The first novel ALPK1 activator for tumor immunotherapy developed by Pyrotech Therapeutics has obtained IND clearance from the FDA

Beijing - November 24, 2023 - Pyrotech (Beijing) Biotechnology Co., Ltd ("Pyrotech Therapeutics"), a company dedicated to developing revolutionary innovative drugs for inflammation and cancer, announced that their independently developed small molecule innate immune agonist PTT-936, with a completely new mechanism of action, has been approved by the U.S. Food and Drug Administration (FDA) for clinical research. This marks the company's first innovative drug to enter clinical evaluation in the United States.

 

PTT-936 is a novel alpha-protein kinase 1 (ALPK1) small molecule agonist that activates the body’s immune system to attack tumors. ALPK1, as a new innate immune receptor, can recognize the small molecule ADP-heptose derived from bacteria and activate the body’s immune response. In 2018, Dr. Feng Shao, a co-founder of Pyrotech Therapeutics, reported this discovery in the journal "Nature" (Zhou et al., Nature 2018). Preclinical studies have shown that activating ALPK1 can efficiently induce anti-tumor immunity. Based on this insight, Pyrotech Therapeutics developed the novel ALPK1 agonist PTT-936.

 

Preclinical studies have demonstrated that PTT-936, either as a monotherapy or in combination with immune checkpoint inhibitors, exhibits excellent anti-tumor activity. Compared to other innate immune agonists with different mechanisms, PTT-936 has a potentially larger therapeutic window. As a small molecule agonist based on a completely new target and mechanism, PTT-936 is expected to circumvent the safety and efficacy issues limiting the utility of existing innate immune agonists and thereby offer a new treatment option for cancer patients.