First European Market Approval for Nanobiotix

First European Market Approval for Nanobiotix

First European Market Approval for Nanobiotix

The French nanomedicine company Nanobiotix has received its first European market approval (CE mark) enabling commercialisation of its lead product Hensify® (NBTXR3) in the 27 EU countries  for the treatment of locally advanced soft tissue sarcoma. “We could not be more proud to receive market approval in Europe for Hensify®. This approval validates more than 15 years of hard work, cutting edge science, and a fierce commitment to changing the lives of patients. This is a significant achievement and represents just one more step in our mission to improve life for millions of people around the world” said Laurent Levy, CEO of Nanobiotix.

A magnified impact of radiotherapy

Hensify® is a first-in-class  product introducing a new, physical mechanism of action. This aqueous suspension of crystalline hafnium oxide (HfO2) nanoparticles is designed for injection directly into a tumor prior to a patient’s first standard radiotherapy treatment. When exposed to ionizing radiation, Hensify® amplifies the localized, intratumor killing effect of that radiation. The dose of X-ray delivered to the tumor is magnified, whilst the dose passing through healthy tissues remains unchanged. This product requires a single administration and will fit into current worldwide standards of radiation care. Approval is based on results of the Act.In.Sarc phase II/III trial. The study  was a prospective, randomized (1:1), multinational, open label and active controlled two armed trial of 180 adult patients with locally advanced STS of the extremity or trunk wall. The objective of the trial was to evaluate the pre-operative efficacy and the safety of Hensify® activated by radiotherapy compared to the standard of care (radiotherapy alone). The positive Act.In.Sarc study results were presented at the 2018 ASTRO and ESMO Annual Congresses. The trial achieved its primary endpoint with a pathological complete response (<5% viable cancer cells) rate of 16.1% in the Hensify® arm compared to 7.9% in the control arm (p=0.0448). In addition, in the subgroup of patients with a more aggressive disease (histologic grade 2 and 3), a pathological complete response was achieved in four times as many patients in the Hensify® arm as in the control arm (17.1% compared 3.9%).
Similar safety profiles were observed in the Hensify® arm and the radiation therapy alone control arm. Hensify® did not impair the patients’ ability to receive the planned dose of radiotherapy and the radiotherapy safety profile was similar in both arms, including the rate of postsurgical wound complications. Hensify® was associated with grade 3-4 acute immune reactions which were manageable and of short duration. Further, Hensify® showed a good local tolerance in the trial and did not have any impact on the severity or incidence of radiotherapy-related adverse events.

Further ongoing developments

Post-approval trials are planned across Europe and discussions on next steps regarding potential further development are ongoing. In the US, based on recent discussions with the FDA, Nanobiotix plans to begin the clinical trial authorization process in the second half of 2019 and commence a phase II/III clinical trial in locally advanced head and neck cancers.  Moreover, the physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers. So, in addition to Hensify®, NBTXR3 is currently under evaluation in various other indications such as lung cancer, head and neck cancers, liver cancer, and prostate cancer. Nanobiotix is also running an immuno-oncology development program. In the United States, the company received approval from the FDA to launch a clinical trial of NBTXR3 activated by radiotherapy in combination with antiPD-1 antibodies in head and neck squamous cell carcinoma and non-small cell lung cancer. The other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma. Further, the company has a large-scale, comprehensive clinical research collaboration with the University of Texas MD Anderson Cancer Center (9 new phase I/II clinical trials in the United States) to evaluate NBTXR3 across head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.