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Instituto de investigación clínica ucraniano busca socios comerciales y fabricantes para la producción a gran escala de vacunas basadas en células dendríticas

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOUA20180907001
Publicado:
27/09/2018
Caducidad:
28/09/2019
Resumen:
Un instituto de investigación clínica ucraniano desarrolla nuevas tecnologías de inmunoterapia para aprovechar células dendríticas (CD) y otras nanopartículas o partículas inmunes en intervenciones terapéuticas en una amplia variedad de tipos de cáncer. Las vacunas basadas en células pueden combinarse perfectamente con otros enfoques inmunooncológicos y permiten desarrollar nuevas terapias combinadas contra tumores difíciles de tratar. El instituto de investigación busca compañías del sector de biotecnología para desarrollar un proceso de producción a escala comercial conforme a las Buenas Prácticas de Manufactura y entrar en el mercado médico. La colaboración se establecerá en el marco de un acuerdo comercial con asistencia técnica.

Details

Tittle:
Ukrainian clinical and research institute is looking for business and manufacturing partners for large-scale production of vaccines based on dendritic cells thought commercial agreement with technical assistance
Summary:
Ukrainian research and development clinical institution that elaborated new immunotherapeutic technologies which focus on the harnessing of dendritic cells (DCs) and other immune and nanoparticles for therapeutic interventions in a wide range of cancers is looking for commercial agreement with technical assistance with partners/ biotech company to develop a GMP-grade commercial-scale production process to enter the medical markets.
Description:
Ukrainian research and development clinical institution was established in 1920. Now it is the leading organization in the country which conducts cancer research on the basic, translational and clinical levels.
R-Y-D Department of the organization has made forces to elaborate new immunotherapeutic technologies which focus on the harnessing of dendritic cells (DCs) and other immune cells as well as nanoparticles for therapeutic interventions, which may be an effective tool for the treatment of a wide range of cancers. Cell-based cancer vaccines can be combined well with other immuno-oncology approaches, to make possible the development of disruptive new combination therapies against hard-to-treat tumor types.
Cancer is still the number one killer disease in the human population and its prevalence will continue to increase with the aging population. There is an immense unmet medical and industrial need to identify effective means for cancer management in addition to other therapies, such as targeted and chemotherapy. Cancer vaccines are amongst the most promising as responses that are triggered by these vaccines reduce the chances for recurrences that inevitably occur in many cancer types. With cancer vaccines, the immune system is stimulated to destroy tumor cells by presentation of tumor-specific antigens to immune effector cells. This can be achieved through infusion of patient-based dendritic cells (DCs) that carry the tumor antigens.
NCIU put forward a high-potential off-the-shelf DCs vaccine. Vaccine technology is characterized by the two cycles of innovation, which consist of DCs activation, maturation, and loading with tumor antigens, and could overcome obstacles associated with the DCs loading by tumor antigens. The competitive advantages of the proposed immunotherapeutic technology will be driven by increased simplicity, safety, and efficiency, as well as decreased laboriousness and expensiveness. Initially exploiting the same platform, the organization is developing cell-based vaccines against different types of cancer.
The high therapeutic effectiveness of this technology has been demonstrated in pre-clinical and clinical settings. The vaccine has shown in clinical studies to be safe and well-tolerated, and they do induce antigen-specific T cells responses which are exactly the desired effect. Obtained results have shown that DC-based cellular immunotherapy enhanced 10-years overall survival (OS) and event-free survival (EFS) in patients with IIIA stage non-small cell lung cancer. Thus, the 5-years OS rate was 44,4% vs. 30,4% and the 10-years OS rate - 30,3% vs. 13,8% in DCs vaccine and control groups respectively (p=0,009); HR=0,60; 95: CI = 0,43-0,85. For patients in DCs vaccine group, the 5-years EFS rate was 42,8 % in contrast to 23,5 % in patients of control group (p=0,0085). At 10-years follow-up, the difference in EFS rates between two groups remains statistically significant: 22,6% vs 10,5 % (p=0,0032); HR=0,58; 95: CI = 0,42-0,80.
These exciting results provide the rationale for the preparation of vaccine batches for clinical phase III studies and beyond, and also start clinical studies in other cancer indications. The execution of clinical studies requires large batches of DCs vaccines that are cultured under GMP conditions. These batches will provide the material volume needed to treat patients in the clinical study setting and will create the potential to produce the vaccines in quantities needed after product approval. Recognizing the unmet needs described above and anticipating the commercial opportunities, there is a need to develop a GMP-grade commercial-scale production process for DCs vaccines for the treatment of lung cancer as well as other cancer indications. The organization is looking for biotech and pharmacy companies to develop a GMP-grade commercial-scale production process to enter the Ukrainian and neighboring countries medical market.
Advantages and Innovations:
Vaccine technology is characterized by the two cycles of innovation, which consist of DCs activation, maturation, and loading with tumor antigens, and could overcome obstacles associated with the DCs loading by tumor antigens. This approach allows avoiding a number of shortcomings associated with peptides use such as risk of inducing tolerance, weak DCs activation, proteolytic degradation and reduction of the rapid turn-over of surface MHC/peptide complexes. The competitive advantages of the proposed immunotherapeutic technology will be driven by increased simplicity, safety, and efficiency, as well as decreased laboriousness and expensiveness. Furthermore, cell-associated antigens are efficiently cross-presented in MHCI, while also providing CD4 epitomes that avoid generation of "helpless"¿ CD8+ T-cells. Moreover, additional activation of DCs occurs by contact with danger-associated molecular patterns (DAMP) and free radicals which formed due to mechanical modification of microparticles of tumor cells.
Stage of Development:
Available for demonstration
IPs:
Patents granted
CommeR Statunts Regarding IPR Status:
Ukrainian institution as an owner of the vaccine is expected to get trade mark number till July 2019 (the registration is in the process).

Partner sought

Type and Role of Partner Sought:
Type of Partner: pharmaceutical laboratory, biotech and pharmacy companies.
Type of agreement: commercial agreement with technical assistance.
Institution is looking for partners to develop a GMP-grade commercial-scale production process to enter the medical markets.

Client

Type and Size of Client:
R&D Institution
Already Engaged in Trans-National Cooperation:
No
Languages Spoken:
English
Russian

Keywords

Technology Keywords:
06002002 Biología celular y molecular
06001003 Citología, cancerología, oncología
06004 Micro y nanotecnología relacionada con las ciencias biológicas
06001006 Vacunas humanas