Sapience Therapeutics ST-36 receives orphan drug designation from FDA

Sapience Therapeutics Inc., a Scarsdale-based biotechnology company that develops therapeutics to address difficult-to-treat cancers, announced that the U.S. Food and Drug Administration granted the company”™s leading candidate, protein-based therapeutic ST-36, orphan drug designation for the treatment of glioma.

“The FDA’s decision is an important milestone in the development of our lead product candidate and highlights the high unmet medical need for new therapies that have the potential to transform the lives of glioma patients and their families,” said Barry Kappel, president and CEO of Sapience.

Gliomas are a form of malignant brain cancer that affect approximately 18,000 to 20,000 people annually in the U.S. Nearly 70 percent of gliomas are glioblastoma, the most deadly form of brain cancer.

Sapience entered into an exclusive licensing agreement with Columbia University in July to develop ST-36, which targets a factor that activates particular genes and may play an important role in allowing certain cells to become cancerous.
Once administered, ST-36 prevents the activation of these genes in tumors, which results in tumor-specific cell death. ST-36 selectively targets a protein that promotes the growth of many types of tumors including glioblastoma.

The orphan drug designation is granted to investigational drugs intended to treat rare diseases affecting fewer than 200,000 people nationwide. The status has the potential to provide several benefits to developers, including tax credits for clinical trials costs, exemptions from certain FDA application fees and seven years of market exclusivity upon approval.

For more information, visit sapiencetherapeutics.com.