Our Way
TolerogenixX will innovate immunosuppression with its newly developed MIC cell treatments.
MIC cell treatment is a curative ATMP approach to achieve a sustained regulation of the immune system in transplanted and autoimmune patients.
Since our first steps in 2015 and the foundation of TolerogenixX GmbH in 2016, we have never tired of fighting for our idea of personalized immune modulation.
TolerogenixX expands Phase II immune-tolerance trial and closes EUR 12 million Series A financing
Heidelberg, July 06, 2023 – TolerogenixX GmbH, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustained immune tolerance to combat organ rejection and autoimmune diseases, today announced that in the TOL2- Phase IIb study in renal transplant patients TolerogenixX has received green light by the Safety Board to initiate the B arm of the study. This arm consists of patients receiving minimal immune suppression drugs, reducing tacrolimus and weaning off enteric-coated mycophenolate sodium and methylprednisolone completely. The study enrolls 63 transplant couples consisting of a donor and a transplant recipient, respectively. The protocol has been published in BMJ Open.
Furthermore, the company is publishing 5-year follow-up data of a Phase I trial of its MIC-Lx cell therapy. The results published in Frontiers in Immunology demonstrate that the use of TolerogenixX's MIC cell therapy prior to transplantation provides long-lasting donor-specific immunosuppression and a sustained, significant increase in regulatory B lymphocytes.
TolerogenixX's MIC-Lx cell therapy (Modified Immune Cells for Living-donor transplants) is a curative cell treatment to induce donor-specific immune tolerance in transplant recipients and also bears potential for autoimmune patients. In living donor transplantation such as kidney transplantation, peripheral blood mononuclear cells (PBMCs) of the donor are harvested by leukapheresis. Donor PBMCs are then modified by the Company's proprietary MIC technology. The resulting cell therapy product, MIC-Lx, subsequently is administered intravenously to the transplant recipient prior to transplantation.
TolerogenixX has already reported positive results from the 1 and 3 year follow-up of 10 transplant recipients of its TOL-1 Phase I trial initiated at Heidelberg University Hospital. All patients who had received MIC infusions prior to kidney transplantation in the TOL-1 clinical trial had a favorable clinical course 3 years after surgery. In the current publication, the Company reports that these 10 MIC patients continued to have excellent clinical outcomes at 5 years, with stable renal graft function, no donor-specific human leukocyte antigen (DSA) antibodies or acute rejections, and no severe opportunistic infections. In comparison, a retrospectively matched control group receiving standard immunosuppressive therapy had a higher incidence of donor-specific HLA antibodies (log rank P = 0.046) and more opportunistic infections (log rank P = 0.033).
Importantly, MIC patients continued to show a lack of anti-donor T lymphocyte reactivity in vitro and a high titer of potent regulatory B-cells crucial for a functional immune system until year 5 after surgery. Specifically, this holds true for the four patients who had been infused the highest cell number 7 days before surgery and who received low immunosuppressive medication during follow-up.
"We are very pleased about these results," said Prof. Dr. Christian Morath, CSO of TolerogenixX. "Five years after transplantation, tolerance is still present. Patients are immunologically better protected, show no severe concomitant symptoms and were able to significantly reduce immunosuppressive therapy."
"These are exciting and clinically highly relevant data," added Prof. Dr. Matthias Schaier, CEO of TolerogenixX. "We see that our MIC therapy opens the perspective of a transformative and effective treatment option for kidney transplant recipients. It can reduce the side effects of conventional chemical immunosuppression and provide for lasting immune suppression without making the transplant recipients more susceptible to opportunistic infections. We are now conducting a Phase IIb study with a larger series of patients treated with MIC and a reduced immunosuppressive drug regimen. Our preclinical studies also demonstrate great potential in autoimmune disease"
On the back of these promising results, TolerogenixX also reported a EUR 7 million second closing of its Series A financing round now totaling EUR 11.6 million.
"We are very pleased that we were able to add EUR 7 million to our Series A financing round," Schaier said. "In the current financing environment, this is a further validation of our approach, enabling us to successfully complete our Phase II program."
New investor in the round is DB Speciality GmbH & Co. KG, Neu Ulm, an investment company of the health care specialist Dr. Dietrich Bruchmann. Dr. Bruchmann is a very experienced investor with highest expertise in the life science sector. Existing investors include Kalodion Fond I, CventureS, Nisus, HTGF, Dr. Dr. Dorow, Dr. Dr. Fakler and Biotech Mountains BV.
The deal was initiated by CoInvest Corporte Finance GmbH, Planegg. CoInvest acted as lead arranger and financial adviser to the transaction.
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About TolerogenixX
TolerogenixX is a privately held biopharmaceutical company focusing on the development of novel, personalized therapies for autoimmune patients and transplant recipients. The Company´s proprietary MIC (modified immune cells) treatment is designed to suppress unwanted immune responses in the body, thereby enabling a targeted, specific and sustained immune tolerance. While the current standard of care, i.e. traditional immunosuppression, is only addressing symptoms and has serious side-effects, MIC treatment is tackling the roots of immune responses and provides increased effectiveness, little or no side effects, significantly increased quality and length of patients´ lives as well as decisive cost advantages.
TolerogenixX´ lead compound MIC-Lx has successfully completed a clinical Phase Ib trial in kidney transplant recipients, demonstrating sustained safety and tolerability after a single application while retaining normal immune responses.
The Company was founded in 2016 and is based in Heidelberg, Germany.
About MIC treatment
MIC treatment is a personalized cell therapy approach modulating the immune system via a novel mode of action to achieve a specific and sustained immune tolerance. It can not only be applied to transplant recipients, but also to patients with autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis.
MIC production is fast, safe, and effective. MIC can be manufactured within 24 hours, using cells obtained by leukapheresis. Due to a standardized procedure, MIC production can be scaled up easily and made available globally using the proprietary approach developed by TolerogenixX.
Contact
TolerogenixX GmbH
Prof. Dr. med. Matthias Schaier
Im Neuenheimer Feld 162
D-69120 Heidelberg/Germany
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
TolerogenixX Publishes Three-Year Follow-Up Data from Phase I Trial of Immune Tolerance-Inducing MIC-Lx Cell Therapy
— Publication in high-impact Journal of the American Society of Nephrology
— Results pave the way for a novel cell therapy in organ transplantation
TolerogenixX GmbH, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustained immune tolerance to combat organ rejection and autoimmune diseases, today announced 3-year follow-up data of a Phase I trial of its MIC-Lx cell therapy. The results published ahead of print in the Journal of the American Society of Nephrology (doi: 10.1681/ASN.2022020210) indicate that donor-specific immunosuppression after MIC infusion is long-lasting and associated with a striking increase in regulatory B lymphocytes.
MIC cell treatment is a curative approach to achieve a sustained regulation of the immune system in transplant recipients and autoimmune patients. In the process for living donor transplantation, peripheral blood mononuclear cells (PBMCs) of the donor are obtained by leukapheresis. PBMCs are then modified using TolerogenixX´ proprietary MIC technology. Subsequently, the resulting cell therapy product called MIC-Lx is intravenously administered to the organ recipient prior to transplantation.
The publication reports results from a follow-up to post-transplant day 1080 in 10 transplant recipients from a Phase I clinical trial who had received MIC infusions prior to kidney transplantation. All MIC-treated patients had a favorable clinical course, showing no donor-specific human leukocyte antigen antibodies or acute rejections. The four patients who had received the highest MIC cell dose 7 days before surgery and were on low immunosuppression showed persistent donor-specific immunosuppression as indicated by an absence of post-transplant cellular stimulation reactivity when tested against their respective donors. Likewise, a number of markers, including gene expression profiles, suggest operational tolerance in these patients, i.e. no need for immunosuppression and normal allograft function.
“MIC treatment is leading to an operationally tolerant phenotype of patients with profound suppression of anti-donor T cell responses,” said Prof. Dr. Christian Morath, CSO of TolerogenixX. “The one-year follow-up data published in 2020 already showed excellent safety and tolerability of our treatment, and we are very happy that these favorable results hold up in the three-year follow-up.”
“The results once again demonstrate that we generate an immunoregulatory cell population which carries the promise of exerting a beneficial effect on kidney transplants,” added Prof. Dr. Matthias Schaier, CEO of TolerogenixX.
PD Dr. Anita Schmitt, CTO of TolerogenixX, said: “These new results show that the effect is long-lasting and associated with a striking increase in regulatory B lymphocytes. They underline the importance of MIC-Lx in paving the way for a novel cell therapy in organ transplantation.”
A multi-center Phase IIb trial codenamed TOL-2 enrolling 63 transplant couples consisting of a donor and a transplant recipient is underway.
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About TolerogenixX
TolerogenixX is a privately held biopharmaceutical company focusing on the development of novel, personalized therapies for autoimmune patients and transplant recipients. The Company´s proprietary MIC (modified immune cells) treatment is designed to suppress unwanted immune responses in the body, thereby enabling a targeted, specific and sustained immune tolerance. While the current standard of care, i.e. traditional immunosuppression, is only addressing symptoms and has serious side-effects, MIC treatment is tackling the roots of immune responses and provides increased effectiveness, little or no side effects, significantly increased quality and length of patients´ lives as well as decisive cost advantages.
TolerogenixX´ lead compound MIC-Lx has successfully completed a clinical Phase Ib trial in kidney transplant recipients, demonstrating sustained safety and tolerability after a single application while retaining normal immune responses.
The Company was founded in 2016 and is based in Heidelberg, Germany.
About MIC treatment
MIC treatment is a personalized cell therapy approach modulating the immune system via a novel mode of action to achieve a specific and sustained immune tolerance. It can not only be applied to transplant recipients, but also to patients with autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis.
MIC production is fast, safe, and effective. MIC can be manufactured within 12 hours, using cells obtained by leukapheresis. Due to a standardized procedure, MIC production can be scaled up easily and made available globally using the proprietary approach developed by TolerogenixX.
Start of Phase IIb clinical trial in living kidney transplantation
Press release
TolerogenixX Receives Approval to Start Phase IIb Trial for its Immune Tolerance-Inducing MIC-Lx Cell Therapy
- Multi-centric clinical study in patients with stage 5 chronic kidney disease (CKD) receiving a living donor kidney
- Study of MIC-Lx cell treatment, a potentially curative approach to achieve sustained immune tolerance in transplanted and autoimmune patients as shown in previous Phase Ib study
Heidelberg, March 28, 2022 – TolerogenixX GmbH, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustained immune tolerance to combat organ rejection and autoimmune diseases, today announced that the German regulatory authority Paul-Ehrlich-Institut has approved a Phase IIb clinical trial for TolerogenixX’s MIC-Lx cell therapy designed to induce immune tolerance. The trial codenamed TOL-2 is scheduled to start in Q2, 2022. It is designed as an open, randomized-controlled, multi-center Phase IIb study of individualized immunosuppression with intravenously administered, donor modified immune cells (MIC-Lx) and will be conducted in patients undergoing living donor kidney transplantation, comparing treatment to standard-of-care (SoC).
MIC-Lx is a cell therapy prepared from an organ donor’s peripheral blood mononuclear cells (PBMC) obtained by leukapheresis. Cells are modified using TolerogenixX´ proprietary MIC technology and, subsequently, MIC-Lx is intravenously administered to the organ recipient prior to transplantation.
The TOL-2 trial is planned to enroll 63 transplant couples, consisting of a donor and a transplant recipient. The 63 organ recipients will be randomized 2:1 to treatment with MIC-Lx (MIC group, N=42) or immunosuppression according to standard-of-care (control arm, N=21). Follow up will be conducted 367 (±28) days after MIC application, corresponding to 360 days after transplantation of the living kidney. In addition, a long-term follow-up will be performed for 2 years after the 12-month follow-up period.
Endpoints have been chosen to determine efficacy of MIC treatment in terms of achieving an operational tolerance-like phenotype compared to standard-of-care, among them absence of biopsy-proven acute rejection, graft loss, graft dysfunction, or death on visit day 367 as well as absence of de novo donor-specific human leukocyte antigen (HLA) antibodies. Secondary endpoints comprise, among others, the number of patient-relevant infections during the first year after transplantation.
The Company previously completed the TOL-1 Phase Ib study, in which kidney transplant patients successfully achieved immune tolerance and absence of organ rejection, based on three-year follow-up data. These results were very positively received in an editorial alongside the publication in the Journal of Clinical Investigation in 2020. TolerogenixX also has completed multiple preclinical studies demonstrating application of its technology to achieve antigen-specific immune tolerance and disease-modifying effects in a broad range of autoimmune diseases.
“We are very much looking forward to the start of this important multi-center trial,” said Prof. Dr. Matthias Schaier, CEO of TolerogenixX. “We have already demonstrated efficacy in our Phase Ib trial, and our goal is to prove safety and efficacy again in a broader patient group. If we succeed, MIC-Lx could be the first approach transforming organ transplantation into a truly curative treatment. Patients may need less or short-term medication, have fewer side effects and, most importantly, would be able to fully recover and live a normal life. We are also extremely excited about the potential of our approach in autoimmune diseases.”
PD Dr. Anita Schmitt, CTO of TolerogenixX, added: ”MIC-Lx is an Advanced Therapy Medicinal Product (ATMP) that can be easily manufactured and has no side effects when administered to patients.”
“In our previous clinical study, patients did not experience graft rejection or de novo HLA antibodies, while retaining full immune competence against bacteria and viruses,” said Prof. Dr. Christian Morath, CSO of TolerogenixX. “In addition, graft function was excellent, and it was possible to markedly reduce administration of standard immunosuppressive drugs, so that patients experienced fewer side effects as compared to standard of care.”
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About TolerogenixX
TolerogenixX is a privately held biopharmaceutical company focusing on the development of novel, personalized therapies for autoimmune patients and transplant recipients. The Company´s proprietary MIC (modified immune cells) treatment is designed to suppress unwanted immune responses in the body, thereby enabling a targeted, specific and sustained immune tolerance. While the current standard of care, i.e. traditional immunosuppression, is only addressing symptoms and has serious side-effects, MIC treatment is tackling the roots of immune responses and provides increased effectiveness, little or no side effects, significantly increased quality and length of patients´ lives as well as decisive cost advantages.
TolerogenixX´ lead compound MIC-Lx has successfully completed a clinical Phase Ib trial in kidney transplant recipients, demonstrating sustained safety and tolerability after a single application while retaining normal immune responses.
The Company was founded in 2016 and is based in Heidelberg, Germany.
About MIC treatment
MIC treatment is a personalized cell therapy approach modulating the immune system via a novel mode of action to achieve a specific and sustained immune tolerance. It can not only be applied to transplant recipients, but also to patients with autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis.
MIC production is fast, safe, and effective. MIC can be manufactured within 24 hours, using cells obtained by leukapheresis. Due to a standardized procedure, MIC production can be scaled up easily and made available globally using the proprietary approach developed by TolerogenixX.
Contact
TolerogenixX GmbH
Prof. Dr. med. Matthias Schaier
Im Neuenheimer Feld 162
D-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
Sept 2021 Meeting Presentation of the MIC technology
German Society of Nephrology September 2021, Rostock
May 2020- Editorial Comment
Sam Kant and Daniel C. Brennan, two experts from Johns Hopkins University, review the MIC therapy
November 2019 - Investment
TolerogenixX closes a financing round with several investors in the amount of € 4.1 million
October 2019 - DTG Lecture
TolerogenixX was invited for a lecture at the Annual Meeting of the Germany Transplant Society in Hannover
October 2019 - DGfN Lecture
TolerogenixX was selected to give a talk at the Annual Meeting of the German Society of Nephrology
September 2019 - Biotech Forum
TolerogenixX participates at the 19th Annual Biotech in Europe Forum in Basel
June 2019 - EULAR
TolerogenixX gave a talk to the benefit of MIC therapy in a murine SLE mouse model at the EULAR congress in Madrid
May 2019 - New IP
TolerogenixX filed new IP in the field of organ transplantation
April 2019 - Lupus 2019
TolerogenixX presented the preclinical SLE data during an oral presentation at the Lupus 2019 Congress in San Francisco
April 2019 - Pitch
TolerogenixX was selected to pitch at the start-up session of the Meeting of the nationwide DIHK committee for health sciences
April 2019 - German Biotechnology Days
TolerogenixX participated in the Start-up Meeting of the German Biotechnology Days in Würzburg
April 2019 - Cell and Gene
Participation at the Cell and Gene Congress in Barcelona
February 2019 - Pitch
TolerogenixX was invited for a pitch in the rising star session of the 12TH ANNUAL EUROPEAN LIFE SCIENCES CEO FORUM in Zürich
October 2018 - Results of TOL-1 Study at ASN
TolerogenixX presented the results of the TOL-1 study on tolerance induction in kidney transplant patients during an oral presentation at the ASN annual congress and this contribution was selected by NephroToday as a congress highlight
Otober 2018 - Quality assessment
TolerogenixX gave a talk to “Induction of donor-specific immunomodulation by clinical MIC cell infusion – a phase I study (TOL-1)” at the annual congress of the German, Austrian and Suisse Society of Hematology and Medical Oncology in Vienna.
September 2018 - Resultate der TOL-1 Studie
TolerogenixX was invited to present the clinical results of the TOL-1 Study at the Annual Congress of the German Society of Rheumatology
June 2018 - Lecture
TolerogenixX was selected to give a lecture at the American Transplant Congress in Seattle
May 2020- Press release
TolerogenixX Reports Positive Phase Ib Data of its Lead Product to Combat Transplant Rejection
November 2019 - ASN
TolerogenixX was invited to present the preclinical SLE data at the Annual congress of the American Society of Nephrology in Washington
September 2019 - Science Award
The preclinical results of the SLE mouse model were awarded with the science prize of the German Society of Rheumatology
June 2019 - ERA-EDTA
TolerogenixX presented the SLE mouse model data at the ERA-EDTA Congress in Budapest
May 2019 - Posterprize
TolerogenixX erhält den Posterpreis der Deutschen Gesellschaft für Nephrologie (DGIM).
March 2019 - World Pharma Pricing and Market Access
Participation and Chairing of a session at the World Pharma Pricing and Market Access meeting in Amsterdam
November 2018 - Results of TOL-1 study
TolerogenixX reported the results of the TOL-1 study at the annual nephrological meeting of the Association of German Renal Centers
November 2018 - Day of Internal Rheumatology
TolerogenixX presented the MIC therapy and its potential for the treatment of autoimmune diseases at the Day of Internal Rheumatology in Heidelberg
November 2018 - Resultate der TOL-1 Studie auf der DTG
TolerogenixX presented the results of the TOL-1 study as an invited presentation at Annual Conference of the German Transplantation Society
October 2018 - Pitch
TolerogenixX was selected to a pitch presentation at the Investment Forum of the Federal Ministry of Economics in Berlin
September 2018 - Swiss Start-up Days
TolerogenixX visited the Swiss Start-up Days
September 2018 - Best Abstract Prize
TolerogenixX was invited to present the clinical results of the TOL-1 Study at the Annual Congress of the German Society of Rheumatology
May 2018 - Resultate der TOL-1 Studie auf der 55. ERA-EDTA
TolerogenixX presented the results of the TOL-1 study as an oral presentation at the ERA-EDTA congress in Copenhagen
February 2018 - Venture Capital Pitch
TolerogenixX holt den 2. Platz in der Gesamtwertung beim Pitchwettbewerb "Best of Baden-Württemberg" Venture Capital Pitch, sowie den 1. Platz im "Life Science" Sektor.
September 2017 - Science Sparks
TolerogenixX takes part in a panel discussion on the topic „Inspirational Stories from Seasoned Entrepreneurs and Newcomers together with their investors“
May 2017 - HTGF Pitch
TolerogenixX pitches at the HTGF Family Day 2017
Award for the 1st prize-winners of the Venture Cup 2015
28. July 2015
The science4Life e.V. office is pleased to announce the Tolerogenixx-Team as the winners of the Venture Cup 2015 and to officially hand over the seal of quality to them.
Sience4Life e.V.
1st prize at the Science 4 Life Venture Cup 2015
14. July 2015
Frankfurt am Main (ots) - TolerogenixX from Heidelberg wins with a therapy that significantly improves the quality of life of organ transplanted patients
The founders of Science4Life e. V. the signs point to success:
DThe patrons, the Hessian Minister of Economic Affairs Tarek Al-Wazir and Prof. Dr. Jochen Maas, Research Director of Sanofi-Aventis Deutschland GmbH, were delighted with the record number of business ideas submitted and praised the ten best founding teams for their innovative ideas and entrepreneurial courage./p>
At the final award ceremony at the Deutsche Bundesbank's head office, the winning teams received not only plenty of praise but also prize money totalling 56,000 euros. The first prize was awarded to TolerogenixX for the development of a tailored therapy without side effects in transplantation and for patients with autoimmune diseases.
September 2017 - Business Development
TolerogenixX was selected to give a company presentation at the European Business Development Conference in Heidelberg
June 2017 - EXIST II
TolerogenixX receives funding (Exist II) from the Federal Ministry of Economic Affairs and Energy (BMWi)
March 2017 - Investment Forum
TolerogenixX was invited to a company presentation at the Investment Forum of the Federal Ministry of Economics in Berlin
December 2016 - Seeding Phase
The High-Tech Gründerfonds (HTGF) invests in TolerogenixX GmbH as a seed investor
December 2016 - Founding
GmbH Founding
July 2015 - Business Plan
TolerogenixX wins 1st place in the Science4Life business plan competition
