Pirche AG and TCBalance Biopharmaceuticals GmbH Announce Collaboration and Partnering Agreement on regulatory T Cell Therapy Research and Development.

Berlin-based tcbalance 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).

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.

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.

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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.”

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.

About Pirche

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

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.

Contact:

TCBalance Biopharmaceuticals GmbH:

Prof. Dr. O. Weber

Marienstr. 7

10117 Berlin

Germany

E-Mail: weber@tc-balance.com

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PIRCHE AG

Timothy Boadi, Head of Marketing

E-mail: info@pirche.com

Phone (Office EU): (+49) 89 9090 153 914

Address (EU): Nördliche Münchner Straße 27a, 82031 Grünwald, Germany

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