Core Insights - Nanobiotix SA announced new results from an ongoing Phase 1 study evaluating JNJ-1900 (NBTXR3) in combination with immune checkpoint inhibitors for advanced cancer patients, specifically focusing on primary cutaneous melanoma [1][4] - The study involved 21 patients who had previously shown resistance to anti-PD-1 treatments, and the combination therapy demonstrated a favorable safety profile [1] - The stock price of Nanobiotix (NBTX) increased by 22.03%, reaching $12.45 [4] Patient Outcomes - A total of 16 patients experienced treatment-emergent adverse events (TEAEs) of grade 1, grade 2, or grade 3+ related to the overall therapeutic regimen [2] - Among 19 evaluable patients, the best observed objective response rate (ORR) was 47.4%, with four complete responses and five partial responses [5] - The disease control rate (DCR) across all lesions was 78.9%, and a DCR of 100% was observed in tumors that were injected and irradiated [5] - The median overall survival (mOS) for all treated patients was 14.6 months [5] Immune Response Insights - A relationship was noted between the depth of local response and systemic tumor regression, indicating potential priming or reactivation of the immune response [4]

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Core Insights - Nanobiotix presented new data from the third cohort of its Phase I 1100 study in melanoma at the Immunorad conference in Paris [2] Company Overview - The conference call was led by Joanne Choi, Head of U.S. Investor Relations, and included participation from Laurent Levy, Co-Founder and CEO [3] Research and Development - The call discussed forward-looking statements regarding the company's research and clinical development, highlighting the potential for significant risks and uncertainties that may affect actual results [3]

Summary of Nanobiotix Conference Call on Melanoma Study Results Company and Industry - **Company**: Nanobiotix - **Industry**: Oncology, specifically focused on melanoma treatment Core Points and Arguments 1. **Study Overview**: The conference call discussed new data from the third cohort of the Phase I 1100 study in melanoma, presented at the ImmunoRad Conference in Paris [2][4] 2. **Product Focus**: NBTXR3 is designed for patients receiving radiation therapy, which constitutes around 60% of cancer patients. The product aims to address unmet medical needs in patients who have failed multiple lines of treatment [4][5] 3. **Patient Recruitment**: A total of 21 patients were recruited for the study, with 19 evaluable for efficacy. The majority of these patients were advanced stage III and IV melanoma patients who had failed PD-1 and other treatments [6][8] 4. **Efficacy Results**: The study reported an overall response rate of 47%, with 9 out of 19 patients achieving complete response (CR) or partial response (PR). The disease control rate (DCR) was noted to be 78% [9][15] 5. **Safety Profile**: No grade four or five adverse events were reported related to NBTXR3, and the safety profile was consistent with previous trials [7][15] 6. **Overall Survival**: The median overall survival (OS) was reported at 14.6 months, with a confidence interval ranging from 11.6 months to non-reach [11][12] 7. **Immune Response**: There is a potential for NBTXR3 to prime an immune response, particularly in patients who have exhausted other treatment options. This was suggested by the correlation between injected irradiated lesions and systemic responses [11][20] 8. **Future Development Plans**: The company is considering further development of NBTXR3 in earlier treatment settings for melanoma and potentially in combination with other therapies [25][27] Additional Important Content 1. **Regulatory Considerations**: Future trials will need to be discussed with regulatory agencies like the FDA, especially regarding the control arm for randomized trials [21][22] 2. **Comparative Context**: The median OS of 14.6 months compares favorably to historical data for similar patient populations, where median OS after failure of PD-1 treatments is around 6.8 months [44][45] 3. **Pipeline Strategy**: Nanobiotix is exploring multiple indications for NBTXR3, with ongoing trials in head and neck cancer and lung cancer being run by Janssen [27][49] 4. **Patient Characteristics**: The study did not find significant baseline characteristics that influenced treatment outcomes, indicating a broad applicability of NBTXR3 across different patient profiles [33][39] This summary encapsulates the key findings and discussions from the Nanobiotix conference call, highlighting the potential of NBTXR3 in treating advanced melanoma and the company's strategic direction moving forward.

Immunorad September 2025 Data on Phase 1 Trial Safety and preliminary efficacy of NBTXR3/SBRT in combination with Immune Checkpoint Inhibitors in anti-PD-1 resistant patients with melanoma treated in the phase I trial Study 1100 Cohort 3 – Melanoma Subgroup Analysis Jason W. Chan, MD, Ari Rosenberg, MD, Alexander Lam, MD, James Lee, MD, Adil Daud, MD, William A. Stokes, MD,Nabil F. Saba, MD, Frances Collichio, MD, Hyeon Yu, MD, Priya Mody, MD, Jared Weiss, MD, Stergios Moschos, MD,Steven Powell, MD, Shannon ...

Core Insights - Nanobiotix announced new results from Phase 1 Study 1100 evaluating JNJ-1900 (NBTXR3) in combination with immune checkpoint inhibitors for patients with advanced primary cutaneous melanoma [2][4][5] Study Results - The study involved 21 patients with anti-PD-1 resistant primary cutaneous melanoma, all of whom had advanced disease and had previously undergone multiple lines of therapy [3][5] - A one-time intratumoral injection of JNJ-1900 was administered, followed by radiotherapy and sequential anti-PD-1 therapy [3] - As of the data cutoff on August 21, 2025, 19 patients were evaluable for tumor response, showing a best observed objective response rate (ORR) of 47.4% and a disease control rate (DCR) of 78.9% [5][6] Safety and Efficacy - The treatment demonstrated a favorable safety profile, with 16 patients experiencing treatment-emergent adverse events (TEAEs) related to the overall regimen [6] - The median overall survival (mOS) for all treated patients was reported at 14.6 months [5][6] - A significant relationship was observed between the depth of local response and systemic tumor regression, indicating potential immune response activation [7][8] Future Directions - Investigators concluded that the preliminary data warrant further investigation in randomized clinical trials as a potential new treatment option for patients with primary cutaneous melanoma [5][8] - Nanobiotix plans to host a conference call to discuss the findings on September 18, 2025 [9]

Summary of Nanobiotix Conference Call Company Overview - **Company**: Nanobiotix - **Product**: NBTXR3, a radioenhancer composed of hafnium oxide nanoparticles designed to enhance the effects of radiotherapy on tumor cells [1][2] Industry Insights - **Biotech/Pharma Industry**: The industry faces uncertainties in targeting specific biological entities for treatment, which can affect the predictability of treatment outcomes [2][3] - **Radiation Therapy**: Contrary to perceptions, radiation therapy is increasingly utilized as a frontline treatment for cancer, with a growing number of patients due to an aging population [8][9] Core Product Insights - **Market Opportunity**: Over 12 million patients receive radiation therapy annually, representing 60% of all cancer patients, indicating a vast market potential for NBTXR3 [5][6] - **Treatment Timing**: NBTXR3 is positioned as a first-line treatment, potentially leading to long-term benefits and reduced need for systemic therapies [5][6] - **Clinical Data**: Initial trials show promising results, with an 80%+ response rate in head and neck cancer patients, significantly higher than the typical 35% response rate [14] Strategic Partnerships - **Collaboration with Janssen Pharmaceuticals**: A significant agreement valued at nearly $3 billion was established, emphasizing the strategic fit in early treatment of tumors [11][12] - **Royalty Structure**: Nanobiotix will receive royalties and has incentives to expand clinical development, fostering a symbiotic relationship with Janssen [15][18] Clinical Development and Future Indications - **Ongoing Trials**: Current focus includes head and neck cancer and lung cancer, with plans to expand into additional solid tumors based on established safety and feasibility [19][20] - **Upcoming Data Releases**: Anticipated clinical data readouts include trials for head and neck cancer, melanoma, and esophageal cancer, with key milestones expected in 2025 and 2026 [22][25] Financial Position - **Cash Reserves**: As of the end of 2024, the company reported a cash balance of approximately €50 million, providing a runway into mid-2026 [28] Additional Developments - **New Platforms**: Nanobiotix is developing two new platforms, Curiline and Oocuity, aimed at addressing multiple indications and CNS diseases, with updates expected by the end of the year [27]

Core Insights - Nanobiotix, a late-stage clinical biotechnology company, is focused on pioneering nanoparticle-based approaches to enhance treatment options for cancer and other significant diseases [1][2]. Company Overview - Nanobiotix was incorporated in 2003 and is headquartered in Paris, France. The company has been listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market since December 2020. It also has subsidiaries in Cambridge, Massachusetts, among other locations [3]. - The company owns over 25 patent families related to three nanotechnology platforms, which have applications in oncology, bioavailability and biodistribution, and disorders of the central nervous system [3]. Upcoming Events - Company management will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 9:00 am EDT / 3:00 pm CEST in New York, NY. Presenters will include Laurent Levy, CEO, and Bart van Rhijn, Chief Financial & Business Officer [1]. - The event will be webcast live, and a replay will be available afterward [1].

Core Insights - Nanobiotix announced significant developments regarding JNJ-1900 (NBTXR3), a potential first-in-class radioenhancer for cancer treatment, which is licensed by Janssen Pharmaceutica NV, a Johnson & Johnson company [1][4] Regulatory Developments - Health authorities in major European countries have reclassified JNJ-1900 (NBTXR3) from a medical device to a drug, aligning its regulatory status with that in the United States and other major markets [2][9] - This reclassification supports a unified global regulatory classification, facilitating future global strategies and filings [9] Intellectual Property - Nanobiotix has filed a new composition of matter patent for JNJ-1900 (NBTXR3) to strengthen the intellectual property foundation supporting the product candidate [3][9] Clinical Development - JNJ-1900 (NBTXR3) is undergoing a comprehensive global clinical development program across multiple tumor types, including a pivotal Phase 3 trial in head and neck cancer [4][6] - The product candidate has shown proof-of-concept in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018 [5] Mechanism of Action - JNJ-1900 (NBTXR3) consists of functionalized hafnium oxide nanoparticles, administered via one-time intratumoral injection and activated by radiotherapy, designed to induce significant tumor cell death and trigger an adaptive immune response [5] Collaboration and Strategy - Nanobiotix has engaged in a collaboration strategy to expand the development of JNJ-1900 (NBTXR3), including a partnership with The University of Texas MD Anderson Cancer Center for several Phase 1 and Phase 2 studies [7]