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 novel nanoparticle products aims to increase the effectiveness of radiotherapy.

This breakthrough therapeutic approach is based on physical rather than biological principles. Nanoparticles developed 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

Nanobiotix has 16 ongoing and/or planned trials in several indications across Europe, the USA and the Asia-Pacific Region

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  :

3Head and neck cancer PharmaEngine trial

PharmaEngine is also conducting a Phase I/II clinical trial of NBTXR3 (PEP503) for patients with head and neck cancers to be treated by radiotherapy with concurrent chemotherapy (cisplatin).

The primary endpoints are to determine the safety profile and recommended dose of NBTXR3 and to assess the preliminary safety and efficacy of NBTXR3 administered by intratumoral injection in combination with radiotherapy plus chemotherapy.

  • Phase I/II (NBTXR3 chemo) clinicaltrials.gov
  • 4Hepatocellular 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

    5Prostate 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

    6Rectal 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

    7NBTXR3 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.

    8Pancreatic cancer

    Pancreatic cancer is a rare, deadly form of the disease. Worldwide, there were approximately 460,000 new cases in 2018. Given that surgery with R0 resection (i.e. macroscopically complete tumor removal with negative microscopic surgical margins) remains the only hope for long-term survival, clinical trials have investigated various neoadjuvant strategies—wherein patients receive anti-cancer drugs or radiation prior to surgery—to increase the surgery-eligible population while also increasing the R0 resection rate.

    The MD Anderson trial is an open-label, single-arm, prospective phase I study consisting of two parts: (i) dose escalation to determine the recommended phase 2 dose (RP2D); and (ii) expansion at RP2D.

    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 novel product is a radioenhancer, which when activated by radiotherapy, is designed to destroy:

    • Tumor cells through physical destruction causing direct cell death
    • Metastasis 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 developed 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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