On June 6, 2023, Sound Biopharmaceuticals reported that the Phase I clinical study of the company’s independently developed second-generation 4-1BB target agonist FTL001 monoclonal antibody injection successfully completed the enrollment and dosing of the first patient at the Affiliated Cancer Hospital of Chongqing University (Press release, Sound Biopharmaceuticals, JUN 6, 2023, View Source [SID1234645030]).

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This study is an open, multi-center, multi-cohort Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and preliminary efficacy of FTL001 in subjects with advanced recurrent metastatic and refractory solid tumors. The clinical trial will be conducted simultaneously in multiple clinical research centers in China.

"We are very pleased to have successfully dosed the first patient of FTL001, which represents a major milestone in the clinical trial of Feitong Bio." Dr. Li Qing, founder and CEO of Feitong Bio, said: "Feitong Bio is committed to unmet clinical needs, and FTL001 is one of the key drugs in our product pipeline for malignant tumors. Through in-depth research on the mechanism of action of 4-1BB, we have developed a series of monoclonal antibody and bispecific antibody products around this target. The first patient dosing of FTL001 is undoubtedly a solid step for us to meet the needs of patients. Feitong Bio is full of confidence in the potential of the 4-1BB target, and will make every effort to efficiently promote the clinical progress of this project, bring substantial clinical benefits to patients with malignant tumors, and open up a new path for tumor immunotherapy."

▶ About F TL001 ◀

4-1BB (CD137), as a T cell co-stimulatory immune checkpoint molecule, is one of the most promising drug targets among members of the tumor necrosis factor receptor superfamily (TNFRSF). FTL001 is the world’s first clinical-stage epitope-specific 4-1BB humanized monoclonal antibody drug, and its binding epitope completely overlaps with the endogenous 4-1BB ligand: it can not only simulate the endogenous ligand to effectively activate T cells and kill tumors in a natural way, but also avoid systemic toxicity caused by excessive activation by blocking the activation amplification effect produced by the ligand, thereby achieving a balance between effectiveness and safety.

▶ About Non-Tong Biology ◀

Feitong Bio is an innovation-driven biopharmaceutical company initiated by a Nobel Prize-winning team, dedicated to the discovery and development of innovative drugs, as well as clinical research and commercialization on a global scale. With its outstanding scientific research and innovative drug development capabilities, the company aims to meet unmet clinical needs, has built various core technology platforms, and established a variety of original biomacromolecule drug product pipelines with great market potential.