PharmaEngine Announces Initiation of Phase 1b/2 Trial of PEP503 (NBTXR3) in Head and Neck Cancer

Taipei, Taiwan, October 19, 2016

PharmaEngine announced today that the first patient has been dosed in a phase 1b/2 trial of PEP503 (NBTXR3) of head and neck squamous cell carcinoma (HNSCC) at Keelung Chang Gung Memorial Hospital (Lovers Lake Branch) in Keelung, Taiwan. The Principal Investigator is Prof. Cheng-Hsu Wang, M.D.

This prospective, open-label, single arm, non-randomized study (PEP503-HN-1002) of PEP503 in patients with HNSCC is being conducted in Taiwan by PharmaEngine. The primary objectives of this study are to determine the optimal dose, safety and preliminary efficacy of PEP503 through intra-tumor injection in combination with the standard treatment of concurrent chemoradiotherapy (CCRT) in SCC of oral cavity. A maximum of 42 patients may be enrolled in the phase 1b/2 study. For detailed information, please visit www.clinicaltrials.gov. (Identifier: NCT02901483).

Our partner, Nanobiotix is conducting a head and neck cancer study (NBTXR3 Study-102) of NBTXR3 (PEP503) in combination with radiation in elderly patients with SCC of oral cavity and oropharynx, who are not suitable for chemotherapy plus radiotherapy. These two studies will then identify the optimal doses for patients who can or cannot receive chemotherapy with radiotherapy plus NBTXR3 (PEP503).

ABOUT PEP503 (NBTXR3)

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 here.

ABOUT PHARMAENGINE

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.

Contact

Chihsing Chang, Vice President, Finance and Administration
P +886 2 2515 8228, ext. 700
chihsing.chang@pharmaengine.com