Immunomic Therapeutics Doses First Participant in Phase 1 Trial of ITI-9001 for Japanese Cedar Pollen Allergy

Phase 1 Clinical Trial Begins in Japan

Immunomic Therapeutics Inc. (ITI), a clinical-stage biotechnology company and subsidiary of HLB, has announced that the first participant has been dosed in its Phase 1 clinical trial evaluating ITI-9001, an investigational therapeutic vaccine for Japanese cedar pollen allergy.

The milestone comes less than one month after Japan's Pharmaceuticals and Medical Devices Agency (PMDA) cleared the company's clinical trial application, allowing the study to move into patient enrollment quickly.

According to the company, the first participant has completed the initial post-dose monitoring visit, and no significant adverse events or safety concerns have been reported so far.

Study Will Evaluate Safety and Immune Response

The Phase 1 study is being conducted as a single-center, randomized, placebo-controlled clinical trial.

Researchers plan to enroll adults between the ages of 18 and 65 who have Japanese cedar pollen allergy.

The study will first evaluate the safety and tolerability of both low-dose and high-dose treatment groups to identify the most appropriate dose for future development.

After selecting the optimal dose, researchers will compare the vaccine with placebo to assess its safety and ability to trigger an immune response.

Japanese Cedar Pollen Allergy Affects Millions

Japanese cedar pollen allergy is one of the most common seasonal allergies in Japan.

The condition is estimated to affect around 48 million people across the country.

People living with the allergy often experience symptoms such as sneezing, nasal congestion, itchy eyes, and runny nose during pollen season. Current treatments mainly focus on controlling symptoms rather than changing the underlying disease.

ITI-9001 Designed to Target the Root Cause

Unlike traditional allergy medicines, ITI-9001 is being developed to modify the body's immune response instead of simply providing temporary symptom relief.

The investigational vaccine targets CryJ2, one of the major allergens responsible for Japanese cedar pollen allergy.

ITI-9001 combines Immunomic Therapeutics' proprietary UNITE platform with self-amplifying RNA (saRNA) technology.

The vaccine also uses lysosome-associated membrane protein (LAMP) technology to improve antigen presentation and stimulate stronger T-cell immune responses. The company hopes this approach will provide longer-lasting therapeutic benefits by addressing the underlying cause of the allergy.

Company Aims to Develop a Disease-Modifying Therapy

Immunomic Therapeutics plans to advance ITI-9001 as a next-generation treatment for Japanese cedar pollen allergy.

The company believes the vaccine has the potential to overcome some of the limitations of currently available allergy therapies by offering a treatment that modifies the disease rather than only managing seasonal symptoms.

CEO Highlights Development Milestone

Dong Gun Kim, Chief Executive Officer of Immunomic Therapeutics, said the company's goal is to develop a therapy that changes the immune response responsible for the disease instead of simply reducing allergy symptoms.

He added that the Phase 1 study is expected to provide important information on the vaccine's safety profile and early immunogenicity, helping support the continued development of ITI-9001 as a potential next-generation immunotherapy for Japanese cedar pollen allergy.

About Immunomic Therapeutics

Immunomic Therapeutics is a clinical-stage biotechnology company focused on developing immune-based therapies using its proprietary UNITE platform and next-generation RNA technologies.

The company's research pipeline includes therapeutic candidates targeting oncology, infectious diseases, and allergy-related conditions, with the aim of developing innovative treatments that improve patient outcomes worldwide.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!