PharmaEngine, Inc. (TWO:4162) announces the first patient has been dosed in for our PEP07 Phase 1 trial for solid tumors.

 

PEP07 obtained approval from Taiwan FDA in September 2023 to conduct Phase 1 clinical trial for patients with solid tumors in Taiwan.

 

Per the latest data provided by World Health Organization’s GLOCAN database, worldwide, in 2022, there was an estimated 19.98 million new cancer cases and around 9.74 million cancer deaths.

 

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About PEP07

PEP07 is a checkpoint kinase 1 (CHK1) inhibitor which targets the DNA Damage Response (DDR) pathway. CHK1 inhibitors have important functions in the cell’s DDR process as it can enhance the damaging effect of cytotoxic therapy on DNA and prevent the self-repair of tumor cells leading to tumor cell deaths. Compared to other competitors targeting the DDR pathway, PEP07 has features such as high kinase selectivity, high potency and brain penetrating. PEP07 also has demonstrated significant single-agent activity and combination potential with standard treatments in preclinical models. Currently, PharmaEngine has been conducting Phase 1 clinical trials for hematologic and solid tumor cancers.

 

PharmaEngine exercised the option for a Worldwide Exclusive License Agreement for PEP07 from UK-based Sentinel Oncology in September 2022.

 

About PharmaEngine, Inc.

PharmaEngine, Inc., headquartered in Taipei, began operations in February 2003. PharmaEngine focuses on new drug development by adopting “Virtual Pharmaceutical Company Business Model”. PharmaEngine has one commercial product, ONIVYDE®, which is currently approved in most major markets including the U.S., Europe, and Asia in combination with fluorouracil and leucovorin for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy. In 2024, ONIVYDE® in combination with oxaliplatin, fluorouracil and leucovorin (NALIRIFOX), for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma also obtained approvals from US FDA, Australia TGA, and Taiwan TFDA.

PharmaEngine also conducts, collaborates or licenses-in early-stage new drug discovery and development projects. With extensive experience in drug development and project management, we continue to expand our pipeline, and accelerate drug development and the subsequent commercialization of new medicines.

 

Media Contact: ChiHsing Chang, Spokesperson/Vice President (info@pharmaengine.com)