PharmaEngine, a bio-pharmaceutical company developing new cancer treatments, and Nanobiotix S.A. a clinical-stage nanomedicine company pioneering in novel approaches for local treatment of cancer, announced that the companies had 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 commercialisation 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-tumour activity. The positive results of the study were presented by Nanobiotix at the American Society of Clinical Oncology Annual Meeting in June 2014.
"We are pleased to join the global pivotal STS study with Nanobiotix, which is the final step before registration for a medical device," said C. Grace Yeh, Ph.D., president and chief executive officer of PharmaEngine, "The promising results of the STS pilot trial encouraged us to continue exploring the safety and efficacy of PEP503 (NBTXR3). We believe that a combined effort with Nanobiotix can speed up the launch of PEP503 in the Asia-Pacific region."
PEP503, the lead compound 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. PEP503 has been classified as class III medical device in several European countries.
Soft tissue sarcomas are cancerous tumors that originate in the soft tissues of the body. There are many kinds of STS which are classified by the type of tissues where they develop, such as fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues. Surgery is the most common treatment for a potential cure of STS. Radiation therapy may be used either before surgery to shrink tumors or after surgery to kill any cancer cells that may have been left behind.