# Salspera · Synthetically Engineered Bacteria for the Treatment of Solid Tumors

Canonical: https://salspera.com/

Saltikva® completed a Phase 2 clinical trial in Stage 4 pancreatic cancer, increasing median overall survival by 75% and progression-free survival by 162%* versus the historical standard of care.

## Overview

Live biotherapeutic · immuno-oncology

Synthetically Engineered Bacteria for the Treatment of Solid Tumors

Saltikva® completed a Phase 2 clinical trial in Stage 4 pancreatic cancer, increasing median overall survival by 75% and progression-free survival by 162%* versus the historical standard of care.

* Patients receiving >5 doses of Saltikva vs. historical FFX controls. Median OS 20.3 vs 11.6 mo; PFS 15.0 vs 5.7 mo.

- Lead program: Saltikva® · stage 4 pancreatic cancer
- Stage: Phase 2 complete · published 2026
- Route: Oral
- Status: Pending Phase III

## Mechanism

From oral dose to tumor cell death.

Saltikva® is a synthetically engineered agent built on a Salmonella chassis, designed for efficacy and safety. Scroll to follow the seven steps of its proposed mechanism, based on preclinical studies.

1. Step 01 · Oral Administration: Saltikva® is orally administered as a liquid suspension.
2. Step 02 · Migration: Saltikva® migrates from the gut directly to solid tumors.
3. Step 03 · Homing: They gather and grow inside solid tumors.
4. Step 04 · Replication: Saltikva® replicates and produces active human IL-2 inside the tumor, designed to limit systemic exposure.
5. Step 05 · Activate: Saltikva® stimulates the immune system to impart a tumor cell kill and also likely competes with the tumor for nutrients.
6. Step 06 · Contact: An NK cell touches a tumor cell’s surface and releases toxic granules at the point of contact.
7. Step 07 · Tumor Kill: A multifactorial approach imparts a tumor cell kill.

## Why Saltikva®

Saltikva® is an orally administered investigational cancer therapy. No serious adverse event has been attributed to Saltikva® in clinical studies to date, and it has shown anti-cancer activity in multiple preclinical and clinical studies.

## Our data

What we have measured.

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

- median overall survival: 20.3 mo (vs 11.56 mo · HR 0.59 · p=0.063 at the published data cutoff (March 1, 2025) · p<0.05 at the latest data recording (October 2026))
- median progression-free survival: 15 mo (vs 5.8 mo)
- overall response rate: 70% (vs 31.6%)
- progressed without new metastases: 80%
- FOLFIRINOX alone (PRODIGE 4, Conroy 2011)
- Saltikva® + FOLFIRINOX / FOLFIRINOX on-site historical control

Published in [J Cell Immunol 2026](https://www.scientificarchives.com/article/live-biotherapeutic-salmonella-il2-saltikva-plus-folfirinox-for-stag-metastatic-pancreatic-ductal-adenocarcinoma-implications-of-a-phase-2-clinical-trial) · [Cancer Immunol Immunother 2026](https://pubmed.ncbi.nlm.nih.gov/41591505/) · [ASCO 2025](https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.2571)

### Phase 1 · safety

No dose-limiting toxicity

single oral dose, up to 10¹⁰ cfu

- 22 patients with solid tumors that had spread to the liver
- No adverse event judged likely or definitely related to treatment
- Circulating NK cells rose from 12.1% to 14.6% five weeks after one dose (p=0.02)

Single-dose escalation, 10⁵ to 10¹⁰ cfu · NK data from 14 patients sampled at 5 weeks · safety study

Published in [J Immunother 2020](https://pubmed.ncbi.nlm.nih.gov/32554977/)

## Pipeline

One platform across solid tumors.

- Saltikva® · Stage 4 metastatic pancreatic cancer: Pending Phase III · Orphan Drug, Fast Track. Oral Saltikva® with FOLFIRINOX. Phase 2 complete; results published 2026. Positive FDA Type C meeting.
- Saltikva® · Metastatic colorectal cancer: Entering Phase 2. IND-enabling work complete under the expanded IND. A Phase 2 study is next.
- Saltikva® · Osteosarcoma: Entering Phase 2 · Orphan Drug. IND-enabling work complete under the expanded IND. A Phase 2 study is next.

## Patient perspective

Hear from a patient.

A patient shares his perspective on Salspera's approach to treating solid tumors.

Dr. Heller · Patient · in his own words

## Team

The team behind Saltikva®.

Salspera is privately held and privately funded. We work with expert consultants in clinical trial monitoring, regulatory affairs and trial design.