Immunomic Therapeutics Announces FDA Clearance of IND Application for a UNITE®-Based Self-Amplifying RNA Vaccine for Triple-Negative Breast Cancer, to Be Studied Alone and in Combination with Keytruda®

Company to Initiate First-in-Human Phase 1 Clinical Trial in Q2 2026

ROCKVILLE, Md.–(BUSINESS WIRE)–#Clinicaltrials–Immunomic Therapeutics, Inc. (“ITI”), a privately held clinical-stage biotechnology company pioneering nucleic acid-based immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has cleared ITI’s Investigational New Drug (IND) application for ITI-5000. This clearance allows ITI to initiate the first-in-human clinical trial evaluating ITI-5000, a UNITE®-based self-amplifying RNA vaccine, as monotherapy and in combination with pembrolizumab (Keytruda®), in patients with Stage II–III Triple-Negative Breast Cancer (TNBC).

The Phase 1, multicenter, open-label, two-part study—known as VITALITI (VITAL-TNBC Study of ITI-5000)—is designed to assess safety, tolerability, and preliminary immunologic activity of ITI-5000 alone and in combination with pembrolizumab. TNBC represents approximately 15%–20% of breast cancer diagnoses and remains associated with poorer outcomes and fewer targeted treatment options, underscoring a substantial unmet medical need. Breast cancer is the fifth leading cause of cancer mortality globally.

ITI-5000 utilizes nucleic acid vaccine constructs engineered to preferentially deliver tumor-associated antigens (TAAs) to the MHC II compartment via LAMP-1, potentially enhancing antigen presentation, antibody generation, and CD4+ T-cell responses.

Pembrolizumab (Keytruda®), a humanized monoclonal antibody and PD-1 inhibitor, is widely used in cancer immunotherapy and has demonstrated benefit across numerous tumor types, including TNBC.

“Preclinical data have demonstrated enhanced efficacy in animal models without additional safety concerns. The FDA’s clearance of our IND application for ITI-5000 marks a significant milestone for us as we advance this program into its first clinical trial,” said DG Kim, Chief Executive Officer of ITI. “This achievement reflects years of innovative research and the dedication of our scientific and technical teams, and it brings us another step closer to offering a potentially transformative therapy for patients with TNBC.”

Dr. Teri Heiland, Chief Scientific Officer of ITI, added, “The ITI-5000 program represents an important evolution of our UNITE® technology, leveraging LAMP-mediated antigen presentation to drive robust CD4+ T cell activation. Our preclinical findings provide strong scientific rationale for advancing ITI-5000 into human studies, particularly in a disease area where new therapeutic approaches are urgently needed. We are excited to translate this promising data into the clinic and further explore the potential of this platform in TNBC.”

ITI expects to begin patient enrollment in the second quarter of 2026 across up to eight U.S. clinical sites.

About UNITE®

ITI’s investigational UNITE® platform, UNiversal Intracellular Targeted Expression, 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 used to create immune responses in tumor types that otherwise do not provoke an immune response.

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately held, clinical stage biotechnology company pioneering the development of vaccines through UNITE®, its proprietary technology platform, which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. UNITE® has a robust 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. For more information, please visit www.immunomix.com.

Forward-Looking Statements

This press release includes statements relating to the current progress of the ITI-5000 program for TNBC (Triple Negative Breast Cancer) and ITI’s technology platform and development efforts. These statements and other statements regarding our future plans and goals constitute “forward-looking statements” and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including, without limitation, whether we are able to capitalize on the ITI-5000 program, achieve positive results in our clinical trials to develop an immunotherapy that is successful in treating TNBC, and be able to advance the utilization of our UNITE® platform. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

Company Contact:
Melissa Kemp

mkemp@immunomix.com
301-968-3501