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Syros Shares Soar As FDA Grants Orphan Drug Status To Pancreatic Cancer Candidate

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Syros Pharmaceuticals (NASDAQ: SYRS) lead candidate SY-5609 for the treatment of pancreatic cancer.

Benzinga · 09/13/2022 16:23

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Syros Pharmaceuticals (NASDAQ:SYRS) lead candidate SY-5609 for the treatment of pancreatic cancer.

The ongoing Phase 1 trial is evaluating SY-5609 in combination with chemotherapy in pancreatic cancer patients who have progressed following treatment with FOLFIRINOX.

The study is assessing safety and tolerability, as well as efficacy measures such as disease control rate and progression free survival. The company anticipates safety and clinical activity data from the safety lead-in portion of the trial in the second half of 2022.

David A. Roth, Chief Medical Officer, commented: "This orphan drug designation underscores the urgency of our efforts to develop SY-5609 for patients with pancreatic cancer, one of the most devastating and difficult to treat malignancies. Based on the early data we reported last year, which demonstrated single-agent activity in heavily pre-treated patients, as well as compelling preclinical data and a strong mechanistic rationale, we believe SY-5609 could deliver meaningful benefit to people with pancreatic cancer, whose tumors have otherwise eluded therapeutic intervention.”

Further, Syros has clinical supply agreement with Roche, supplying SY-5609 for a combination dosing cohort in Roche's ongoing Phase 1/1b INTRINSIC trial.

In the Roche sponsored INTRINSIC trial, this cohort is evaluating the combination of SY-5609 and atezolizumab in patients with BRAF-mutant colorectal cancer.

FDA grants orphan designation to promote the development of a drug that is expected to have significant therapeutic advantage over existing treatments that target a condition affecting 200,000 or fewer U.S. patients annually.

Price Action : Syros shares are trading around 9 percent higher at $0.83 on Tuesday during after-hours session.