Xenikos, a Nijmegen biotech, developed T-Guard, a combination of two toxin-loaded antibodies against T cells designed to "reset" the immune system in severe immune diseases. It was selected in the EIC Accelerator's October 2022 cut-off for MIT-ID, described in the award list as "Modulatory immunotherapy for severe immune disease". No grant agreement for Xenikos appears on CORDIS, the EU's register of funded projects.
In June 2022 Xenikos had started a pivotal Phase 3 trial comparing T-Guard with the approved drug ruxolitinib in steroid-refractory acute graft-versus-host disease, a complication of stem cell transplants. According to the trial record on ClinicalTrials.gov, it was terminated because it "met the protocol defined stopping boundary for Day 60 mortality when comparing mortality between the T-Guard and ruxolitinib arms". Four of the seven patients on T-Guard died, against one of five on ruxolitinib. Primary completion was recorded on 10 November 2022, five weeks after the EIC cut-off. In March 2023 the company announced on its website that the study had been stopped "and Xenikos has decided to cease operations".
Company file
- Legal entity
- Xenikos B.V., Nijmegen, in liquidation
- Product
- T-Guard, two toxin-conjugated anti-T-cell antibodies
- Investors
- Veloxis Pharmaceuticals, Medicxi, RA Capital, Oost NL, Sanquinnovate
- Phase 3 trial
- NCT04934670, started June 2022, terminated
- Status
- Ceased operations, March 2023
- EIC project
- MIT-ID, no CORDIS record
- EIC funding
- Grant first
Where Xenikos Stands Now
The company's website still carries the closure notice, which says Xenikos felt the monitoring board's conclusion "may be premature" but put patient safety first, and that it was being explored whether T-Guard could be developed for other indications. Business directory Kompass lists the company as Xenikos B.V. in liquidatie, in liquidation. Snapshots of the website in the Internet Archive show the notice appeared between 6 and 24 March 2023. No new owner of T-Guard has been announced.
"Although we feel that the DSMB's conclusion may be premature, patient safety is our highest priority; therefore, the study has been stopped, and Xenikos has decided to cease operations."
Xenikos, company website, March 2023The Therapy: Resetting the Immune System
T-Guard combined two antibodies carrying a toxin, aimed at T cells, to calm an immune attack quickly. In graft-versus-host disease, donor immune cells attack the patient's body; patients whose disease does not respond to steroids have few options. The Phase 3 trial was run with the US Blood and Marrow Transplant Clinical Trials Network, designated BMT CTN 2002.
What the EIC Project Promised, and What CORDIS Shows
The EIC award title promised modulatory immunotherapy for severe immune disease. There is no project page, budget or report on CORDIS, and no grant agreement is recorded. The trial on which the company depended met its stopping boundary five weeks after the cut-off. Whether the EIC knew about the trial's status when it selected Xenikos, and whether any money was committed, is not public.
- EIC grant signedUnverifiedNo CORDIS record.
- Pivotal Phase 3MissedStopped on mortality.
- Approval of T-GuardMissedDevelopment halted.
- Company survivalMissedCeased operations.
The Money
In September 2021 Xenikos closed €40 million in convertible debt in two tranches, led by Veloxis Pharmaceuticals with Medicxi, RA Capital Management, Oost NL and Sanquinnovate, to fund the Phase 3 trial, Veloxis announced. Veloxis received call options to acquire the company. What investors recovered is not public.
What Cannot Be Checked
Questions for the EIC
Whether the EIC evaluators knew the Phase 3 trial had met a mortality stopping boundary, whether any grant or equity was committed or paid are not public.
Why Europe Should Care
T-Guard's failure was a clinical one. What matters for the EIC is timing: it selected a company whose pivotal study was, within weeks, formally stopped for deaths. Its public records never show whether the award was withdrawn.
What the project promised
A modulatory immunotherapy for severe immune disease, built on T-Guard.
What the record shows
A Phase 3 trial stopped for mortality, closure in March 2023, and no EIC project on file.
The Verdict
Closed before it began
Xenikos was selected by the EIC as its lead drug failed. The company shut down, and no EIC-funded work appears ever to have started.
Xenikos's liquidators and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
