PharmaEngine Starts the PEP503 (NBTXR3) Phase 2 Study in Locally Advanced or Unresectable Rectal Cancer

Taipei, Taiwan, Oct. 20, 2020 – PharmaEngine’s (TWO: 4162), announced the first patient has been enrolled in the phase 2 part of the rectal cancer study for PEP503 (also known as NBTXR3, Hensify@).

In the phase 1 study part, there were 20 patients recruited from two medical centers in Taiwan and the data had been reviewed by the Independent Data Monitoring Committee. The phase 1 results planned to be presented in early next year. The phase 2 part is opened in 3 medical centers in Taiwan and the last subject is expected to be enrolled by the end of 2021.

“The safety data and preliminary efficacy evidence in the phase 1 study support we continue the development of PEP503 in the radiotherapy of rectal cancer. We look forward to more substantial data from the phase 2 part, and will also evaluate the clinical trial initiation in Asia Pacific region.” – Yu-Fang Hu, President of PharmaEngine.

About PEP503 (NBTXR3, Hensify@)

PEP503, the lead project of the NanoXray pipeline of Nanobiotix, is a nanoparticle formulation of hafnium oxide crystals. It is a first-in-class product designed to destroy, when activated by radiotherapy, tumors through physical cell death and metastasis via immunogenic cell death leading to specific activation of the immune system. In August 2012, PharmaEngine licensed the development and commercialization rights of NBTXR3 in the Asia-Pacific region from Nanobiotix.PEP503 has been classified as a class III medical device in many European and certain Asian countries.

About PharmaEngine (TWO: 4162)

PharmaEngine, Inc. is a commercial stage oncology company headquartered in Taipei,Taiwan. PharmaEngine focuses on the development of new medications for the treatment of cancer diseases. PharmaEngine has three ongoing projects: ONIVYDE (Irinotecan Liposome Injection) has received marketing authorizations in Taiwan, US, Europe, Japan and other countries for the treatment of metastatic pancreatic cancer patients who progressed on gemcitabine; PEP503 (NBTXR3, Hensify@) in a positive global pivotal trial of soft tissue sarcoma, and in other cancers. For further information, please visit PharmaEngine’s website at


Chihsing Chang
Vice President, Finance and Administration
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