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First personalized diagnosis for progressive COPD
The CORE 1 program makes use of the targets characterizing the core mechanisms of COPD development and will achieve authority approval for the first predicitive diagnosis of COPD, a quantum leap and game changer in the field of chronic inflammatory diseases.
The completion of CORE-1 marks the equivalent pharmaceutical development value at € 450 Mio.
Currently at Technical Readiness Level 6
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Complete analysis for all clinically relevant markers in lung tissue based on 3-year observation per subject, representing COPD progression over more than 30 years.
The significance of stage-specific, personalized diagnosis and treatment
Regenerative Precision Medicine for Chronic Inflammation
A new approach: Chronic inflammation and fibrosis in the aging lung
The future of medicine is individual.
The term presently coined for this is Personalized or Precision Medicine.
Precision medicine is defined by the simultaneous identification (diagnosis) and targeted elimination (treatment) of metabolic defects causing and driving a particular disease at a decisive stage of its manifestation. It relies on clinically validated biomarkers.
In future, biomarkers will directly link diagnosis to treatment (beyond all present clinical, pathological, imaging or laboratory procedures):
- in accordance with the precise stage of metabolic disease development at the time of recording, and
- with an accordingly targeted therapy (based on detailed assessment of the relevant abnormalities in both organ structure and function).
Why so?
Because this combination of biomarker-based diagnosis and the corresponding marker-based treatment permits:
- an unprecedented increase of effectiveness of any given therapy, while, at the same time, resulting in
- a significant reduction of both number andseverity of undesired side effects of treatment.
Presently, we are still at the dawn of Precision Medicine.
Primary advances made in the field of tumor disease plainly demonstrate the enormous advantages of Precision Medicine.
However, Precision Medicine applies not only to tumor disease currently accounting for 30 percent of all diseases in people over 50 years of age.
It applies as well to the group of Chronic Inflammatory Diseases representing the majority of diseases in aging populations (accounting for up to 70 percent after the age of 50), and there, Precision Medicine is badly needed.
The lessons from our pilot study:
Maintenance of matrix structures and its significance for healthy aging.
Surface and matrix structures create borders within the body and its organs. These borders separate reaction spaces, called the compartments of the body. Intact surface and matrix structures control and guarantee regular organ function by separating potentially hazardous biochemical and biophysical reactions running continually within these compartments.
The body’s surface and matrix structures are many and wide. The more expanded and the more mobile these structures are (for example, to gaseous atmospheres in and around the body or to fluids, like the blood-stream), the more profound the effects of their dissolution.
This process is termed loss of surface integrity. Why is it dangerous?
Because hazardous biochemical and biophysical reactions will run uncontrolled and in the wrong places causing reactive inflammation and need of repair. Once such a loss of surface integrity becomes permanent, both inflammation and need for repair (or in other word:wound healing) will become permanent and progressively intense affecting regular organ function, as organ function relies on the same structures.
Thus, maintenance of matrix structures ensures functional reaction spaces, prevents inflammation, and preserves proper function of organs, i.e. health. This maintenance process is called regenerative repair or primary wound healing. Because of its importance, the body will uphold it over decades, and with considerable effort.
Regenerative repair will only become slow and ineffective, when the metabolic processes necessary to maintain it become ineffective. This is exactly what happens with age.
This explains the danger posed by the combination of persisting loss of surface integrity and progressively declining regenerative repair. Due to this combination, medicine witnesses a steady increase in number and severity of Chronic Inflammatory Diseases in aging societies affecting various organs, such as lung, vascular system, bowels, joints and skin.
The lungs have a surface are a equivalent to a tennis court. With each breath (and just at rest, we breathe roughly 16 times per minute), this huge surface is pulled wide by muscle force and then contracted again only by the elastic structure of the lung.
The biophysical forces put on this lung structure during breathing are considerable. Therefore, the loss of surface (matrix) integrity in structurally and functionally critical lung compartments, such as the small bronchi (the air-conducting space) and the alveoli (the gas-exchanging space) has tremendous effects, inflammation being just its first result.
Not surprisingly, acute pneumonia(pulmonary inflammation) is the most common cause of death in aging individuals - regardless of what other disorder is simultaneously occurring in the body.
Chronic pulmonary inflammation is equally disastrous, but much less apparent, as the body’s regenerative repair capacity (shrinking with age) masks its effects on structure and function. As a result, the critical outcome of chronic inflammation are usually difficult to diagnose before the age of 50. This is unfortunate, because the combined pathology of structural disintegration will become progressive at that stage, as the body has no primary repair capacity anymore to withstand. The result is both renewed inflammation and a different repair quality called secondary repair (i.e. scarring = fibrosis).
While medical and pharmaceutical development has centered on inflammatory processes for many decades, persistent loss of structural integrity combined with a growing inability to sustain regenerative wound healing have only recently gained attention.
Transgenion’s new knowledge concerns the very basis of Precision. Accordingly, our identification process has centered on prospective clinical studies identifying stage-specific biomarkers during the entire course of disease development, e.g. in COPD covering up to 30 years.
Fortunately, this has been possible, as each stage of disease comprises critical periods characterized by clinically well-characterized structural and functional features allowing the correct association with the key biomarkers linking structural failure to inflammation, fibrosis and loss of function.
Not very surprisingly, many of the clinically validated key markers originate from processes controlling and enabling repair.
First-time sequential recording of all relevant markers throughout the entire COPD course (from the risk stage to end-stage).
The significance of stage-specific, personalized diagnosis and treatment
Regenerative Precision Medicine for Chronic Inflammation
A new approach: Chronic inflammation and fibrosis in the aging lung
The future of medicine is individual.
The term presently coined for this is Personalized or Precision Medicine.
Precision medicine is defined by the simultaneous identification (diagnosis) and targeted elimination (treatment) of metabolic defects causing and driving a particular disease at a decisive stage of its manifestation. It relies on clinically validated biomarkers.
In future, biomarkers will directly link diagnosis to treatment (beyond all present clinical, pathological, imaging or laboratory procedures):
- in accordance with the precise stage of metabolic disease development at the time of recording, and
- with an accordingly targeted therapy (based on detailed assessment of the relevant abnormalities in both organ structure and function).
Why so?
Because this combination of biomarker-based diagnosis and the corresponding marker-based treatment permits:
- an unprecedented increase of effectiveness of any given therapy, while, at the same time, resulting in
- a significant reduction of both number andseverity of undesired side effects of treatment.
Presently, we are still at the dawn of Precision Medicine.
Primary advances made in the field of tumor disease plainly demonstrate the enormous advantages of Precision Medicine.
However, Precision Medicine applies not only to tumor disease currently accounting for 30 percent of all diseases in people over 50 years of age.
It applies as well to the group of Chronic Inflammatory Diseases representing the majority of diseases in aging populations (accounting for up to 70 percent after the age of 50), and there, Precision Medicine is badly needed.
Maintenance of matrix structures: Significance for healthy aging
Surface and matrix structures create borders within the body and its organs. These borders separate reaction spaces, called the compartments of the body. Intact surface and matrix structures control and guarantee regular organ function by separating potentially hazardous biochemical and biophysical reactions running continually within these compartments.
The body’s membrane structures are many and wide. The more expanded and the more mobile these structures are (for example, to gaseous atmospheres in and around the body or to fluids, like the blood-stream), the more profound the effects of their dissolution.
This process is termed loss of surface integrity. Why is it dangerous?
Because hazardous biochemical and biophysical reactions will run uncontrolled and in the wrong places causing reactive inflammation and need of repair. Once such a loss of surface integrity becomes permanent, both inflammation and need for repair (or in other word:wound healing) will become permanent and progressively intense affecting regular organ function, as organ function relies on the same structures.
Thus, maintenance of matrix structures ensures functional reaction spaces, prevents inflammation, and preserves proper function of organs, i.e. health. This maintenance process is called regenerative repair or primary wound healing. Because of its importance, the body will uphold it over decades, and with considerable effort.
Regenerative repair will only become slow and ineffective, when the metabolic processes necessary to maintain it become ineffective. This is exactly what happens with age.
This explains the danger posed by the combination of persisting loss of surface integrity and progressively declining regenerative repair. Due to this combination, medicine witnesses a steady increase in number and severity of Chronic Inflammatory Diseases in aging societies affecting various organs, such as lung, vascular system, bowels, joints and skin.
The lungs have a surface are a equivalent to a tennis court. With each breath (and just at rest, we breathe roughly 16 times per minute), this huge surface is pulled wide by muscle force and then contracted again only by the elastic structure of the lung.
The biophysical forces put on this lung structure during breathing are considerable. Therefore, the loss of surface (matrix) integrity in structurally and functionally critical lung compartments, such as the small bronchi (the air-conducting space) and the alveoli (the gas-exchanging space) has tremendous effects, inflammation being just its first result.
Not surprisingly, acute pneumonia(pulmonary inflammation) is the most common cause of death in aging individuals - regardless of what other disorder is simultaneously occurring in the body.
Chronic pulmonary inflammation is equally disastrous, but much less apparent, as the body’s regenerative repair capacity (shrinking with age) masks its effects on structure and function. As a result, the critical outcome of chronic inflammation are usually difficult to diagnose before the age of 50. This is unfortunate, because the combined pathology of structural disintegration will become progressive at that stage, as the body has no primary repair capacity anymore to withstand. The result is both renewed inflammation and a different repair quality called secondary repair (i.e. scarring = fibrosis).
While medical and pharmaceutical development has centered on inflammatory processes for many decades, persistent loss of structural integrity combined with a growing inability to sustain regenerative wound healing have only recently gained attention.
Transgenion’s new knowledge concerns the very basis of Precision. Accordingly, our identification process has centered on prospective clinical studies identifying stage-specific biomarkers during the entire course of disease development, e.g. in COPD covering up to 30 years.
Fortunately, this has been possible, as each stage of disease comprises critical periods characterized by clinically well-characterized structural and functional features allowing the correct association with the key biomarkers linking structural failure to inflammation, fibrosis and loss of function.
Not very surprisingly, many of the clinically validated key markers originate from processes controlling and enabling repair.
Unique dataset fully patented (25 patents across US, Europe and Japan).
In summary, this results in a market lead of at least 10 years.
Unique Investment Opportunity
Work Package 1 - First Returns in 2027
Confirmation trial for first clinically validated diagnostic COPD Test.
Work Package 2 - Return in 2028
Validation of Targets, pre-clinicial data set and therapeutic compounds
Work Package 3 - Return in 2029
Application trial for first clinically validated diagnostic test for COPD
Opportunity for the advancement of CID Treatment
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Additional Information
Starting with the CORE Programs, Transgenion is realizing the first useful diagnosis and causal treatment for CID.
Your investment leads to the approval of the first personalized diagnosis for progressive COPD by two independent clinical studies, the development of the first transgenic model system for COPD, as well as the identification of the most suitable candidates for causal treatment at the respective stage of COPD. In particular:
- Validation of biomarkers and targets derived from the COPD pilot study (first study conducted between 2007 and 2013) for diagnosis of progressive COPD by two prospective clinical studies required for approval.
- The validation study (Transgenion’s Clinical Study #2 planned 2024 – 2028) will validate the pulmonary biomarkers and targets and correlate the findings with new serum markers based on chip-based whole genome mRNA profiling.
- Preclinical study set #1: Screening and acquisition of preclinical data regarding suitable drug candidates for the first causal treatment of COPD based on the main target.
- Preclinical study set #2: Development of the first transgenic pulmonary model systems for COPD for evaluation of metabolic and intervention pathways based on the biomarkers and targets derived from Transgenion’s pilot study (Clinical Study #1).
- The Diagnostic Approval Study (Clinical Study #3, prospective multicenter Phase 2 trial planned 2025 – 2029) will seek authority approval for Transgenion’s new diagnostic test (Prediction of progressive COPD and Indication for new causal therapy).
- Registration of additional IP based on the results from the successful European FP7 project 'Resolve'.