LianBio Enters into Agreement Assigning its Rights for NBTXR3 in China and Other Asian Markets
26 Dezember 2023 - 8:00AM
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 NBTXR3NBTXR3 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.
LianBio licensed rights from Nanobiotix in May 2021 for the
development and commercialization of NBTXR3 in Mainland China, Hong
Kong, Macau, Taiwan, Thailand, South Korea, and Singapore.
About LianBioLianBio is a cross-border
biotechnology company on a mission to bring transformative
medicines to historically underserved patients in China and other
Asian markets. Through partnerships with highly innovative
biopharmaceutical companies around the world, LianBio is advancing
a diversified portfolio of clinically validated product candidates
with the potential to drive new standards of care across
cardiovascular, oncology, ophthalmology, and inflammatory disease.
LianBio is establishing an international infrastructure to position
the company as a partner of choice with a platform to provide
access to China and other Asian markets. For more information,
please visit www.lianbio.com.
Cautionary Note Regarding Forward-Looking
StatementsStatements in this press release about future
expectations, plans and prospects, as well as any other statements
regarding matters that are not historical facts, may constitute
forward-looking statements. The words “potential”, “continue,”
“will,” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Forward-looking
statements in this press release include, but are not limited to,
statements regarding the payments LianBio will receive pursuant to
the agreement with Janssen, LianBio’s plans to support the
transition of assets to Janssen and Janssen’s ability to expedite
the NANORAY-312 Phase 3 trial. Actual results may differ materially
from those indicated by such forward-looking statements as a result
of various important factors, including: LianBio’s ability to
successfully initiate and conduct its planned clinical trials and
complete such clinical trials and obtain results on its expected
timelines, or at all; LianBio’s plans to leverage data generated in
its partners’ global registrational trials and clinical development
programs to obtain regulatory approval and maximize patient reach
for its product candidates; LianBio’s ability to identify new
product candidates and successfully acquire such product candidates
from third parties; competition from other biotechnology and
pharmaceutical companies; general market conditions; the impact of
changing laws and regulations and those risks and uncertainties
described in LianBio’s filings with the U.S. Securities and
Exchange Commission (SEC), including LianBio’s Annual Report on
Form 10-K for the year ended December 31, 2022 and subsequent
filings with the SEC. Any forward-looking statements contained in
this press release speak only as of the date hereof, and LianBio
specifically disclaims any obligation to update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Readers should not rely upon this information as current
or accurate after its publication date.
For investor inquiries, please contact:
Elizabeth Anderson, VP Communications and Investor
Relations E:
elizabeth.anderson@lianbio.com T: +1 646 655
8390
For media inquiries, please contact:
Katherine Smith, Evoke Canale
E: katherine.smith@evokegroup.com
T: +1 619 849 5378
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