NANOBIOTIX ANNOUNCES FIRST EVER RADIOENHANCER TO RECEIVE EUROPEAN MARKET APPROVAL
- Hensify®(NBTXR3) received European market approval (CE mark) enabling commercialization in 27 European Union countries for the treatment of locally advanced soft tissue sarcoma
- Hensify®--a first-in-class radioenhancer--offers cancer patients an innovative treatment with a broadly applicable mechanism of action
- After positive phase II/III data, this approval represents significant step forward in establishing NBTXR3 as a major oncology treatment
Laurent Levy, CEO of Nanobiotix, commented, “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.”
Paris, France, and Cambridge, Massachusetts (USA) April 4, 2019 – NANOBIOTIX (Euronext : NANO – ISIN : FR0011341205), a clinical-stage nanomedicine company pioneering new approaches in the treatment of cancer, announced today that Hensify® (NBTXR3) has obtained a CE mark for the treatment of locally-advanced soft tissue sarcoma (“STS”). Hensify® is the brand name for NBTXR3 as approved for the treatment of locally-advanced STS.
Hensify® is a first-in-class product introducing a new, physical mechanism of action. This innovative product was designed by Nanobiotix to physically destroy tumors and activate the immune system for both local control and systemic disease treatment when combined with radiation therapy. 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.
Hensify® is an aqueous suspension of crystalline hafnium oxide (HfO2) nanoparticles 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. Hensify® requires a single administration and will fit into current worldwide standards of radiation care.
STSs are rare cancers that develop in different types of soft tissues including fat, muscles, joint structures and blood vessels. Radiotherapy followed by surgery is part of the typical treatment regimen for STS patients in Europe. The Act.In.Sarc phase II/III trial 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.
Post-approval trials are planned across Europe and discussions on next steps regarding potential further development are ongoing.