Nanobiotix is an oncology focused nanomedicine company developing an innovative nanoparticle technology. Their NanoXray technology comprises three products having the potential to cause a paradigm shift in cancer therapy. NanoXray products are developed to selectively increase the efficacy of radiotherapy in the tumor cell.
The following video is showing how this disruptive technology is acting in the patient’s body.
The Company made major clinical and financial progress, including broadening of indications and strategic plans across Europe, Asia and the US.
NBTXR3 flagship of the clinical development
The company is developing three different products that can be administered either by direct injection into the tumor (NBTXR3), intravenous injection (NBTX-IV) or topical application to fill tumor cavities just after tumor surgery (NBTX-TOPO). NBTXR3 is the first product of the NanoXray portfolio to reach clinical development. The product comprises nanoparticles which can be injected directly into tumor. With the application of radiotherapy, these nanoparticles absorb X-rays which significantly enhances the radiation dose within the cancer cells without increasing the dose to the surrounding healthy tissues. Currently, NBTXR3 is classified as a medical device in Europe and a drug in the United States (US).
In June 2014, the Company presented positive Phase I clinical study results for NBTXR3, demonstrating feasibility and safety of intratumoral injection of the product followed by radiotherapy in patients with locally advanced STS. In addition to the feasibility and safety data presented, promising signs of efficacy have been demonstrated. The positive results led the French National Security Agency for Medicines and Health Products (ANSM) to allow Nanobiotix to enter into a Phase II/III pivotal trial, which is the final step before registration (CE mark).
This study started end 2014 in France and will be broadened out to 25-30 sites in Europe once further authorizations are received. This international multi-center pivotal study is expected to be completed towards the end of 2016 with interim results in mid-2016.
In the Asia-Pacific region, Nanobiotix’s partner, PharmaEngine intends to participate in the pivotal study by opening clinical sites in several Asia-Pacific countries. In the US, depending on the interim clinical results, expected mid-2016, the Company will decide if doable to expand the development of NBTXR3 through a bridge study in this indication to access this market.
NBTXR3 is also in development for elderly patients with locally advanced head and neck cancer. The aim is the decrease of the tumor size and the preservation of the local functions. Nanobiotix is currently conducting a pilot trial for this indication, for which interim results are expected in H1 2015. In 2014, two new sites were opened in Spain for this pilot trial.
New Indications with High Potential: Liver Cancers and Prostate Cancer
Liver cancers are potentially the largest indication for NBTXR3. Nanobiotix is already pursuing the non-clinical evaluation phase of NBTXR3 in primary liver cancer, and as part of its expanded development plan, is also evaluating the compound in liver metastases (metastases arising from colorectal cancers, breast cancer, etc.). Nanobiotix plans to initiate clinical trials in this indication in the second half of 2015 and will include patient populations with both Primary liver cancer and liver metastases. For this patient population, the aim of treatment is to increase and prolong patients’ survival rates. This program is being supported with a €2.8m grant from Bpifrance through the NICE project..
The Company is also seeking to develop NBTXR3 for patients with high risk prostate cancer, with the aim of providing effective tumor control combined with tumor destruction. It represents a significant potential new market for the product. The planned pilot trial is expected to start in the second half of 2015 and will involve approximately 24-30 patients that are newly diagnosed with high risk prostate cancer.
NBTXR3 could be also developed in other indications as the potential is broad especially for esophagus cancer, glioblastoma, cervix cancer, etc.
So What’s next?
Nanobiotix is pursuing a standalone development and commercialization strategy for its lead product NBTXR3 in Europe. As part of the international strategy, in September, Nanobiotix opened an affiliate office in Cambridge, MA. In the Asia-Pacific region, Nanobiotix is already partnered with PharmaEngine. During 2014, the company completed two capital raises, totaling €38.5m, with the potential for another €24.1m.
Nanobiotix is in a strong financial position to pursue its standalone strategy in both Europe and US. In 2015, further clinical progress are expected and Nanobiotix is also preparing for the future by expanding its pipeline with two other NanoXray products (NBTX-TOPO and NBTX-IV) and beyond.
The way seems clear for Nanobiotix and the paradigm in cancer therapy could change in the future thanks to their innovation.
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