoke an immune response.
Immunomic Therapeutics, Inc. (ITI) 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.