PharmaEngine, Inc. announced TFDA approved PEP07 Phase I Clinical Trial forSolid Tumor Cancers. New drug name or code: PEP07. Indication: PEP07 is a checkpoint kinase 1 (CHK1) inhibitor featuring high kinase selectivity, brain penetrating and oral bioavailability which targets the DNA Damage Response (DDR) network.

PEP07 has demonstrated significant single-agent activity and combination potential with standard treatments in preclinical models. Planned development stages: Phase I, II, III clinical trial, and New Drug Application. Current development stage: (1) Application submission/approval/disapproval/each of clinical trials (include interim analysis): A PEP07 Phase I clinical trial in solid tumor cancers has been approved by TFDA.

(ClinicalTrials.gov Identifier: NCT05983523) (2) Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur: Not applicable. Accumulated investment expenditure incurred: For negotiation on potential licensing deals in the future, and for the best interest of shareholders, this information is kept confidential temporarily.