Btobioinnovation.com
Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation jcm9144@gmail.com
SPECIAL REPORT #16
Nanobiotix Receives European Market Approval for its Nanoparticle Radioenhancer
Nanobiotix, a Paris based nanomedicine company, founded and incorporated by Laurent Levy in 2003, has obtained a CE mark for the treatment of locally-advanced soft tissue sarcoma (STS) for Hensify®, or NBTXR3, a first-in-class nanoparticle radioenhancer.
Hensify® is an aqueous suspension of crystalline hafnium (Hf02) nanoparticles designed for injection directly in a tumour prior to patients’ first standard radiotherapy treatment and constitutes a new kind of product introducing a physical mechanism to destroy tumors and activate the immune system locally. When exposed to ionizing radiation Hensify® amplifies the localized, intratumour killing effect of that radiation. Under the current use of Hensify® the dose of radiation of X-Ray delivered to the tumour is notably amplified while remaining the same through healthy tissues. Hensify® requires a single administration and fits into worldwide standards of radiation care.
The current approval of Hensify® is limited to STSs, which are rare cancers that develop in soft tissues such as fat, muscles, joint structures and blood vessels. The pivotal phase 2/3 clinical trial underlying the European approval achieved its primary endpoint with pathological complete response rate of 16.1% in the Hensify® group versus 7.9% in the control arm. In a more aggressive setting the complete response in the Hensify® arm was four time more effective than the control arm.
Nanobiotix is actively evaluating NBTXR3 in a large series of other cancers such as head and neck with locally advanced squamous cell carcinoma of the oral cavity, liver cancers alone and in combination with chemotherapy, locally advanced or unresectable rectal cancer in combination with chemotherapy, as well as prostate adenocarcinoma. Nanobiotix is also running an Immuno-Oncology program and has received US FDA approval to launch a combination trial with NBTXR3 and PD-1 antibodies to assess the value of such a combination in lung cancer as well as in head and neck cancer patients. In addition, Nanobiotix has entered a comprehensive clinical trial collaboration with the University of Texas at the MD Anderson Cancer Center to evaluate NBTXR3 across a large variety of cancers including head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.
In a recent note, Jefferies Financial Group considers that NBTXR3 “has the potential to be used in up to 60% of all cancers treated by radiotherapy”. Nanobiotix does not intend to immediately launch Hensify® in the 27 European countries where CE mark has been obtained for STS until it has received other cancer indication approvals. Nevertheless, the product will be available, in Europe, on a “free of charge basis” for soft carcinoma cancer patients within a long term real world evidence clinical trial.
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