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News & Release

Tyligand Bioscience Receives Clinical Trial Clearance from U.S. FDA and China NMPA for Dual Function Immune Agonist TSN222

Shanghai, Feb. 16, 2023 – Tyligand Bioscience, a clinical stage biotech company focused on the development of innovative drugs to treat drug-resistant tumors, today announced that it has received Investigational New Drug clinical trial approval recently from both U.S. Federal Food and Drug Administration (FDA) and Chinese National Medical Product Administration (NMPA) for TSN222, the world's first dual action small molecule immune agonist. TSN222 is a novel bifunctional small molecule designed with sequential and synergistic release of both immune agonism and cytotoxic functions modulated in vivo by pharmacokinetics. It not only activates interferon production in the tumor microenvironment, but also selectively kills tumors cells to prime the adaptive immune system. TSN222’s preclinical data showed good tolerability, excellent tumor suppression efficacy and sustainable immune memory.

"TSN222 is the first product off the DATIA® (Dual Action Tumor Immune Agonist) platform to enter clinical development," said Tony Zhang, PhD., co-founder and CEO of Tyligand, " The achievement of this important milestone demonstrates the team's ability to produce quality clinical candidates by actualizing the "Tie + Ligand" platform concept with innovative molecular design capabilities. We will build a differentiated product pipeline based on the DATIA® platform and actively expand external collaborations to accelerate the discovery and development of more effective and accessible therapeutic options for the patients."

Founded in 2018, Tyligand Bioscience is a clinical-stage biotechnology company focused on the discovery and development of cancer therapeutics to address drug resistant tumors. Leveraging deep insights into the chemistry of biomolecule phosphorylation, the company has efficiently built a differentiated pipeline and technology platforms including 1st-in-class Dual Action Tumor Immune Agonist (DATIA®) assets and a novel platform for ADC payload design and development.

- Tyligand Bioscience (Shanghai) Limited