Immunomic Therapeutics Doses First Patient in Phase 1 Trial of ITI-5000 Therapeutic Cancer Vaccine for Triple-Negative Breast Cancer
Immunomic Therapeutics, Inc. (ITI), a clinical-stage biotechnology company and U.S.-based subsidiary of HLB, has announced an important milestone in the development of its cancer immunotherapy pipeline with the successful dosing of the first participant in the Phase 1 clinical trial of ITI-5000, an investigational therapeutic cancer vaccine designed to treat triple-negative breast cancer (TNBC). The announcement marks the beginning of first-in-human clinical evaluation for the experimental therapy and represents a significant step forward in the company’s efforts to develop innovative immune-based treatments for one of the most aggressive forms of breast cancer.
According to the company, the first participant successfully received the initial dose of ITI-5000 and completed the required post-treatment safety monitoring period. Investigators reported that no significant adverse events or major safety concerns have been observed thus far, providing an encouraging early indication of the therapy’s initial tolerability as clinical development moves forward.
The Phase 1 study, known as VITALITI, is designed to evaluate the safety, tolerability, and preliminary immune activity of ITI-5000 in patients with Stage II and Stage III triple-negative breast cancer. Researchers will also investigate the vaccine both as a standalone treatment and in combination with current standard-of-care adjuvant therapies.
Addressing an Urgent Need in Triple-Negative Breast Cancer
Triple-negative breast cancer is one of the most challenging subtypes of breast cancer to treat. Unlike many other forms of the disease, TNBC lacks expression of estrogen receptors, progesterone receptors, and human epidermal growth factor receptor 2 (HER2). Because these molecular targets are absent, patients are not eligible for several of the targeted hormonal and HER2-directed therapies commonly used in other breast cancer subtypes.
As a result, treatment options for TNBC are generally limited to surgery, chemotherapy, radiation therapy, and, in selected patients, immunotherapy. Although these approaches can be effective, the disease remains associated with a higher risk of recurrence, faster progression, and poorer long-term outcomes compared with other forms of breast cancer.
The aggressive nature of TNBC has driven significant interest in developing novel therapeutic strategies capable of stimulating the body’s immune system to recognize and eliminate cancer cells while providing durable protection against disease recurrence.
Immunomic Therapeutics believes ITI-5000 may represent one such approach.
A Therapeutic Cancer Vaccine
Unlike preventive vaccines designed to protect healthy individuals from infectious diseases, therapeutic cancer vaccines are intended to stimulate immune responses in patients who have already been diagnosed with cancer.
The objective is to train the immune system to recognize proteins expressed by tumor cells and generate targeted immune responses capable of eliminating remaining cancer cells after primary treatment.
By strengthening anti-tumor immunity, therapeutic vaccines may help reduce the likelihood of cancer recurrence while complementing existing treatment approaches.
ITI-5000 has been specifically developed to generate targeted T-cell responses directed against tumor-associated antigens expressed in triple-negative breast cancer.
The company hopes this immune activation may produce durable anti-cancer activity capable of improving long-term patient outcomes.
Combining Two Innovative Technology Platforms
ITI-5000 incorporates two advanced biotechnology platforms developed to enhance immune activation.
The investigational vaccine combines:
- Immunomic Therapeutics’ proprietary UNITE® platform
- Next-generation self-amplifying RNA (saRNA) technology
The integration of these technologies is intended to improve both antigen presentation and immune system activation.
The UNITE® Platform
The UNITE® platform serves as the immunological foundation of ITI-5000.
A distinguishing feature of this technology is the fusion of target antigens with lysosome-associated membrane protein (LAMP).
LAMP plays an important role in directing antigens toward intracellular pathways involved in immune processing.
By linking tumor-associated antigens to LAMP, the vaccine is designed to enhance antigen presentation through major histocompatibility complex pathways, thereby stimulating stronger activation of T lymphocytes.
T cells play a central role in recognizing and destroying cancer cells.
The company believes this targeted immune activation may improve the body’s ability to identify residual tumor cells following conventional treatment.
Self-Amplifying RNA Technology
The second major component of ITI-5000 is its use of self-amplifying RNA (saRNA) technology.
Unlike conventional messenger RNA, self-amplifying RNA is designed to replicate within cells after administration, allowing production of larger amounts of target antigen from smaller administered doses.
Potential advantages of saRNA technology include:
- Enhanced antigen expression
- Stronger immune activation
- Lower dosing requirements
- Potentially prolonged immune responses
The technology has attracted increasing interest in recent years as researchers explore new approaches to vaccine development for infectious diseases, cancer, and other therapeutic applications.
By combining saRNA with the UNITE® platform, Immunomic Therapeutics hopes to generate robust and durable anti-tumor immune responses.
The VITALITI Phase 1 Clinical Trial
The ongoing VITALITI study represents the first clinical evaluation of ITI-5000 in human participants.
The trial has been designed as a:
- Multicenter study
- Open-label clinical trial
- First-in-human investigation
- Phase 1 safety study
Researchers will enroll patients diagnosed with Stage II or Stage III triple-negative breast cancer.
The study’s primary objectives include evaluating:
- Safety
- Tolerability
- Preliminary immunologic activity
Investigators will also examine how the therapy performs under two treatment strategies.
Participants may receive ITI-5000:
- As monotherapy
- In combination with standard-of-care adjuvant treatment
Evaluating both approaches allows researchers to better understand how the vaccine may integrate into existing treatment regimens.
Focus on Preventing Disease Recurrence
One of the long-term goals of the ITI-5000 development program is reducing the risk of cancer recurrence.
Even after successful surgery and chemotherapy, patients with triple-negative breast cancer remain at relatively high risk of disease returning.
Residual microscopic cancer cells that survive initial treatment may eventually lead to recurrent or metastatic disease.
By stimulating sustained T-cell immunity against tumor-associated antigens, Immunomic Therapeutics hopes ITI-5000 can help eliminate remaining cancer cells before recurrence develops.
Although the current Phase 1 study is primarily designed to assess safety, future clinical trials may investigate whether immune activation translates into meaningful improvements in recurrence-free survival.
Leadership Highlights Clinical Milestone
Commenting on the first patient dosing, Dong-Gun Kim, Chief Executive Officer of Immunomic Therapeutics, described the event as an important milestone for the company’s clinical development program.
According to Kim, initiating human evaluation of ITI-5000 represents a major step toward demonstrating the therapy’s safety and immune activity while advancing development of what the company believes could become a next-generation therapeutic cancer vaccine.
He emphasized that the Phase 1 study will generate important information regarding both the safety profile and immunologic effects of the investigational treatment.
These early findings will help guide subsequent stages of clinical development.
Expanding the Company’s RNA Therapeutics Pipeline
The initiation of the VITALITI study also reflects Immunomic Therapeutics’ broader strategy of expanding its pipeline of RNA-based immunotherapies.
The company has increasingly focused on leveraging advanced nucleic acid technologies to develop innovative treatments capable of modulating immune responses across multiple disease areas.
ITI-5000 represents one of the company’s first self-amplifying RNA therapeutic candidates to enter clinical testing.
Successful advancement of the program could establish a foundation for additional saRNA-based oncology therapies targeting other tumor types.
The combination of RNA technology with the UNITE® immune platform also demonstrates the company’s commitment to developing differentiated immunotherapies designed to generate durable cellular immune responses.
The successful dosing of the first participant in the Phase 1 VITALITI study marks an important beginning for the clinical development of ITI-5000 and underscores Immunomic Therapeutics’ continued investment in innovative cancer immunotherapies. Early safety observations have been encouraging, with no significant adverse events reported following administration of the initial dose, providing initial support for continued evaluation of the investigational therapeutic vaccine.
As enrollment progresses, researchers will gather additional data on the safety, tolerability, and immune activity of ITI-5000 in patients with Stage II and Stage III triple-negative breast cancer. By combining the company’s proprietary UNITE® platform with next-generation self-amplifying RNA technology, the vaccine is designed to stimulate targeted T-cell responses against tumor-associated antigens with the goal of reducing disease recurrence.
If future clinical studies confirm its therapeutic potential, ITI-5000 could contribute to a new generation of immune-based treatments for patients with triple-negative breast cancer, an area where significant unmet medical need continues to drive the search for more effective and durable treatment options.
About ITI-5000
ITI-5000 is an investigational immunotherapy that combines Immunomic Therapeutics’ proprietary UNITE® platform with self-amplifying RNA technology. ITI-5000 encodes two tumor-associated antigens (CT83 and HERV-K envelope protein) and is being developed as a disease-modifying treatment intended to provide durable clinical benefit for patients with TNBC.
About Immunomic Therapeutics, Inc.
Immunomic Therapeutics is a clinical-stage biotechnology company focused on developing transformative immune therapies using its proprietary UNITE® platform and next-generation RNA technologies. The Company is advancing a pipeline of innovative therapeutic candidates across oncology, infectious disease, and allergy indications with the goal of improving patient outcomes worldwide.