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

On November 24, 2021 Pyrotech (Beijing) Biotechnology Co., Ltd ("Pyrotech Therapeutics"), a company dedicated to developing revolutionary innovative drugs for inflammation and cancer, reported 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 (Press release, Pyrotech, NOV 24, 2023, View Source [SID1234643789]). This marks the company’s first innovative drug to enter clinical evaluation in the United States.

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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.