▎Edited by the WuXi AppTec content team
On March 25, Phanes Therapeutics announced that the U.S. FDA granted Fast Track designation to its PT886 for the treatment ofMetastatic Claudin 18.2-Positive Pancreatic CancerPatient. Previously, PT886 was granted orphan drug designation by the FDA for the treatment of pancreatic cancer in 2022 and received approval to conduct clinical trials in China this February.
PT886 is a bispecific antibody under research, targeting Claudin 18.2 and CD47, and is being developed for the treatment of gastric cancer, gastroesophageal junction cancer, and pancreatic cancer.Among them, Claudin 18.2 is one of the isoforms of Claudin 18, a member of the Claudin protein family. It exhibits high expression in various tumors such as gastric cancer, esophageal cancer, pancreatic cancer, lung cancer, ovarian cancer, and colon cancer. CD47 is a transmembrane protein expressed on tumor cells, which transmits the "don't eat me" signal to its receptor signal regulatory protein α (SIRPα) on phagocytes. Blocking the CD47-SIRPα interaction can promote the phagocytosis of tumor cells by macrophages.According to the public information from Phanes,PT886 can directly kill tumor cells through the ADCP activity of macrophages and the ADCC activity of NK cells, and expand the scope of tumor killing by simultaneously targeting Claudin 18.2 and CD47, which are highly expressed on the surface of tumor cells.。Currently, the multicenter Phase 1 clinical trial (TWINPEAK study) of PT886 is being evaluated in the United States.PT886 in patients with locally advanced or metastatic gastric adenocarcinoma, gastroesophageal junction cancer, and pancreatic cancerThe safety, tolerability, pharmacokinetics, and preliminary efficacy in these patients who experienced disease progression after receiving existing available standard therapies, or for whom standard therapies were proven ineffective, intolerable, or deemed inappropriate.Dr. Minghan Wang, founder and CEO of Phanes, stated: "PT886 has the potential to become a transformative treatment option for patients with metastatic Claudin 18.2-positive pancreatic cancer, a disease where the current standard of care offers limited benefit. PT886 is the result of Phanes' ingenious innovation in the design of novel therapeutic approaches and practical technologies."References:
[1] Phanes' PT886 Granted FDA Fast Track Designation for the Treatment of Metastatic Claudin 18.2-Positive Pancreatic Cancer Patients. Retrieved Mar 25, 2024, from https://mp.weixin.qq.com/s/3YQfr-lnnJRksLbBdS6lLA
[2] Phanes Therapeutics' Claudin 18.2/CD47 Bispecific Antibody PT886 Clinical Trial Application Accepted by CDE.Retrieved Dec 11, 2023, from https://mp.weixin.qq.com/s/WVQe3sRqWtICBvyGt62cOA
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