TiumBio announced on Sunday the fourth-quarter global clinical trial updates for its lead pipelines, including its endometriosis drug candidate TU2670.

TiumBio is currently conducting a phase 2a clinical trial of TU2670 in endometriosis patients in Europe, with plans to generate European top-line data in the first half of next year. Additionally, in Korea, TiumBio's partner Daewon Pharmaceutical is conducting a phase 2a trial in patients with uterine fibroids, while in China, Thiumbio's partner Hansoh Pharma is conducting a phase 1 trial in patients with endometriosis.

TU2670, an endometriosis treatment, is a gonadotropin-releasing hormone (GnRH) antagonist. Tiumbio aims to enhance its convenience and effectiveness by developing TU2670 as an oral formulation. This approach is expected to offer greater convenience in administration compared to existing injectable treatments. Moreover, it seeks to optimize the regulation of sex hormones by delivering them at optimal doses, thereby minimizing the side effects associated with bone loss.

Another clinical pipeline, TU2218, an oral cancer immunotherapy that simultaneously inhibits TGF-ß (transforming growth factor) and VEGF (vascular endothelial growth factor), will be presented at the European Society for Medical Oncology (ESMO) 2023 Annual Meeting in Madrid, Spain, in October, with phase 1a data of TU2218 alone in patients with advanced solid tumors.

In June 2022, TiumBio entered into a clinical collaboration and supply agreement with MSD, securing complimentary access to the immune checkpoint inhibitor Keytruda (pembrolizumab). This collaboration was established to facilitate a phase 1b trial of TU2218 in combination with Keytruda. The company plans to wrap up phase 1b dosing by the end of this year and proceed into a phase 2a study next year.

The third clinical pipeline, TU7710, is a treatment for hemophilia patients with neutralizing antibodies. According to TiumBio, TU7710 has a half-life that is six to seven times longer than existing therapies, which is expected to reduce the number of doses for hemophilia patients, improving convenience and quality of life.

In particular, TiumBio emphasized that its researchers played a pivotal role in the development of the hemophilia drug Apstila (lonotocog alfa). Notably, Apstila received approvals from regulatory authorities such as the U.S. FDA, the European Medicines Agency (EMA), Japan's Ministry of Health, Labor and Welfare, and Korea's Ministry of Food and Drug Safety while these researchers were affiliated with SK chemicals.

"Our short-term goal is to successfully disclose the data of phase 1a of immunotherapy TU2218 in the second half of this year, and top-line results for endometriosis drug TU2670, scheduled for the first half of next year," said Kim Hun-taek, CEO of TiumBio. “Building upon these achievements, we aim to solidify our position as a prominent global drug development company with three approved drugs."