Our data

What we have measured.

All publicly disclosed data, with sources.

Clinical · Phase 2

Phase 2 Clinical Trial - Stage 4 Pancreatic Cancer (mPDAC)

Results published (2026)
Overall survival
Saltikva® + FOLFIRINOX (n=20)Historical FOLFIRINOX (n=40)
Shaded: 95% CI · ticks: censored · data cutoff 2025-03-01 (as published) · click to enlarge

Median 20.3 vs 11.6 months · HR 0.58 · p=0.063 (log-rank) at the published data cutoff (March 1, 2025) · p<0.05 at the latest data recording (October 2026)

Progression-free survival
Saltikva® + FOLFIRINOX (n=20)Historical FOLFIRINOX (n=34)
Shaded: 95% CI · ticks: censored · data cutoff 2025-03-01 (as published) · click to enlarge

Median 15.0 vs 5.7 months · HR 0.34 · p<0.001 (log-rank)

Response rate
70%overall response rate (95% CI 45.5–87.9%) · vs 31.6% FOLFIRINOX alone
New metastases
80%progressed without new metastases (post-hoc)
Safety
0serious adverse events attributed to Saltikva® by the independent Data Safety Monitoring Committee
Clinical · Phase 1

Safety and oral administration

FindingOral Saltikva® was tested in a human Phase 1 dose-escalation safety study.
Participants22
Adverse eventsNo dose-limiting toxicity (single oral dose up to 10¹⁰ cfu)
Source and methods ↗ J Immunother 2020
Preclinical

Robust Cancer Kill and Cancer Prevention of New Metastases

Antitumor effectiveness across multiple murine tumor models and the companion dog trial.

Colonization

Bacteria collect and grow inside tumors in mouse models.

IL-2 in tumor

Active IL-2 produced within the tumor, in mouse models.

Immune activation

NK cells activated, with CD8 T cells contributing.

Companion dogs

In 19 pet dogs with osteosarcoma treated with amputation and doxorubicin, 22% of dogs given Saltikva® were free of metastases at one year, vs under 10% of comparison dogs (Fritz et al., Vet Med Sci 2016;2(3):179–190 ↗).

With chemotherapy

In a mouse breast-cancer study, adding Saltikva® let researchers cut the chemotherapy (doxorubicin) dose by 75% and still kill as many tumor cells as the full dose.

Mouse liver photographs · single oral dose

Single Oral Dose Is Highly Effective in Treating Primary and Recurrent Disease

Liver following treatment by saline control
Mouse liver following saline-control treatment, the comparison for a single oral dose of Saltikva® in treating primary and recurrent disease, with original annotations marking tumor nodules and a large tumor mass.
Liver following a single oral dose of Saltikva®
Mouse liver following a single oral dose of Saltikva® in treating primary and recurrent disease, with an original annotation marking a tumor nodule.
Mouse livers following treatment with saline control or a single oral dose of Saltikva®, from the slide titled “Single Oral Dose Is Highly Effective in Treating Primary and Recurrent Disease”. Arrows in the original photographs mark tumor nodules and a large tumor mass in the saline-control liver, and a tumor nodule in the Saltikva® liver.
Publications

Peer-reviewed work behind the platform

2026A phase 2 study of orally administered live biotherapeutic salmonella-IL2 with FOLFIRINOX for stage IV pancreatic cancerCancer Immunol Immunother 75(2):60
2025Influence of salmonella-IL2 in combination with FOLFIRINOX on overall and progression-free survival in stage IV metastatic pancreatic cancerJ Clin Oncol 43(16_suppl):2571 (ASCO)
2020A Phase I, Dose Escalation, Single Dose Trial of Oral Attenuated Salmonella typhimurium Containing Human IL-2 in Patients With Metastatic Gastrointestinal CancersJ Immunother 43(7):217–221
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