Salspera, a clinical-stage immuno-oncology biotech, has filed for a U.S. initial public offering (IPO) to fund development of its novel live bacterial cancer therapy. The Cambridge, MA-based company aims to raise up to $50–85 million, reflecting investor interest in innovative cancer treatments. Proceeds will support pivotal trials of Salspera’s lead candidate, Saltikva, in hard-to-treat solid tumors, especially metastatic pancreatic cancer. Saltikva has already shown encouraging results in a Phase 2 study for stage IV pancreatic cancer, significantly extending patient survival when added to chemotherapy. The planned IPO comes as Salspera positions Saltikva for Phase 3 development in pancreatic cancer, an indication with few effective therapies.
Saltikva’s Live Bacterial Immunotherapy Mechanism
Saltikva (Salmonella-IL2) is a first-in-class “live biopharmaceutical” – an attenuated Salmonella typhimuriumbacterium genetically engineered to carry the human interleukin-2 (IL-2) gene. The therapy is administered orally, allowing the non-pathogenic bacteria to selectively colonize tumor tissues and locally secrete IL-2. IL-2 is a cytokine that expands populations of natural killer (NK) cells and CD8+ T-cells, key immune cells that can destroy cancer cells. By releasing IL-2 directly within the tumor microenvironment, Saltikva is designed to provoke an immune attack against the cancer in situ without causing systemic toxicity.
This microbial-based immunotherapy approach takes advantage of bacteria’s intrinsic tumor-homing ability and immune-stimulating properties. Preclinical models have shown that Salmonella-IL2 can induce significant anti-tumor effects in pancreatic cancer and other malignancies, providing a strong rationale for clinical trials in patients.
Salspera/LinkedIn
Phase 2 Pancreatic Cancer Results
Salspera recently completed a Phase 2 trial evaluating Saltikva in combination with standard chemotherapy for advanced pancreatic cancer. In this open-label study, patients with stage IV pancreatic ductal adenocarcinoma received Saltikva alongside first-line FOLFIRINOX chemotherapy. The addition of Saltikva yielded improved outcomes compared to historical results with chemotherapy alone. Notably, patients who received Saltikva with FOLFIRINOX had a median progression-free survival of about 15 months and median overall survival of 20.3 months.
These survival times markedly exceed the typical ~7-month PFS and ~11-month OS reported for FOLFIRINOX in metastatic pancreatic cancer literature. The trial reported no serious adverse events attributable to Saltikva, with toxicity driven by the chemotherapy, indicating a favorable safety profile for the bacterial therapy. While no complete tumor remissions occurred, partial responses were achieved in 70% of patients, contributing to an overall response rate of 70%. The robust immune-mediated tumor control and extended survival observed with Saltikva have encouraged Salspera to advance into pivotal Phase 3 testing.
Saltikva has already received FDA Fast Track designation in pancreatic cancer, as well as Orphan Drug status for pancreatic cancer and osteosarcoma, underscoring its potential to address unmet needs. If confirmed in larger trials, Saltikva’s novel approach could introduce a new treatment modality for pancreatic cancer, a disease notorious for poor prognosis and limited therapeutic progress.
You can find more insights on pancreatic cancer and its current treatment options on articles provided by OncoDaily.
Pancreatic Cancer: Symptoms, Causes, Types, Diagnosis & Treatment.
Pancreatic Cancer: What patients should know about.
Therapeutic Vaccines in Pancreatic Cancer: Challenging a Historically Immune-Resistant Disease.