Healthcare professionals

BACKGROUND

Radiotherapy is one of the most common treatment modalities for cancer. More than 60% of cancer patients undergo radiotherapy at some point during their treatment. With surgery, radiotherapy is the standard of care for local cancer treatment as it improves the prognosis for many patients.

However, the dose and ultimate efficacy of RT will always be limited by the potential toxicity of radiation exposure to surrounding normal tissues. As a result, many cancer patients receive a dose that is insufficient for tumor destruction.

To meet these high unmet medical needs, Nanobiotix’s pipeline of first-in-class nanoparticle products aims to increase the effectiveness of radiotherapy.

This breakthrough therapeutic approach is based on physical rather than biological principles. Nanoparticles developped by Nanobiotix have been designed to increase the X-ray’s dose energy absorption and deposition, without increasing the dose in the surrounding healthy tissues, and thus should not cause additional damage.

Our aim is to develop a new standard of care by transforming radiotherapy into radiotherapy plus nanoparticles to potentially help millions of patients. A European market approval in Soft Tissue Sarcomas was obtained on April 4, 2019.

Clinical trial

With its nanoparticles, Nanobiotix is currently running trials in several indications across Europe, the USA and the Asia-Pacific Region: (i) a Phase I extansion trial in Head and Neck cancers, (ii) Phase I/II trials in Liver cancers (HCC and Metastatic) and Prostate cancer; (iii) and in Asia via its partner PharmaEngine, in Head and Neck and Rectal cancers treated by radiotherapy plus chemotherapy.

NANOBIOTIX CLINICAL TRIALS LIST

1Soft tissue sarcoma

Soft tissue sarcomas (STSs) are a rare type of cancer that develops in different types of soft tissues, including muscles, joint structures, fat, nerves and blood vessels. Although STS can develop at any anatomic site, it occurs in the extremities (arms and legs) in approximately 60% of cases.1

To know more about the clinical trials run by Nanobiotix in this indication:

2Head and neck cancer

Head and Neck cancers include cancers in the larynx, throat, lips, mouth, nose, and salivary glands These structures play a critical role in a patient’s ability to swallow, breathe and speak. These cancers represent a major public health concern. Chemotherapy in combination with concomitant radiation is the standard treatment for locally advanced head and neck cancers in both the United States of America and the European Union. However, such treatment cannot usually be proposed to elderly and frail patients, as they are unable to endure the physical strain inherent in chemotherapy treatment.

To know more about the clinical trials run by Nanobiotix in this indication  :

3Hepatocellular cancer and liver metastases

According to the World Health Organization, Liver cancer is currently the fourth most common cause of cancer death in the world.2

Liver cancers are from two types: hepatocellular carcinoma (HCC), the most common type of Liver cancer, and secondary Liver cancer, or liver metastases, which occurs when cancer from another part of the body spreads to the liver. Surgical resection cannot usually be proposed to patients with either HCC or liver metastasis, while local and systemic treatment options are few in number, with significant limitations. Radiotherapy has been shown to improve outcomes for these patients, as it has been observed from third party clinical trials a direct correlation between higher doses of radiation and increased survival rates.

To know more about the clinical trials run by Nanobiotix in this indication:

2 Cancer. (2019)from https://www.who.int/news-room/fact-sheets/detail/cancer

4Prostate cancer

Prostate cancer is the second leading cause of death from cancer and the second-most common form of cancer in the United States in men.3 Achieving local control is key for treatment of prostate cancer to prevent relapse and subsequent spreading of the disease. Prostate cancer patients typically receive one of two forms of radiotherapy—External beam radiotherapy (EBRT) or brachytherapy combined with EBRT. It is shown from third-party clinical data that radiotherapy, and specifically the increasing of the radiation dose delivered, significantly improves local control of prostate tumors and reduces recurrence and metastasis.

To know more about the clinical trials run by Nanobiotix in this indication :

3 Prostate Cancer - Statistics. (2019), from https://www.cancer.net/cancer-types/prostate-cancer/statistics

5Rectal cancer

The American Cancer Society estimates that in 2019 in the United States of America, approximately 44,180 people will be diagnosed with Rectal cancer. Colorectal cancer is the third most common cancer in men and the second most common cancer in women. The five-year survival rate for patients with Rectal cancer is 64.4%, but varies greatly depending on the stage of the cancer and whether the cancer has spread.4

4 Cancer of the Colon and Rectum - Cancer Stat Facts. (2019), from https://seer.cancer.gov/statfacts/html/colorect.html

6NBTXR3 in combination with immune checkpoint inhibitors in the US

The NANORAY-1100 study is a multicenter, multi-arm, that aims to evaluate the safety, efficacy, and tolerability of NBTXR3 activated by radiotherapy in combination with anti-PD-1 therapy in Locoregional recurrent (LRR) or recurrent and metastatic (R/M) head and neck squamous-cell carcinoma (HNSCC) and Lung and Liver metastasis. It aims to evaluate the hypothesis that the combination of NBTXR3 activated by RT with anti-PD-1 therapy will act synergistically to enhance the therapeutic window of radiation therapy maximizing the local effect, will overcome radio-resistance and increase the efficacy of immunotherapy, and potentially produce an abscopal effect for improved distant tumor control.

Hafnium nanoparticles

Nanoparticles of Nanobiotix are an aqueous suspension of crystalline hafnium oxide with an average size of 50nm, designed for injection directly into a malignant tumor prior to standard radiotherapy. Our first-in-class product is a radioenhancer, which when activated by radiotherapy, is designed to destroy:

  • Tumor cells through physical destruction and cell death
  • Metastasis lesions due to immunogenic cell death leading to activation of the immune system and transforming tumors into immunologically active lesions

Mode of action

Once injected into the tumor, nanoparticles developped by Nanobiotix are designed to accumulate in cancer cells in clusters while remaining inert thanks to their specific size and their negatively-charged particular coating.

The principle of action is based on the interaction of the high electron density nanoparticles and ionizing radiation (e.g. radiotherapy) to locally generate photons and secondary electrons within the cell and subsequent radical production. The energy released from these clusters of nanoparticles constitutes what we call a dose deposit “hotspot,” which should lead to high, localized destruction of biological subcellular structures and increased cell death.

Ionizing radiation can be applied to the nanoparticles repeatedly because they return to their inactive, inert state after each exposure to radiation. Multiple courses of radiotherapy can be administered to a tumor that has received a single injection of our nanoparticles.

In our preclinical studies, the radiation-activated nanoparticles have also been observed to trigger metastatic cell destruction due to immunogenic cell death, leading to activation of the immune system. Based on these observations we believe that our nanoparticles may prime the body’s immune response, rendering tumors more prone to recognition by a patient’s immune system.

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