On November 11, 2021 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for its wholly owned clinical therapeutic candidate, LYT-200, for the treatment of pancreatic cancer (Press release, PureTech Health, NOV 11, 2021, View Source [SID1234595265]).

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LYT-200 is a fully human IgG4 monoclonal antibody (mAb) targeting a foundational immunosuppressive protein, galectin-9, for the potential treatment of solid tumors, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC) and cholangiocarcinoma (CCA), that are difficult to treat and have poor survival rates. LYT-200 is currently being evaluated in the first stage of an adaptive Phase 1/2 trial, with topline results from the Phase 1 portion expected in the first half of 2022 to allow for continued dose escalation as a maximum tolerated dose has not yet been reached.

"The FDA’s decision to grant orphan drug designation for LYT-200 reflects its potential as a novel anti-cancer therapy designed to block multiple immunosuppressive pathways in the tumor microenvironment," said Julie Krop, M.D., Chief Medical Officer at PureTech. "Too many pancreatic cancer patients do not respond to existing immunotherapy agents and other standard of care regimens. We are looking forward to advancing LYT-200 through the clinic in hopes of meeting this substantial need."

The FDA grants orphan drug designation to novel drug and biologic products for the treatment, diagnosis or prevention of conditions affecting fewer than 200,000 persons in the U.S. Orphan drug designation qualifies PureTech for incentives under the Orphan Drug Act, including tax credits for some clinical trials and eligibility for seven years of market exclusivity in the U.S., if the drug is approved.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting a foundational immunosuppressive protein, galectin-9, for the potential treatment of solid tumors, including pancreatic ductal adenocarcinoma, colorectal cancer and cholangiocarcinoma, that are difficult to treat and have poor survival rates. PureTech has presented 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. LYT-200 is currently being evaluated in a Phase 1/2 adaptive design trial. Results from the Phase 1 dose escalation portion of the trial are expected in the first half of 2022.