PharmaEngine Announces Its Partner, Nanobiotix, Received an IND Approval from US FDA to Conduct a Phase I/II trial of PEP503 (NBTXR3)

Taipei, Taiwan, December 27, 2017

PharmaEngine’s (TWO: 4162) announced that its partner, Nanobiotix (Euronext: NANO), has been granted an Investigational New Drug(IND) approval by the U.S. Food and Drug Administration (FDA) for PEP503 (NBTXR3) activated by radiotherapy, and administered in combination with an anti-PD1 antibody (nivolumab or pembrolizumab).

For further information view Nanobiotix’s press release:

Press Release

NBTXR3, the lead project of the NanoXray pipeline of Nanobiotix, is a nanoparticle formulation of hafnium oxide crystals for the local treatment of tumors to enhance the efficacy of radiotherapy. In August 2012, PharmaEngine licensed the development and commercialization rights of NBTXR3 in the Asia-Pacific region from Nanobiotix.In 2014, Nanobiotix presented the pilot study results for NBTXR3 in patients with soft tissue sarcomas at ASCO, which showed a good safety profile and positive signs of efficacy. Then the preliminary pilot studyresults in head and neck cancerpatients (without receiving chemotherapy) and liver cancer patients presented at ASCO 2017and ASCO GI 2018,respectively, also showedpromisingsigns of anti-tumoreffect.

There are other indications being developed for NBTXR3 by Nanobiotix and PharmaEngine. These includehead and neck cancer in patients receiving chemotherapy (Phase I/II, PharmaEngine), rectal cancer (Phase I/II, PharmaEngine), liver cancer (Phase I/II, Nanobiotix)andprostate cancer (Phase I/II, Nanobiotix). NBTXR3 has been classified as a class III medical device in many European and certain Asian countries. Learn more.


PharmaEngine, Inc. is a biopharmaceutical company headquartered in Taipei, Taiwan with a wholly owned subsidiary, PharmaEngine Europe Sarl in Paris, France. PharmaEngine focuses on the development of new medications for the treatment of cancer and Asian prevalent diseases. PharmaEngine has three ongoing projects: ONIVYDE® has received regulatory approvals in 37 countries; PEP503 (NBTXR3) is in a global pivotal trial of soft tissue sarcoma, and patient recruitment has been completed; and PEP06 is in preclinical development. Get to know more here.


Chihsing Chang, Vice President, Finance and Administration
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