IGEA is currently involved in the development of two SARS-CoV-2 DNA vaccines that will be delivered by electroporation. It is also providing the injection technology for a third vaccine, CORVax-12, currently undergoing human trials in the United States.
Opencorona The OPENCORONA ‘Rapid vaccine development through Open novel Coronavirus Vaccine Platform’ project is funded by the European Union under the call SC1-PHE-CORONAVIRUS-2020. The project is coordinated by Prof. Matti Sällberg of the Karolinska Institutet in Stockholm and involves IGEA as an industrial partner. As part of the OPENCORONA project, IGEA is responsible for the electroporation technology used to transfer part of the viral genome into cells in order to express a pool of viral proteins capable of activating a strong immune response against the SARS-CoV-2 virus. The project is currently at the pre-clinical stage, with the phase I/II clinical trial planned for the second half of 2021. https://ki.se/en/research/opencorona
Covid-eVax Covid-eVax is a DNA vaccine directed against the spike protein of the SARS-CoV-2 virus, responsible for COVID-19. In pre-clinical studies in animal models, Covid-eVax induced an immune response comparable to ten times that observed in the blood of patients who had recovered from COVID-19. The vaccine is currently in phase I/II clinical trials. The Covid-eVax vaccine will be entirely conceived, developed and produced by Italian companies. https://www.linkedin.com/company/takis/
CORVax12 CORVax12 is the only DNA vaccine that uses an immunostimulant to promote an immune system response against the SARS-CoV-2 virus. CORVax12 combines the delivery of TAVO™ (IL-12 plasmid) with that of DNA encoding for the viral spike protein or ‘S’ glycoprotein in order to increase the immunogenicity of the product developed at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center in the U.S. CORVax12 is designed to induce a coordinated vaccine response, capable of stimulating both humoral and cell-mediated immunity. This combined approach has the potential to generate a robust antiviral response. The vaccine is currently in clinical trials in the U.S.
Immunotherapy against hepatitis B virus (HBV)
Pre-clinical studies have shown that the DNA vaccine against the preS1 protein of HBV is effective in blocking HBV entry into hepatocytes. DNA vaccine administered by electroporation induces the formation of HBV-specific antibodies and T cells. Anti-HBV antibodies protect against infection in an animal model representative of human disease.
DNA-based cancer drugs are widely recognised as a new frontier in the field of cancer therapy. IGEA’s electroporation technologies are used for the delivery of the following DNA-based cancer therapies:
Cancer DNA vaccines represent a very promising strategy to induce a specific and long-lasting immune response against cancer antigens.
TERT vaccination Pre-clinical studies on B-cell lymphosarcoma in dogs have shown that the DNA vaccine targeting the enzyme telomerase is effective in activating a tumour-specific immune response and, in combination with standard chemotherapy protocols, significantly increases the survival rate of treated animals.
They consist of the administration of nucleic acids that encode for cytokines or factors capable of modulating the immune response in order to stimulate the patient’s immune system to recognise and attack the cancer.
Numerous pre-clinical studies and preliminary results of clinical trials (phase IIb KEYNOTE-695 trial for metastatic melanoma and phase II KEYNOTE-895 trial for triple-negative breast cancer) have demonstrated that immune-modulating therapies (in particular IL-12 based therapy, TAVOTM) can be an effective solution in the control of metastatic disease. Treatment can be administered either locally, via intratumoural injections in accessible nodules, or intramuscularly with systemic therapeutic intent.
A specific DNA sequence is delivered directly into the cells in order to allow the endogenous synthesis of monoclonal antibodies to attack the tumour or increase the effectiveness of the immune system.
A pre-clinical study performed in sheep shows that electroporation is an effective method of delivering plasmids encoding for monoclonal antibodies (pOVAC, encoding for ovine anti-CEA monoclonal antibody and pOVAE, encoding for ovine anti-EGFR monoclonal antibody). EGT enables sufficient serum antibody levels to exert a therapeutic effect.
Electroporation allows DNA encoding for proteins that exert an anti-tumour therapeutic effect to be delivered into cells.
Two phase I clinical trials demonstrated the safety, feasibility and tolerability of electroporation-mediated transfer of DNA encoding for anti-angiogenic metargidin peptide (AMEP) in patients with metastatic melanoma or advanced solid tumours.
Genetic disorders are caused by one or more abnormalities of the genotype, such as gene mutations or chromosome alterations. Many genetic disorders are the result of genetic changes present in every cell of the body. As a result, these disorders often affect many systems of the body and most cannot be cured. In some cases, approaches are available to treat or manage some of the signs and symptoms associated with these conditions. One potential curative approach for genetic diseases is gene therapy, which involves replacing the mutated gene with the normal gene.
Some of the most common genetic diseases include: cystic fibrosis, Huntington’s disease, Down syndrome, Duchenne muscular dystrophy and sickle cell anaemia.
Glycogen storage disease Type III
Glycogen storage disease type III is a rare genetic disorder (1 in 100,000 births) caused by a mutation in the AGL gene. This mutation causes the onset of a metabolic disease due to the deficiency of one of the enzymes involved in glycogen degradation, which manifests in the accumulation of glycogen in several organs, including the liver and muscles. The main clinical manifestations are liver failure and myopathy. IGEA is collaborating with ENEA (National Agency for New Technologies, Energy and Sustainable Economic Development) for the development of a safe and low-cost gene therapy for glycogen storage disease type III (GSDIII). In collaboration with Dr Franconi of the ENEA Biomedical Technologies Laboratory, a gene therapy will be developed that transfers the ‘normal’ gene by electroporation into the patient’s muscle cells. https://www.enea.it/it/Stampa/news/ricerca-enea-brevetta-nuovo-composto-per-il-trattamento-di-una-malattia-genetica-rara
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