2024-08-13 07:00:00
L’Usine Nouvelle – In recent months, Nanobiotix has published promising progress with its first product, NBTXR3, in certain cancers, particularly head and neck cancers. What makes your technology unique?
Laurent Levy – Our technology is based on physics and not just biology. While drug development has focused on chemistry since the 1940s and then biology since the 1980s, we are bringing physics into the heart of the cell. This is what makes Nanobiotix unique.
How would you describe the first product, NBTXR3? Is it a vector? medicine?
It is a new therapeutic tool. It is activated through radiation therapy and can work alone or in combination with medications. We start with cancer, which spans dozens of indications and where the mainstay of treatment remains surgery and radiation therapy. This treats 60% of patients and is the most commonly used tool. Its power is very powerful, but it is also very limited, because tumors in the human body are always surrounded by healthy tissue, and the rays that illuminate it must also pass through these healthy tissues. This limits the dose that can be deposited into tumors due to side effects. We rely on nanophysics to increase dose to tumors without increasing radiation to healthy tissue.
NBTXR3 is a crystalline nanoparticle, hafnium oxide, inert material and X-ray super absorber that is not radioactive and is used, for example, to shield uranium rods in nuclear power plants to stop rays. Our hafnium oxide particles are produced at our facility in Villejuif (Val-de-Marne), are approximately 50 nanometers in size, and can be injected directly into tumors. When a patient receives radiation therapy, these particles absorb the energy from the radiation therapy and deliver it inside the tumor, causing cell death.
Do I need multiple injections?
No, it is not the same as the biomolecules that are consumed and metabolized. The product can be reused multiple times because it is inert and will not degrade due to radiation therapy. It remains in the tumor from the first day until the end of radiation therapy.
You mentioned that this technology is 80% effective and patients respond better, right?
Yes, this is the response rate shown in head and neck cancer. This high reaction rate may be related to the physical principles we use. In the context of chemotherapy, some tumors respond well, some do not respond at all, and some develop resistance. This is all biological variability, and every tumor has different cells, but technically there are no tumors that are resistant to physical stimulation.
Can it treat any cancer?
That’s the purpose. Being able to use this product will be helpful to the majority of patients undergoing radiation therapy. Nanophysics makes it possible to think about mass medicine rather than personalized medicine. We bet on a common pattern of action. We have treated hundreds of patients in clinical trials across a variety of cancers, such as pancreatic, esophageal, liver, lung, head and neck, sarcoma, prostate, and more.
Why also test NBTXR3 in combination with other anti-cancer drugs?
60% of patients who receive radiation therapy are targeted to localized tumors. In this case, our product may be enough because the cancer has not metastasized yet. When metastasis occurs, we don’t irradiate the whole body, which would cause too much damage, so we can play a dual role by using our product for radiation therapy to destroy the cells of the main tumor and then target the metastasis. . However, we have observed that our products also elicit immune responses against tumors and metastases.
Comment?
When tumors are different enough from the body, they are detected by the immune system and antibodies are produced, just as it is with viruses. But many tumors remain hidden and tumor cells multiply because they are not recognized by the immune system. Then we have to get our immune system to recognize the tumor. This is the dual role of our products. By injecting into the tumor and irradiating it, by destroying it, we send a warning signal to the immune system, which will look at and detect the many parts of the tumor exposed by the destruction. It then springs into action and attacks tumors and metastases in the body. These are the results that we just demonstrated in patients with head and neck cancer. Therefore, it needs to be used in conjunction with certain drugs, such as immunotherapy, because once this immune response is triggered, it is important to maintain it.
Last year, you concluded a $2.5 billion (€2.3 billion) agreement with the US laboratory J&J. What would this change?
This deal will allow us to deploy our first product and sell it around the world while also making the company financially independent. This also validates our entire approach and is endorsed by major pharmaceutical companies and the scientific and medical community.
What about on a financial level?
We have received an initial payment, nearly 10% equity in Johnson & Johnson, and the first milestone of $20 million, but the bulk of the payment will be made during product development and registration, and then based on revenue levels. Johnson & Johnson will now deploy and market it globally in early indications and incur corresponding costs.
Will the first indication be head and neck cancer?
Yes. We are transferring the global Phase III clinical trial to Johnson & Johnson, with enrollment expected to close in the first half of 2026, and Johnson & Johnson will prepare for first commercialization. Johnson & Johnson also received FDA authorization [autorité sanitaire américaine, ndlr] A Phase II trial for Phase 3 lung cancer has been initiated, and we are also formulating clinical development plans for other indications.
How is your production going?
Our factory in Villejuif has been operating under GMP conditions for almost seven years and covers an area of more than several hundred square meters. [bonnes pratiques de fabrication] and produces clinical batches for us and Johnson & Johnson. We will be able to produce enough product for the first markets, and Johnson & Johnson is working hard to replicate this plant to produce in parallel to support and prepare for larger markets.
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