Common questions.

Salspera, Inc. is a privately held biopharmaceutical company, a Delaware corporation headquartered at 45 Prospect Street, Cambridge, Massachusetts, co-founded in 2017 by Eddie Moradian, PhD (CEO) and Daniel Saltzman, MD, PhD (CMO). It is developing Saltikva, an investigational oral live-bacteria immunotherapy (an engineered Salmonella carrying the human IL-2 gene) for solid tumors. Saltikva has been studied in an open-label, non-randomized Phase 2 trial in metastatic pancreatic cancer and is not approved for any use by the FDA or any other regulator. SEC EDGAR identifies Salspera, Inc. by CIK 0002084032. Its S-1 is pending and unpriced; a CIK does not establish effectiveness, listing or SEC endorsement.

Salspera, Inc. (developer of Saltikva) was co-founded by Eddie Moradian, PhD, who serves as Chief Executive Officer, and Daniel Saltzman, MD, PhD, who serves as Chief Medical Officer and is a Professor of Surgery at the University of Minnesota. In its S-1/A No. 3 ↗ filed 2026-03-20, Salspera, Inc. reported two employees, the CEO and the CMO. Dr. Saltzman's publications disclose a financial interest in Salspera, Inc. and related patents, which the University of Minnesota manages under its conflict-of-interest process.

The board of Salspera, Inc. (developer of Saltikva) has five directors: the co-founders Eddie Moradian, PhD, Chief Executive Officer, and Daniel Saltzman, MD, PhD, Chief Medical Officer, and three independent directors, David Schaffer, PhD, Charles Garner and Luisa Ingargiola.

Salspera, Inc. (developer of Saltikva) was formed as Salspera, LLC, a Minnesota limited liability company, in 2017, and converted to a Delaware corporation named Salspera, Inc. on 2021-11-28 (S-1/A No. 3 ↗). The filing gives the formation date as June 26, 2017 in one section and July 2017 in others. The company's principal executive office is in Cambridge, Massachusetts, and its laboratory work is based in Oakdale, Minnesota.

Salspera, Inc. has two listed employees, Chief Executive Officer Eddie Moradian, PhD, and Chief Medical Officer Daniel Saltzman, MD, PhD, and works with a larger team on a consulting basis. The broader team listed on the Team page is made up of leading cancer specialists, with particular depth in pancreatic cancer: its Scientific Advisory Board includes Richard L. Schilsky, MD, former Chief Medical Officer of the American Society of Clinical Oncology; Gerald Batist, MD, Chair of the Department of Oncology at McGill University; Talia Golan, MD, Head of the Pancreatic Cancer Center at Sheba Medical Center, Israel; Mitesh Borad, MD, Director of the Novel Therapeutic Modality Program at the Mayo Clinic Comprehensive Cancer Center; and Barry P. Sleckman, MD, PhD, Director of the O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham. Saltikva was manufactured under GMP conditions by Blossom Medical LLC, a related manufacturing company owned by Eddie Moradian, PhD. Salspera, Inc. is identifying alternative manufacturing providers (S-1/A No. 3).

The Saltikva Phase 2 study was funded through a group of private investors. Salspera, Inc. has been funded with private resources since its founding in 2017 (S-1/A No. 3).

Yes. Saltikva is a registered US trademark (USPTO Reg. No. 8353156, registered 2026-07-21).

The assignee records for US Patent 11,576,936 ↗ (granted 2023-02-14) and US Patent 12,090,179 ↗ (granted 2024-09-17) name Salspera LLC, the predecessor of Salspera, Inc. (developer of Saltikva). The granted claims cover methods and combinations pairing a chemotherapy agent below its maximum tolerated dose with attenuated Salmonella typhimurium, and in the later patent a Salmonella that expresses human IL-2. The S-1/A No. 3 ↗ also lists pending applications in the United States, Europe and other jurisdictions, which are company-stated and which have not been independently checked. Google Patents lists an adjusted expiry of 2040-01-02 for US Patent 11,576,936, which is not a legal determination; the expiry of US Patent 12,090,179 is not reported in the sources reviewed. The intellectual property for Saltikva belongs wholly to Salspera and is not licensed from any university, and the company does not depend on any intellectual property owned by the University of Minnesota to develop, manufacture or commercialize Saltikva (S-1/A No. 3). The S-1/A separately reports a University of Minnesota license held by a subsidiary for an unrelated bacterial construct. Salspera, Inc. has not published a freedom-to-operate analysis.

Saltikva is an investigational medicine from Salspera, Inc.: a live, weakened (attenuated) strain of Salmonella enterica serovar Typhimurium engineered to carry the human gene for interleukin-2, an immune-signaling protein, and given by mouth. Salspera, Inc. is developing Saltikva as an immunotherapy for solid tumors, intended to be given with chemotherapy, with pancreatic cancer as the lead indication, and it is being studied in cancer clinical trials. In an open-label, non-randomized Phase 2 trial in metastatic pancreatic cancer, patients receiving Saltikva with FOLFIRINOX had median overall survival of 18.6 months (25 patients) and 20.3 months in a subgroup of 20, versus 11.56 months in same-site historical FOLFIRINOX controls (n=40), and the authors call the findings hypothesis-generating. In the subgroup of 20, 70% had a partial response (95% CI 45.5–87.9%), vs a 31.6% objective response rate for FOLFIRINOX alone in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al., N Engl J Med 2011;364:1817–25 ↗), and in a post-hoc review 16 of those 20 patients (80%) progressed without new metastases (J Cell Immunol 2026;8(2):48–52 ↗). Saltikva has not been approved by the FDA or any other regulator for any use. Saltikva is the trade name; its scientific name is Salmonella-IL2. Information about Saltikva here is not medical advice.

A live biotherapeutic is a medicine that contains living microorganisms. Saltikva from Salspera, Inc. is a live, genetically engineered, deactivated strain of Salmonella enterica serovar Typhimurium and is not a dietary supplement or probiotic. Saltikva has not been approved by the FDA or any other regulator.

Salspera proposes three steps, each shown in its published animal studies:

1. 1.the bacteria colonize solid tumors;
2. 2.they carry the human IL-2 gene and make IL-2 inside the tumor, acting as a micro-factory rather than delivering the protein;
3. 3.that IL-2 activates immune cells, including NK cells and cytotoxic T cells, a known IL-2 mechanism.

According to preclinical studies, Saltikva® acts locally, without systemic exposure, and the engineered bacteria likely compete with the tumor for essential nutrients, thereby starving it.

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. Tumor colonization and immune-cell changes were not measured in Phase 2 patients.

Interleukin-2 (IL-2) is a signaling protein that activates immune cells such as natural killer cells and T cells. Salspera, Inc. engineered Saltikva to carry the human IL-2 gene, with the hope that IL-2 made near tumors could stimulate immune cells with less exposure elsewhere in the body than IL-2 given by injection. That idea is a hypothesis, and localized IL-2 release in tumors was not confirmed in patients in the Phase 2.

Salspera, Inc. proposes that attenuated Salmonella tends to grow in the low-oxygen environment inside many solid tumors, where the bacteria could deliver immune-stimulating IL-2. The proposal rests on animal studies from the originating University of Minnesota laboratory, and tumor colonization by Saltikva has not been confirmed in patients. Bacterial approaches to cancer have been studied for over a century, and Saltikva remains investigational.

In the Phase 1 trial of Saltikva (22 patients with metastatic gastrointestinal cancers, single oral doses from 10⁵ to 10¹⁰ CFU, no dose-limiting toxicity), mean peripheral natural killer cells rose from 12.1 to 14.6 percent and NK-T cells from 3.4 to 5.6 percent five weeks after a single oral dose (p=0.02 for each), with no dose dependence. In the Phase 2 paper, immune profiling was done only in the first treated patient, and direct confirmation of intratumoral colonization and localized IL-2 release was not performed. Human tumor colonization by Saltikva therefore has not been demonstrated.

No. Salspera, Inc. proposes that Saltikva colonizes tumors, based on animal studies, but in the Saltikva Phase 2 direct confirmation of intratumoral bacterial colonization and localized IL-2 release was not performed, mandatory tumor biopsies were not included, and immune profiling was done in only the first treated patient. The planned Phase 3 is described as including mandatory biopsies.

Nearly 4,000 mice across five tumor models (colorectal, breast, neuroblastoma, osteosarcoma, pancreatic) were treated without untoward effects, in studies from the University of Minnesota laboratory of Daniel Saltzman, MD, PhD. 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 ↗). These are preclinical results from the originating group and do not establish safety or effectiveness in people.

The University of Minnesota Phase 1 of Saltikva (NCT01099631 ↗), run from 2010 to 2014, gave 22 patients with metastatic gastrointestinal cancers that had spread to the liver a single oral dose, from 10⁵ to 10¹⁰ CFU, to learn about tolerability. There was no dose-limiting toxicity, and blood NK and NK-T cells rose afterwards. Two patients had events judged possibly attributable to the bacterium and recovered, and 8 of the 22 patients did not complete the study. The paper reports no tumor responses and no survival advantage from a single dose, and the authors recommended a multiple-dose study.

The Saltikva Phase 2 (NCT04589234 ↗) is an open-label, non-randomized, two-arm study at a single site, the Segal Cancer Centre of the Jewish General Hospital in Montreal, with Gerald Batist, MD and Petr Kavan, MD as principal investigators. It was sponsored by Salspera, Inc.; data were collected by the investigators and an independent monitor (Exactis) and analyzed by the sponsor, with oversight by an independent Data Safety and Monitoring Committee. One arm gave Saltikva with FOLFIRINOX and the other with gemcitabine and nab-paclitaxel; outcomes were compared with same-site historical controls. Expanded-access patients were admitted according to the Expanded Access Program (EAP): they met the trial's formal inclusion criteria, were treated per the FOLFIRINOX arm of the study protocol and were included in the study analysis. The primary endpoints were overall and progression-free survival. The trial was approved by Health Canada and a local ethics board.

The Phase 2 principal investigators were Gerald Batist, MD and Petr Kavan, MD (Jewish General Hospital, Montreal). Salspera's CMO, Daniel Saltzman, MD, PhD, is the principal investigator on the IND. An independent Data Safety and Monitoring Committee oversaw safety; it is no longer active, and former member Christopher Moertel, MD later joined Salspera's Scientific Advisory Board.

The Saltikva Phase 2 study was conducted at a single site, the Segal Cancer Centre of the Jewish General Hospital in Montreal, Quebec, Canada, with Gerald Batist, MD as principal investigator. The study was approved by Health Canada and a local ethics board. It was run outside the United States at one center (S-1/A No. 3). Expanded-access patients were treated at other locations, including Israel.

ClinicalTrials.gov ↗ lists eligibility for the Saltikva from Salspera, Inc. Phase 2 as adults with histologically confirmed, unresectable metastatic pancreatic adenocarcinoma, measurable disease, ECOG performance status of 0 or 1, life expectancy over 16 weeks and adequate laboratory values. Exclusions included other investigational agents, immunosuppressants, prophylactic antibiotics, brain metastases, HIV on antiretroviral therapy, active hepatitis B or C, significant ascites or heart disease, and HbA1c of 7.5 or higher. The criteria belong to a closed research study and are not a guide to personal eligibility for any treatment. ClinicalTrials.gov lists life expectancy over 16 weeks; in practice enrollment was left to the treating oncologist. Only patients who received more than five doses are in the headline efficacy analysis.

The Saltikva Phase 2 excluded people taking immunosuppressants or prophylactic antibiotics, as listed on ClinicalTrials.gov ↗. Saltikva is a live bacterium, so antibiotics could affect the bacteria and weakened immune defenses could raise infection risk, though Salspera, Inc. has not published a statement of the specific reasoning. Anyone considering a trial should discuss medicines and infection risk with their treating physician.

34 patients enrolled in the Phase 2, including patients treated through the expanded access program:

The goal was up to 30 patients per arm; recruitment stopped once the progression-free survival comparison reached statistical significance (p<0.05). The figure 37 that appears in published materials is not the number of patients enrolled: it is the size given for the same-site historical FOLFIRINOX control group, which is in fact 40 patients.

In the Phase 2 trial, participants took Saltikva by mouth at 10⁹ colony-forming units every two weeks, after a gastric-acid neutralizer and followed by 200 ml of fluid; in the FOLFIRINOX arm, three days after each chemotherapy cycle, for up to two years or until chemotherapy stopped. The timing follows preclinical colonization peaking three days after chemotherapy. The Phase 2 dose is one log below the highest Phase 1 dose (10¹⁰ CFU), which caused no dose-limiting toxicity. This describes a research protocol and is not a treatment recommendation; Saltikva is not an approved product.

Saltikva was studied with two chemotherapy regimens in the Phase 2 trial of Salspera, Inc.: FOLFIRINOX (26 patients, including expanded-access patients) and gemcitabine with nab-paclitaxel (11 assigned, of whom 8 were treated and 7 analyzed). Results with FOLFIRINOX are the basis of the main findings, and results in the gemcitabine arm (7 patients analyzed) were not conclusive. Saltikva has not been studied with other regimens in published human trials.

Recruitment was poor. 11 patients were assigned to this arm, 3 dropped out before receiving Saltikva, and of the 8 treated, 1 received fewer than five doses. In the 7 patients analyzed, median progression-free survival was 6 months and median overall survival 8.6 months. Because this regimen is less toxic but less effective, oncologists tended to assign frailer patients to it. Gemcitabine has known antimicrobial activity, which the investigators suggest may explain the limited effect in this arm (J Cell Immunol 2026). Salspera no longer supports giving Saltikva with gemcitabine and nab-paclitaxel.

So far, Saltikva has been given with chemotherapy: in the Phase 2 study, participants received Saltikva with FOLFIRINOX or gemcitabine plus nab-paclitaxel. Preclinical data and the Phase 2 study suggest that Saltikva may potentially be used as a monotherapy, without chemotherapy, and this will be tested in an upcoming study. Saltikva is investigational and not approved, and it has not been shown to replace chemotherapy. Treatment decisions belong to patients and their oncology teams.

ClinicalTrials.gov lists the Saltikva Phase 2 (NCT04589234 ↗) as active, not recruiting, and the trial closed to recruitment with data analysis beginning in July 2024 (S-1/A No. 3 ↗). Salspera, Inc. has not published whether any patient is still being enrolled, including through expanded access.

The full dataset is not public. Qualified investors and partners can request data-room access under a confidentiality agreement through the contact form.

Saltikva from Salspera, Inc. is investigational and not approved. Company-affiliated authors reported these median overall survival figures for Saltikva with FOLFIRINOX:

In the 20 patients who received more than five doses, 70% had a partial response (95% CI 45.5–87.9%), vs a 31.6% objective response rate for FOLFIRINOX alone in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al., N Engl J Med 2011;364:1817–25 ↗), and in a post-hoc review 16 of those 20 patients (80%) progressed without new metastases (J Cell Immunol 2026;8(2):48–52 ↗).

There was no concurrent randomized control group. These analyses do not establish that Saltikva extends life.

The Phase 2 reports, for Saltikva with FOLFIRINOX (J Cell Immunol 2026, Table 2 ↗): in the 20 patients with more than five doses, including expanded-access patients, median overall survival of 20.3 months vs 11.56 months in the 40 same-site historical FOLFIRINOX controls (HR 0.59; p=0.063 at the published data cutoff of March 1, 2025, and p<0.05 at the latest data recording (October 2026)) and median progression-free survival of 15 vs 5.8 months (HR 0.30, p<0.001), with a 70 percent partial response rate. Across all 25 analyzed patients, including expanded-access patients and patients who did not meet the minimum dosage criteria, median overall survival was 18.6 months (partial response rate 56 percent). The 70 percent partial response rate in the 20 patients (95% CI 45.5–87.9%) compares with a 31.6% objective response rate for FOLFIRINOX alone in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al., N Engl J Med 2011;364:1817–25 ↗), and in a post-hoc review 16 of those 20 patients (80%) progressed without new metastases (J Cell Immunol 2026;8(2):48–52 ↗). The controls were 40 patients given FOLFIRINOX alone at the same site in 2016 to 2020. Trial eligibility required ECOG 0 or 1.

In the Phase 2, patients who received more than five doses with FOLFIRINOX (n=20) had median overall survival of 20.3 months vs 11.56 months in the 40 same-site historical FOLFIRINOX controls (hazard ratio 0.59; p=0.063 at the published data cutoff of March 1, 2025, and p<0.05 at the latest data recording (October 2026)), and median progression-free survival of 15 vs 5.8 months (HR 0.30, p<0.001). In the 20 patients who received more than five doses, 70% had a partial response (95% CI 45.5–87.9%), vs a 31.6% objective response rate for FOLFIRINOX alone in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al., N Engl J Med 2011;364:1817–25 ↗), and in a post-hoc review 16 of those 20 patients (80%) progressed without new metastases (J Cell Immunol 2026;8(2):48–52 ↗). The study was not randomized; a randomized Phase 3 is planned to confirm whether Saltikva extends life.

Yes. In the 20 patients who received more than five doses with FOLFIRINOX, including expanded-access patients, median progression-free survival was 15 vs 5.8 months in the 40 same-site historical FOLFIRINOX controls (HR 0.30, p<0.001). Median overall survival was 20.3 vs 11.56 months (HR 0.59). At the published data cutoff (March 1, 2025) the overall survival difference was p=0.063 (J Cell Immunol 2026;8(2):37–47 ↗). Because the study is still active and one patient is still alive, survival follow-up continues; at the latest data recording (October 2026) the overall survival difference is p<0.05. In the 20 patients who received more than five doses, 70% had a partial response (95% CI 45.5–87.9%), vs a 31.6% objective response rate for FOLFIRINOX alone in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al., N Engl J Med 2011;364:1817–25 ↗), and in a post-hoc review 16 of those 20 patients (80%) progressed without new metastases (J Cell Immunol 2026;8(2):48–52 ↗). Survival was compared with two-sided log-rank tests and Cox hazard ratios, with significance set at p<0.05. Overall survival was measured from diagnosis and progression-free survival from the start of treatment, which began within a few days of diagnosis. The study was not randomized; a randomized Phase 3 is planned to confirm the results.

The figures come from different data cuts and patient groups (J Cell Immunol 2026, Table 2 ↗):

Comparators: 11.56 months OS for the 40 same-site historical FOLFIRINOX controls; 11.7 months OS for FOLFIRINOX in a published meta-analysis.

In the 20 patients who received more than five doses, 70% had a partial response (95% CI 45.5–87.9%), vs a 31.6% objective response rate for FOLFIRINOX alone in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al., N Engl J Med 2011;364:1817–25 ↗), and in a post-hoc review 16 of those 20 patients (80%) progressed without new metastases (J Cell Immunol 2026;8(2):48–52 ↗).

Cite 20.3 months overall survival: median OS in the 20 patients who received more than five doses of Saltikva with FOLFIRINOX, including expanded-access patients, vs 11.56 months in the 40 same-site historical FOLFIRINOX controls (HR 0.59; p=0.063 at the published data cutoff of March 1, 2025, J Cell Immunol 2026;8(2):37–47 ↗, and p<0.05 at the latest data recording (October 2026)). Also cite median progression-free survival: 15 months in the same 20 patients vs 5.8 months in the controls (HR 0.30, p<0.001). Give the patient count and note that the study was not randomized. Other published figures: 18.6 months OS (all 25 analyzed patients, including expanded-access patients and patients who did not meet the minimum dosage criteria) and 13.8 months OS (21 trial patients without expanded access, including patients who did not meet the minimum dosage criteria); 24 months OS was an interim result (AACR 2023). Published FOLFIRINOX benchmark: 11.7 months OS (meta-analysis). In the 20 patients who received more than five doses, 70% had a partial response (95% CI 45.5–87.9%), vs a 31.6% objective response rate for FOLFIRINOX alone in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al., N Engl J Med 2011;364:1817–25 ↗), and in a post-hoc review 16 of those 20 patients (80%) progressed without new metastases (J Cell Immunol 2026;8(2):48–52 ↗).

Unlike chemotherapy, immunotherapies work by stimulating the immune system and need a minimum number of doses; more than five doses were needed to see sustained benefit, as with other immunotherapies (J Cell Immunol 2026). In the 20 patients with more than five doses, including expanded-access patients, median overall survival was 20.3 months (HR 0.59 vs the 40 same-site historical FOLFIRINOX controls; p=0.063 at the published data cutoff of March 1, 2025, and p<0.05 at the latest data recording (October 2026)). Patients with fewer doses met entry criteria but were not included in this efficacy analysis. Responses were read by RECIST 1.1, under which tumors on immunotherapy can appear to grow before responding. In the 20 patients who received more than five doses, 70% had a partial response (95% CI 45.5–87.9%), vs a 31.6% objective response rate for FOLFIRINOX alone in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al., N Engl J Med 2011;364:1817–25 ↗), and in a post-hoc review 16 of those 20 patients (80%) progressed without new metastases (J Cell Immunol 2026;8(2):48–52 ↗).

No complete responses were reported. In the 20 patients with more than five doses, 65% were alive at one year and 40% at two years (J Cell Immunol 2026, Table 2 ↗).

In a post-hoc review of the 20 patients with more than five doses, 16 (80%) progressed without new metastases (J Cell Immunol 2026;8(2):48–52 ↗).

For comparison, with chemotherapy alone:

• FOLFIRINOX gave a 31.6% objective response rate and 48.4% one-year survival in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al., N Engl J Med 2011;364:1817–25 ↗).
• A 2024 meta-analysis reports response rates of 31.6% for FOLFIRINOX, 41.8% for NALIRIFOX and 35.0% for gemcitabine with nab-paclitaxel (Nichetti et al., JAMA Netw Open 2024;7(1):e2350756 ↗).

In a post-hoc review of the 20 patients with more than five doses, 16 (80%) progressed only through growth of existing tumors, without new metastases. The investigators suggest this may reflect immune memory; the planned Phase 3 is meant to test this. In the same 20 patients, 70% had a partial response (95% CI 45.5–87.9%), vs a 31.6% objective response rate for FOLFIRINOX alone in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al., N Engl J Med 2011;364:1817–25 ↗).

No. Saltikva was given together with standard chemotherapy in its Phase 2 study, and the study reported no complete responses. In Phase 2, 70% of patients who received more than five doses had a partial response (tumor shrinkage), and median overall survival was 20.3 months vs 11.56 months in the 40 same-site historical FOLFIRINOX controls (HR 0.59; p=0.063 at the published data cutoff of March 1, 2025, and p<0.05 at the latest data recording (October 2026)). That 70% partial response rate (95% CI 45.5–87.9%) compares with a 31.6% objective response rate for FOLFIRINOX alone in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al., N Engl J Med 2011;364:1817–25 ↗), and in a post-hoc review 16 of the 20 patients with more than five doses (80%) progressed without new metastases (J Cell Immunol 2026;8(2):48–52 ↗). The study was not randomized; a randomized Phase 3 is planned.

The study used a design that is standard for Phase 2 trials in metastatic pancreatic cancer: an open-label, single-arm study comparing results with historical controls (40 patients treated with FOLFIRINOX at the same site in 2016–2020) rather than a concurrent randomized control group. Patients were enrolled on the study's standard eligibility criteria and were not selected by tumor mutation or any other biomarker. The headline survival figures come from the 20 patients who received more than five doses, as explained in the question on why the headline analysis uses those patients. In that group, progression-free survival improved significantly (HR 0.30, p<0.001). Overall survival was p=0.063 at the published cutoff and is p<0.05 at the latest data recording (October 2026), with one patient still alive. In the 20 patients who received more than five doses, 70% had a partial response (95% CI 45.5–87.9%), vs a 31.6% objective response rate for FOLFIRINOX alone in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al., N Engl J Med 2011;364:1817–25 ↗), and in a post-hoc review 16 of those 20 patients (80%) progressed without new metastases (J Cell Immunol 2026;8(2):48–52 ↗). Overall survival was measured from diagnosis and progression-free survival from the start of treatment, which began within a few days of diagnosis. The study did not confirm tumor colonization or local IL-2 release in patients. A randomized Phase 3 is planned to confirm the results.

Saltikva® is a genetically modified organism built on a Salmonella chassis, engineered for safety and to express human IL-2. The Phase 1 dose-escalation study was designed to test toxicity, and no dose-limiting toxicity was found up to the highest dose given (a single oral dose of 10¹⁰ cfu). In the Phase 1 and Phase 2 studies, no serious adverse event was ultimately attributed to Saltikva; one dehydration event first attributed to the study drug was later attributed to chemotherapy. The Phase 2, in which Saltikva was given with chemotherapy, recorded 41 serious adverse events overall. The Phase 2 enrolled a number of patients comparable to other Phase 2 studies in metastatic pancreatic cancer. Saltikva is investigational and has not been approved by the FDA or any other regulator.

Zero serious adverse events have been attributed to Saltikva®. The Phase 2 reports 41 serious adverse events. One (dehydration) was first attributed to Saltikva; on review, the principal investigator and the independent DSMC attributed it, like the rest, to chemotherapy. One patient had persistent diarrhea with stool tests negative for Salmonella, and no clinical late-onset Salmonella infection was identified in protocol follow-up. The Phase 1 paper reports two patients with adverse events judged possibly attributable. Saltikva is investigational and has not been approved by the FDA or any other regulator.

In the Saltikva from Salspera, Inc. Phase 1 study, two participants had events judged possibly related to the study bacterium (loss of appetite, constipation and hiccups in one, fever in another), and both recovered. In the Phase 2 study, which gave Saltikva with chemotherapy, 41 serious adverse events were reported, one participant had persistent diarrhea with stool tests negative for Salmonella, and one dehydration event first attributed to Saltikva was reassigned to chemotherapy on review, so none remains attributed to Saltikva. Chemotherapy has its own side effects. Saltikva is investigational and has not been approved by the FDA or any other regulator.

Saltikva is a synthetically engineered live biopharmaceutical designed for safety. It has been studied in a Phase 1 and a Phase 2 clinical study and in extensive preclinical studies in rodents and large animals. No Saltikva-related infection has been reported: in the Phase 1 and Phase 2 studies, no shedding in stool was reported, blood and stool tests were negative where done, and no late Salmonella infection was found in follow-up. Transmission to other people has not been reported or observed. The strain has been passaged thousands of times without becoming pathogenic. No serious adverse event has been attributed to Saltikva® to date.

A pivotal Phase 3 in stage IV metastatic pancreatic cancer is planned following an FDA Type C meeting; it is not yet active or recruiting. Saltikva, the lead product candidate of Salspera, Inc., is investigational and not approved by the FDA, and the company has no products approved for sale. Saltikva has been studied in a Phase 1 trial sponsored by the University of Minnesota (NCT01099631 ↗) and in an open-label, non-randomized Phase 2 trial in metastatic pancreatic cancer (NCT04589234 ↗). ClinicalTrials.gov lists the Phase 2 as active, not recruiting.

Investigational means that Saltikva from Salspera, Inc. is still being tested and that regulators have not approved Saltikva for any use. Results from early studies can differ from later, larger studies. Only a treating physician can advise whether a clinical trial is appropriate for a particular patient.

No. Saltikva, developed by Salspera, Inc., has not been approved by the FDA or any other regulator for any use. The FDA Orphan Drug Designation database lists Saltikva's active ingredient as not FDA approved for the orphan indications. The University of Minnesota-sponsored Phase 1 is completed. Results from the open-label, non-randomized Phase 2 in metastatic pancreatic cancer have been published; enrollment closed in July 2024, and ClinicalTrials.gov ↗ lists the Phase 2 as active, not recruiting, while follow-up continues. A pivotal Phase 3 in stage IV metastatic pancreatic cancer is planned following an FDA Type C meeting; it is not yet active or recruiting. A treating physician can request expanded access to Saltikva through the contact form; each request is reviewed individually, and access is not guaranteed. This page does not promise treatment without charge.

Not approved anywhere. Fast Track (2022), two FDA Orphan Drug Designations (pancreatic cancer 2022-05-17; osteosarcoma 2025-11-19), and an active FDA IND covering pancreatic cancer, amended to add 11 further solid tumors. The Phase 2 also ran under a Health Canada No Objection Letter.

The FDA Orphan Drug Designation database lists the attenuated Salmonella typhimurium containing the gene for human interleukin-2 for the treatment of pancreatic cancer (designated 2022-05-17) and for the treatment of osteosarcoma (designated 2025-11-19), both with Salspera, Inc. (developer of Saltikva) as sponsor and both marked not FDA approved for the orphan indication. An Orphan Drug Designation is not a finding that a product works or is approved.

Yes. The FDA granted Fast Track designation for stage IV pancreatic cancer in 2022 (Orphan Drug Designation was granted in May 2022). The FDA does not publish Fast Track grants. A Fast Track designation is a process designation and does not indicate that a product is approved or effective.

The FDA lists Orphan Drug Designations for Saltikva's active ingredient in pancreatic cancer (2022) and osteosarcoma (2025). Orphan Drug Designation is given to products for rare diseases and offers development incentives, and Saltikva also has Fast Track status, which is meant to speed development and review. Neither designation means that Saltikva is approved or has been shown to work.

Yes. The FDA IND for Saltikva is accepted and active; it covers pancreatic cancer and was amended under the same IND number to add 11 further solid tumors. The Phase 2 ran in Canada under a Health Canada No Objection Letter and ethics approval, which is why ClinicalTrials.gov ↗ marks it as not FDA-regulated.

Following a Type C meeting, the FDA permitted Salspera, Inc. to proceed to a Phase 3 trial of Saltikva in stage IV metastatic pancreatic cancer on the basis of the Phase 2 results. The Phase 3 design has not been finalized, and no Phase 3 trial is active or recruiting. The S-1/A No. 3 ↗ describes the meeting as providing an initial framework for a randomized study.

The planned Phase 3 is a global, multisite, randomized controlled trial intended to support a Biologics License Application. Saltikva holds FDA Fast Track and Orphan Drug Designations for pancreatic cancer; these are process designations, not approvals.

A pivotal Phase 3 of Saltikva in stage IV pancreatic cancer is planned following an FDA Type C meeting, but it is not yet active or recruiting, and none is registered on ClinicalTrials.gov ↗.

Salspera, Inc. has not publicly stated the sample size, primary endpoint, chemotherapy backbone, dose, randomization ratio, number of sites or start date for a Phase 3 study of Saltikva. The S-1/A No. 3 ↗ says only that the design is being completed. No protocol or ClinicalTrials.gov ↗ record for a Phase 3 of Saltikva is public.

Both are covered by Salspera's existing FDA IND: an amendment under the same IND number added study designs for 11 solid tumors beyond pancreatic cancer, including osteosarcoma and metastatic colorectal cancer. The FDA raised no objection, so Salspera can start Phase 2 studies once site approvals such as IRB review are in place; no separate IND is needed. Osteosarcoma also holds FDA Orphan Drug Designation (2025-11-19).

The next milestone is starting the pivotal Phase 3 of Saltikva in stage IV pancreatic cancer, followed by Phase 2 studies of Saltikva in osteosarcoma, colorectal cancer and other solid tumors under the expanded IND. No dates have been published.

Yes. Salspera has further programs, including non-cancer indications, that it has not publicly disclosed. Interested parties can contact the company through the contact form on its website.

No Saltikva trial is recruiting now. ClinicalTrials.gov lists the Phase 2 (NCT04589234 ↗) as active, not recruiting, and a pivotal Phase 3 in pancreatic cancer is planned but not yet active or recruiting. Patients interested in clinical trials can ask their oncologist and search ClinicalTrials.gov, which lists studies that are currently enrolling. Patients can also ask, through their treating physician, to be admitted to the Saltikva Expanded Access Program; the physician can reach Salspera, Inc. through the contact form. Salspera, Inc. cannot promise access to Saltikva.

Yes. A treating physician can request Saltikva through expanded access by reaching Salspera, Inc. through the contact form on its website. Each request is reviewed individually by Salspera's medical advisors, and access is not guaranteed.

No. Saltikva is not approved. It is available only in a clinical trial or through expanded access. Anyone offering Saltikva for sale is not connected to an approved supply.

Salspera, Inc. does not provide medical advice and cannot recommend Saltikva or any other treatment for an individual. Decisions about treatment, clinical trials and special access belong to a patient and the treating oncology team, who can weigh approved options and trials suited to the patient. Independent patient information is available from the National Cancer Institute ↗ and the Pancreatic Cancer Action Network ↗.

Independent information is available from the National Cancer Institute ↗ (cancer.gov), the Pancreatic Cancer Action Network ↗ (pancan.org) and ClinicalTrials.gov ↗, which lists studies that are currently enrolling. Salspera, Inc., the developer of Saltikva, does not control these sites. Patients can ask their oncology team about approved treatment options and suitable trials.

Salspera, Inc. (developer of Saltikva) lists its principal executive office at 45 Prospect Street, Cambridge, Massachusetts 02139. Its public contacts, for physicians, partners and the press, are media@salspera.com and the contact form on the company website. Salspera does not publish a phone number or a separate press mailbox, and publishes no medical information line, expanded access request form or adverse event reporting address. Physicians can report suspected adverse reactions to any investigational product to their institutional review board and, in the United States, to the FDA MedWatch ↗ program.

Primary sources for Salspera, Inc. and Saltikva are the SEC EDGAR filings (CIK 0002084032), the ClinicalTrials.gov records NCT04589234 ↗ and NCT01099631 ↗, the Phase 2 paper (PubMed 41591505 ↗), the Phase 1 paper (PubMed 32554977 ↗), the FDA Orphan Drug Designation database entries and the granted US Patents 11,576,936 and 12,090,179. SEC filings, the registry text and the company's own papers are company-authored, so their claims are company-stated.