Pharma Focus Asia

Phanes Therapeutics’ PT886 granted Orphan Drug Designation for the treatment of pancreatic cancer by the FDA

Friday, July 01, 2022

Phanes Therapeutics, Inc., an emerging leader in innovative discovery research and clinical development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PT886 for the treatment of pancreatic cancer. Earlier this month, the FDA granted orphan drug designation to the company’s PT217 for the treatment of small cell lung cancer.

PT886 is a first-in-class bispecific antibody targeting claudin 18.2 (CLDN18.2) and cluster of differentiation 47 (CD47) being developed for patients with pancreatic cancer as well as gastric and gastroesophageal cancers. Pancreatic cancer is an aggressive form of cancer characterized by high mortality rates and significant morbidities. The 5-year survival rate of patients with pancreatic cancer is only 10.8% and projections for 2022 estimate that approximately 50,000 Americans will die of pancreatic cancer this year and by 2030 is projected to exceed breast, prostate, and colorectal malignancies as the leading cause of cancer-related deaths in the US.

“PT886 has the potential to be a transformative treatment option for pancreatic cancer patients whose current standard of care is severely limited.” said Dr. Ming Wang, Founder and CEO of Phanes Therapeutics. “This orphan drug designation comes in the same month with our recent IND clearance for PT886, which we are rapidly progressing into the clinic. These important milestones the company has achieved in Q2 this year follow the March IND clearance for PT199, an anti-CD73 monoclonal antibody for the treatment of multiple solid tumors.”

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended to treat, diagnose, or prevent rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation provides certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval.

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