Perseus Proteomics Inc. announced that the clinical trial notification of the Phase I/II investigator-led clinical trial among aggressive NK-cell leukemia (ANKL) patients using in-development anti-transferrin receptor antibody PPMX-T003 as a therapeutic was submitted to the PMDA by Hiroshima University Hospital (Director, Yoshiki Kudo). ANKL is a blood cancer categorized as malignant lymphoma, and originates in NK (natural killer) cells, one of immune cells. It is fulminant type of refractory hematological malignancy, where symptoms will progress rapidly once developed.

Due to the rarity of the disease with few reported cases, there is a need to discover its causes and establish the effective standard treatment as soon as possible. Under such circumstances, the research and development on PPMX-T003 As a new therapeutic drug of ANKL was adopted as Project Promoting Support for Drug Discovery Support Program for Orphan drug prior to the Designation by AMED in March 2022. Following the adoption, this investigator-led clinical trial will be conducted for the purpose of assessing the safety and tolerability in administering PPMX-T003 to ANKL patients, as well as efficacy and pharmacokinetics.

The investigator-led clinical trial will been initiated after the review by PMDA and registration of participating patients. The Company expects the clinical trial costs of JPY 100 million to be incurred in the fiscal year ending March 31, 2024. The Company will receive the subsidy of JPY 100 million from AMED in the same fiscal year, however, it will book the subsidy as long-term deposits received until the actual amount will be determined at the inspections to be conducted by AMED.