Date: 2014-10-08

Type of information: Licensing agreement

Compound: NBTXR3

Company: Nanobiotix (France) PharmaEngine (Taïwan)

Therapeutic area: Cancer - Oncology

Type agreement:


Action mechanism:

NBTXR3 is a nanoparticle consisting of hafnium oxide crystals and it is intended to enhance the local destruction of the tumor mass during radiotherapy. Once injected into the tumor, NBTXR3 accumulates in the cancer cells. Due to the physical properties of hafnium oxide, the particles emit huge amounts of electrons upon radiation. This leads to the formation of radicals within the tumor cell, which in turn damage the cancer cells and cause their targeted destruction. NBTXR3 particles are inert and emit electrons only during their exposure to radiotherapy. As a result, the destructive power of standard radiation therapy could be locally and selectively enhanced within the tumor cells.

Disease: prostate cancer, colorectal cancer, hepatocarcinoma, soft tissue sarcoma


* On August 6, 2012, PharmaEngine, a biopharmaceutical company focused on the development of new drugs for the treatment of cancer and Asian prevalent diseases, and the nanomedicine company Nanobiotix have entered into an exclusive license and collaboration agreement for the development and commercialization of NBTXR3, currently being investigated in a phase I study with soft tissue sarcoma patients.

Financial terms:

Under the terms of the agreement, PharmaEngine will receive the exclusive rights to develop and commercialize NBTXR3 in Australia, China, India, Japan, Korea, Taiwan and other countries in the Asia-Pacific region. Nanobiotix will receive an upfront payment of US$1 million, and is eligible to receive up to a total of US$56 million upon achievement of certain development, regulatory and sales milestones, as well as tiered, up to double-digit royalties on net product sales of NBTXR3 in the licensed territory. PharmaEngine will further fund the clinical development of NBTXR3 in three different indications according to an agreed upon time schedule and development plan.

Latest news:

* On October 8, 2014, PharmaEngine and Nanobiotix have strengthened their collaboration by jointly conducting a global pivotal trial of NBTXR3 in soft tissue sarcoma (STS) in Europe and Asia. Nanobiotix expects recruitment of the first patient in Europe by the end of 2014. In conjunction with the accelerated clinical development, PharmaEngine will make a milestone payment of US$1 million to Nanobiotix. In August 2012, PharmaEngine licensed the development and commercialization rights of NBTXR3 (designated as PEP503 by PharmaEngine) in Asia-Pacific region from Nanobiotix. Nanobiotix reported results of a pilot study of STS in mid-2014. Twenty patients were enrolled and received a single intratumoral injection of NBTXR3 (PEP503), at escalating volumes, followed by five weekly sessions of standard radiotherapy (50 Gy), after which the patients underwent surgical resection. The treatment regimen was well tolerated and showed promising signs of anti-tumor activity. The positive results of the study were presented by Nanobiotix at the American Society of Clinical Oncology Annual Meeting in June 2014.

Is general: Yes