Salspera announces FDA Acceptance of IND Application for Saltikva in Stage 4 Metastatic Pancreatic Cancer
OAKDALE, MN., June 01, 2021 -- Salspera, LLC, a clinical-stage biotechnology company pioneering the discovery and development of its platform of tumor microbiome immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) for Saltikva, its lead candidate for the treatment of metastatic pancreatic cancer. The active IND enables Salspera to initiate a Phase 2 clinical trial designed to assess the efficacy of Saltikva in conjunction with standard chemotherapy in patients with metastatic pancreatic cancer.
Eddie Moradian, PhD, Chief Executive Officer of Salspera commented, “We are extremely proud of the Salspera team in achieving this milestone and excited to initiate this FDA-approved clinical trial to further explore the potential of Saltikva in battling metastatic cancer.”
Salspera is a private, clinical stage biotech company developing its platform of orally administered microbiome immunotherapies in solid tumors. The deep pipeline consists of orally administered microbiome immunotherapies, genetically engineered to eliminate pathogenicity and express various cytokines and cytotoxic proteins within the tumor microenvironment. The lead asset, Saltikva, is currently in an on-going phase 2 clinical study in metastatic pancreatic cancer patients in Canada. It is also being developed in additional solid tumors with the plan to initiate further phase 2 studies. The platform consists of numerous constructs engineered to deliver among others, PD-L1, CTLA-4, IL-15 intra-tumorally. These are currently undergoing IND enabling studies with plans to move them to the clinic.
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