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

The PEP07 clinical trial adopts the multi-country, multi-center method and has obtained approvals from Australia's TGA and Taiwan's TFDA to conduct Phase 1 clinical trials for hematological cancers. PEP07 has shown potential in single-agent activity and combination therapies with standard treatments, which may be used on indications such as acute myeloid leukemia (AML) and mantle cell lymphoma (MCL) for hematological cancers. 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%.

Moreover, with PEP07's potential indications also including solid tumor cancers. PharmaEngine is preparing to initiate Phase 1 clinical trial for solid tumor cancers in the near future.

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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 (info@pharmaengine.com)