Immunomic Therapeutics, HLB Subsidiary, Receives Approval for Phase 1 Clinical Trial of Japanese Cedar Allergy Vaccine in Japan
Immunomic Therapeutics, the U.S. subsidiary of HLB, has received approval to conduct a Phase 1 clinical trial in Japan for 'ITI-9001,' a vaccine candidate for the treatment of Japanese cedar pollen allergy.
According to HLB on June 15, this clinical trial is a single-center, randomized, placebo-controlled study targeting adults aged 18 to 65 with Japanese cedar pollen allergy. First, the safety and tolerability will be evaluated in both low-dose and high-dose groups. After determining the optimal dose, a comparative evaluation with the placebo group will be conducted.
ITI-9001 is a next-generation therapeutic vaccine candidate developed by Immunomic Therapeutics, which combines its proprietary immunotherapy vaccine platform 'UNITE' with self-amplifying RNA (saRNA) technology. The UNITE platform enhances antigen presentation efficiency by linking the antigen to lysosome-associated membrane protein (LAMP), thereby maximizing the T-cell immune response and inducing a strong and sustained immunotherapeutic effect.
ITI-9001 is being developed with the goal of fundamentally improving the disease by targeting 'CryJ2,' the main antigen responsible for Japanese cedar pollen allergy, and modulating the immune response—going beyond conventional symptomatic treatments.
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Kim Donggeon, CEO of Immunomic Therapeutics, stated, "This PMDA approval marks a pivotal turning point that will accelerate the clinical development of ITI-9001," adding, "We aim to introduce a new therapeutic approach targeting the fundamental improvement of allergic diseases based on the UNITE platform and saRNA technology, and will continue to verify the potential for expansion into various immune disorders in the future."
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