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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.

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

May 2020 - Publication

TolerogenixX publishes the TOL-1 Study in Journal of Clinical Investigation

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.

TOLEROGENIxX PD Dr. Matthias Schaier, MBA - 7. Venture Capital Pitch

click play




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.

Press report

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

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