· All 63 donor-recipient pairs enrolled and treated according to protocol across multiple clinical centers
· Randomized, controlled Phase IIb trial evaluating TolerogenixX’s proprietary MIC technology, a first-in-class immune tolerance-inducing cell therapy, in living-donor kidney transplantation
· Designed to address one of transplantation’s key issues: lifelong systemic immunosuppression
· Key milestone in the clinical development of MIC-Lx and TolerogenixX’s proprietary MIC technology platform
Heidelberg, Germany, June 29, 2026. TolerogenixX, a clinical-stage biopharmaceutical company founded in 2016 developing personalized cell therapies to induce antigen-specific immune tolerance, today announced that the last patient has undergone kidney transplantation in TOL-2, the Company’s randomized, controlled Phase IIb clinical trial evaluating MIC-Lx in living-donor kidney transplantation (ClinicalTrials.gov identifier: NCT05365672 and EudraCT No.: 2021-000561-33).
Kidney transplantation saves lives, but
patients typically need lifelong systemic immunosuppression. These drugs increase
infection risk, add toxicity and create
a major long-term treatment burden.
MIC-Lx is designed
to address this core limitation by teaching the immune system to accept the donor organ while preserving its protective immune function.
This milestone completes
the transplantation phase of the TOL-2 study. TolerogenixX will publish topline efficacy and safety data in the first half of 2027.
A total of 63 donor-recipient pairs were
enrolled and treated according to protocol across multiple clinical centers. Patients
were randomized 2:1 to receive either MIC-Lx in addition to individualized
immunosuppression (MIC group, n=42) or standard-of-care immunosuppression alone
(control group, n=21).
The primary endpoint
of TOL-2 assesses the achievement of an operational tolerance-like phenotype at day 367 following MIC-Lx administration. This endpoint measures
the absence of biopsy-proven acute rejection, graft
loss, graft dysfunction or death, as well as the absence of de novo
donor-specific HLA antibodies. Secondary endpoints include patient-relevant
infections, graft function, and additional immunological parameters.
“The completion of the last patient
transplant in TOL-2 puts TolerogenixX on a clear pathway towards one of the
most important clinical readouts in immune tolerance,” said Prof. Dr. Matthias Schaier, CEO
of TolerogenixX. “With all 63 donor-recipient pairs treated according to
protocol, we believe MIC-Lx has the potential to transform transplant immunotherapy.
This milestone strengthens our clinical, regulatory and partnering pathway as
we prepare for topline Phase IIb data in H1 2027.”
MIC-Lx is manufactured from
donor-derived peripheral blood mononuclear cells (PBMCs), obtained by
leukapheresis and modified via TolerogenixX’s proprietary MIC technology. The customized therapy
is administered intravenously to transplant
recipients prior to transplantation and is designed to induce donor-specific
immune tolerance while preserving protective immune responses.
“TOL-2 was designed to test whether
MIC-Lx can reproduce the donor-specific immune tolerance signals observed in TOL-1 within
a randomized, controlled Phase IIb setting,” said Prof. Dr. Christian Morath, CSO of TolerogenixX. “This
study addresses one of the key challenges in kidney
transplantation, reducing the burden of lifelong immunosuppression without
compromising graft protection.”
The TOL-2 study builds on findings from
the previous TOL-1 Phase Ib trial, in which kidney transplant recipients
treated with MIC-Lx showed long-term donor-specific immune tolerance signals,
preserved graft function and reduced use of conventional immunosuppressive
medication. All patients in the TOL-2 study will continue to be followed according
to protocol, including a 12-month primary observation period and subsequent
long-term follow-up.
The Company’s lead program focuses on
living-donor kidney transplantation, with a planned expansion into additional
transplant settings and selected autoimmune indications.
Beyond
living-donor kidney transplantation, TolerogenixX is developing MIC-Lx
as a potential immune tolerance platform covering additional transplant
settings and selected autoimmune diseases, including systemic lupus
erythematosus and multiple sclerosis.
MIC production is a standardized process designed for smart manufacturing and
scalable roll-out. Using cells obtained by leukapheresis, MICs are manufactured
through a proprietary process developed by TolerogenixX.
About TolerogenixX TolerogenixX is a privately held biopharmaceutical company
developing novel, personalized therapies to induce antigen-specific immune
tolerance in transplantation and autoimmune diseases. Its proprietary MIC
(modified immune cells) technology aims to modulate the immune system in a
targeted manner, potentially reducing the need for long-term systemic
immunosuppression.
The Company’s lead candidate MIC-Lx has
completed a Phase Ib clinical trial (TOL-1) in kidney transplant recipients
demonstrating sustained safety and tolerability after a single administration
while preserving normal immune responses. A Phase IIb study (TOL-2) is
currently ongoing. TolerogenixX was founded in 2016 and is headquartered in
Heidelberg, Germany.
About MIC treatment MIC treatment is a personalized cell therapy
approach to modulate the immune system via a novel mode of action to achieve
specific and sustained immune tolerance. It could not only benefit transplant
recipients, but also patients with autoimmune diseases such as systemic lupus erythematosus and
multiple sclerosis.
MIC production is fast, safe, and effective.
Using cells obtained by leukapheresis, MIC can be manufactured within 24 hours.
Due to a standardized procedure, MIC production can be scaled up easily and
made available globally using the proprietary approach developed by TolerogenixX. Forward-Looking
Statements This press release contains
forward-looking statements, including statements regarding the expected timing
of topline data from the TOL-2 study, the potential clinical benefits of
MIC-Lx, future regulatory interactions, development plans, scale-up production,
partnering opportunities and the broader potential of the MIC Platform. These
statements are based on current expectations and involve risks and
uncertainties. Actual results may differ materially from those expressed or
implied by these forward-looking statements. TolerogenixX is under no
obligation to update forward-looking statements except when required by
applicable law.
Contact TolerogenixX GmbH Prof. Dr. med. Matthias Schaier Im Neuenheimer Feld 162 69120 Heidelberg Germany schaier@tolerogenixX.com Tel. +49 162 2638005
akampion Dr. Ludger Weß / Ines-Regina Buth Managing Partners info@akampion.com Tel. +49 40
88 16 59 64 Tel. +49 30
23 63 27 68
