Summary
- Profile Type
- Technology offer
- POD Reference
- TODE20230217007
- Term of Validity
- 17 February 2023 - 16 February 2025
- Company's Country
- Germany
- Type of partnership
- Investment agreement
- Research and development cooperation agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- A German university has developed a biomarker that allows continuous monitoring of "high zone tolerance" of hemophilia patients treated with a specific protein replacement therapy. The university is offering both a licensing agreement and technological cooperation agreement.
- Full Description
-
Hemophilia A is an X chromosome-linked inherited bleeding disorder with an incidence of 1 in 5,000 male births. It results from mutations of the F8-gene coding for coagulation factor VIII (FVIII) causing low plasma levels or activity of the FVIII protein. Patients with hemophilia A suffer from lifelong bleeding tendencies including spontaneous or traumatic bleeding episodes. Most patients receive protein replacement therapy with plasma-derived or recombinant FVIII, administered by intravenous infusion. The main complication regarding this therapy is the formation of neutralizing anti-FVIII antibodies that occurs in approximately 30% of patients with severe hemophilia A. Such antibodies neutralize the infused FVIII protein, leading to increased hemophilia A morbidity and mortality.
To overcome this complication, the standard approach to induce FVIII-specific tolerance is the so-called immune tolerance induction therapy (ITI). ITI involves repetitive injections of high doses of FVIII with or without bypassing agents. This approach is reminiscent of an immunological phenomenon described almost 50 years ago termed “high-zone tolerance”, which denotes the empiric observation that repetitive application of large antigen doses often induces immune tolerance. However, approximately 20-40% of patients undergoing ITI do not achieve long-lasting peripheral tolerance.
The invention of a German university provides a biomarker that allows continuous monitoring of the patients‘ responses to the aforementioned therapy. It also serves as a risk assessment tool to monitor FVIII inhibitor development.
The university offers companies in the diagnostic industry a licensing agreement. If there is interest in further development of the process, the university also offers technological cooperation. - Advantages and Innovations
-
- Novel biomarker for development of neutralizing anti-drug antibodies
- Biomarker can be measured in an easy and objective way
- Enables continuous monitoring of therapeutic response
- Allows risk assessment for failure of immune tolerance induction treatment
There are more than 240,000 hemophilia A patients worldwide (Annual global survey, world federation of hemophilia, 2020). The global FVIII market is estimated to grow to USD 11 billion in 2021 (Global Factor VIII Deficiency Treatment Market 2017-2021, Technavio). Due to the development of alloantibodies against FVIII, 30% of these patients require immune tolerance therapy. Costs for immune tolerance therapy are estimated at EUR 1 million / year. Hence, the method offered by the invention to closely monitor therapeutic success of FVIII treatment and ITI meets substantial medical and economic needs. - Stage of Development
- Lab tested
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
- IPR status
- IPR applied but not yet granted
- IPR notes
- Applied at the Europen and US patent office.
Partner Sought
- Expected Role of a Partner
- The university offers companies in the diagnostic industry a licensing agreement. If there is interest in further development of the process, the university also offers technological cooperation.
- Type and Size of Partner
- SME <=10
- SME 50 - 249
- Big company
- SME 11-49
- Other
- Type of partnership
- Investment agreement
- Research and development cooperation agreement
Dissemination
- Technology keywords
- 06001005 - Diagnostics, Diagnosis
- Market keywords
- 005001008 - Diagnostic test products and equipment
- 05001001 - Diagnostic services
- Targeted countries
- All countries
