WuXi Biologics and Japan's Toregem BioPharma signed a memorandum of understanding on the development of anti-USAG-1 antibodies

SHANGHAI, Oct.
12, 2022 /PRNewswire/ -- WuXi Biologics (2269.
HK), a leading global contract research, development and manufacturing (CRDMO) services company, and Toregem BioPharma (Toregem), a start-up biotechnology company incubated by Kyoto University in Japan, today announced that The two parties signed a memorandum of understanding (MOU)
on the research and development of the USAG-1 monoclonal antibody TRG035 for the treatment of congenital tooth loss.

According to the MOU, Toregem will advance TRG035 R&D
through WuXi Biologics' end-to-end services in cell line development, cell line library and assay development, cell culture process development, stock solution and formulation manufacturing, and bioactive method development.
WuXi Biologics will support the New Drug Clinical Trial Application (IND) for this program to accelerate Toregem's R&D process
.

Dr.
Honoka Kiso, CEO of Toregem, said, "We are pleased to partner with WuXi Biologics, who have extensive experience in enabling cutting-edge research in universities to transform into therapeutically promising products, and are the best partner for
the company to accelerate the introduction of products to clinical trials and achieve ultimate commercialization goals 。 With WuXi Biologics' integrated IND enablement capabilities and global GMP manufacturing capacity, Toregem BioPharma is able to focus on realizing the maximum therapeutic potential
of TRG035.
We look forward to the successful launch of this dental regenerative drug for the benefit of patients around the
world.
" "

Dr.
Zhisheng Chen, CEO of WuXi Biologics, said, "We are excited to be a partner of Toregem to accelerate the TRG035 development process through end-to-end services and professional insights, which is the first comprehensive project
empowered by WuXi Biologics in the Japanese market from early-stage scientific research to clinical stage.
We are proud to empower global partners of all types, including multinational pharmaceutical companies, biotechnology companies, and research universities, to help address unmet clinical needs for the benefit of patients
.
"

About Toregem BioPharma

Toregem BioPharma is a start-up incubated by Kyoto University, established in May 2020, based on the research of Dr.
Katsu Takahashi, Department of Dental and Oral Surgery, Kyoto University (Takahashi K.
, Inflamm Regen, 40, 21, 2020, Murashima-Suginami A.
, Sci Adv, 7,eabf, 2021).
Focus on the development of antibody drugs
that regenerate teeth.

The morphogenesis of individual teeth depends on the interaction of several molecules, including bone morphogenetic protein (BMP) and Wnt signaling
.
USAG-1 is a bifunctional protein that antagonizes BMP and Wnt, two signaling molecules
necessary for tooth development.
Therefore, Dr.
Takahashi studied
the efficacy of monoclonal antibodies targeting USGA-1.
Experiments have shown that the BMP/Wnt signaling pathway is critical for determining the number of teeth in mice, and that a single administration is sufficient to grow a complete tooth
.

Although the average normal adult has 32 teeth, about 1% of people are born with too many or too few
congenital teeth.
Scientists have studied the genetic causes of too many teeth to help study ways to
regenerate teeth in adults.
This study demonstrates for the first time the efficacy of monoclonal antibodies on tooth regeneration, providing new treatment ideas
for clinical problems that can only be solved by dental implants and other artificial methods.

Dr.
Takahashi said, "Traditional tissue engineering techniques are not suitable for tooth regeneration
.
Our study shows that cell-free molecular therapies have a wide range of effects
on congenital tooth loss.
The Phase I clinical study of TRG035 is scheduled to begin in
early 2024.

About WuXi Biologics

WuXi Biologics (stock code: 2269.
HK) is a leading global contract research, development and production (CRDMO) company
.
Through an open, integrated biopharmaceutical capability and technology enablement platform, the company provides a full range of end-to-end services to help partners discover, develop and produce biopharmaceuticals, realize the whole process from concept to commercial production, accelerate the global biopharmaceutical R&D process, reduce R&D costs, and benefit patients
.

WuXi Biologics has more than 10,000 employees
in China, the United States, Ireland, Germany and Singapore.
With a professional services team of these employees, as well as superior technology and insight, the company provides customers with efficient and cost-effective biopharmaceutical solutions
.
As of the end of June 2022, WuXi Biologics has helped customers develop and manufacture 534 integrated projects, including 14 commercial manufacturing projects
.

WuXi Biologics regards environmental, social and governance (ESG) as an important part of business development and entrepreneurial spirit, and is committed to becoming an ESG leader in the global biopharmaceutical CRDMO, such as leading the industry in
the application of greener, next-generation biopharmaceutical technologies and energy.
The company has established an ESG committee led by the CEO to fully implement its ESG strategy and commitment to
sustainability.

For more information, please visit: www.
wuxibiologics.
com
.