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Journal of Cellular Immunology

ISSN: 2689-2812

Commentary Open Access

Live Biotherapeutic Salmonella-IL2 (Saltikva) Plus FOLFIRINOX for Stage IV Metastatic Pancreatic Ductal Adenocarcinoma – Implications of a Phase 2 Clinical Trial

Daniel A. Saltzman1,3, Petr Kavan2, Lance Augustin3, Janet Schottel4, James T. Lee3, Jordan Moradian1, Eddie Moradian1, Gerald Batist2
  • 1Salspera, Cambridge MA USA
  • 2Segal Cancer Center, McGill University Center for Translational Research, McGill University, Jewish General Hospital, Montreal, Quebec, Canada
  • 3Department of Surgery, University of Minnesota, Minneapolis, MN, USA
  • 4Department of Biochemistry, Molecular Biology and Biophysics, University of Minnesota, Minneapolis, MN, USA
+ Affiliations - Affiliations

Corresponding Author

Daniel Saltzman, DSaltzman@Salspera.com; Saltz002@umn.edu

Received Date: March 11, 2026

Accepted Date: May 08, 2026

Citation:

Saltzman DA, Kavan P, Augustin L, Schottel J, Lee JT, Moradian J, et al. Live Biotherapeutic Salmonella-IL2 (Saltikva) Plus FOLFIRINOX for Stage IV Metastatic Pancreatic Ductal Adenocarcinoma – Implications of a Phase 2 Clinical Trial. J Cell Immunol. 2026;8(2):37–47.


Copyright: © 2026 Saltzman DA, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Background: Salmonella-IL2 is an attenuated Salmonella Typhimurium strain carrying the human gene for IL-2. When orally administered in preclinical trials, the bacterium colonizes tumors and locally releases IL-2, triggering immunologically-mediated tumor cell killing without untoward side effects. In addition, extensive preclinical studies and a human phase I trial demonstrated robust NK cell subset population surge with oral administration of Salmonella-IL2.

Objective: A non-randomized, two-arm phase 2 study evaluated the combination of Salmonella-IL2 with standard of care (SOC) chemotherapy was conducted.

Methods: Arm One patients received Salmonella-IL2 plus FOLFIRINOX (FFX). Arm Two patients received Salmonella-IL2 plus Gemcitabine/nab-Paclitaxel (GEM/nabP). Overall survival (OS), progression-free survival (PFS), safety, and biomarker data in each arm were collected and compared to corresponding values for reference patients with stage IV pancreatic cancer (SOC Controls) receiving care at the study site from 2016 to 2020. Four patients with stage IV pancreatic cancer were treated via Salspera’s Expanded Access Program (EAP) using the Arm One regimen.

Results: In total, 34 patients (30 in the trial, 4 via EAP) were enrolled: 26 received Salmonella-IL2 with FOLFIRINOX and eight received Salmonella-IL2 with GEM/NabP. SOC Control patients comprised of 37 administered FOLFIRINOX and 31 given GEM/nabP. Those patients who received more than five doses of Salmonella-IL2 with FOLFIRINOX (n=20) had a mPFS (median Progression Free Survival) of 15 months vs. 5.8 months (p<0.001) in control patients who had received only FOLFIRNOX. For those same compared cohorts, the mOS (median Overall Survival) was 20.3 months vs. 11.5 months (p<0.1). Only eight patients were enrolled in the GEM/NabP Arm thus limiting useful conclusions. Overall, 41 serious adverse events (SAEs) were noted and attributed to SOC chemotherapy agents but none to Salmonella-IL2. Overall Response Rate (ORR) was 70%.

Conclusions: Addition of Salmonella-IL2 to FOLFIRINOX demonstrates a remarkable safety profile in that no serious adverse events were attributed to this study drug. In addition, the compelling preliminary efficacy with an overall response rate of 70% and with a statistically significant increased mPFS and mOS supports a global, 2-Arm, multicenter and randomized phase III trial for stage 4 metastatic pancreatic cancer. ClinicalTrials.gov identifier: NCT04589234.

Keywords

Bacterial based immunotherapy, Cancer immunology, Immunotherapy, Tumor immunology

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