On May 30, the "Phase I clinical study on the safety, tolerability, and preliminary efficacy of SG1906 for injection in patients with CLDN18.2-positive advanced malignant solid tumors" sponsored by CNBG Sumgen Biopharmaceuticals (Hangzhou) Co., Ltd. (hereinafter referred to as "CNBG Sumgen") completed the first dose for the first patient at the People's Liberation Army General Hospital.
Ms. Na Li, Vice President and Clinical Head of Sumgen Biotech and CNBG Sumgen, commented: "SG1906 for injection is a recombinant CLDN18.2/CD47 bispecific antibody developed independently by CNBG Sumgen, which has been optimized for affinity. The project has shown good anti-tumor activity in various CLDN18.2-positive solid tumor models in preclinical studies. Currently, there are no approved drugs targeting CLDN18.2 or CD47, and there is a significant unmet clinical need in this area. The clinical trials for SG1906 were approved by the U.S. FDA in October 2022, followed by approval by the China National Medical Products Administration (NMPA) in February 2023. The rapid initiation and progress of this project are thanks to the strong support from Director Jianming Xu of the People's Liberation Army General Hospital, leaders at all levels of the hospital, and CNBG. We also appreciate the collective efforts of the project team. We will further accelerate the clinical process, looking forward to achieving positive progress that will benefit more cancer patients."
About the phase I clinical trial of SG1906
SG1906 is an innovative anti-CLDN18.2/CD47 bispecific antibody developed based on Sumgen Biotech BIMA bispecific antibody platform.The SG1906 phase I clinical trial is a phase Ia/Ib study that evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of SG1906 in patients with CLDN18.2-positive locally advanced unresectable or metastatic solid tumors. The trial is registered on the CDE Clinical Trial Public Platform with the registration number CTR20230722. The lead unit of this clinical research is People's Liberation Army General Hospital, and the principle investigator is Professor Jianming Xu.
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