On December 20, GT919, the first molecular glue pipeline for oral administration of Gluetacs Therapeutics, a ShanghaiTech-incubated pharmaceutical company, obtained the implied permission for clinical trials from the Center for Drug Evaluation (CDE). Founded in 2020, Gluetacs has raised venture capital of more than 100 million yuan, and signed exclusive patent licensing agreements with ShanghaiTech with a contract value of over 100 million yuan. Among all ShanghaiTech-incubated projects, the GT919 is the first one that has obtained approval for a clinical trial in China.
Since its official operation in March 2021, Gluetacs has demonstrated itself to be an efficient, professional and enterprising R&D biopharmaceutical company, through the confirmation of pre-clinical candidate compounds and the rapid application of non-clinical research.
The main indication of GT919 is hematological malignancies, aiming to solve the current clinical issues due to the lenalidomide resistance and safety concerns. It is expected that the first patient will be enrolled in the trial in Q1 2023.
The implied permission for clinical trials from CDE
In addition, GT929 and GT838 (another protein degradation pipeline for oral administration) developed by the GLUETACSTM platform are scheduled for Pre-IND submissions in early 2023 and mid-2023, respectively, targeting hematological malignancies and solid tumors with clinical drug resistance and unmet clinical needs.
The great milestone stems from the dedicated work spirit of the entire Gluetacs team, the financial support and valuable guidance of investors, the instructions and support of the experienced and skilled consultant team, and the expertise of all CRO companies involved. In the future, Gluetacs will strive to become a clinical-stage biotechnology company and bring better treatment options to patients.