HLB Immunomic Receives Approval for Phase 1 Clinical Trial Plan in Japan for Japanese Cedar Pollen Allergy Vaccine

Combination of UNITE Platform and saRNA Technology

Immunomic Therapeutics, the U.S. subsidiary of HLB, announced on June 15 that it has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for its phase 1 clinical trial plan for 'ITI-9001,' a vaccine candidate for the treatment of Japanese cedar pollen allergy.

This clinical trial is a single-center, randomized, placebo-controlled study targeting adults aged 18 to 65 with Japanese cedar pollen allergy. The study will first evaluate safety and tolerability in both low-dose and high-dose groups, after which the optimal dose will be selected and compared to a placebo group.

ITI-9001 is a next-generation therapeutic vaccine candidate that combines Immunomic's proprietary immune therapy vaccine platform, 'UNITE,' with self-amplifying RNA (saRNA) technology. The UNITE platform binds antigens to lysosome-associated membrane protein (LAMP) to enhance antigen presentation efficiency and maximizes T-cell immune responses, leading to strong and sustained immunotherapeutic effects.

ITI-9001 is being developed with the aim of fundamentally improving (disease-modifying) Japanese cedar pollen allergy by targeting 'CryJ2,' the major antigen of the allergy, to modulate immune responses, going beyond conventional symptomatic treatments.

Japanese cedar pollen allergy is a representative allergic disease affecting about 40% of the Japanese population. It causes a variety of symptoms such as runny nose, nasal congestion, and itchy eyes, significantly lowering patients' quality of life. The prevalence rate in Japan has steadily increased from 16.2% in 1998 to 26.5% in 2008 and 38.8% in 2019. The size of the related treatment market is estimated to reach approximately 100 billion yen (about 950 billion won) per year.

Currently, symptom-relieving treatments such as antihistamines and steroid nasal sprays, as well as immunotherapy, are mainly used. However, symptom-relieving treatments only provide temporary effects, and immunotherapy, which may be able to control the disease, requires long-term administration, presenting limitations. Accordingly, ITI-9001 is emerging as a more efficient allergy immunotherapy option that can overcome the limitations of existing treatments.

Donggun Kim, CEO of Immunomic Therapeutics, stated, "This PMDA approval marks a significant turning point in the full-scale clinical development of ITI-9001," adding, "Based on the UNITE platform and saRNA technology, we aim to present a new therapeutic approach targeting fundamental improvement of allergic diseases and will continue to verify the potential for expansion into various immune disorders in the future."

This content was produced with the assistance of AI translation services.