Our Company

Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms. These investigational technologies have the potential to alter how we use immunotherapy for cancer, allergies and animal health.

The mission of Immunomic Therapeutics is to pioneer vaccines that transform lives.

Pipeline

Name
Partner / Collaborator
Phase

ITI-1000 GBM - Cell Therapy

University of Florida

Phase 2 | ONGOING

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ITI-1000 is a dendritic cell therapy comprised of autologous dendritic cells (DCs) loaded with messenger ribonucleic acid (mRNA) encoding the human Lysosomal Associated Membrane Protein (hLAMP) gene fused in frame to a human Cytomegalovirus (hCMV) matrix protein, pp65 gene (hLAMP:pp65) and subsequently administered with Granulocyte-macrophage colony-stimulating factor (GM-CSF) and Tetanus/diphtheria (Td) toxoid which serve as adjuvants. The primary mechanism of action of ITI-1000 is to generate a T cell-mediated immune response against malignant glial cells expressing the CMV pp65 protein. While the presence of the CMV pp65 antigen itself is expected to induce a general effector T cell response, fusion of the antigen to Lysosomal Associated Membrane Protein (LAMP) is intended to compel processing of the antigen through a pathway that presents antigens specifically to CD4+ T cells and results in a robust Th1- type response (Arruda, 2006). As a result, a robust T cell response by both CD4+ and CD8+ T cells is expected to drive antitumor activity of this product. ITI-1000 is being studied at the University of Florida in a randomized, blinded, and placebo-controlled phase 2 study in patients with newly-diagnosed glioblastoma (GBM). GBM patients’ white blood cells are removed, matured into dendritic cells and vaccinated against the pp65 viral protein, then returned to the patient. The company believes this approach may harness the body’s immune system to recognize, attack and destroy tumor cells that express CMV, which is over-expressed in GBM.

ITI-1001 GBM - pDNA

Internal Development

Phase 1 | ONGOING

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ITI-1001 represents an off-the-shelf cancer immunotherapy approach that leverages ITI’s proprietary UNITE® platform to target CMV-associated antigens (pp65, IE-1 & gB) in Newly-Diagnosed Glioblastoma Multiforme (GBM). The primary mechanism of action of ITI-1001 is to enable specific presentation of the antigens via the lysosome mediated pathway in the antigen presenting cells (APC). The antigens mainly elicits TH1 response leading to cytokine release, development of cytotoxic CD8 T cells and memory CD4 T cells. In addition to TH1 response, we also observe antigen specific antibodies indicative of TH2 response further enhancing the anti-tumor potential of this vaccine. ITI-1001 is currently being tested in a Phase 1 clinical trial at the Dana Farber Cancer Institute under the direction of Dr. David A. Reardon.

ITI-3000 Merkel Cell Carcinoma - pDNA

Internal Development

Phase 1 | ONGOING

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ITI-3000 is a plasmid DNA vaccine targeting the large T antigen (LT) of Merkel cell polyomavirus (MCPyV). The majority of Merkel cell carcinomas (MCC), a rare but aggressive form of skin cancer, are associated with MCPyV infection, making LT an attractive target for this cancer vaccine. While induction of tumor-reactive CD8+ T cells is a major goal of cancer therapy, CD4+ T cells provide essential support to CD8+ T cells by promoting their expression of cytotoxic effector molecules and increasing their migratory capacity. Cytokines secreted by CD4+ T cells, such as IFNγ, can also exert desirable effects on the tumor microenvironment. ITI-3000 is currently being tested in a Phase 1 clinical trial at the University of Washington and Fred Hutchinson Cancer Research Center under the direction of Dr. Paul Nghiem.

ITI-8000 ALK7 MAb

Internal Development

Pre-Clinical | In Process

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ITI-8000 is a next generation checkpoint inhibitor that targets the activin A1c receptor. By blocking the binding of activin A, this antibody effectively limits FoxP3 expression and dramatically reduces Treg cell responses. Tregs are well known to act to block the effect of cytotoxic T-cells in the tumor.

About the UNITE® platform

Immunomic Therapeutics’ investigational UNITE® platform is founded in a combination of complementary technologies and capabilities: ITI’s proprietary lysosomal targeting technology, optimal use of adjuvants, antigen selection and optimization, a breadth of delivery methods, and the ability to manufacture material at a large scale. Immunomic Therapeutics’ nucleic acid vaccines have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE® at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. ITI’s lysosomal targeting technology is currently being employed in two Phase I clinical trials as a cancer immunotherapy. Preclinical data is currently being developed to explore whether the UNITE® platform may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

UNITE® TECHNOLOGY