PharmaEngine, Inc. (TWO:4162) announces MFDS (South Korea's Ministry of Food and Drug Safety) has approved PEP08 Phase 1 clinical trial for solid tumor cancers. (ClinicalTrials.gov Identifier: NCT06973863)

 

PEP08 is a second-generation PRMT5 inhibitor (protein arginine methyltransferase 5). PRMT5 has important functions in maintaining stable cell survival, including gene transcription, cell growth, DNA damage response, and immune regulation, so inhibiting the PRMT5 function can lead to tumor cell apoptosis. Compared with the first-generation PRMT5 inhibitors, PEP08 is more precise in inhibiting only tumor cells with the MTAP gene deletion and does not affect the growth of normal cells. It is expected to have a better therapeutic window and safety profile and is likely to improve clinical treatment efficacy.

 

The Phase I clinical trial of PEP08 is being conducted as a multicenter, multinational study and has initiated patient enrollment in Australia and Taiwan. The first patient was dosed in October 2025.

 

The approval from MFDS further strengthens PEP08's global clinical development strategy for Asia. The addition of the South Korean clinical sites is expected to expand patient enrollment and improve recruitment efficiency, thereby accelerating dose escalation and expansion for the determination of the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) while providing a foundation for future indication expansion.

 

The Company will continue to accelerate the clinical development of PEP08 for MTAP-deleted cancers and explore related combination therapies to further enhance the product's differentiation and competitive positioning while creating long-term value.

 

 

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About PEP08

PEP08 is a second-generation PRMT5 inhibitor (protein arginine methyltransferase 5). PRMT5 has important functions in maintaining stable cell survival, including gene transcription, cell growth, DNA damage response, and immune regulation, so inhibiting the PRMT5 function can lead to tumor cell apoptosis. Compared with the first-generation PRMT5 inhibitors, PEP08 is more precise in inhibiting only tumor cells with the MTAP gene deletion and does not affect the growth of normal cells. This feature also allows PEP08 to achieve lower toxicity and improved safety compared to first-generation PRMT5 inhibitors.

 

Preclinical animal experiments have shown that PEP08 can significantly inhibit the growth of tumor cells with MTAP gene deletion. Pharmacokinetic data also shows that PEP08 can penetrate the blood-brain barrier to reach the brain and inhibit brain tumor growth, which has great potential for the future treatment of brain cancer.

 

Moreover, current research data shows that PEP08 has a better tumor cell inhibition effect than other competitors. Therefore, PEP08 has the most potential to become the best-in-class candidate drug for PRMT5 inhibitors currently under development for MTAP gene deletion tumors.

 

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 for the treatment of adult patients with metastatic pancreatic adenocarcinoma. PharmaEngine also conducts, collaborates or licenses-in 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)