Objective
The main objective of this project is to demonstrate that our biotechnological product, our plasmovirus expressing Apoptin(r):
- is effective and safe in animal cancer-models and - can be produced at an industrial scale. - to be able to initiate and raise funds for Phase I and II clinical trials with patients suffering cancers
The project brings together three SME's, LEADD BV, Leiden, The Netherlands, GENOPOIETIC/SARL, Paris, France and BIOTECNOL, Lda, Porto Salvo, Portugal. All SME's originated and developed in the vicinity of academic centers of excellence. Two Universities, PIERRE ET MARIE CURIE UNIVERSITY, Paris, France and LEIDEN UNIVERSITY, Leiden, The Netherlands, both harboring an Academic Hospital are partner in this project..
GENOPOIETIC/SARL has generated the novel gene transfer vector system, which is called plasmovirus. It combines the simplicity of plasmids, with the infectivity and long-term expression of retroviruses. The plasmoviruses represent a new generation of gene-therapy vectors, which should be easy to produce in large quantity as clinical grade materials and allow efficient and safe in-vivo targeting for tumor cells. GENOPOIETIC applied for an international patent on this know-how.
LEADD BV has generated the novel anti-tumor agent Apoptin(r), which is specifically active in malignant cells, but not in normal cells. Therefore, the toxic effect of an Apoptin treatment might be relatively low. The fact that Apoptin induces a p53-independent and Bcl-2-stimulated type of apoptosis suggests that Apoptin-treatment is possible for various types of tumors, among those resistant to chemotherapy. LEADD holds international patents on this know-how.
In the past months (Exploratory Award: BIO4-CT97-9064) the plasmovirus vector expressing Apoptin was successfully produced (Prototype-I). We demonstrated that it initiates production of Apoptin in tumor cells leading to apoptosis, but not in normal cells.
BIOTECNOL, Lda (below indicated as BIOT) has expertise in the field of genetic and metabolic optimization of plasmids and expression systems. Its expertise in this applied area will provide the project valuable know-how regarding production and optimisation of industrial-scale production.
This demonstration project will envisage the efficacy and safety of the Prototype-I as anti-tumor agent. Animal models based on the chemoresistant melanoma and on immunogenic-responsive liver tumors will be used. The Prototype-I will be combined with the chemotherapeutic agent cis-platin. To enhance immunotherapies, studies will be done in combination with a plasmovirus expressing IL-2, which is known to stimulate the immune system. The backbone of Prototype-I and its metabolic production aspects will be optimized. The studies on the protoptype I will lead towards an optimized prototype II, which will be used alone or in combination with cis-platin and/or expression of IL-2. A second round of efficacy and safety studies will be carried out. Finally, Prototype-II will be produced under GMP conditions and an initial Clinical Phase I/II Trial protocol will be written for the application of recombinant-Apoptin plasmovirus as an anti-tumor therapy in patients with metastatic melanomas.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences medical biotechnology genetic engineering gene therapy
- medical and health sciences clinical medicine oncology skin cancer melanoma
- medical and health sciences basic medicine immunology immunotherapy
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Coordinator
2300 RA LEIDEN
Netherlands
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