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Syros Receives FDA Orphan Drug Designation for SY-5609 for the Treatment of Pancreatic Cancer

Wednesday, September 14, 2022

Syros Pharmaceuticals, Inc., a leading company in the field of gene expression control medicines, has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to SY-5609 for the treatment of pancreatic cancer. SY-5609 is an orally administered cyclin-dependent kinase 7 (CDK7) inhibitor that demonstrates high selectivity and potency. It is currently undergoing evaluation in combination with chemotherapy as a potential treatment for patients with relapsed metastatic pancreatic cancer.

Dr. David A. Roth, Chief Medical Officer of Syros, emphasized the importance of the orphan drug designation, stating, "This designation underscores the urgency of our efforts to develop SY-5609 for patients with pancreatic cancer, a disease that is particularly devastating and challenging to treat. Based on the early data we reported last year, which demonstrated activity as a single agent in heavily treated patients, along with compelling preclinical data and a strong mechanistic rationale, we believe SY-5609 has the potential to provide significant benefits to individuals with pancreatic cancer, for whom effective treatment options are currently limited. We eagerly anticipate sharing initial data from the safety lead-in portion of our ongoing Phase 1 study later this year."

The FDA's Office of Orphan Drug Products grants orphan status to support the development of medicines for rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation offers certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials, and an exemption from FDA application fees.

Syros is currently conducting a Phase 1 trial to evaluate SY-5609 in combination with chemotherapy for patients with pancreatic cancer who have experienced disease progression following FOLFIRINOX treatment. Patients in the trial have been randomized to receive either SY-5609 in combination with gemcitabine or SY-5609 in combination with gemcitabine and nab-paclitaxel, using approved doses of the combination agents. The study is assessing the safety, tolerability, and efficacy measures such as disease control rate and progression-free survival. Safety and clinical activity data from the safety lead-in portion of the trial are expected to be available in the second half of 2022.

Through an existing clinical supply agreement with Roche, Syros is also providing SY-5609 for a combination dosing cohort in Roche's ongoing Phase 1/1b INTRINSIC trial. This cohort is evaluating the combination of SY-5609 and atezolizumab in patients with BRAF-mutant colorectal cancer. Roche serves as the sponsor of the INTRINSIC trial.

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