Immunethep and the EIC Accelerator: A Superbug Vaccine Waits
Immunethep, based in Cantanhede, Portugal, develops PNV, a vaccine aimed at five bacteria at once: Staphylococcus aureus, Streptococcus pneumoniae, Klebsiella pneumoniae, E. coli and group B streptococcus. Rather than attacking the bacteria directly, it blocks a protein, bacterial GAPDH, that the company says all five release to suppress the immune system. Its EIC project called PNV "the world's first vaccine not only to prevent multiple bacterial infections but for all invasive serotypes, including multi-resistant strains", according to CORDIS.
The European Innovation Council granted €2,500,000 towards a €7.4 million project from January 2023 to November 2026, to support GMP production of the vaccine and a first-in-human Phase 1 trial. The first report, covering the period to March 2024 and the only one on CORDIS, lists a new patent filed in September 2023, studies of human blood samples to set antibody thresholds, talks with GMP suppliers, and advice from Ireland's medicines regulator, HPRA, that PNV could go from Phase 1 straight to Phase 2. With two months of the project left, Immunethep's own pipeline page lists PNV as preclinical, and no PNV trial appears on ClinicalTrials.gov.
Company file
- Legal entity
- Immunethep S.A., VAT PT510824439, Cantanhede
- Lead product
- PNV (Paragon Novel Vaccine), multivalent antibacterial vaccine
- Other programmes
- PNV_Ent vaccine; monoclonal antibodies against enterobacteria, streptococci and staphylococci
- Other funders
- CARB-X, PACE
- EIC project
- 1 Jan 2023 to 30 Nov 2026
- EIC funding
- Grant first, with possible EIC Fund equity
Where Immunethep Stands Now
In February 2025 the non-profit accelerator CARB-X awarded Immunethep $2 million for a separate conjugated peptide vaccine against invasive E. coli infections, according to the company's news page. In April 2025 it received funding from PACE for its monoclonal antibody programme and strengthened a research collaboration with the i3S institute. Immunethep says the EIC award made it "eligible for additional Equity investment from the EIC Fund for a project that comprises a total investment of €17.5 million", on its partnerships page; no such investment has been announced.
The record
A five-bacteria vaccine still waiting for its first trial
Immunethep's EIC project was meant to support GMP production and a first-in-human trial of PNV. With two months left, its own pipeline page still shows PNV as preclinical.
- Jun 2022EIC Accelerator cut-offParagon Novel Vaccine (PNV)grant first
- Oct 2022Award announcedGrant plus eligibility for EIC Fund equity
- Jan 2023EIC project starts€7.40M project€2.50M grant
- Sep 2023New patent filedFinal vaccine composition
- 2023-24Irish regulator adviceHPRA backs going from Phase 1 straight to Phase 2
- Feb 2025CARB-X awardE. coli vaccine programme$2M
- Nov 2026EIC project due to endPNV still listed as preclinical
CORDIS and Immunethep.
"This first-in-human trial is critical to de-risk the project and allow for the entrance of private investors to move forward in the clinical roadmap ahead."
Immunethep, report to the EIC, 2024The Technology: Unmasking the Bacteria
The report, citing the CDC, says these five bacteria cause 80% of life-threatening infections in humans and that existing vaccines cover only S. pneumoniae, and only up to 20 of its 95 serotypes. PNV targets a mechanism Immunethep says is shared by all five, so it would work regardless of serotype and would not put pressure on bacteria to develop resistance. The company says preclinical studies showed high efficacy and a good safety profile.
The problem
The antimicrobial resistance case Immunethep makes
Figures cited in the EIC report: deaths per year from antimicrobial resistance today and projected for 2050, in millions.
CORDIS project 190152193, report.
What the EIC Project Promised, and What CORDIS Shows
The EIC project
The EU pays 34% of a €7.4M project
The project runs from January 2023 to November 2026. CORDIS lists it as signed and shows only the first report, to March 2024.
CORDIS project 190152193. Values in € millions.
The project promised GMP production of PNV and support for its first human trial. The public record shows preparatory work in its first 15 months and nothing on production or trial start since. The project has not yet formally ended, so a final report may still document more. CORDIS lists the project as signed.
- Patent protectionDeliveredNew patent, 2023.
- Regulatory roadmapDeliveredHPRA advice.
- GMP vaccine productionNot shownSuppliers in talks, 2024.
- First-in-human trialNot registeredNone on ClinicalTrials.gov.
The Money
The EIC grant covers about a third of the project; Immunethep had to raise the rest. It has not announced an equity round since the award or published its accounts.
The money
Public and non-profit funding announced
In € millions, except CARB-X in US dollars. The €17.5M is the total project investment Immunethep says the EIC award could support with EIC Fund equity; whether that equity was invested is not public.
Immunethep; CORDIS.
What Cannot Be Checked
Questions for the EIC
Whether the EIC Fund invested, whether GMP batches of PNV were made, when the Phase 1 trial will start and why no progress report after March 2024 is public are not known.
Why Europe Should Care
The report cites 1.27 million deaths a year from antimicrobial resistance, projected to pass 10 million by 2050. By the report's figures, the five bacteria PNV targets cause over 60% of those deaths. The EIC bet on Immunethep to test it in people; no PNV trial has yet appeared on ClinicalTrials.gov.
What the project promised
GMP production of PNV and a first-in-human trial to de-risk the vaccine.
What the record shows
A patent, regulatory advice and other grants, with PNV still preclinical near the project's end.
The Verdict
Big idea, still in the lab
Immunethep has pursued an ambitious vaccine and attracted other funders for related work. The human trial the EIC grant was meant to enable has not been registered on ClinicalTrials.gov with two months of the project left.
Immunethep and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
Industry
HealthBiopharmaceuticals
- Focus
- Vaccines
- Technologies
- Vaccine technology
- Keywords
- Antimicrobial resistance
- Bacterial infections
- Multivalent vaccines
- Staphylococcus aureus