Pharma Focus Europe

FDA Fast Tracks Phanes Therapeutics' PT886 for Metastatic Claudin 18.2-Positive Pancreatic Adenocarcinoma Treatment

Thursday, March 21, 2024

Phanes Therapeutics, Inc. (Phanes), a leading biotechnology company specializing in innovative oncology drug discovery and development, made an announcement today regarding PT886. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT886 for treating patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma. PT886 had previously received orphan drug designation for pancreatic cancer from the FDA in 2022.

PT886 is a novel native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47, developed by Phanes for treating gastric, gastroesophageal junction, and pancreatic adenocarcinomas. Phanes utilized its proprietary bispecific antibody platforms, PACbody® and SPECpair®, to assemble PT886.

Pancreatic cancer is known for its aggressiveness and poor prognosis, with a 5-year survival rate of only 3% for patients diagnosed with metastatic disease. It is estimated that approximately 51,000 Americans will die from pancreatic cancer in 2024, and projections suggest it will become the leading cause of cancer-related deaths in the US by 2030, surpassing breast, prostate, and colorectal cancers.

Ming Wang, Founder and CEO of Phanes Therapeutics, expressed confidence in PT886's potential as a transformative treatment option for patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma, where existing standard therapies often fall short. Wang highlighted PT886 as a product of Phanes' innovative approach to therapeutic design and practical technologies.

The Phase I clinical trial of PT886 (NCT05482893), known as the TWINPEAK study, is currently underway at multiple centers. This trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction, and pancreatic cancers who have either progressed after standard therapies or for whom standard treatments are ineffective, intolerable, or inappropriate.



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