FDA GRANTS FAST TRACK DESIGNATION 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 Fast Track Designation 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.
The FDA's decision is informed by the results of Salspera's nonclinical studies and a Phase 2 clinical study of Saltikva in metastatic pancreatic cancer.
"Receiving Fast Track Designation is an important milestone for Saltikva. This designation reinforces our belief in Saltikva as a potential treatment for metastatic pancreatic cancer as well as additional solid tumors," said Eddie Moradian, PhD, Chief Executive Officer, Salspera.
Fast Track Designation
Fast Track designation aims to facilitate the development and accelerate the review of new therapeutics that are intended to treat serious or life-threatening conditions and that potentially address an unmet medical need. Drugs that are granted this designation are given the opportunity for more frequent interactions with the FDA, as well as potential pathways for expedited approval.
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.