Bone Therapeutics, Link Health and Pregene to develop and
commercialize the ALLOB allogeneic bone cell therapy platform in
China and Southeast Asia
Regulated Information
Bone Therapeutics grants exclusive
license to Link Health and Pregene for the development and
commercialization of ALLOB in Greater China and a number of other
major Asian countries
Terms include €55 million in total
upfront and milestone payments with €10 million expected in next 24
months as well as tiered double-digit royalties on net
sales
Gosselies, Belgium, 5 October 2020, 7am
CEST – BONE THERAPEUTICS (Euronext Brussels and Paris:
BOTHE), the cell therapy company addressing unmet medical needs in
orthopedics and other diseases, Link Health Pharma Co., Ltd (“Link
Health”) and Shenzhen Pregene Biopharma Company, Ltd (“Pregene”)
today announce the signing of an exclusive license agreement for
the manufacturing, clinical development and commercialization of
Bone Therapeutics’ allogeneic, off-the-shelf, bone cell therapy
platform ALLOB in China (including Hong Kong and Macau), Taiwan,
Singapore, South Korea, and Thailand.
Under the agreement, Bone Therapeutics is
eligible to receive up to €55 million in development, regulatory
and commercial milestone payments including €10 million in upfront
and milestone payments anticipated in the next 24 months. Bone
Therapeutics is also entitled to receive tiered double-digit
royalties on annual net sales of ALLOB. Bone Therapeutics retains
development and commercialization rights to ALLOB in all other
geographies outside of those covered by this agreement. As a
result, Bone Therapeutics will continue to concentrate on its
development and commercialization plans for ALLOB in the US and
Europe and novel innovative cell-based products globally.
“This collaboration between Bone Therapeutics,
Link Health and Pregene expands our geographic reach and
demonstrates the global commercial potential of ALLOB,”
said Miguel Forte, MD, PhD, Chief Executive Officer of Bone
Therapeutics. “We already have operational experience in
Asia with the Phase III clinical trial of our lead product JTA-004
in Hong Kong. We selected Link Health and Pregene to partner with
us in Asia as a result of their expertise in advanced therapeutics
and cell therapies, their proven track record of development and
commercial implementation in Chinese and Asian markets, and
Pregene’s well established cell therapy manufacturing capacity.
Bone Therapeutics will continue to develop the ALLOB cell therapy
platform for other markets while exploring additional partnership
opportunities in the U.S. and Europe.”
The agreement grants Link Health and Pregene
exclusive rights to clinically develop and commercialize ALLOB for
the treatment of human bone disorders in Greater China, Taiwan,
Singapore, South Korea, and Thailand. All rights for China will be
transferred to Pregene and Link Health will gain rights for the
remaining countries Bone Therapeutics will share its patented
proprietary manufacturing expertise for the expansion and
differentiation of bone-forming cells and has the option to sell
clinical supplies to Link Health and Pregene in preparation for
their clinical development of ALLOB.
“This collaboration and license agreement for
Bone Therapeutics’ ALLOB provides a strong addition to our
pipeline. ALLOB has demonstrated the potential to reduce the
recovery time and stimulate bone growth for a variety of bone
conditions, and to have a considerable impact on patients’ lives,”
said Yan Song, PhD, Chief Executive Officer of Link
Health. “It is important for Link Health to collaborate
with companies that have strong therapeutic product portfolios and
entrepreneurial management. This partnership with Bone Therapeutics
is a direct result of our shared commitment to appreciate the
enormous potential of cell therapy and regenerative medicine.”
“Pregene now has a flourishing portfolio of
CAR-T cell therapy-based cancer treatments. Bone Therapeutics’
ALLOB provides an allogeneic, off-the-shelf cell therapy that
expands our portfolio of cell therapies to include the sizable
commercial potential of orthopedics,” said Hongjian Li,
Co-founder and Chief Executive Officer of Pregene. “We
expect to be able to leverage our extensive international cell and
gene therapy experience to develop Bone Therapeutics’ ALLOB
platform and subsequently launch products in China and Southeast
Asian markets.”
ALLOB, an allogeneic and off-the-shelf cell
therapy product manufactured through a proprietary, scalable
production process, consists of human bone-forming cells derived
from cultured bone marrow mesenchymal stem cells of healthy adult
donors. In preclinical studies ALLOB has shown to reduce healing
time in a delayed-union fracture model by half, and has
demonstrated good tolerability and signs of efficacy in two Phase
IIa studies for two separate indications. The Company’s randomized,
placebo-controlled, double-blind Phase IIb clinical trial in
patients with difficult tibial fractures has received approval from
regulatory authorities in six of the seven planned European
countries to date, and is expected to enroll the first patient
later this year.
About Link Health Pharma Co.,
Ltd
Link Health is a leading Chinese pharmaceutical
company based in Guangzhou, Southern China, focusing on the
development of innovative drugs for unmet medical needs.
Link Health has created a highly professional
team with diverse expertise in drug development, medical affairs
and regulatory affairs. Leveraging deep understanding of China
market, regulatory environment and strong network with global
biopharmaceutical companies, Link Health is well positioned to
bring innovative drugs to the market efficiently. The company has a
drug development pipeline of 5 clinical stage assets and 1 under
NDA reviewing in China.
The company has also established a fully owned
subsidiary in Amsterdam, the Netherlands. The Dutch office builds
and further strengthen collaborations with global pharma/biotech
partners and research institutes.
About Pregene Biopharma Co.,
Ltd
Shenzhen Pregene Biopharma Co. Ltd is a leading
enterprise in the cell and gene therapy field with the core
technology for industrialization. The company's core team comes
from well-known institutions and companies including the Academy of
Military Medical Sciences, the University of Toronto, and the US
FDA.
Pregene has established the gene editing
platform, viral vector and cell production platform, nanobody
selection platform and other small to pilot trial manufacturing
system, with total investment over 100 million CNY. It has the
laboratories and GMP plants for cell and gene therapy of over
10,000 square meter.
The company focuses on the research and
development of cell and gene therapy drugs, and participated in the
drafting the national standard "Considerations for CAR-T Cell
Quality Study and Non-clinical Evaluation " issued by the National
Institutes for Food and Drug Control in June 2018. The CAR-T cell
therapy for the treatment of multiple myeloma have obtained NMPA
IND clearance as the Class I new drug, which is the first in China
and fastest in the world using the humanized single domain antibody
in CAR construct, and phase I clinical trials are now in progress.
Other pipelines such as CAR-T, TCR-T and mRNA drugs for tumors,
autoimmune diseases and other indications are in the development at
different stages. The company has broad development prospects with
the abundant backup technologies.
Looking forward to the future, the company will
build the core capacity in one-stop solution for cell and gene
therapy drugs, and fulfill the Express of innovative medicine
development from drug discovery to clinical products.
About Bone Therapeutics
Bone Therapeutics is a leading biotech company
focused on the development of innovative products to address high
unmet needs in orthopedics and other diseases. The Company has a,
diversified portfolio of cell and biologic therapies at different
stages ranging from pre-clinical programs in immunomodulation to
mid-to-late stage clinical development for orthopedic conditions,
targeting markets with large unmet medical needs and limited
innovation.
Bone Therapeutics is developing an off-the-shelf
next-generation improved viscosupplement, JTA-004, which is
currently in phase III development for the treatment of pain in
knee osteoarthritis. Consisting of a unique combination of plasma
proteins, hyaluronic acid - a natural component of knee synovial
fluid, and a fast-acting analgesic, JTA-004 intends to provide
added lubrication and protection to the cartilage of the arthritic
joint and to alleviate osteoarthritic pain and inflammation.
Positive phase IIb efficacy results in patients with knee
osteoarthritis showed a statistically significant improvement in
pain relief compared to a leading viscosupplement.
Bone Therapeutics’ core technology is based on
its cutting-edge allogeneic cell therapy platform with
differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs)
which can be stored at the point of use in the hospital. Currently
in pre-clinical development, BT-20, the most recent product
candidate from this technology, targets inflammatory conditions,
while the leading investigational medicinal product, ALLOB,
represents a unique, proprietary approach to bone regeneration,
which turns undifferentiated stromal cells from healthy donors into
bone-forming cells. These cells are produced via the Bone
Therapeutics’ scalable manufacturing process. Following the CTA
approval by regulatory authorities in Europe, the Company is ready
to start the phase IIb clinical trial with ALLOB in patients with
difficult tibial fractures, using its optimized production process.
ALLOB continues to be evaluated for other orthopedic indications
including spinal fusion, osteotomy, maxillofacial and dental.
Bone Therapeutics’ cell therapy products are
manufactured to the highest GMP standards and are protected by a
broad IP (Intellectual Property) portfolio covering ten patent
families as well as knowhow. The Company is based in the BioPark in
Gosselies, Belgium. Further information is available at
www.bonetherapeutics.com.
For further information, please
contact:
Bone Therapeutics SAMiguel
Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief
Financial OfficerTel: +32 (0)71 12 10
00investorrelations@bonetherapeutics.com
For Belgian Media and Investor
Enquiries:BepublicCatherine HaquenneTel: +32
(0)497 75 63 56catherine@bepublic.be
International Media Enquiries:Image Box
CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20
8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Media and Investor
Enquiries:NewCap Investor Relations & Financial
CommunicationsPierre Laurent, Louis-Victor Delouvrier and
Arthur RouilléTel: +33 (0)1 44 71 94 94bone@newcap.eu
For US Media and Investor Enquiries:LHA
Investor RelationsYvonne BriggsTel: +1 310 691
7100ybriggs@lhai.com
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beliefs and opinions in this press release are forward-looking,
which reflect the Company or, as appropriate, the Company
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