Saltikva (attenuated Salmonella typhimurium expressing IL-2) / MD Biosciences, Salspera - LARVOL DELTA

The renaissance of Salmonella-based cancer therapy: convergence of AI, synthetic circuits, and TME remodeling. (PubMed, Front Immunol) - "In addition to cytotoxicity effects, we focus on how Salmonella reprograms the metabolic environment of the TME and discuss specific metabolic pathways, such as asparagine depletion-mediated T-cell paralysis, that contribute to rescuing exhausted effector cells. Finally, linking preclinical advances with recent clinical successes (e.g., Saltikva), we hypothesize that next-generation engineered Salmonella is more than just a vector but rather a full immunological modulator delivering the potential to convert "cold" tumors into "hot" environments capable of providing a synergistic platform to enhance checkpoint inhibitors and chemotherapeutics."

Journal • Review • Oncology

A phase 2 study of orally administered live biotherapeutic salmonella-IL2 with FOLFIRINOX for stage IV pancreatic cancer. (PubMed, Cancer Immunol Immunother) - P2 | "Addition of Salmonella-IL2 to FOLFIRINOX is associated with increased mPFS and mOS when compared to previously reported outcomes with FOLFIRINOX alone in the literature. A multicenter, randomized, phase 3 trial is warranted. ClinicalTrials.gov identifier: NCT04589234."

Journal • P2 data • Colon Cancer • Colorectal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • IL2

Influence of salmonella-IL2 in combination with FOLFIRINOX on overall and progression-free survival in stage IV metastatic pancreatic cancer. (ASCO 2025) - P2 | "Arm Two patients received Salmonella-IL2 plus Gemcitabine/nab-Paclitaxel (GEM/nabP)... Addition of Salmonella-IL2 to FOLFIRINOX for treating stage IV pancreatic cancer is associated with increased mPFS and mOS. A multicenter, randomized, phase III trial is warranted."

Combination therapy • Metastases • Colon Cancer • Colorectal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • IL2

Saltikva for Metastatic Pancreatic Cancer (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Salspera LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Addition of Salmonella-IL2 to FOLFIRINOX for metastatic stage 4 pancreatic cancer nearly doubles median survival (AACR 2023) - "Addition of Salmonella-IL2 to FOLFIRINOX for stage 4 metastatic pancreatic cancer results in the near doubling of median survival when compared to historical and site-specific controls receiving FOLFIRNOX only. These findings strongly indicate that a larger pivotal phase 3 multicenter trial is warranted."

Metastases • Colon Cancer • Gastrointestinal Cancer • Oncology • Osteosarcoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Sarcoma • Solid Tumor • IL2

[VIRTUAL] Microbial based immunotherapy: Saltikva as a novel therapeutic for solid tumors (AACR 2021) - P2 | "With a median life expectancy of just 11 months, this patient is now in month 24 post-diagnosis, is feeling extremely well with complete resolution of her pulmonary metastases and significant diminution of her liver metastases and primary pancreatic cancer. A Phase II clinical study of Saltikva in metastatic pancreatic cancer is currently ongoing (NCT04589234)."

Late-breaking abstract • Gastrointestinal Cancer • Oncology • Oral Cancer • Pancreatic Cancer • Solid Tumor • IL2

Salspera (BIO 2022) - "With a median life expectancy of just 11 months, this patient is now in month 36 post-diagnosis, is feeling extremely well with complete resolution of her pulmonary metastases and significant diminution of her liver metastases and primary pancreatic cancer. A Phase II clinical study of Saltikva in metastatic pancreatic cancer is currently ongoing."

Gastrointestinal Cancer • Gene Therapies • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • IL2

[VIRTUAL] Salspera, LLC (BIO 2021) - P2 | "With a median life expectancy of just 11 months, this patient is now in month 30 post-diagnosis and is feeling extremely well with complete resolution of her pulmonary metastases and significant diminution of her liver metastases and primary pancreatic cancer. A Phase II clinical study of Saltikva in metastatic pancreatic cancer is currently ongoing (NCT04589234)."

Gastrointestinal Cancer • Gene Therapies • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • IL2

Saltikva for Metastatic Pancreatic Cancer (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: Salspera LLC

Clinical • New P2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Saltikva for Metastatic Pancreatic Cancer (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Salspera LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor