PharmaEngine, Inc. (TWO: 4162) today announced the phase 1 results of a phase 1b/2 clinical study evaluating NBTXR3 (PEP503) activated by radiotherapy with concurrent chemotherapy.in locally advanced or unresectable rectal cancer patients were presented at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI 2021). The study is performed at 2 medical centers in Taiwan and enrolled 20 patients in the dose-escalation phase. Subjects received PEP503 intratumoral injection before radiotherapy with concurrent chemotherapy (CCRT), and received surgery after the CCRT. The safety data showed good tolerability of PEP503 even at the highest dose level (22% of tumor volume). There were no observed adverse events directly associated with PEP503, and the toxicity profile of CCRT was not affected.
More than 70% of patients in the study showed objective tumor response after CCRT. Around 90% of patients underwent total mesorectal excision (surgery) with R0 resection; and near 20% achieved pathological complete response (pCR). Half of the patients receiving surgery had good tumor regression. Based on the above data, PharmaEngine has proceeded to phase 2 part at 3 medical centers in Taiwan, starting from October, 2020, for further evaluation of the efficacy of PEP503 in rectal cancer patients.
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 http://www.pharmaengine.com.