PharmaEngine announces TFDA approval of PEP07 Phase I clinical trial for solid tumor cancers

PharmaEngine, Inc. (TWO:4162) announces TFDA has approved PEP07 Phase 1 clinical trial for solid tumor cancers.

PharmaEngine’s PEP07 clinical trial design includes hematologic cancers and solid tumor cancers. Recently, the first patient has been dosed in for Phase 1 clinical trial for hematologic cancers. The next step is to begin conducting Phase 1 clinical trial for solid tumor cancers.

Per GLOBOCAN 2020 Report published by World Health Organization, worldwide, in 2020, there was an estimated 19.29 million new cancer cases and around 9.96 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, brain penetrating and oral bioavailability. PEP07 also has demonstrated significant single-agent activity and combination potential with standard treatments in preclinical models. 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, was established in February 2003. PharmaEngine focuses on new drug development by adopting “Virtual Pharmaceutical Company Business Model”. PharmaEngine has one commercial product, ONIVYDE®, which has received marketing approvals in more than 40 countries worldwide for the treatment of metastatic pancreatic cancer patients who have progressed on gemcitabine. PharmaEngine is current advancing and growing early-stage pipelines.

Media Contact: ChiHsing Chang, Spokesperson/Vice President (



Chihsing Chang
Vice President, Finance and Administration
TEL +886 2 2515 8228, ext. 700
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