On April 29, 2021 NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (Euronext : NANO – NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported operational progress and cash position for the first quarter of 2021 (Press release, Nanobiotix, APR 29, 2021, View Source [SID1234578843]).
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"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) (Free AACR Whitepaper) 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 (ASCO) (Free ASCO Whitepaper) 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) (Free ASCO Whitepaper) 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
About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.
NBTXR3 is being evaluated primarily in locally advanced head and neck squamous cell carcinoma (HNSCC). The company-sponsored phase I dose escalation and dose expansion study has produced consistently favorable safety data and early signs of efficacy; and a phase III global registration is planned to launch in 2021. In February 2020, the United States Food and Drug Administration granted the regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the planned phase III.
Nanobiotix has also prioritized a company-sponsored Immuno-Oncology development program—a phase I clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.
Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration with strategy with world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 The University of Texas MD Anderson Cancer Center engaged in a broad, comprehensive clinical research collaboration with Nanobiotix to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.