PharmaEngine, Inc. announced that Phase 1 clinical study of PEP07 has been approved by TFDA. 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.

Current development stage: (1)Application submission/approval/disapproval/each of clinical trials (include interim analysis): a PEP07 Phase I clinical trial in hematological cancers (e.g., AML or MCL) has been approved by TFDA. (ClinicalTrials.gov Identifier: NCT05659732) Estimated date of completion: actual timeline depends on clinical progress and subsequent regulatory review.