WuXi Biologics and Toregem BioPharma Sign MOU for Development of Anti-USAG-1 Antibody

SHANGHAI,Oct. 11,2022 --WuXi Biologics ("WuXi Bio") (2269.HK),a leading global Contract Research,Development and Manufacturing Organization (CRDMO),and Toregem BioPharma,a biotech startup company from Kyoto University,today announced that they have signed a Memorandum of Understanding (MOU) to form a strategic partnership in the development of TRG035,a monoclonal antibody targeting USAG-1 for the treatment of congenital adentia.

Within the partnership,Toregem BioPharma will have access to WuXi Biologics' integrated CMC services in cell line development,cell banking and testing services,cell culture development,biologics GMP manufacturing,bioassay development,and related services. WuXi Biologics will support Toregem BioPharma on the TRG035 project for its Investigational New Drug (IND) application.

"We are glad to be collaborating with WuXi Biologics as they are experienced in enabling universities to turn advanced technologies into promising products," said Dr. Honoka Kiso,CEO of Toregem BioPharma. "By utilizing WuXi Biologics' comprehensive IND-enabling capabilities and large global footprint with extensive GMP production capacities,Toregem BioPharma will be able to focus on realizing and maximizing the therapeutic potential of TRG035. WuXi Biologics is the best partner for us as we step forward to conduct the clinical trial and realize the eventual commercialization of our unique product. We look forward to bringing this tooth regeneration drug to the global market,treating patients across the world."

Dr. Chris Chen,CEO of WuXi Biologics,commented,"We are very pleased to partner with Toregem BioPharma,and this is one of the first integrated CMC projects in Japan that we have supported – with our integrated services and experience – from early academic research phase all the way to clinical phase. WuXi Biologics is proud to support all kinds of global partners in bringing new biologics solutions to life for patients in multiple markets worldwide."

About Toregem BioPharma

Toregem Bio Pharma Co.,Ltd. is a startup venture from Kyoto University that was founded in May,2020,for the purpose of research and development and launch of a tooth regeneration antibody drug based on the research results of Dr. Katsu Takahashi,Oral and Maxillofacial Surgery,Kyoto University. (Takahashi K.,Inflamm Regen,40,21,Murashima-Suginami A.,Sci Adv,7,eabf,2021.)

The morphogenesis of individual teeth depends on the interactions of several molecules,including BMP and Wnt,which are two signaling molecules essential for tooth development. Recognizing that USAG-1 is a bifunctional protein that antagonizes BMP and Wnt,Dr. Takahashi investigated the effects of a monoclonal antibody for USGA-1. His experiments with this antibody revealed that BMP/Wnt signaling was indeed critical for determining the number of teeth in mice,and moreover,a single administration of the antibody was enough to generate a whole tooth.

Although the normal adult mouth has 32 teeth,about 1% of the population has more or fewer due to congenital conditions. Scientists have explored the genetic causes for cases of having too many teeth as clues for regenerating teeth in adults. The study was the first to show the benefits of monoclonal antibodies on tooth regeneration and provides a new therapeutic framework for a clinical problem that currently can be resolved only with implants and other artificial measures.

"Conventional tissue engineering is not suitable for tooth regeneration. Our study shows that cell-free molecular therapy is effective for a wide range of congenital tooth agenesis," said Dr. Takahashi.

The Phase I clinical study of TRG035 is planned to start in early 2024.

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research,Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover,develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.

With over 10,000 skilled employees in China,the United States,Ireland,Germany and Singapore,WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery,development and manufacturing solutions. As of June 30,2022,WuXi Biologics is supporting 534 integrated client projects,including 14 in commercial manufacturing.

WuXi Biologics views Environmental,Social,and Governance (ESG) responsibilities as an integral component of our ethos and business strategy,and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation,enhancing our commitment to sustainability.

For more information about WuXi Biologics,please visit: www.wuxibiologics.com.