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HLB announced on July 3 that its US subsidiary, Immunomic Therapeutics, has completed the dosing of the first patient in the Phase 1 clinical trial for its Japanese cedar pollinosis vaccine candidate, ITI-9001. The patient has reportedly shown no specific adverse events or safety issues following the administration.

This first dosing was achieved less than a month after receiving Phase 1 Investigational New Drug (IND) approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA), drawing evaluations that the clinical development schedule is progressing rapidly.

The Phase 1 trial targets adults aged 18 to 65 with Japanese cedar pollen allergies. The study is designed as a single-center, randomized, placebo-controlled trial. The company plans to verify safety and tolerability in low-dose and high-dose cohorts to determine the optimal dose, and subsequently evaluate safety and immunogenicity by comparing the selected dose cohort against a placebo group.

ITI-9001 is a next-generation therapeutic vaccine candidate that integrates self-amplifying RNA (saRNA) technology into Immunomic's immunotherapy vaccine platform, UNITE. The mechanism fuses antigens with Lysosomal-Associated Membrane Proteins (LAMP) to enhance antigen presentation efficiency and induce T-cell immune responses. The company aims to achieve fundamental improvement of the disease by regulating immune responses targeting CryJ2, the primary antigen of Japanese cedar pollinosis.

According to a nationwide epidemiological survey conducted by the Japanese Society of Otorhinolaryngology in 2019, approximately 38.8% of Japan's total population suffered from Japanese cedar pollen allergies. Based on the current population, it is estimated that around 48 million people are affected by the condition.

"ITI-9001 aims to improve the disease itself by regulating the immune response, rather than simply alleviating symptoms," said Dong-Kun Kim, CEO of Immunomic Therapeutics. "Through this clinical trial, we will verify the safety and early efficacy to accelerate its development as a next-generation allergy immunotherapy."

                                                                                                        Moon Jung-woo