PharmaEngine Inc. (4162.TWO) announces Phase 1 clinical study in hematological cancer (e.g., AML or MCL) of PEP07, our product under development, has been approved by Taiwan Food and Drug Administration (TFDA). 

 

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. 

 

PharmaEngine applied for first-in-human clinical trials for PEP07 in December 2022 and the application has been approved by Australia HREC in March 2023. Today, the Company received TFDA confirmation on Phase 1 clinical trial in Taiwan shows we continue to hold true to our vision and strive to develop new cancer drugs. We work to improve patients' well-being, enhance quality of life, and extend lives through innovation. 

 

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., 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 has received marketing approvals in more than 40 countries worldwide for the treatment of metastatic pancreatic cancer patients who have progressed on gemcitabine. 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)