Our motivation Our aim is to alleviate the suffering of patients with inflammatory diseases by means of a targeted immunomodulatory therapy. As an energetic, international team with its roots in Germany and a passion for science and advances in the treatment of immune diseases, we are breaking new ground by selectively activating regulatory T cells. Read more

Our motivation is to aleviate the suffering of patients with inflammatory diseases by means of a targeted immunomodulatory therapy. As an energetic international team with its roots in Germany and a passion for science and real advances, we are breaking new ground by selectively activating regulatory T cells. Read more
Das Unternehmen
Der Wirkstoff
Das Potenzial

T-Balance® Therapeutics

Company history

T-Balance® Therapeutics was founded in 2019 under the name OGen GmbH. The biotechnology start-up in Frankfurt/Main and Munich encompasses an international team with a network of renowned partners in the fields of CMC, Regulatory Affairs, preclinical and clinical development. The focus of T-Balance® Therapeutics is apparent from its name – the development of the humanized monoclonal antibody—tregalizumab—which can restore immune system balance to prevent or treat autoimmune disorders and inflammatory conditions.

Tregalizumab

Tregalizumab selectively activates the immunomodulatory subpopulation of T cells called regulatory T cells or Tregs. Tregs are essential for maintaining peripheral immune tolerance; they suppress autoreactive T cells (i.e. cells targeted against the body’s own structures) and thereby prevent the excessive activation of T lymphocytes seen in autoimmune and inflammatory diseases. Tregalizumab acts early in the inflammatory cascade, providing the opportunity for a novel therapeutic approach aimed at the prevention and treatment of inflammatory conditions.

Tregalizumab binds to its target, CD4, in a unique manner and unlike other molecules in its class specifically activates Tregs. In so doing, tregalizumab does not activate effector T-cells nor does it deplete CD4-positive T-cells, which are crucial for the adaptive immune response.


Therefore, tregalizumab has the potential to help treat a wide variety of autoimmune diseases and conditions associated with the signs and symptoms of inflammation.

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Strenghts

  • Unique specificity
    Activates regulatory T cells (Tregs) in a highly selective manner
  • At an advanced stage of clinical development
    More than 700 subjects have already been dosed with tregalizumab
  • Robust safety profile
  • Signs of efficacy in previous clinical studies
    Responses in psoriasis were durable even after treatment cessation
  • Well investigated pharmacokinetic profile:
    Established dose range and method of application (s.c. and i.v.)
  • Acts early in the immune cascade

High potential

Tregalizumab holds promise in a wide breadth of T-cell mediated disorders

Innovative Treatment Approach

Tregalizumab activates regulatory T-cells, which are an attractive target in a variety of T-cell mediated disorders. A better scientific understanding of both the function of Tregs as well as disease pathogenesis fosters an innovative treatment approach for tregalizumab. To unlock tregalizumab´s full potential, the selection of the most appropriate indications and/or disease stages is critical. Furthermore, early intervention may be key to blocking pathological T-cell responses early in the course of disease to potentially prevent the onset or manifestation of a disease.

Unlocking Tregalizumab’s Potential

A variety of different T-cell mediated disorders with a high unmet medical need are being explored in parallel at the non-clinical and clinical level.
A Proof of Concept (PoC) Phase 2a study in allergic asthma was recently completed. Preclinical evidence in additional indications is currently being generated and further clinical development in promising indications is planned.

4 7th International Conference on Infectious Diseases, Bacteriology and Antibiotics. October 12-13, 2020 Prague, Czech Republic. Abstract of Autoimmune Disease Session. URL: https://infectiousdiseases.annualcongress.com/events-list/autoimmune-disease. Cited: 5 June 2020 

Milestones

First milestones passed

Tregalizumab has already undergone intensive scientific and clinical studies in autoimmune diseases and is in Phase 2 clinical development. Historical clinical data from 8 clinical trials are available. In these studies, broad ranges for i.v. and s.c. administration were tested and almost 700 subjects dosed for up to 48 weeks.


Tregalizumab’s mode of action has been tested in preclinical studies using human cellular in vitro models. In vitro testing of tregalizumab on patient cells with allergic asthma has revealed a very promising immunomodulatory potential for this therapeutic indication.


Altogether, the preclinical evidence and a favorable safety and tolerability profile of tregalizumab justified proceeding to a Phase 2 clinical study in a new indication (asthma) without the need for a Phase 1 study.

The next milestone

A Phase 2a study in allergic asthma has recently been completed. The design of this PoC study is well-established and standardized. It utilizes an allergen challenge approach to measure bronchoconstriction. This concept has been used in other successful clinical development programs. Clinical efficacy measured during allergen challenge studies can be considered predictive for endpoints in pivotal studies.


As of January 2022, the last patient visit was conducted. The results of the proof-of-concept study in asthma are expected later this year.

Asthma

Asthma is a chronic, inflammatory lung disease characterized by reversible airway obstruction usually resulting from an allergic reaction or hypersensitivity. Global figures show that about 262 million people suffer from asthma1. This number is expected to rise to an estimated 400 million by the year 20252. Worldwide, some 495,000 people die from asthma every year.3

1 Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204-22
2 Nunes et al. Asthma Research and Practice (2017) 3:1
3 Global, regional and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 2018; 392:1736-88.