Locally Advanced Head and neck Cancer (LA-HNSCC) represents a significant clinical challenge. The standard of care (SOC) typically involves a combination of surgery, chemotherapy, and radiation therapy. However, there are significant limitations associated with these treatments, particularly in delivering a high enough radiation dose to completely destroy the tumor without causing unacceptable damage to surrounding healthy tissues. Nanobiotix, a company specialized in developing nanomedicine for cancer treatment, has developed a novel radioenhancer, NBTXR3, that aims to address this unmet need.
Current Standard of Care (SoC) of Locally Advanced Head & Neck Cancer (LA-HNSCC)
The current SoC for LA-HNSCC involves a combination of treatments, including surgery, chemotherapy, and radiation therapy. Radiation therapy, which uses high-energy radiation beams to target and kill cancer cells, is a key component of the SOC. However, delivering a high enough radiation dose to completely destroy the tumor without causing unacceptable damage to surrounding healthy tissues is particularly challenging in LA-HNSCC. This is due to the large primary tumors that may invade underlying structures or spread to regional nodes. As a result, the efficacy of radiation therapy alone in achieving local control and improving overall survival is limited, especially in elderly patients who may have limited therapeutic options.
Nanobiotix’s Position in the LA-HNSCC Disease Landscape
Nanobiotix has developed NBTXR3, a first-in-class radioenhancer composed of hafnium oxide nanoparticles. NBTXR3 can be incorporated into the current SOC of radiation therapy and, when activated by radiation, increases the localized dose of radiotherapy delivered to the tumor cells where it is present, leading to greater tumor cell destruction. Importantly, NBTXR3 achieves this without increasing the dose in surrounding healthy tissues.
The NANORAY-312 trial is a phase III study that aims to assess the effectiveness and safety of radiotherapy-activated NBTXR3, with or without cetuximab, compared to radiotherapy alone with or without cetuximab in elderly patients with high-risk, locally advanced head and neck squamous cell carcinoma. This research is crucial as it aims to provide alternative treatment options for elderly patients who are ineligible for cisplatin-based therapy and are dealing with locally advanced head and neck cancer.
Key Differentiating Attributes of NBTXR3
- Unique Mechanism of Action (MoA): NBTXR3 increases the localized dose of radiotherapy delivered to the tumor cells, leading to greater tumor cell destruction without increasing the dose in surrounding healthy tissues.
- Potential Immunogenic Effect: NBTXR3 has shown the potential to induce an immunogenic response, which can stimulate the immune system to recognize and attack cancer cells. This may enhance the efficacy of immunotherapy treatments when used in combination with NBTXR3.
- Potential to Improve Outcomes for Patients Ineligible for Chemotherapy: By enhancing the efficacy of radiation therapy and increasing tumor cell destruction, NBTXR3 may render the tumor more operable or help destroy it completely, improving the feasibility of surgical resection and potentially extending survival.
Clinical and Commercial Differentiating Attributes
- High Response Rate: In clinical trials, NBTXR3 has demonstrated a high response rate of 85% with a 63% complete response.
- Potential Immunomodulatory Effects: Preclinical models have shown that NBTXR3 can increase immune activity and facilitate the infiltration of CD8+ T cells into abscopal tumors.
- Localized Effect: NBTXR3 remains on the tumor site only, decreasing systemic side effects.
- Broad Commercial Application: With more than 60% of all cancer patients being treated with radiotherapy, NBTXR3 has the potential to disrupt outcomes in cancer treatment without disrupting clinical practice.
|First in Class
|Hafnium oxide nanoparticles
|Addressable Patient Pool
|NBTXR3 + RT
|Clinical Differentiating Attributes
|1) High response rate of 85% with 63% complete response
2) Potential Immunomodulatory Effects: In preclinical models, shown increased immune activity, facilitate the infiltration of CD8+ T cells into abscopal tumors
3) Localized Effect: Remain on Tumor site only, decreases systemic side effects
|Commercial Differentiating Attributes
|Broad Commercial Application: More than 60% of all cancer patients being treated with radiotherapy, the potential to disrupt outcomes in cancer treatment without disrupting clinical practice.
Nanobiotix’s NBTXR3 has the potential to address the significant unmet need in the treatment of LA-HNSCC by enhancing the efficacy of radiation therapy, inducing an immunogenic response, and improving outcomes for patients who are ineligible for chemotherapy or intolerant to other treatments. Preliminary data from clinical trials are promising, and further studies are ongoing to evaluate the safety and efficacy of NBTXR3 in combination with other treatments.