FDA green light sets Nanobiotix up to start nanoparticle prostate cancer trial

Nanobiotix (EPA:NANO) is gearing up for the first U.S.-based clinical trial of its nanoparticle therapy, NBTXR3. The FDA signed off on an IND for a clinical trial of the asset in prostate cancer late last year, setting Nanobiotix up to aim to start enrolling the first of 24 patients for the preliminary stage of the Phase I/II study.

Nanobiotix CEO Laurent Levy

Paris, France-based Nanobiotix will test NBTXR3 in an open-label Phase I/II trial, in which people with prostate cancer will receive the experimental nanoparticle in conjunction with one of two types of radiotherapy. The expectation is that NBTXR3, a nano-sized radio-enhancer that is injected into the tumor, will ratchet up the intensity of the energy applied to cancer cells by radiotherapy, enabling physicians to treat the malignancy more effectively without causing additional damage to healthy tissues.

Nanobiotix plans to work with three oncology centers in the U.S. on the trial. The centers will enroll 24 patients who have several risk factors for the dose-escalation phase of the study. Nanobiotix has yet to set a timeline for the enrollment of the first patient or the delivery of top-line data, a spokesperson for the company told FierceBiotech. Once the dose-escalation stage of development is wrapped up, Nanobiotix will enrol 20 patients into each arm of its Phase II trial. Each participant will receive an injection of NBTXR3 alongside a form of radiotherapy.

Half of participants will receive NBTXR3 plus external beam radiation therapy. Patients in the other arm will receive the same regimen, plus brachytherapy. The nonexperimental treatment regimens in both arms have already proven somewhat successful--the Prostate Cancer Foundation puts the 5-year disease-free rate for the brachytherapy approach at around 50%--but Nanobiotix thinks NBTXR3 can tip the odds further in the favor of patients. The belief is underpinned by Nanobiotix's testing of the science behind NBTXR3 and some early clinical trial data.

NBTXR3, like other products from Nanobiotix's NanoXray suite, is designed to be small enough to enter cancer cells and have a high electron density. When the nanoparticles are exposed to X-rays, Nanobiotix expects them to interact strongly, releasing a flood of electrons that ramp up the level of damage inflicted on the tumor. Results from a Phase I/II soft tissue sarcoma (STS) suggest NBTXR3 isn't causing any harm, while hinting that it may enhance antitumor activity. Nanobiotix is advancing NBTXR3 through a pivotal trial in STS, interim data from which are expected this year.

Beyond that, Nanobiotix is looking to the upcoming Phase I/II trial in the U.S. to give it an indication of the applicability of NBTXR3 to prostate cancer. And the company is also joining the scrum scrapping for a slice of the immuno-oncology market. Nanobiotix revealed this week that it is setting up a preclinical program to investigate the potential for NBTXR3 to boost immunogenicity.

- read the IND release
- and the I-O statement