CBA-1205 has progressed from safety confirmation to data analysis and evaluation of high doses in pediatric patients.

For CBA-1205, the development assessment focus has shifted from simply continuing the clinical trial to organizing safety and preliminary efficacy data across multiple patient populations. As of FY2026-H1, enrollment in the first part had been completed, and a high level of safety had been confirmed at doses of up to 30 mg/kg. In the second part, enrollment in hepatocellular carcinoma and melanoma had been completed, and data analysis was under way. The earnings supplementary materials disclosed 22 treated patients and a maximum dose of 30 mg/kg.

In terms of efficacy, a patient in the first-part melanoma cohort has maintained a RECIST v1.1 SD assessment accompanied by tumor shrinkage for more than 4 years. Previous disclosures had successively extended the reported treatment duration beyond 27, 30, 33, 36 and 42 months, reaching more than 48 months in FY2026-H1. However, the existence of long-term SD cases does not demonstrate efficacy for the phase 1 trial as a whole. The next earnings release will therefore be important for determining whether analyses beyond individual cases are disclosed, including the number of cases, population-specific assessments, and the breakdown of PR, SD and PD.

In pediatric cancer, the company moved to add a new part after a collaborative study with a European research institution suggested potential efficacy, against the background of treatment experience in adult patients. As of FY2026-H1, the safety evaluation of the initial-dose cohort had been completed and the high-dose cohort was under way. In FY2026-Q3, it will be necessary to confirm the number of pediatric cancer patients treated, dose levels, treatment continuation status, and whether any grade 3 or higher or serious adverse events have occurred. Disclosure of analysis results following completion of enrollment in hepatocellular carcinoma and melanoma would also directly strengthen the company’s case to potential licensees.