WuXi Biologics, Toregem BioPharma To Develop Tooth-Regenerating Antibody

Chinese CDMO giant WuXi Biologics has agreed to develop Japan-based Toregem BioPharma’s anti-USAG-1 antibody that holds the potential to regenerate teeth. 

Called TRG035, the monoclonal antibody is indicated for congenital adentia, a rare genetic condition where an individual may be born with missing teeth. 

The partnership gives Toregem access to WuXi’s integrated CMC services in cell line development, cell banking and testing services, cell culture development, biologics GMP manufacturing, and bioassay development among other services. WuXi will also support the Investigational New Drug (IND) application of TRG035. 

WuXi’s IND-enabling capabilities and global GMP production capacities will help Toregem BioPharma realize the therapeutic potential of TRG035, said Dr. Honoka Kiso, the company’s CEO.

The Phase 1 clinical study of TRG035 may start in early 2024, the companies said. 

Related Article: WuXi Biologics Adds Microbial Fermentation to CDMO Offering in Hangzhou

USAG-1 Role In Tooth Regeneration 

Toregem was founded in May 2020 as a startup venture from Kyoto University. The fledgling biopharma is built around a tooth regeneration antibody that targets the USAG-1 protein pinpointed by the research of Dr. Katsu Takahashi from Kyoto University’s Oral and Maxillofacial Surgery department. 

Dr. Takahashi’s research on mice has shown that USAG-1 inhibits BMP and Wnt, two important signaling proteins that determine the number of teeth the mice will have. Further experiments showed that suppressing USAG-1 gene expression with an antibody stimulated tooth growth in mice with congenitally missing teeth. 

Missing teeth is a clinical problem that is currently solved with implants or 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.

Toregem’s approach has garnered some local interest. As of March 2022, Toregem has raised $3.9 million in early-stage VC funding with participation from Astellas Venture Management, Gemseki (a CRO), Kyoshin Social Capital, Kyoto University’s innovation fund, and Kyoto City’s startup fund. 

Now, Toregem has an additional ally in WuXi, which is looking to expand its integrated CMC projects in Japan designed to help young biotechs reach the clinic. 

Author

Joy Lin

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