PharmaEngine, Inc. (TWO:4162), a new drug development company that focuses on oncology therapy, today announced that the first patient has been dosed in Phase I of PEP08 clinical trial for solid tumor cancers.

 

The PEP08 clinical trial adopts the multi-country, multi-center method and has obtained approvals from Australia’s Human Research Ethics Committee (HERC), acknowledge by Therapeutic Goods Administration (TGA) and Taiwan’s Food and Drug Administration (TFDA) to conduct Phase 1 clinical trials for solid tumor cancers. Developed using artificial intelligence (AI) as one of the tools in the early stage of drug discovery, PEP08 is the first in-house new cancer drug for PharmaEngine. A second-generation PRMT5 inhibitor, PEP08 is more precise in inhibiting only tumor cells with the MTAP gene deletion and does not affect the growth of normal cells compared to the first-generation PRMT5 inhibitors.

 

“The MTAP gene deletion characteristic is observed in 10-15% of human cancers. This includes brain cancer, pancreatic cancer, non-small cell lung cancer, stomach cancer and gastric cancer. Among them, brain cancer has the highest MTAP gene deletion rate of more than 40%, followed by pancreatic cancer and bladder cancer with 20-25% of MTAP gene deletion.” stated Hong-Ren Wang, Ph.D., CEO and President of PharmaEngine. “Having the first patient for PEP08 Phase I clinical trial be dosed is a major step toward PharmaEngine’s goal of providing more therapy options for cancer patients with an MTAP deletion characteristic.”

 

According to Globocan 2022 data, there are about 20 million new cancer patients worldwide, so it is estimated that 2-3 million cancer patients will have MTAP gene deletion.

 

 

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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 in most major markets including the U.S., Europe, and Asia for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression. 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)