Nanobiotix announces first quarter operational and financial updates
- Expanded clinical data set supporting tumor agnostic potential of NBTXR3 in presentation of first results in rectal cancer at ASCO-GI 2021
- Initiated new combination study evaluating NBTXR3 activated by radiation in combination with chemotherapy in esophageal cancer and reported new preclinical data in immunotherapy at AACR RSM 2021, providing further support for radioenhancer NBTXR3 as a therapeutic combination-agnostic that could prime adaptive immune response for local and systemic control
- New collaboration agreement signed by subsidiary Curadigm with Sanofi evaluating novel Nanoprimer technology in gene therapy
- Cash, cash equivalents, and short-term investments were €107.1 million at March 31, 2021, continuing to support robust development plans into the second quarter of 2023
Paris, France; Cambridge, Massachusetts (USA); April 29, 2021 – NANOBIOTIX (Euronext : NANO – NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced operational progress and cash position for the first quarter of 2021.
“The first quarter of this year saw further progress in development for Nanobiotix,” said Laurent Levy, co-founder and chief executive officer of Nanobiotix. “We continue to generate data reinforcing our vision for NBTXR3 as a first-in-class radioenhancer that could have a significant impact for patients across solid tumor types and therapeutic combinations. We are also encouraged that Sanofi has seen the potential of Curadigm’s Nanoprimer and look forward to a successful collaboration between the two companies in gene therapy.”
Financial Updates Supporting Nanobiotix Development and Corporate Plans
Cash, cash equivalents, and short-term investments were €107.1 million at March 31, 2021, supporting robust development plans into the second quarter of 2023, compared to €28m as of March 31st, 2020.
Following the decision to conclude a License and Collaboration agreement with PharmaEngine, Inc., the Company did not generate any revenue during the first quarter of 2021. This compares to €24k for the first quarter of 2020, which resulted from cross-charges associated with the collaboration.
Clinical Activities and Achievements Advancing Solid Tumor-Agnostic and Combination-Agnostic Potential of NBTXR3
- Preclinical data, developed in collaboration with the University of Texas MD Anderson Cancer Center (MD Anderson), further suggesting that NBTXR3 could prime adaptive immune response and combine with several immune checkpoint inhibitors was presented at the first American Association of Cancer Research (AACR) Virtual Special Conference on Radiation Science and Medicine in March. This data demonstrated that a combo therapy including NBTXR3, anti-PD-1, anti-TIGIT, and anti-LAG3 augmented anti-tumor response in both irradiated and unirradiated tumors, improving local and distant tumor control and increasing survival rate. The 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.
- First clinical results in rectal cancer including recommended phase II dose from the complete phase Ib part of a phase Ib/II study evaluating NBTXR3 activated by radiation therapy with concurrent chemotherapy were presented in January at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI 2021). The data showed that the intra-tumoral injection of NBTXR3 was feasible and well tolerated at all dose levels. More than 70% of patients showed objective tumor response and approximately 90% of patients underwent total mesorectal excision (surgery), and 17.6% achieved pathological complete response. In addition, 50% of the patients receiving surgery had good tumor regression. PharmaEngine, Inc. will implement the termination and wind-down of the phase II part of this clinical study pursuant to the agreement regarding the conclusion of this collaboration.
- First patient injected in esophageal cancer, a new indication for NBTXR3, in a phase I study evaluating NBTXR3 activated by radiation therapy with concurrent chemotherapy (Study 2020-0122) in January. The trial is being conducted with MD Anderson as part of an ongoing clinical collaboration.
Corporate Activities and Achievements Expanding Value Creation Opportunities for Nanobiotix
- Collaboration agreement between Sanofi and Nanobiotix subsidiary, Curadigm, in January. Pursuant to Sanofi’s selection of a project involving Curadigm’s Nanoprimer technology as a promising option to significantly improve gene therapy development, Curadigm entered into a one-year agreement with the pharmaceutical company inclusive of direct funding and scientific exchanges. The goal of the project is to establish proof-of concept for the Nanoprimer as a combination product that could improve treatment outcomes for gene therapy product candidates.
- Retention of intellectual property rights for NBTXR3 in the Asia-Pacific region in March 2021 pursuant to a mutual agreement with PharmaEngine, Inc. to conclude the collaboration entered into in August 2012.
Upcoming Corporate and Clinical Events in the Second Quarter of 2021
- May 24th: UBS Global Healthcare conference
- June 1st: Jefferies Healthcare Conference
- June 4th: American Society of Clinical Oncology (ASCO) congress 2021
- June 11th: Virtual KOL Event Review Potential Therapeutic Potential of NBTXR3 in Combination with Check Point Inhibitors for Patients with Advanced Cancers
Updated Financial Agenda
- July 20th: Second Quarter Corporate Update and Financial Update
- September 8: Half Year Corporate Update and Financial Update
- October 20th: Third Quarter Corporate Update and Financial Update
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.
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