LianBio Partner NANOBIOTIX Enters into License Agreement with Janssen for Radioenhancer NBTXR3, with LianBio Retaining Development and Commercialization Rights in Greater China, South Korea, Singapore and Thailand
18 Julio 2023 - 7:00AM
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to
bringing innovative medicines to patients in China and other major
Asian markets, today announced that partner Nanobiotix has
entered into a license agreement with Janssen Pharmaceutica NV
(“Janssen”), one of the Janssen Pharmaceutical Companies of Johnson
& Johnson, for the investigational, potential first-in-class
radioenhancer NBTXR3.
Nanobiotix will grant Janssen a worldwide license for the
co-development and commercialization of NBTXR3. The license is
exclusive, excepting territories previously licensed to
LianBio.
“Data generated to date suggest NBTXR3 has potential to address
the treatment limitations of standard of care radiotherapy across
multiple solid tumor indications,” said Yizhe Wang, Ph.D., Chief
Executive Officer of LianBio. “We believe Nanobiotix’s
collaboration with Janssen will provide additional expertise and
financial resources to broadly develop NBTXR3 in areas of high
unmet medical need.”
Details and financial terms of the Nanobiotix and Janssen
collaboration are available on the investor section of the
Nanobiotix website.
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. LianBio
and Nanobiotix are currently enrolling patients in NANORAY-312, a
global Phase 3 trial designed to investigate 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. This pivotal trial is expected to
enroll 500 patients globally, with approximately 100 patients in
LianBio’s licensed territories expected to participate in the
study. More information about NANORAY-312 can be found on
ClinicalTrials.gov (NCT04892173).
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. 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.
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 “expect,” “believe,”
“potential,” “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 LianBio’s beliefs
regarding the potential of NBTXR3 to address the treatment
limitations of standard of care radiotherapy across multiple solid
tumor indications and the potential for the Nanobiotix and Janssen
collaboration to provide additional expertise and financial
resources to broadly develop NBTXR3 in areas of high unmet medical
need, and LianBio’s and Nanobiotix’s plans for 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.
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.
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:
Josh Xu, Director of Communications
E: josh.xu@lianbio.com T: +86 136
6140 8315
Katherine Smith, Evoke Canale
E: katherine.smith@evokegroup.com
T: +1 619 849 5378
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