On December 18, 2024, Suzhou Evopoint Biosciences Co., Ltd. (referred to as "Evopoint" or "the company") announced that its independently developed first-in-class drug XNW29016 targeting PARG (Poly [ADP-ribose] glycohydrolase) has obtained the CTA Approval issued by the National Medical Products Administration (NMPA) and will soon start a Phase I clinical trial in China. This clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of XNW29016.
"We are pleased to announce the CTA approval of XNW29016, which represents an important milestone for Evopoint in the field of synthetic lethality anticancer therapeutics. XNW29016 provides a new treatment option for patients with DNA repair defects-related tumors. We look forward to further validating the potential of XNW29016 through this trial and bringing hope to cancer patients who are not adequately served by existing treatment options."
About XNW29016
XNW29016 is an efficient and selective oral inhibitor of PARG (Poly ADP-ribose glycohydrolase), with a target in the same pathway as the clinically validated Poly ADP-ribose polymerase (PARP) but possessing unique biological activity. Pre-clinical studies indicated that XNW29016 can significantly inhibit PARG activity in tumor cells, thereby impeding DNA repair and leading to sustained lethal DNA damage. Tumor models with specific DNA repair defects showed high sensitivity to XNW29016, including HRD (Homologous Recombination Deficiency) tumor models resistant to PARP inhibitors, providing a significant opportunity for precision medicine. Additionally, XNW29016 demonstrated significant tumor suppression effects in in vivo studies and exhibited favorable tolerability and safety.
The focus of this Phase I clinical trial includes patients with solid tumors related to HRD (e.g., ovarian cancer, breast cancer, prostate cancer, etc., which carry HRD). XNW29016 will be assessed as a monotherapy for its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in tumors harboring HRD (e.g. patients with BRCA1/2-mutant tumors).
Evopoint owns all of the R&D and commercialization rights to XNW29016 and will continue to advance it into the next clinical stages in order to bring innovative precision cancer treatment options to global patients
