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# PureTech Orphan Status for Pancreatic Cancer Drug
- URL: https://www.fdaweb.com/puretech-orphan-status-for-pancreatic-cancer-drug/
- Published: 2021-11-11T12:00:00.000Z
- Updated: 2026-09-14T17:22:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150561

FDA has granted PureTech Health an orphan drug designation for LYT-200 and its use in treating pancreatic cancer. The IgG4 monoclonal antibody is designed to target an immunosuppressive protein, galectin-9, for the potential treatment of solid tumors, including pancreatic ductal adenocarcinoma, colorectal cancer and cholangiocarcinoma, according to the company. LYT-200 is currently being evaluated in the first stage of an adaptive Phase 1/2 trial, with topline results expected in the first half of next year.  

The company says the designation was based on preclinical data “demonstrating high expression of galectin-9 across breast cancer, pancreatic and cholangiocarcinoma samples and found that the highest levels of galectin-9 correlated with shorter time to disease relapse and poor survival. These data suggest that galectin-9 could be significant both as a therapeutic target for a range of cancers and as a cancer biomarker.” Preclinical and patient-derived organoid tumor models also showed the potential efficacy of LYT-200 and the importance of galectin-9 as a target, it adds.