Release Details

• First patient injected in phase I trial evaluating tumor-agnostic NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer
• This first injection expands evaluation of NBTXR3 to its seventh indication either as a single agent activated by radiotherapy or in combination with other anti-cancer therapies, including immune checkpoint inhibitors and chemotherapy
• This trial is executed within the scope of an existing clinical collaboration agreement and does not represent incremental costs for the company beyond previously announced financial terms

“We believe that NBTXR3 could have a positive impact for patients with cancer in any case where radiotherapy is a part of the standard of care. Expansion into esophageal cancer represents not only another step toward achieving our goals, it also highlights the ongoing progress of our clinical collaboration agreement with The University of Texas MD Anderson Cancer Center.” – Laurent Levy, CEO of Nanobiotix

Paris, France ; Cambridge, Massachusetts (USA) ; January 28, 2021 – NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’), a clinical-stage biotechnology company focused on developing first-in-class product candidates that use proprietary nanotechnology to transform the treatment of cancer, today announced that the first patient has been injected in a phase I study evaluating tumor-agnostic NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer. The trial is being conducted at The University of Texas MD Anderson Cancer Center (MD Anderson) as part of an ongoing clinical collaboration.

Background and Opportunity

According to the World Health Organization, esophageal cancer is currently the sixth most common cause of cancer death in the world and is estimated to have caused over 508,585 deaths in 2018. The American Cancer Society estimates that in 2020 in the United States, there were approximately 18,440 new esophageal cancer cases diagnosed, and approximately 16,170 deaths due to esophageal cancer. Approximately 20% of patients survive esophageal cancer at least five years after diagnosis.

Phase I Study of NBTXR3 Activated by Radiotherapy with Concurrent Chemotherapy for Patients with Esophageal Cancer (MD Anderson Study 2020-0122)

This study is an open-label, single-arm, prospective phase I study consisting of two parts: (i) dose-escalation to determine the RP2D of NBTXR3 activated by radiotherapy with concurrent chemotherapy, and (ii) expansion at RP2D with toxicity monitoring.

The patient population will include adults (age ≥ 18 years) with stage II-III adenocarcinoma of the esophagus that are treatment-naïve and radiographically non-metastatic at screening. The number of participants enrolled will be determined based on the maximum number required to establish the RP2D of NBTXR3 activated by radiation therapy. Up to 24 subjects will be enrolled, including a maximum of 12 subjects for the dose-escalation part. Twelve additional subjects will be enrolled for the RP2D expansion part. Recruitment is ongoing and the planned enrollment period is 24 months.

Updates on this trial will be provided as they are made available by MD Anderson.

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. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, Germany and Switzerland.
Nanobiotix has been listed on the regulated market of Euronext in Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.

Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. The company's resources are primarily devoted to the development of its lead product candidate– NBTXR3 —which is the product of its proprietary oncology platform and 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220104005866/en/

Nanobiotix

Communications Department
Brandon Owens
VP, Communications
+1 (617) 852-4835
contact@nanobiotix.com

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Kate McNeil
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+1 (609) 678-7388
investors@nanobiotix.com

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Dan Childs
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Source: Nanobiotix