THE 30STARTUPS OF KANSAI

Toregem BioPharma is a clinical-stage biotechnology company originating from Kyoto University, founded in 2020 to translate pioneering tooth regeneration research into therapies for patients. The company was co-founded by Dr. Katsu Takahashi, who has dedicated decades to understanding the mechanisms of tooth development and regeneration, together with colleagues committed to bringing this research into clinical practice. Toregem is developing TRG035, a humanized antibody targeting USAG-1, a protein that suppresses tooth development. Our initial focus is congenital tooth agenesis, with the ultimate goal of establishing tooth regeneration as a new therapeutic option for people who have lost or are missing teeth.

Tooth loss affects eating, speech, appearance, and overall quality of life, yet current treatments primarily replace missing teeth with artificial devices such as dentures and dental implants. The challenge is particularly significant for children with congenital tooth agenesis, whose developing jawbones can limit available treatment options. Toregem aims to shift the paradigm from “replacing” missing teeth to “regenerating” a patient’s own teeth. By offering a potentially curative biological treatment, our technology could address a major unmet medical need for patients with congenital tooth agenesis and, in the future, provide a new option for millions of people affected by tooth loss worldwide.

Our approach targets USAG-1, a naturally occurring protein that suppresses tooth development. TRG035 is designed to neutralize USAG-1, thereby unlocking the body’s intrinsic potential to generate teeth. Unlike dentures or dental implants, which replace missing teeth with artificial structures, our approach seeks to regenerate a patient’s own biological teeth through antibody therapy. The potential of anti-USAG-1 antibodies to induce tooth formation has been demonstrated in multiple animal models. TRG035 has completed a Phase I clinical trial in Japan, and in August 2026, the PMDA completed its investigation of the Clinical Trial Notification for a Phase IIa trial in patients with congenital tooth agenesis.

Toregem’s first goal is to deliver TRG035 as a new treatment for patients with congenital tooth agenesis. Following completion of the Phase I clinical trial in Japan, we are advancing clinical development while preparing for future global development, including in the United States. Looking beyond congenital conditions, we envision expanding tooth regeneration therapy to people who have lost teeth due to acquired causes such as dental disease, aging, or injury. Ultimately, our vision is to create a world where tooth regeneration becomes a practical treatment option, enabling people to maintain the ability to eat, speak, smile, and live with their own teeth throughout life.