FDA GRANTS ORPHAN DRUG DESIGNATION (ODD) TO SALSPERA'S SALTIKVA, AN INNOVATIVE IMMUNOTHERAPEUTIC APPROACH TO TREAT METASTATIC PANCREATIC CANCER
Salspera today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for Saltikva, a novel immunotherapy for the treatment of Metastatic Pancreatic Cancer. Saltikva is a novel tumor microbiome immunotherapy that targets solid tumor tissues and stimulates a robust immunologic mediated tumor cell kill. Salspera is currently conducting a phase 2 clinical trial of Saltikva in metastatic pancreatic cancer.
"This important designation is a milestone in the development of Saltikva and highlights the need for new treatment options for patients with pancreatic cancer," said Eddie Moradian, Ph.D., Chief Executive Officer of Salspera. In addition, Daniel Saltzman MD PhD, Salspera’s Chief Medical Officer, remarked "We are extremely excited about the very promising early results coming out of our phase 2 clinical trial where Saltikva is orally administered to patients with pancreatic cancer also receiving standard of care chemotherapy. We look forward to advancing this novel candidate further in the clinic and to patients in need."
FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.
Salspera is a clinical stage biotechnology company pioneering the development of tumor microbiome immunotherapies. Salspera has a novel microfabrication platform targeting solid tumors that enables the production of any biologic drug intratumorally without systemic exposure.