Expanding our platform for controlling human T-cell immune activity to develop a first-of-its-kind, immediate causal intervention in flare-ups of autoimmune diseases such as MS and Crohn’s disease by suppressing pathogenic T-cell activation.
The control of the human immune system is one of the last unsolved z problems.
About 10 million people worldwide are diagnosed with autoimmune diseases such as multiple sclerosis (MS), rheumatoid arthritis, lupus erythematosus, inflammatory bowel diseases such as ulcerative colitis, Crohn’s disease and many other diseases.
Most patients suffering from autoimmune diseases have a lifelong and often life-threatening disease course characterized by recurrent acute flare-ups interspersed with relatively quiescent periods.
T cell silencers promise a unique, immediate medical intervention in autoimmune diseases such as multiple sclerosis by directly suppressing their pathogenic cause.
Dr. Thomas Harder has performed, documented and published (Harder et al., 2014) in vitro experiments modeling T-cell silencers.
These T-cell silencers directly induce a quiescent state in isolated human T-cells in which they do not activate their functions in immune responses. After Silencer inactivation, T cells quickly wake up and are once again ready to perform their vital immune defense functions.
These results underscore T cell silencers as potent suppressors of T cell activation and their potential as a causal intervention against pathologies of unwanted, pathogenic T cell activity.
Unfortunately, although the treatment options for patients with multiple sclerosis (MS) have increased in recent years, the therapeutic options are still not satisfactory. “Silencing” dysregulated T cells, which are particularly implicated in the pathology of MS, with a targeted biological approach is a promising new strategy that clearly deserves further investigation for its therapeutic potential”.
dr Harder’s early work in cell biology contributed significantly to the idea that locally coalescing membrane raft domains function as platforms for membrane-related cell activities, such as surface receptor signaling or cytoskeleton-membrane interactions. Based on this concept, research teams he led at the Basel Institute for Immunology and at the Sir William Dunn School of Pathology at the University of Oxford characterized the cell biology, biochemistry, biophysics and immunology of plasma membrane rafts that control the activities of T cells .
T cells (in green) “hug” activating beads (in red) and this “hug” triggers all T cell activation responses
The “embrace” of the activating surfaces is restrained by T-cell silencers and consequently all T-cell activation responses are strictly suppressed.
Around 5-8% of the population worldwide are currently affected by around 80-100 different autoimmune diseases and are the third most common group of diseases after cardiovascular diseases and tumor diseases.
The T-cell silencer promises clinical intervention in numerous autoimmune diseases caused by pathogenic T-cell activation: There is a strong demand from more than 10 million patients worldwide for new drugs that treat the root cause of these diseases immediately.
Initial focus lies in development of the T-cell Silencer technology toward clinical treatment of Multiple Sclerosis (MS). Funding will be needed to cover costs for laboratory, office, salaries, administration, biochemicals, outsourcing the production of antibody-mimetics, optimization of humanized T-cell Silencers in vitro, translation to mouse models.
Tranquil Immune is developing a platform for the first indication of multiple sclerosis. Multiple indications are envisioned (up to 80-100 autoimmune diseases) that can be developed with various pharma partners. The anti TNF market is a huge and growing indication. TNF antibodies have been the top-selling drugs for many years, first offered by Humira and the failure rate for antibodies is lower than for SME. Drug development and regulatory approvals are done with strategic partners through participation and licensing.
First commercial Decision Point by long-term investment and licensing and/or take-over of T-cell Silencers by pharmaceutical industry for clinical studies in humans (to be reached at any time along the 12 month route towards T-cell Silencers matured in mouse models.
pharmaceutical industry can be expected.
The extension to the treatment of other diseases caused by pathogenic T cell activation outlines an enormous growth potential.
Development of the T-Cell Silencer in vitro – Patent
Company Foundation – Start PoC
PoC Decision Point 1+2
1. Round of Financing
PoC Decision Point 3+4
Start Production / Clinical Phase
2. Round of Financing / Strategic Pharma Partner
Clinical Studies: Tox / PD (GLP), FIH, Max Dose, Dose Response, POC – PK, PIII, Submission GMP Produktion R&D extension rheumatoid arthritis, Crohn’s disease etc.
3. Round of Financing with Strategic Pharma Partner
Wolfgang Hennes (CEO), is an Entrepreneur and leading figure in AI technology in Germany. Wolfgang has co-founded successful Start-up companies, has a huge network in order to integrate TRANQUIL IMMUNE into the German Start-up ecosystem and combining Biotech with Machine Learning.
Dr. Thomas Harder-Knaub (CSO), Reader in Pathology, is a pioneering scientist who developed T-cell Silencer technology. Thomas gathered his profound scientific expertise at the Basel Institute for Immunology and at the University of Oxford. He will guide T-cell Silencers to a medical intervention in MS.
Prof. Dr. Martin Sieber, Science Cooperation Partner HRBS is Clinical Researcher & Drug Developer and was Head of Laboratory and Senior Global Clinical Project Manager and at Bayer for almost 11 years. Martin is a professor at the University of Applied Sciences Bonn-Rhein-Sieg and accompanies the Pre- and Clinical Phase at Tranquil Immune with his scientific team and laboratories.
Michael Schäfer is a student at Bonn Rhine-Sieg University of Applied Sciences at the Department of Natural Science and Institute for Functional Gene Analysis (IFGA) and is involved in the isolation of nanobody “hits” using phage display technology – successful assembly into biological T cell silencers that stop human T cell activation in vitro.
Life Science Inkubator GmbH, represented by Dr. Jörg Fregien, has been supporting life science ideas in their development to financing and marketability since 2008. With evaluation and start-up audit, the LSI offers various modules in order to be able to assess the probability of realization of an innovative life science idea at a very early stage. At the same time, the necessary alignment for a successful transfer is developed as part of the conceptual design.