Beijing - March 14, 2025 - Pyrotech (Beijing) Biotechnology Co., Ltd. ("Pyrotech Therapeutics"), a company dedicated to developing revolutionary therapies for inflammation and cancer, announced that its internally developed small-molecule innate immune agonist PTT-936, featuring a novel mechanism of action, has received approval from China's Center for Drug Evaluation (CDE) to initiate clinical trials in China. This follows its earlier clearance by the U.S. Food and Drug Administration (FDA) for clinical studies.
PTT-936 is a first-in-class small-molecule agonist targeting ALPK1 (Alpha-kinase 1), designed to combat tumors by activating the body’s immune system. ALPK1, a groundbreaking innate immune receptor, recognizes bacterial-derived molecules such as ADP-heptose to trigger immune responses. This discovery was first published in Nature in 2018 by a team led by Dr. Shao Feng, co-founder of Pyrotech Therapeutics (Zhou et al., Nature 2018). Preclinical studies demonstrated that ALPK1 activation potently induces anti-tumor immunity, forming the scientific foundation for Pyrotech’s development of PTT-936.
Preclinical findings indicate that PTT-936 exhibits robust anti-tumor activity both as a monotherapy and in combination with immune checkpoint inhibitors, with a potentially wider therapeutic window compared to other innate immune agonists. As a novel small-molecule drug targeting an unprecedented pathway, PTT-936 aims to overcome the safety and efficacy limitations of existing therapies, offering a transformative approach for cancer patients.
Previously, PTT-936 entered Phase 1b clinical trials in the United States in 2024, evaluating its efficacy and safety as a standalone treatment or in combination with anti-PD-1/L1 therapies for patients with locally advanced or metastatic solid tumors.
Pyrotech Therapeutics operates R&D centers in Beijing, Shanghai, and the United States, with a team of nearly 120 employees focused on pioneering drug discovery across innate immunity, pyroptosis pathways, and related fields. Its pipeline includes entirely first-in-class candidates spanning autoimmune diseases, neurological disorders, anti-infectives, and oncology. Upcoming milestones include clinical entry for a Gasdermin inhibitor (designed to protect neurons via a novel mechanism) and an ALPK1 inhibitor targeting autoimmune conditions.
