PharmaEngine announces Phase I clinical study of PEP07 has been approved by Australia HREC and acknowledged by Australia TGA

PharmaEngine, Inc. (TWO:4162) announces PEP07 Phase I clinical trial in hematological cancers (e.g., AML or MCL) has been approved by Australia HREC (Human Research Ethics Committee, HREC) and acknowledged by Australia TGA (Therapeutic Goods Administration, TGA). ( Identifier: NCT05659732)

Per the report published by Datamonitor, the acute myeloid leukemia (AML) drug market is expected to nearly triple in size over the 10-year forecast period (2021-2031), growing from US$1.3bn in 2021 to nearly US$3.6bn in 2031, at a CAGR of 10.3%.

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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. was established in February 2003 based on the international strategic alliance concept. The Company has been adopting the “Virtual Pharmaceutical Company Business Model” to focus on the R&D of new drug developments while lowering the related risks. In addition to conducting early drug development, PharmaEngine also licenses in and leads many new drug development projects. PharmaEngine uses extensive experience in project management to accelerate clinical trials and the post-launch product marketing.

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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