COMPANY
Immunomic Therapeutics, Inc.
Immunomic Therapeutics develops nucleic acid vaccines from its investigational UNITE platform, which combines lysosomal targeting technology, adjuvants and antigen selection. Immunomic Therapeutics' pipeline focuses on immunotherapeutics for treating and preventing oncology indications. From company website Source · Source · checked 2026-10-19
Sources for this description (2)
- Immunomic Therapeutics develops nucleic acid vaccines from its investigational UNITE platform, which combines lysosomal targeting technology, adjuvants and antigen selection.
- “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.” https://immunomix.com/ (2026-10-19)
- “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.” https://immunomix.com/ (2026-10-19)
- Immunomic Therapeutics' pipeline focuses on immunotherapeutics for treating and preventing oncology indications.
- “Stemming from our UNITE® Platform, Immunomic Therapeutics has developed a robust pipeline focused on immunotherapeutics with an emphasis in treating and preventing many oncology indications by leveraging specific characteristics of a type of antigen.” https://immunomix.com/pipeline/ (2026-10-19)
Timeline
- Trial start 1: Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer source ↗
- Trial start 1: Phase 1, First in Human (FIH), Open-Label, Single-Arm, Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Ceda source ↗
- Trial start Phase 1: Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM) source ↗
- Trial start Phase 1: Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC) source ↗
- Trial start IC: A Safety and Immunogenicity Phase IC Study of CryJ2 -DNA-LAMP Plasmid Vaccine for Assessment of Intradermal (ID) Route of Administration Using the Biojector 2000 Device source ↗
- Trial start IB: A Safety and Immunogenicity Phase IB Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid Assessing the Long Term Safety of Previously Treated Subjects source ↗
- Trial start I: A Safety and Immunogenicity Phase I Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid source ↗
Upcoming milestones
- 2028-02 (ESTIMATED) · 1 · Phase 1, First in Human (FIH), Open-Label, Single-Arm, Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Cedar ( · NCT07726147
- 2028-02 (ESTIMATED) · 1 · Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer · NCT07652242
Clinical trials (lead sponsor) 7
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07726147 | Phase 1, First in Human (FIH), Open-Label, Single-Arm, Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Cedar (JRC) Pollinosis | 1 | Recruiting | Jun 20, 2026 | 2028-02 (estimated) |
| NCT07652242 | Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer | 1 | Recruiting | Jul 14, 2026 | 2028-02 (estimated) |
| NCT05698199 | Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM) | Phase 1 | Completed | Aug 21, 2023 | Feb 11, 2026 (actual) |
| NCT05422781 | Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC) | Phase 1 | Completed | Jun 13, 2022 | Jun 27, 2023 (actual) |
| NCT02146781 | A Safety and Immunogenicity Phase IC Study of CryJ2 -DNA-LAMP Plasmid Vaccine for Assessment of Intradermal (ID) Route of Administration Using the Biojector 2000 Device | IC | Completed | 2014-06 | 2015-03 (actual) |
| NCT01707069 | A Safety and Immunogenicity Phase I Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid | I | Completed | 2012-10 | 2013-05 (actual) |
| NCT01966224 | A Safety and Immunogenicity Phase IB Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid Assessing the Long Term Safety of Previously Treated Subjects | IB | Completed | 2013-09 | 2013-12 (actual) |