LianBio Enters into Agreement Assigning its Rights for NBTXR3 in China and Other Asian Markets
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LianBio Enters into Agreement Assigning its Rights for NBTXR3 in China and Other Asian Markets

LianBio
LianBio

SHANGHAI, China and PRINCETON, N.J., Dec. 26, 2023 (GLOBE NEWSWIRE) -- LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced that the company has entered into an agreement with Janssen Pharmaceutica NV (“Janssen”), a Johnson & Johnson company, whereby Lian has assigned to Janssen LianBio’s exclusive rights to develop and commercialize NBTXR3, an investigational, potential first-in-class radioenhancer, in China, South Korea, Singapore and Thailand.

Under the terms of the agreement, LianBio will receive a one-time payment of $25 million. In addition, LianBio is eligible to receive a sales milestone payment of $5 million. Following the deal close, LianBio will support the transition of the asset to Janssen for a period no longer than six months.

In July 2023, Nanobiotix granted Janssen a worldwide exclusive license, excepting territories previously licensed to LianBio, for the co-development and commercialization of NBTXR3.

“NBTXR3 has demonstrated the potential to improve treatment outcomes across a number of high need solid tumor indications,” said Konstantin Poukalov, Executive Chairman of the LianBio Board of Directors. “We believe this transaction will build upon the strong foundation LianBio has built for NBTXR3 in Asia.”

“LianBio has served as an important partner in the ongoing pivotal NANORAY-312 clinical trial of NBTXR3 in head and neck squamous cell carcinoma,” said Laurent Levy, co-founder and chairman of the executive board at Nanobiotix. “We look forward to continuing to advance the clinical development of NBTXR3 in Asia and bringing new treatment options to those in need around the globe.”

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, NBTXR3 could potentially 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 in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway, with a Phase 3 global registrational study ongoing called NANORAY-312. The global study is investigating the efficacy and safety of radiotherapy-activated NBTXR3 with or without cetuximab versus radiotherapy with or without cetuximab in high-risk, chemotherapy-ineligible elderly patients with locally advanced head and neck squamous cell carcinoma. Eligible participants for NANORAY-312 will be treated with NBTXR3 at a 1:1 ratio after an Investigator’s Choice of radiotherapy alone or radiotherapy in combination with cetuximab. More information about NANORAY-312 can be found on ClinicalTrials.gov (NCT04892173). In February 2020, the United States Food and Drug Administration granted 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 Phase 3 study.