Targeting Sustainable
Immune Modulation

tcbalance
Biopharmaceuticals

Welcome

About tcbalance

More than 10% of chronic diseases are due to undesired/pathogenic immune response with high impact for patients and society (>120 bn EUR/a direct health costs alone in EU). Conventional therapy leaves many problems unresolved and usually requires lifelong immunosuppression, which is associated with numerous side effects and high costs, and thus carries a high unmet medical need.

tcbalance develops a sustainable therapy concept that could have the potential to revolutionize the current treatment strategy for such diseases by restoring the immune balance through natural peacemakers called regulatory T cells (Treg).

Using a most innovative modular technology platform for generating and applying innovative Treg products, tcbalance targets a path forward from autologous bridging therapies towards allogenic “off-the-shelf” products for multiple immune diseases.

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Modular Technology Platform

A core element of tcbalance's story is based on the robust and effective expansion and generation of multitasking Treg by applying our unique “modular block building” system — this is believed to accelerate and de-risk the clinical development of Treg therapy for various medical indications.

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Research & Clinical Cooperation

tcbalance drives an agile development approach that is based on close interaction between academic research and clinical development. Our approach carries the potential of achieving fast and flexible clinical “proof of concept”.

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Founders and Team

Our team brings together extensive expertise in Teff/Treg-cell manufacturing and clinical application, gene editing, high-end cell product specification, biomarker profiling, as well as business leadership by the founders and the teams behind.

Solution

Scientific principle

Conventional therapeutic approaches to immune diseases, regardless of whether they are aimed at broad immunosuppression with numerous side effects (e.g., risk of tumors, infections, cardiovascular diseases, diabetes) or specifically inhibit individual pathogenic signaling molecules, generally do not allow readjustment of the shifted immune balance. This reduces the sustainability of these approaches, and often subsequently require a long, often lifelong treatment. Regulatory T cells (Treg) are a small subpopulation of T cells and have the task of attenuating undesired and excessive immune reactions — without Treg we are not able to survive.

However, partial under-numbering and/or under-functioning can also lead to insufficiently balanced and undesired immune responses such as in autoimmunity, transplant rejection, graft-versus-host diseases, hyperinflammation, and unwanted reactions against gene therapy drugs. Numerous data generated worldwide from preclinical model systems show that cell therapy with activated Treg may lead to impressive and lasting therapeutic effects. First early clinical studies confirm the feasibility and safety of such a cell-based therapy and provide promising hints for sustainable effectiveness (e.g., Roemhild et al. BMJ 2020).

Strategic Goals

“off-the-shelf” Allogeneic Multitasking Treg Products

Stepwise proof and implementation of modular building block with bridging products on the path to the ultimative goal: off-the-shelf allogeneic multitasking Treg products.

Modular Elements

Advanced Technology
Platform

Modular building block

  • Engrafment
  • Survival
  • Specificity
  • Synergy with temporary Standard-of-Care

Our Team

The tcbalance Founders

The founders of tcbalance have, alltogether, more than 50 years of experience in the area.

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Prof. Dr. Olaf Weber
CEO

More than 25 years of experience in the pharmaceutical industry

Previous SVP and Head R&D / Medical Affairs for Bayer Radiology; former CFO / Head of Finance Bayer Radiology

Adjunct Professor; Medical Faculty, University of Bonn

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Prof. Dr. Hans-Dieter Volk
CSO

Professor of Immunology at Charité since 1994

Multipe honors and awards including Humboldt Prize

Member of the leadership team at Einstein Center for Regenerative Therapies

Authored and co-authored 800+ scientific publications

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Prof. Dr. Petra Reinke
CMO & Head of Clinical Development & Cell Therapy Manufacturing

Professor of Medicine at Charité since 2000

Founding Director and Head of the Berlin Center for Advanced Therapies at Charité

Published more than 350 scientific papers

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Dr. Dimitrios L. Wagner
Head of Research & Preclinical Development

Regarded expert in immunotherapies and gene editing technologies

Heads R&D at the Berlin Center for Advanced Therapies (BeCAT), Charité

Committee member in the American Society for Cell and Gene Therapy

Pressrelease    R&D Collaboration

tcbalance & Pirche

Berlin-based Biopharmaceuticals GmbH and Munich/Utrecht-based Pirche Digital Diagnostics AG, have agreed to enter into a strategic research collaboration and partnering agreement. Together, the two leading European technology companies aim to advance the development of potentially ground-breaking cell therapeutics based on regulatory T cells. Regulatory T cells (Treg) are a small subpopulation of T cells that have the task of attenuating undesired and excessive reactions of the body’s immune system — without Treg we are not able to survive, they are also called the “peace-makers” of the immune system.
Immunological disorders such as autoimmune diseases may have a major impact on patient’s life. A hallmark of such diseases is an imbalance within the immune system. Conventional therapeutic approaches to immune diseases generally do not readjust the immune balance which reduces the sustainability of these approaches and often require a long, even lifelong treatment.
Numerous data generated worldwide from preclinical model systems show that cell therapy with activated Treg may lead to impressive and lasting therapeutic effects and first early clinical studies point toward the feasibility and safety of such a cell-based therapy and provide promising hints for sustainable effectiveness (e.g., Roemhild et al. BMJ 2020).

About tcbalance

tcbalance is pioneering a therapeutic concept based on regulatory T cells using a most innovative modular technology platform for generating and applying innovative Treg products.

More than 10% of chronic diseases are due to undesired/pathogenic immune response with high impact for patients and society (>120 bn EUR/a direct health costs alone in EU). Conventional therapy leaves many problems unresolved and usually requires lifelong immunosuppression, which is associated with numerous side effects and high costs, and thus carries a high unmet medical need. tcbalance develops a sustainable therapy concept that could have the potential to revolutionize the current treatment strategy for such diseases by restoring the immune balance through natural peacemakers called regulatory T cells (Treg). Using a most innovative modular technology platform for generating and applying innovative Treg products, tcbalance targets a path forward from autologous bridging therapies towards allogenic “off-the-shelf” products for multiple immune diseases.

contact

TCBalance Biopharmaceuticals GmbH:
Prof. Dr. O. Weber
Marienstr. 7
10117 Berlin Germany
e-Mail: weber@tc-balance.com

About Pirche

Pirche specializes in epitope matching technology, integrating genetic typing and AI-driven immunological simulations. Its exclusive digital diagnostics platform is already in use and commercialization for transplant medicine, offering pre-transplant donor-recipient risk assessment, organ allocation, and developing personalized immunosuppression in post-transplant care. Within this partnering agreement, Pirche focuses on design support of allogeneic cell therapies and selecting "off-the-shelf" solutions through immune risk profiling across multiple immune diseases thus expanding its business into the burgeoning field of allogeneic cell therapies.

Under the Research Collaboration and Partnering Agreement the companies explore options to develop and commercialize allogeneic, or “off-the-shelf”, Treg products. This is addressing a major current challenge of adopting existing cell therapies which require an ultracomplex supply chain.

The partnering agreement relates to research and clinical development. Financial Details of the agreement were not disclosed.

„We are driven by the vision to bring innovative therapies to patients in need that are based on regulatory T cells. Our collaboration with Pirche AG is targeting a path forward toward a much desired allogeneic “off-the-shelf” Treg product”, says tcbalance co-founder and CEO Prof. Dr. Olaf Weber.

Pirche founder and CEO Thomas Klein is delighted with this partnering agreement: “The exclusive Pirche technology will be used for the first time in the development of allogeneic cell therapies and the “off-the-shelf” selection using immune risk profiles in the areas of severe diseases. This is a significant step for Pirche towards the wider business of digital therapeutics.”

Pirche’s digital diagnostic platform, “TxPredictor”, merges genetic typing with real-time, AI-supported immunological simulations, enabling clinicians and drug developers to make precise, personalized medical decisions. By integrating cutting-edge algorithms and data analysis techniques, Pirche aims to improve the accuracy of donor-recipient matches, reduce transplant or allogeneic cell rejection rates, and enhance patient outcomes. Learn more: www.pirche.com

contact

PIRCHE AG:
Timothy Boadi, Head of Marketing
Nördliche Münchner Straße 27a
82031 Grünwald, Germany
e-Mail: info@pirche.com

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by TCB management or Pirche management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. The companies assume no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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