Nanobiotix and LianBio Announce Strategic Partnership to Develop and Commercialize First-in-Class Radioenhancer NBTXR3 in Asia

VCBeat learned on May 11, 2021, that NANOBIOTIX (Euronext: NANO; Nasdaq: NBTX), a late-stage clinical biotechnology company dedicated to expanding treatment possibilities for cancer patients through physics-based therapies, and LianBio, a biopharmaceutical company focused on bringing disruptive medicines to patients in China and key Asian markets, announced a partnership today. The two companies will collaborate on the development and commercialization of Nanobiotix’s lead candidate, NBTXR3—a potential first-in-class radioenhancer—in China, South Korea, Singapore, and Thailand.

LianBio, founded by Perceptive Advisors and headquartered in Shanghai and Princeton, employs an innovative collaboration model dedicated to the research, development, and commercialization of novel therapies for China and other Asian markets. With robust multinational development and commercialization capabilities and a strong presence in oncology, LianBio has NBTXR3 as the third anti-cancer drug candidate in its pipeline. Given the significant unmet medical needs worldwide for locally advanced and metastatic tumors, and existing research demonstrating NBTXR3’s therapeutic potential against solid and metastatic tumors, Nanobiotix will continue to leverage strategic partnerships with world-leading collaborators to expand and accelerate its product pipeline, while optimizing resource allocation to support development in head and neck cancer and immunotherapy.

“Working alongside industry peers committed to benefiting humanity to discover disruptive treatments for serious diseases based on physical principles is Nanobiotix’s mission. We have always believed that NBTXR3 will significantly improve treatment outcomes for patients with solid or metastatic tumors. We are grateful to move forward with a partner like LianBio, which boasts both talent and capability. Cancer is a disease without borders, and we are determined to bring our innovative achievements to patients in Greater China as soon as possible,” said Laurent Levy, CEO and Co-Founder of Nanobiotix.

“We have crafted a next-generation licensing model tailored specifically for LianBio, providing robust support to our corporate partner’s global development strategy and thereby accelerating the delivery of disruptive therapies to patients across Asia,” said Konstantin Poukalov, Managing Director at Perceptive Advisors and Executive Chairman of LianBio. “We believe that NBTXR3’s highly targeted nature and broadly applicable mechanism of action enable it to overcome key limitations of current standards of care, potentially transforming the paradigms of radiotherapy and tumor immunotherapy.”

“Nanobiotix’s therapeutic approach offers a promising path to reducing the disease burden across various tumor types,” said Dr. Jiujun Yu, President and Chief Business Officer of LianBio. “Through this collaboration, we aim to leverage our regional expertise to support Nanobiotix in benefiting the growing population of cancer patients in China and other key Asian markets, providing them with better treatment options.”

Under the terms of the agreement, LianBio will obtain an exclusive license to develop and commercialize NBTXR3 in Greater China, South Korea, Singapore, and Thailand; Nanobiotix will receive a $20 million upfront payment and will be eligible for potential development and commercialization milestone payments totaling up to $220 million. Nanobiotix will also receive low-double-digit tiered royalties on net sales of NBTXR3 within the licensed territories. LianBio will participate in the global Phase 3 registration study for head and neck cancer by enrolling 100 patients in China to evaluate the efficacy of NBTXR3 in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). In addition to participating in the global Phase 3 head and neck cancer study, LianBio has committed to supporting patient enrollment in four additional registration studies led by Nanobiotix, which involve various tumor indications and different combination regimens that may include immunotherapy. All development and commercialization costs within the collaborative territories will be borne by LianBio, while costs outside these territories will be covered by Nanobiotix.

NBTXR3 is a novel, potential first-in-class anti-tumor agent composed of functionalized hafnium oxide (HfO2) nanoparticles, administered via a single intratumoral injection and activated by radiotherapy. The physical mechanism of action (MoA) of this candidate product is designed to induce extensive tumor cell death within the injected lesion upon activation by radiotherapy, subsequently triggering an adaptive immune response and long-term anti-cancer memory. Leveraging this physical MoA, Nanobiotix believes that NBTXR3 can be extended to any solid tumor treatable with radiotherapy and to any combination regimen, particularly in combination with immune checkpoint inhibitors.

NBTXR3 is currently being primarily evaluated for its efficacy in treating locally advanced head and neck squamous cell carcinoma (HNSCC). A Phase I dose-escalation and dose-expansion study sponsored by the company has yielded consistent, robust safety data and early signs of efficacy; a global Phase III registrational trial was planned to launch in 2021. In February 2020, the U.S. Food and Drug Administration (FDA) granted NBTXR3 Fast Track designation for the treatment of patients with locally advanced HNSCC who are ineligible for platinum-based chemotherapy (with or without cetuximab)—the planned Phase III trial will evaluate this same patient population.

Nanobiotix also places significant emphasis on the development of oncology immunotherapy programs. Starting with a company-sponsored Phase I clinical trial, the study aims to evaluate the effect of radiotherapy-activated NBTXR3 in combination with anti-PD-1 checkpoint inhibitors. The study population includes patients with locally recurrent or recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), as well as patients with lung or liver metastases from primary cancers who are eligible for anti-PD-1 therapy.

Considering the company’s key focus areas and balancing them with the scalable potential of NBTXR3, Nanobiotix has entered into strategic collaborations with world-leading partners to further develop its candidate products while optimizing their development pathways. In line with this strategy, Nanobiotix initiated an extensive and comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center in 2019, launching multiple Phase I and Phase II clinical trials to evaluate the efficacy of NBTXR3 across various tumor types and in combination with different treatment regimens.

Nanobiotix is a late-stage clinical biotechnology company that collaborates with industry peers dedicated to benefiting humanity, delivering unprecedented therapeutic outcomes for millions of patients through disruptive, physics-based treatments. The company’s philosophy is “to constantly transcend known boundaries and create infinite possibilities for human life.”

Nanobiotix was founded in 2003 and is headquartered in Paris, France. The company also has subsidiaries in the United States (Cambridge, Massachusetts), France, Spain, and Germany. Nanobiotix was listed on Euronext Paris in 2012 and subsequently listed on the NASDAQ Global Select Market in New York in December 2020.

Nanobiotix holds more than 30 comprehensively protected patents spanning three nanotechnology platforms, applicable to: 1) oncology; 2) bioavailability and biodistribution; and 3) central nervous system disorders. The company’s resources are primarily dedicated to the development of its lead candidate, NBTXR3, which originated from its proprietary oncology platform and has received marketing authorization in Europe under the trademark Hensify® for the treatment of patients with soft tissue sarcoma.

LianBio’s mission is to deliver optimal, science-driven breakthrough therapies to patients in China and other major Asian markets through efficient product development, enabled by strategic partnerships with leading global biopharmaceutical companies. By collaborating with world-class partners across diverse therapeutic areas and geographies, LianBio has built a disease-focused product pipeline that leverages translational mechanisms and precision therapies to improve patient outcomes.