NBTX Nanobiotix S.A.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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NBTXR3 (Study 102 Expansion)
Head and Neck Cancer
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Phase 1
Phase 1
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Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
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NBTXR3 (Study 1100)
Advanced Cancers
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Phase 1
Phase 1
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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NBTXR3
Non-small Cell Lung Cancer
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Phase 1
Phase 1
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Phase 1 dosing initiated late-2020.
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NBTXR3 (NANORAY-312)
Head and Neck Cancer
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Phase 3
Phase 3
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Phase 3 trial planned for 2021 with futility analysis due 18 months later.
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NBXTR3 with concurrent chemoradiation (CCRT)
Colorectal cancer
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Phase 1/2
Phase 1/2
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Phase 1b/2 initial data presented at ASCO GI January 15, 2021. More than 70% of patients in the study showed objective tumor response after CCRT.
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NBTXR3
Esophageal Cancer
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Phase 1
Phase 1
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Phase 1 commencement of dosing announced January 28, 2021.
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NBTXR3
Pancreatic cancer
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Phase 1
Phase 1
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Phase 1 trial enrolling. Dosing commenced October 2020.
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NBTXR3
Liver Cancer
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Phase 1
Phase 1
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Phase 1 completed. Next steps to be communicated post Study 312 launch.
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Latest News
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Regulatory News:
NANOBIOTIX (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the filing of its universal registration document for the financial year ended December 31, 2020 with the French financial market authority (Autorité des marchés financiers or AMF), as well as its annual report on Form 20-F for the financial year ended December 31, 2020 with the U.S. Securities and Exchange Commission (SEC).
These documents are available on Nanobiotix's website at https://www.nanobiotix.com/regulated-information/. In addition, the 2020 universal registration document is available on the AMF website (www.amf-france.org) and the 2020 Annual Report on Form 20-F is available on the SEC website (www.sec.gov).
In particular, the Company's 2020 universal registration document includes its:
- 2020 annual financial report,
- Management report including the report on corporate governance
- Reports from the Company's statutory auditors and information on their fees
- Required information in relation to the Company's share buyback program
About NANOBIOTIX: www.nanobiotix.com
Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The company's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.
Incorporated in 2003, Nanobiotix is headquartered in Paris and also has subsidiaries in France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and completed a successful initial public offering (IPO) on the Nasdaq Global Select Market in New York City in December 2020. The company is one of only 7 dual-listed biotech companies with headquarters in France.
Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanomedicine platforms: 1) applied to oncology; 2) applied to bioavailability and biodistribution; and 3) applied to disorders of the central nervous system. The lion's share of the company's resources are devoted to the development of its lead product candidate–NBTXR3—which was born from its proprietary oncology platform and is has already achieved market authorization in Europe for the treatment of patients with soft tissue sarcoma under the brand name Hensify®.
For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter
Disclaimer
This press release contains certain "forward-looking" statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management's current expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials, the timing of our presentation of data, the results of our preclinical studies and their potential implications. Such forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix considers to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including with respect to the risk associated with the evolving nature of the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to it. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) on April 7, 2021 (a copy of which is available on www.nanobiotix.com), as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210407005997/en/
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- Substantial progress in priority development pathway in head and neck cancer with clinical registration plan announced, Fast Track designation granted by US Food and Drug Administration, and new data from phase I dose expansion showing 83% objective response rate in primary lesion.
- First clinical data reported phase I immuno-oncology trial showing conversion of anti-PD-1 non-responders to responders.
- Extended global capital markets presence with a successful Nasdaq IPO that provided gross proceeds of €93.5 million ($113.3 million).
- Cash, cash equivalents, and short-term investments were €119.2 million at December 31, 2020, supporting robust development plans into the second quarter of 2023.
Regulatory News:
NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported business highlights and financial results for the fiscal year ending December 31, 2020.
"2020 was a banner year for Nanobiotix, despite challenges posed by COVID-19. Our company achieved several milestones to advance our priority development pathways in head and neck cancer and immuno-oncology; and our successful Nasdaq IPO positioned us to keep our pace in 2021. We look forward to building on our progress to ensure that we deliver the potential benefits of NBTXR3 to patients with deliberate speed," commented Laurent Levy, founder and chairman of the executive board of Nanobiotix.
2020 Financial Highlights
- In 2020 total revenue remained stable compared to 2019 and amounted to €2.5M. €0.05M corresponded to the license and collaboration agreement signed with PharmaEngine, a former partner. €1.9M corresponded to the Research Tax Credit (CIR). There we €0.5M in subsidies from the government of France, of which €0.3M was in the context of partial unemployment and €0.2M went to Curadigm SAS from BPI.
- Research and development expenses decreased from €30.4M in 2019to €24.3M. This decrease is primarily a result of the Company's cost-control efforts relating to R&D subcontracting and consulting fees, as well as a reduction in the number of Group employees assigned to research and development.
- Selling, general and administrative expenses in 2020 were €14.6M compared to €18.9M in 2019. This decrease is due mainly to the decrease in external costs mainly related to savings due to the COVID-19 pandemic (especially consulting fees) and to the 2019 reclass of the Nasdaq IPO costs.
- Net loss for the year ended December 31, 2020 was €33.6M, or €1.4 per share (basic and diluted), compared to net loss of €50.9 million, or €2.3 per share for the same period in 2019.
- Cash, cash equivalents, and short-term investments were €119.2 million on December 31, 2020.
Clinical activities and achievements advancing NBTXR3 toward global phase III registration trial in head & neck cancer:
- Clinical registration plan for global phase III head and neck cancer study for elderly patients ineligible for platinum-based chemotherapy announced following feedback from the US Food and Drug Administration (FDA) in January 2020. The FDA also agreed to the chemistry, manufacturing, and controls (CMC) development plan for NBTXR3, to support the future New Drug Application (NDA) for the product candidate and its use in the phase III clinical study.
- Fast track designation granted by FDA for the patient population in the global phase III head and neck cancer study in February 2020.
- Preliminary safety and efficacy data from the dose expansion part of phase I study in head and neck cancer reinforcing NBTXR3 as a potential new option for patients presented in October 2020 at the annual meeting of the American Society for Radiation Oncology ("ASTRO"). Among 31 evaluable patients, overall response rate according to RECIST 1.1 was 83.9% of the evaluable patients, 67.7% had achieved a complete response of the injected lesion.
Clinical activities and achievements advancing I/O combination strategy:
- First clinical data suggesting NBTXR3 could convert anti-PD-1 non-responders to responders presented at the 35th Anniversary Annual Meeting of The Society for Immunotherapy of Cancer (SITC) in November 2020. Data from company-sponsored study 1100 provided a strong signal that NBTXR3 activated by radiation therapy in combination with pembrolizumab or nivolumab (anti-PD-1 checkpoint inhibitors) could convert anti-PD-1 non-responders to responders. Eight of nine patients treated on study showed tumor regression, including six of seven prior anti-PD-1 non-responders. Four of the anti-PD-1 non-responders had multiple lesions, and three of the four experienced tumor regression in the non-injected local and/or distant lesions. One patient with prior anti-PD-1 resistance experienced delayed tumor regression, suggesting an adaptive immune response aided by NBTXR3 activated by radiation therapy. The early data also demonstrated that administration of NBTXR3 via intra-tumoral injection had been feasible and well tolerated in all patients (head and neck cancer, lung metastasis, and liver metastasis). One patient in the head and neck cancer cohort experienced 4 severe adverse events related to anti-PD-1, of which 2 events were also reported as possibly related to NBTXR3.
- Positive new preclinical data from two studies suggesting that NBTX3 could have a significant impact in immunotherapy presented at SITC in November 2020. The first study demonstrated that NBTXR3 activated by radiotherapy produced a strong abscopal effect without checkpoint inhibitor combination, stimulated adaptive antitumor immunity and increased TCR repertoire diversity in treated tumors compared to radiation therapy alone. The second study suggested that NBTXR3 plus high dose and low dose radiation (RadScopal™) combined with anti-PD-1 and anti-CTLA-4 could significantly improve the control of both the primary and secondary tumors, extended survival, and reduced lung metastases in an anti-PD-1 resistant lung cancer model. The NBTXR3 combination also promoted anti-tumor response both at molecular and cellular levels and produced long-term anti-tumor memory.
Clinical activities and achievements advancing clinical collaboration with The University of Texas MD Anderson Cancer Center and expanding the evaluation of NBTXR3:
- Activation of first study in the collaboration and first patient injected in pancreatic cancer, in May 2020 and September 2020, respectively.
- Regulatory ‘safe to proceed' granted for a phase I esophageal cancer study in October 2020 and was activated in November 2020. The first patient was subsequently injected in January 2021.
- Regulatory ‘safe to proceed' granted for two phase II head and neck cancer studies evaluating NBTXR3 in combination with anti-PD-1 in November 2020. The first clinical study (Study 2020-0541) targets patients with recurrent or metastatic head and neck squamous cell carcinoma with limited PD-L1 expression, or that are refractory to PD-1 blockade. The second clinical study (Study 2020-0354) targets patients with inoperable locoregional recurrent head and neck squamous cell carcinoma amenable to re-irradiation.
- Regulatory ‘safe to proceed' granted for a phase I study in lung cancer amenable to re-irradiation in October 2020.
Corporate activities and achievements enhancing Nanobiotix balance sheet and advancing subsidiary Curadigm:
- Successful IPO on Nasdaq Global Select Market in December 2020. The offering, including the full exercise of the underwriters' over-allotment option, included a capital increase of 8,395,000 new shares consisting of 6,540,000 ordinary shares in the form of American Depositary Shares (ADSs), each representing one ordinary share, and 1,855,000 ordinary shares placed in certain jurisdictions outside of the United States. The total gross proceeds of the global offering amounted to €93.5 million ($113.3 million), or net proceeds of €82.8 million ($100.4 million) after deducting underwriting commissions and other estimated offering expenses.
- Successful raise of €20 million in placement of ordinary shares with US and EU investors in July 2020. Nanobiotix placed 3,300,000 new ordinary shares for total gross proceeds of approximately €20.1 million by means of an accelerated bookbuild offering reserved for a specific class of investors in the US and EU.
- €10M in non-dilutive financing secured in June 2020. Nanobiotix a total of €10 million from HSBC and Bpifrance for in the form of state-guaranteed loans (Prêts Garantis par l'Etat, or PGE in France).
- Validation of novel nanoprimer technology from subsidiary Curadigm in RNA therapeutics with preclinical data presented at the American Association for Cancer Research (AACR) in June 2020. The data showed that the Curadigm nanoprimer could increase the efficacy of RNA-based therapeutics up to 50% by decreasing rapid liver clearance.
Expected 2021 Milestones
- 2021 – Expect first patient injected in phase III trial for elderly head and neck cancer patients (NANORAY-312).
- Q2 2021 – Presentation of updated phase I dose expansion results in head and neck cancer (Study 102 Expansion)
- Q2 2021- Updated results with new patients and additional follow up in phase I I/O basket study (Study 1100)
- H1 2021 – Expect first patient injected in phase II study of NBTXR3 in combination with anti-PD-1 for patients with recurrent/metastatic head and neck cancer
- H1 2021- Expect first patient injected in phase II study of NBTXR3 in combination with anti-PD-1/L1 for patients with inoperable head and neck cancer
- H1 2021 – Expect first patient irradiated in phase I lung reirradiation study (first patient injected H2)
- H2 2021 – Expect launch of post-registration study in soft tissue sarcoma to launch in EU
- Additional news on other clinical trials and preclinical programs
Next financial press release: revenue for Q1 2021 on April 30, 2021
Annual General Meeting will be held on April 28, 2021.
About NANOBIOTIX:
Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The company's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.
Incorporated in 2003, Nanobiotix is headquartered in Paris, France and Cambridge, Massachusetts (United States) and is currently staffed by 90 employees (70 in France, 20 in the US). The company also has subsidiaries in France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and completed a successful initial public offering (IPO) on the Nasdaq Global Select Market in New York City in December 2020. The company is one of only 7 dual-listed biotech companies with headquarters in France.
Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanomedicine platforms: 1) applied to oncology; 2) applied to bioavailability and biodistribution; and 3) applied to disorders of the central nervous system. The lion's share of the company's resources are devoted to the development of its lead product candidate–NBTXR3—which was born from its proprietary oncology platform and is has already achieved market authorization in Europe for the treatment of patients with soft tissue sarcoma under the brand name Hensify®.
For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter
Disclaimer
This press release contains certain "forward-looking" statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management's current expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials, the timing of our presentation of data, the results of our preclinical studies and their potential implications. Such forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix considers to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including with respect to the risk that subsequent studies and clinical trials may not generate favorable data notwithstanding positive preclinical result and the risks associated with the evolving nature of the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to it. Furthermore, many other important factors, including those described in our prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption "Risk Factors" and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.20-010 on May 12, 2020 (a copy of which is available on www.nanobiotix.com), as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
The consolidated financial statements for the fiscal year ending December 31, 2020 have been approved by the Company's executive board and reviewed by the supervisory board on March 17, 2021. The Company's statutory auditors have completed their audit work on the 2020 financial statements, but they have not issued their audit report yet.
Consolidated Income Statement:
In K€
2020
2019
Total revenue and other income
2.512
2.541
Sales
50
68
Service
50
40
Other sales
-
28
Other revenue
2.462
2.473
Research Tax Credit
1.927
2.437
Subsidies
526
20
Other
10
17
Research & Development (R&D) costs
(24.330)
(30.411)
Selling, General and Administrative (SG&A) costs
(14.611)
(18.909)
Operating loss
(36.428)
(46.779)
Financial loss
2.847
(4.133)
Income tax
(9)
(3)
Net loss for the period
(33.590)
(50.915)
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Regulatory News:
NANOBIOTIX (NASDAQ:NBTX), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that the Company has reached an agreement with PharmaEngine, Inc. ("PharmaEngine") to terminate the License and Collaboration agreement that the Company and PharmaEngine entered into in August 2012.
As previously disclosed in the Nanobiotix prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020, in November 2020, Nanobiotix notified PharmaEngine of a material breach of the terms of the License and Collaboration agreement. In a letter dated December 1, 2020, PharmaEngine responded to the Company's notification of material breach, denying a material breach of the License and Collaboration agreement, and asserting certain material breaches of that agreement by Nanobiotix. After discussion between the two parties, this agreement to terminate the License and Collaboration agreement represents a full resolution of outstanding disagreements over a number of issues with respect to the development of NBTXR3 in the Asia-Pacific region.
The License and Collaboration agreement provided PharmaEngine exclusive rights to further the development of NBTXR3 in the Asia-Pacific region. While both Nanobiotix and PharmaEngine believe in the potential of NBTXR3 to improve treatment outcomes for patients with cancer, the parties have had disagreements regarding the optimal strategy for development in the Asia-Pacific region. As such, Nanobiotix and PharmaEngine have mutually agreed to discontinue the collaboration.
Pursuant to their Termination and Release agreement, Nanobiotix will retain all rights to the development and commercialization of NBTXR3 in the Asia-Pacific region. PharmaEngine is to receive payments, not to exceed $5 million in total, upon the completion of various administrative steps in connection with the winding-up of the collaboration.
In the future, PharmaEngine will be entitled to receive a payment of $7.5 million upon a second regulatory approval of NBTXR3 in any jurisdiction of the world for any indication, unless the Company announces a collaboration with a new partner for the Asia-Pacific region within 6 months of the effective date of the agreement. If that occurs, PharmaEngine will be entitled to an immediate $2.5 million payment and will be eligible to receive a payment of the remaining $5 million upon such second regulatory approval of an NBTXR3-containing product. The Company has also agreed to pay royalties to PharmaEngine at low-single digit royalty rates with respect to sales of NBTXR3 in the Asia-Pacific region for a 10-year period commencing on the corresponding first date of sales in the region.
Retention of all rights regarding NBTXR3 will open new near- and long-term possibilities for the Company, and Nanobiotix will evaluate the Asia-Pacific region for potential inclusion in its upcoming global phase III registration trial in head and neck cancer.
About NBTXR3
NBTXR3 is a first-in-class radioenhancer composed of sterile, functionalized, crystalline hafnium oxide nanoparticles. The product candidate is designed to increase the radiotherapy energy deposit inside tumor cells through the nanoparticles' high atomic number core packaged in the space for interaction with ionizing radiation, and subsequently increase of tumor cell death when compared to radiotherapy alone—without adding toxicity to adjacent healthy tissues. NBTXR3 requires a single, intratumoral administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The primary physical mechanism of action of NBTXR3 activated by radiotherapy could be universal, making it potentially applicable across any solid tumor indication where radiotherapy is a part of standard of care including head and neck, lung, prostate, liver, colorectal, and esophageal cancers. The biological secondary mechanism of action of NBTXR3 activated by radiotherapy has been shown in preclinical studies to prime adaptive immune response, which would potentially bring a new dimension to cancer immunotherapies.
About NANOBIOTIX: www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases.
The Nanobiotix philosophy is rooted in bringing highly effective, generalized solutions to address unmet medical needs and challenges.
The Company's first-in-class, proprietary lead technology, NBTXR3, is being evaluated in an expansive global development program both as a single agent activated by radiotherapy and in combination with other anti-cancer therapies including chemotherapy and immune checkpoint inhibitors.
Nanobiotix is listed on the regulated market of Euronext in Paris (GREY:NNBXF, Bloomberg: NANO: FP))) and on the Nasdaq Global Select Market (NASDAQ:NBTX). The Company's headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany.
Disclaimer
This press release contains certain "forward-looking" statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management's current expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials, the timing of our presentation of data, the results of our preclinical studies and their potential implications. Such forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix considers to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including with respect to the challenges associated with developing NBTXR3 in the Asia-Pacific region or identifying a suitable collaboration partner for such development activities, the risk that subsequent studies and clinical trials may not generate favorable data notwithstanding positive preclinical result and the risks associated with the evolving nature of the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to it. Furthermore, many other important factors, including those described in our prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption "Risk Factors" and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.20-010 on May 12, 2020 (a copy of which is available on www.nanobiotix.com), as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
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Regulatory News:
NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (NASDAQ:NBTX), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that Laurent Levy, Chief Executive Officer, will speak during a fireside chat at the H.C. Wainwright Global Life Science Conference, being held virtually on March 9-10, 2021.
Event Details:
- Title: H.C. Wainwright Global Life Sciences Conference
- Date: Tuesday, March 9, 2021 to Wednesday, March 10, 2021
- Time: Available on Demand
- Registration: https://hcwevents.com/globalconference/
Members of the Nanobiotix management team will also be available to participate in virtual one-on-one meetings with investors who are registered to attend the conference. The Company's corporate presentation can be downloaded here.
About NBTXR3
NBTXR3 is a first-in-class radioenhancer composed of sterile, functionalized, crystalline hafnium oxide nanoparticles. The product candidate is designed to increase the radiotherapy energy deposit inside tumor cells through the nanoparticles' high atomic number core packaged in the space for interaction with ionizing radiation, and subsequently increase of tumor cell death when compared to radiotherapy alone—without adding toxicity to adjacent healthy tissues. NBTXR3 requires a single, intratumoral administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The primary physical mechanism of action of NBTXR3 activated by radiotherapy could be universal, making it potentially applicable across any solid tumor indication where radiotherapy is a part of standard of care including head and neck, lung, prostate, liver, colorectal, and esophageal cancers. The biological secondary mechanism of action of NBTXR3 activated by radiotherapy has been shown in preclinical studies to prime adaptive immune response, which would potentially bring a new dimension to cancer immunotherapies.
About NANOBIOTIX: www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases.
The Nanobiotix philosophy is rooted in bringing highly effective, generalized solutions to address unmet medical needs and challenges.
The Company's first-in-class, proprietary lead technology, NBTXR3, is being evaluated in an expansive global development program both as a single agent activated by radiotherapy and in combination with other anti-cancer therapies including chemotherapy and immune checkpoint inhibitors.
Nanobiotix is listed on the regulated market of Euronext in Paris (GREY:NNBXF, Bloomberg: NANO: FP))) and on the Nasdaq Global Select Market (NASDAQ:NBTX). The Company's headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany
Disclaimer
This press release contains certain "forward-looking" statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management's current expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials, the timing of our presentation of data, the results of our preclinical studies and their potential implications. Such forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix considers to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including with respect to the challenges associated with developing NBTXR3 in the Asia-Pacific region or identifying a suitable collaboration partner for such development activities, the risk that subsequent studies and clinical trials may not generate favorable data notwithstanding positive preclinical result and the risks associated with the evolving nature of the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to it. Furthermore, many other important factors, including those described in our prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption "Risk Factors" and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.20-010 on May 12, 2020 (a copy of which is available on www.nanobiotix.com), as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
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- Combo therapy including augmented anti-tumor response in both irradiated and unirradiated (abscopal) tumors, improving local and distant tumor control, and increasing survival rate
- Survivor mice were immune to re-injections of tumor cells, maintained significantly higher percentages of memory immune cells and stronger anti-tumor immune activities than control
"Evaluation of NBTXR3 as a tumor-agnostic, combo-agnostic product candidate is instrumental to our aim of significantly improving treatment outcomes for millions of patients with cancer. Our early clinical data in several tumor types have support that the physical primary mode of action of NBTXR3 could be universal and potentially benefit patients with any tumor type where radiotherapy is part of the standard of care. Our prior pre-clinical and early data from our ongoing clinical I/O program have provided further support that the biological secondary immune priming effect of NBTXR3 could help patients overcome resistance to anti-PD-1. The data from this preclinical experiment suggest that we may be able to expand the application of NBTXR3 across checkpoint inhibitors, and long-term anti-tumor memory is an outcome we are eager to continue exploring." – Laurent Levy, CEO of Nanobiotix
Regulatory News:
NANOBIOTIX (NASDAQ:NBTX), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced positive new preclinical data investigating first-in-class radioenhancer NBTXR3, which is being evaluated as a tumor-agnostic, combo-agnostic product candidate across several tumor types. The data is being shared via poster presentation at the first American Association of Cancer Research (AACR) Virtual Special Conference on Radiation Science and Medicine, held March 2-3, 2021, by researchers from the University of Texas MD Anderson Cancer Center (MD Anderson).
PRECLINICAL DATA ON NBTXR3 COMBO
NBTXR3 is composed of sterile, functionalized, crystalline hafnium oxide nanoparticles that are delivered by intratumoral injection one time prior to radiotherapy (XRT). After activation by XRT, the product candidate has a physical primary mechanism of action through which a higher dose of radiation is delivered within the tumor, enhancing the tumor-killing effect of XRT without increasing the dose in surrounding healthy tissues. The subsequent biological secondary mechanism of action that we are evaluating is the potential activation of several immune pathways upon tumor cell destruction, generating adaptive immune response within the body.
NBTXR3 is being evaluated in an expansive global development plan both as a single agent activated by XRT and in combination with other anti-cancer therapies including chemotherapy and immune checkpoint inhibitors. This study examined NBTXR3 activated by XRT in combination with anti-PD-1 along with TIGIT and LAG3 inhibitors in an in vivo anti-PD-1 resistant mouse model (344SQR).
Key Findings Include:
- The combination therapy of NBTXR3 + XRT + anti-PD-1 + anti-LAG3 + anti-TIGIT (Combo therapy) significantly promoted the proliferation activity of CD8+ T cells, improved local and distant tumor control, and increased survival rate
- The anti-tumor efficacy of the Combo therapy was heavily dependent on CD4+ and CD8+ Tcells
- The survivor mice from the groups treated with the Combo therapy were immune to re-injections of tumor cells
- The survivor mice maintained significantly higher percentages of memory CD4+ and CD8+ T cells, as well as stronger anti-tumor immune activities than control
- The Combo therapy augmented anti-tumor response in both irradiated and unirradiated (abscopal) tumors
POSTER PRESENTATION
- Title: Integration of anti-TIGIT and anti-LAG3 with NBTXR3-mediated Immunoradiation Therapy Improved Abscopal Effect and Induces Long-term Memory Against Cancer
- Timing: View on-demand starting at 9:30am EST on March 2, 2021 on Virtual Conference platform
- Poster Number: PO-040
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About NBTXR3
NBTXR3 is a first-in-class radioenhancer composed of sterile, functionalized, crystalline hafnium oxide nanoparticles. The product candidate is designed to increase the radiotherapy energy deposit inside tumor cells through the nanoparticles' high atomic number core packaged in the space for interaction with ionizing radiation, and subsequently increase of tumor cell death when compared to radiotherapy alone—without adding toxicity to adjacent healthy tissues. NBTXR3 requires a single, intratumoral administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The primary physical mechanism of action of NBTXR3 activated by radiotherapy could be universal, making it potentially applicable across any solid tumor indication where radiotherapy is a part of standard of care including head and neck, lung, prostate, liver, colorectal, and esophageal cancers. The biological secondary mechanism of action of NBTXR3 activated by radiotherapy has been shown in preclinical studies to prime adaptive immune response, which would potentially bring a new dimension to cancer immunotherapies.
About NANOBIOTIX: www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases.
The Nanobiotix philosophy is rooted in bringing highly effective, generalized solutions to address unmet medical needs and challenges.
The Company's first-in-class, proprietary lead technology, NBTXR3, is being evaluated in an expansive global development program both as a single agent activated by radiotherapy and in combination with other anti-cancer therapies including chemotherapy and immune checkpoint inhibitors.
Nanobiotix is listed on the regulated market of Euronext in Paris (GREY:NNBXF, Bloomberg: NANO: FP))) and on the Nasdaq Global Select Market (NASDAQ:NBTX). The Company's headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany
Disclaimer
This press release contains certain "forward-looking" statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management's current expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials, the timing of our presentation of data, the results of our preclinical studies and their potential implications. Such forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix considers to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including with respect to the risk that subsequent studies and clinical trials may not generate favorable data notwithstanding positive preclinical result and the risks associated with the evolving nature of the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to it. Furthermore, many other important factors, including those described in our prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption "Risk Factors" and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.20-010 on May 12, 2020 (a copy of which is available on www.nanobiotix.com), as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
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