Summary
- Profile Type
- Technology offer
- POD Reference
- TOTR20241125002
- Term of Validity
- 25 November 2024 - 25 November 2025
- Company's Country
- Turkey
- Type of partnership
- Commercial agreement with technical assistance
- Research and development cooperation agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- The product developed for CIN treatment as 3rd generation filgrastim which indicates superior properties compared to the existed reference/biosimilar products in efficacy, safety, and immunomodulation.
- Full Description
- The innovative design of product set a new class in filgrastim family by their structural and functional differences. Although the mechanism of action and targeted indication demonstrate similarity to prior generations of filgrastim, this product has signs to be defined as biobetter based on non-clinical and clinical findings obtained so far.
- Advantages and Innovations
- The innovation includes superiority in its structure, function, and production. In structural perspective, the product is designed with hyFc platform which adds a novel value in all filgrastim family therapeutics and thus, referred as 3rd generation. Former generations of G-CSF drugs, Neupogen ® and Neulasta ®, are compared to the product simultaneously in preclinical and clinical trials of I and II. Renal clearance of G-CSF is blocked and Fc of the product could bind to FcRn (neonatal Fc receptor) of endothelial cells in the human body, thereby enabling the recycle of hyFc-fused proteins resulting in the product with markedly longer half-life. Till current stage, clinical outcomes of the product indicated several advantages over Pegfilgrastim including no infection in patients and 1.5x faster neutropenia reduction period. In addition, the product is found comparable to Pegfilgrastim in terms of half-life. In the aspect of safety, the product demonstrated 1-4 times lower no-observed adverse effect level (NOAEL) value compared to Pegfilgrastim. In the same aspect, minimal immunogenicity and no anti-drug antibody (ADA) formation had been detected.
- Stage of Development
- Available for demonstration
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
- IPR description
- The Turkish Biotechnology Company seeks for co-operation in Phase III clinical trials and CMC partnership/s with businesses large and small including clinical research organizations (CROs). The Turkish Company will upskill the partner’s developer(s) and possible agreements will be secured with non-disclosure agreements (NDAs) between partner(s) and will be a part of the product commercialization.
Partner Sought
- Expected Role of a Partner
- The Turkish Biotechnology Company seeks for co-operation in Phase III clinical trials and CMC partnership/s with businesses large and small including clinical research organizations (CROs). The Turkish Company will upskill the partner’s developer(s) and possible agreements will be secured with non-disclosure agreements (NDAs) between partner(s) and will be a part of the product commercialization.
- Type and Size of Partner
- SME 50 - 249
- SME 11-49
- Big company
- Type of partnership
- Commercial agreement with technical assistance
- Research and development cooperation agreement
Dissemination
- Technology keywords
- 06001013 - Medical Technology / Biomedical Engineering
- 06001005 - Diagnostics, Diagnosis
- 06001012 - Medical Research
- Market keywords
- 05003001 - Therapeutic services
- 05005014 - Oncology
- 05001005 - Molecular diagnosis
- Sector Groups Involved
- Health
- Targeted countries
- All countries