Validation is one of the most critical phases in technology transfer. In this step, new technologies are pushed forward into applicable products and services. This involves identifying the most promising fields of application and developing working demonstrators, expediting production outside of the laboratory, and conducting (pre)clinical studies.
Projects that bridge the gap between research results and their marketable applications have been assisted by the Helmholtz Validation Fund (HVF) since 2011. Around three to six projects are selected each year, totaling 34 selected projects from 2011 to 2017 and up to €2 million in funding.
Four additional projects have been added in 2018 through the joint Proof of Concept Initiative (PoC) with Fraunhofer and Deutsche Hochschulmedizin. These projects use synergy potentials in validation in the life science sector and will be conducted up to early clinical proof of concept.
A new therapy concept for the treatment of Small Cell Lung Cancer (SCLC) based on novel Gold-DTC complexes. The use of the complex after a successful primary treatment can prevent the recurrence of cancer in the long term.
Bispecific antibody for treatment of acute leukemia. In addition the novel format attenuates "off target" T cell activation and reduces side effects and allows for a higher therapeutic efficacy.
Validation of a blood test for Alzheimer's dementia. The routine blood test is far less invasive and has been found to be more acceptable to patients than the traditional Spinal Fluid Collection (CSF) procedure.
This system will provide three-dimensional, high-resolution 360-degree visibility to diving robot pilots. This is based on combining sensor data from different camera systems, laser scanning, and an innovative lighting technology based on patented underwater LED technology.
This project focuses on demonstrating the applicability of an indoor positioning system in motion analysis. The technology is based on the continuous phase analysis of high-frequency radio signals. This enables highly precise determination of position and movement in terms of time and space. In just milliseconds, the technology can localize objects to within a millimeter. Unlike existing systems, it can simultaneously pursue any number of objects inside buildings or even outdoors. The system could be applied to medical diagnostics or rehabilitation. Another possible application is indoor navigation, for example for robots.
A new vaccine to protect against human papillomavirus will be clinically tested in this project. These viruses cause cervical cancer, among other things. The new vaccine will be thermostable. This would eliminate the need for a cold chain and would lead to a significant increase in immunization, especially in countries with inadequate infrastructure for refrigerated transportation.
A submersible sensor for underwater use will be developed by building on a new infrared technology. The sensor will be able to simultaneously identify and quantify a broad range of dissolved compounds. Initial laboratory tests have shown that the sensor can already perform single gas measurements at low concentrations. Possible areas of application would be gas and oil prospecting as well as monitoring pipelines for leakage. It could also be applied to environmental and climate research for ocean and inland water monitoring.
In this project, researchers will use two new control approaches, called the VITAL methods, to efficiently control traffic lights and to make traffic as eco-friendly as possible. This takes advantage of novel information and communication technologies with previously unused control parameters, innovative data transmission technologies, and situation forecasts for improved traffic control. In previous projects, average savings of 15% - 33 % regarding waiting times for traffic participants were demonstrated at two test intersections in Braunschweig and Halle an der Saale with an accompanying economic investment cost/benefit ratio of between 3 and 13.
- Frankfurt Fraunhofer Project Group translational medicine and pharmacology TMP, Fraunhofer Institute for Molecular Biology and Applied Ecology IME
- Goethe University Frankfurt am Main
- German Cancer Consortium for Translational Cancer Research (DKTK) at the University Hospital in Frankfurt – partner location of the German Cancer Research Center (DKFZ)
Over 25 years ago, a new cancer drug came onto the market that is now an integral part of cancer treatment: Paclitaxel. Today it is used to treat a wide variety of cancers such as breast cancer, prostate cancer, and ovarian cancer. However, the pharmaceutical agent can have unpleasant side effects, such as neuropathies, which are characterized by tingling or numbness in the fingers and toes. So far, there is no drug that can reduce these side effects.
A possible candidate for this would be the active ingredient Telmisartan. This has already been successfully tested in preclinical studies. The study has been designed to demonstrate the effectiveness and safety of the active ingredient in treatments for patients with ovarian or breast cancer in a Phase II study.
- Justus Liebig University Giessen
- Helmholtz Zentrum München - German Research Center for Environmental Health
- Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
Fatigue, shortness of breath, and poor physical stamina: These are the symptoms of patients with pulmonary hypertension. Increasingly narrowing pulmonary arteries are indicative of the disease. The right ventricle then begins to pump harder to compensate for the resulting poor blood circulation. This chronic strain damages the heart over time. While a few years ago the only possible treatment for the severe form of the disease was a lung transplant, most patients today can be treated with various medications. But this only lightens the load on the heart and alleviates symptoms. There is no cure yet for pulmonary hypertension.
A promising approach will be researched in the project. Biocompatible nanoparticles will be developed during the project for patients to inhale. These nanoparticles are used as a miniature transport vessel to administer active ingredients in a targeted manner. They are expected to reduce the increased division of the cells in the pulmonary vascular wall, thereby significantly reducing pulmonary hypertension.
- University Hospital of Würzburg, Medical Clinic and Polyclinic II
- Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC)
- Fraunhofer Institute for Cell Therapy and Immunology IZI
Impressive treatment results could be achieved in clinical trials using CAR-T cell therapy – particularly in patients with leukemia. In order to obtain CAR-T cells, white blood cells are collected from cancer patients and the T cells – which are responsible for initiating an immune response to a disease – are isolated from the white blood cells. The cells are genetically modified to form the chimeric antigen receptors (CARs). This gives the CAR-T cells the ability to specifically recognize cancer cells. They are multiplied in the laboratory and re-administered to the patient via infusion. If the T cells detect cancer cells in the body, they multiply and attack the tumor cells.
In this case, the chimeric antigen receptors identify the ROR1 molecule. The molecule is barely present in healthy cells, but is far more present in cancerous cells, such as those of leukemia, breast cancer, or lung cancer. Up until now, CAR genes have been transferred to T cells using viral shuttles. The gene transfer is carried out by the “Sleeping Beauty” transposon system in this research project now funded by the PoC Initiative. Transposons are mobile DNA segments in the genome, also known as jumping genes. The research team will use the funding to complete preclinical studies and perform clinical trials on the safety and efficiency of the ROR CAR-T cells.
- Helmholtz Zentrum München – German Research Center for Environmental Health
- Fraunhofer Institute for Cell Therapy and Immunology IZI
- Rechts der Isar Hospital of the Munich Technical University (TUM)
- University Medical Center Hamburg-Eppendorf (UKE)
The hepatitis B virus can be found in the blood of about 260 million people. This makes hepatitis B one of the most common chronic viral diseases. It often leads to liver cirrhosis and liver cancer, claiming the lives of 880,000 people each year. There is no treatment yet to cure the disease.
The PoC initiative finances a research project working to find a cure for hepatitis B. The prime-boost method will be used for the innovative, therapeutic vaccination. First, a vaccine containing both hepatitis B surface proteins and hepatitis B core proteins will be administered. This prime vaccine induces the first desired immune response. This is followed by a boost, a second vaccine, based on the Modified Vaccinia Ankara (MVA) virus and expresses antigens against other hepatitis proteins. This is expected to significantly strengthen the immune response – especially of the T cells. The novel therapeutic vaccination for hepatitis B has already been successfully tested in preclinical studies. Further preclinical studies, immunotoxicological studies, and a Phase I clinical study will be performed using the funding.
The immunX project, which will receive 600,000 euros for one year, is focused on testing active ingredients to determine whether they can trigger inflammatory reactions, and thus intolerance, when used for treatment. The project is to be expanded to create an innovative testing platform that will systematically reduce the risk of undesired reactions during active ingredient development and discovery. The platform is intended to facilitate the development of new medications and treatments. After successful validation, immunX will first be used as an internal DZNE service and marketed with non-exclusive licenses. The applicants are also considering a spin-off later on. External parties have already expressed interest in the project.
Point of contact: Dr. Eugenio Fava, e-mail: eugenio.fava(at)dzne.de, German Center for Neurodegenerative Diseases (DZNE)
The goal of the project, which will receive around 877,000 euros in funding over two years, is to perform the critical pre-clinical trials and production steps for a new additive called bis-(3’,5’)-cyclic dimeric adenosine monophosphate (c-di-AMP) for a hepatitis C virus vaccination. Its application as an adjuvant will then be validated and refined in a clinical Phase 1 study with the vaccine candidate. In animal study models, c-di-AMP has already induced enhanced cellular and hormonal immune responses. After successful validation, the plan is to license the adjuvant in conjunction with further clinical trials by the applicant.
Point of contact: Prof. Dr. Carlos Guzman, e-mail: CarlosAlberto.Guzman(at)helmholtz-hzi.de, Helmholtz Centre for Infection Research (HZI)
The scientists in this project are working to develop gene therapy for multiple myeloma, a blood cancer that does not yet have a cure, as well as for mature B cell Non-Hodgkin's lymphomas. To do so, they are using CAR-T cell therapy. The researchers extract T cells from the patients and provide the cells with an artificial immune receptor, the chimeric antigen receptor (CAR). The modified immune cells are then returned to the patients. The receptor allows the therapeutic T cells to recognize certain characteristics (cancer antigens) on the surface of tumor cells and kill them. This is expected to suppress and heal blood cancer.
In this project, a prototype for a next generation UHF MRI-compatible brain PET application for dedicated neuroimaging will be developed and built. The BrainPET 7T will enable simultaneous molecular, functional, and structural imaging of UHFMR CT scans with unprecedented image quality.
The application of the soon-to-be-developed PET will be three to four times more sensitive and will possess a significantly improved and homogeneous spatial image resolution of 1.5-2.5 mm by using the latest detector and manufacturing technologies and an improved system design. The latter means a 20 times reduction in the voxel volume compared to modern, commercially available full-body systems.
Glioblastomas are tumors with very poor prognoses. No other type of tumor robs the patient of so many years. During the project, a Lu 177-linked Fab fragment that was derived from the developed and patented antibody 6A10 will be validated in a clinical Phase I/II study on radioimmunotherapy to treat glioblastomas. The radioimmunotherapy could significantly extend the survival rate of these patients in clinical studies. Using Lu-177-linked Fab fragment is an innovative approach that has significantly further developed this treatment.
Large amounts of reactive oxygen species (ROS) that are harmful to the organism can form due to ischemia and the subsequent restoration of the blood flow (reperfusion), for example after a heart attack or stroke, or even after surgery. In this project, scientists are researching a drug to repair the tissue damage that can occur during reperfusion after ischemia (inadequate blood supply).
The active ingredient is expected to better protect cells against ischemia reperfusion damage and maintain tissue function.
Completed Projects (since 2013)
The current gold standard for treating chronic hepatitis B can only control the propagation of the virus; it does not cure the disease however. This validation project focuses on a novel concept of curative treatment for chronic hepatitis B, which could also be applied to liver cell carcinoma with the hepatitis B virus (HBV). A combination of two bispecific antibodies is used, one to bind to the harmful hepatitis B virus and the other to active useful T cells.
A key necessity for today's autonomous driving are high-precision road maps with the exact layout of the lanes, since every inch counts. So far, coordinates that are precise to the inch can only be executed in a complex and selective way on site with the help of a receiver. The largely automated DriveMark procedure, on the other hand, generates precise and extensive coordinates. It builds on a technology that adjusts the radar satellite signals for atmospheric interference and environmental influences.
With an innovative fully automated forming process, early profile forms can be produced from dry fiber semi-finished products for fiber-reinforced plastic (FRP) in motor vehicle and commercial vehicle bodies, such as roof bows or longitudinal and cross beams on the bottom of a car. The process can be integrated into existing FRP manufacturing processes and can be used to replace semi-automated or less efficient procedures. The research team hopes the COPRO² procedure will reduce manufacturing costs by around 35 percent compared to conventional methods. COPRO² also considerably increases the quality of components and can be transferred directly into batch production.
In this project, the use of a rotating receiver system with ceramic particles is being researched for use as a heat transfer medium in solar tower power plants. The goal is to commercially produce heat that can compete with liquid fuels in sunny locations. In solar thermal power plants, direct sunlight is collected by several mirrors; nearly black ceramic particles are used as an energy carrier and storage medium in this procedure. The particles can be heated up to 1,000 degrees Celsius and the material flow can be efficiently controlled via a patented centrifugal receiver. Thanks to the simple and direct storage option, 24-hour operation is possible. Areas of application include sites where temperatures greater than 400 degrees Celsius are required or electricity is generated by steam or gas turbines.
This project is driving the development of an electrochemical sensor to identify malaria infections. This sensor is intended to replace conventional detection methods at the point of care as in vitro diagnostic use (IVD). The redox cycling detection allows for highly sensitive and specific quantitative detection. This lowers the production costs of nanoscalable automated printing processes far below the current piece costs of comparable IVD. In addition to the first product option of the malaria sensor, there is also the possibility of developing further sensors based on the technology for many other indications at a significantly lower cost.
RACE-LAB is expected to simplify, and further automate, the industrial use of robots. The latest generation of robots are characterized mainly by their lightweight design, interactive ability, and sensitivity. For this purpose, scientists are developing an intelligent program management and software library that enable the various robot skills such as drilling, screwing, filing, or recording. RACE-LAB is also intended to facilitate recurring interactive processes, such as the transfer of objects from human to robot. Complex action sequences such as the interaction between human and machine will thus be safer and more dynamic with little programing effort.
Products with individual characteristics could also be manufactured with great economic efficiency and in an automated way at small and medium-sized companies, such as joineries or in medical technology – an absolutely unthinkable manufacturing process up until now.
An effective way to meet the ever-growing volume of traffic lies in the use of intelligent traffic control systems. An essential element of transportation stabilization is the intelligent control of light signal systems (LSS). A new LSS control procedure (VITAL) was developed, its effectiveness was demonstrated in simulation studies, and a patent application was filed. The technical feasibility and economic potential of this procedure was validated in a subsequent applied orientation phase.
AcListant led to the validation of a product that uses voice processing technology to extract information from the radio communications between air traffic controllers and pilots to improve existing pilot assistance systems. The end users for this product are air traffic controllers who coordinate approaching, taxiing, and departing traffic. The product can be integrated into existing air traffic control assistance systems as an additional module. The target customers for the product are German SMEs in the area of ATM as companies that want to adopt and market technologies within a short period of time. Transfers to related domains in which assistance systems support groups of people using voice communication, e.g. rail transport, shipping, fire services and police departments.
In this project, the effectiveness of a novel diabetes treatment that eliminates a certain element in the liver will be researched. This would improve insulin sensitivity in the liver and in other organs. The target molecule plays a key role in regulating the insulin signaling pathway and this provides us with a new approach for treating diabetes. The treatment approach could be a long-awaited alternative, especially for patients who cannot receive conventional standard treatments due to non-response or diabetic kidney damage.
The researchers in this project are seeking to introduce bispecific antibodies that have been optimized in several respects into the clinical treatment of prostate cancer and squamous cell carcinoma. The antibodies are made of components of two different antibodies and bind both to the cancer cells as well as to the immune cells, or T cells, which are then activated to kill cancer cells. Compared to bispecific antibodies available thus far, the new construct is intended to cause significantly fewer side effects and to be easier to administer for both the patient and doctor.
The KID2 biomarker technology will be developed further in this project to diagnose changes in human calcium balance with significantly greater precision than conventional, comparable procedures. For the first time, osteoporosis and other diseases associated with calcium, such as certain cancers (e.g. multiple myeloma) and kidney failure – all of which are challenges of an increasingly aging society – can be diagnosed safely, early, simply, and in a non-harmful way using the KID biomarker technology. The technical proof of concept of the KID biomarkers has already been carried out in the laboratory and in small scale clinical studies.