Transcription of the interview with Dr. Gillian Martínez Donato in the informative program En tiempo real, of the Caribbean Channel, of Cuban television
What is the current state of Jusvinza’s clinical development?
First of all, I would like to say that Jusvinza is not a vaccine, it is an innovative therapeutic product developed by the Center for Genetic Engineering and Biotechnology (CIGB). The active ingredient of this product is a 27 amino acid peptide, which is nothing more than a fragment of an intracellular protein: the 60 kilodalton cellular stress protein. This protein is overexpressed upon stress in the organism and passes from the inside of the cell to the outside of the cell. This stress could be a viral infection. This causes an inflammatory response in the body. This protein is related to the pathogenesis of many autoimmune diseases and also to hyperinflammation; that is, it is related to diseases in which hyperinflammation occurs, a cytokine storm that can lead to respiratory distress in patients, multiple organ failure and, as a consequence, death. This was specifically what happened during the COVID-19 pandemic in critically ill patients, where Jusvinza was used with very good results. The product increased the survival of these patients and kept the lethality of the virus at very low levels; even at levels less than half of what was reported at that time in the world. These results were achieved not only with Jusvinza, but also with other products that were included in the COVID-19 protocol, which also contributed to maintain the lethality at very low values and to reduce mortality during the pandemic.
Jusvinza was obtained using bioinformatics tools. We predicted an epitope (molecule) responsible for the contact of this protein with the immune system to induce this inflammatory response; in other words, we could modify this molecule and in this way control the immune response, and somehow turn off this hyperinflammatory response that was related to the severity of numerous diseases.
Currently the clinical studies they are developing with Jusvinza are designed to treat autoimmune diseases, specifically rheumatoid arthritis. The Phase I clinical study in patients with rheumatoid arthritis with moderate activity, led by doctors from the Instituto de Diez de Octubre, specifically Dr. Dinorah, Dr. Jorge Alexis and Dr. María del Carmen Domínguez, the latter from the CIGB, who is the scientific leader of the product and has been involved in the development of the molecule since its inception, was carried out a few years ago. This Phase I clinical study showed that the product is safe and that it reduces the inflammatory response that is present in patients with rheumatoid arthritis at the joint level and that it contributed to improving the patients’ quality of life by more than 70%, compared to the same patient before receiving the product. All these positive results made it possible to initiate a Phase II clinical study. The first study was conducted with the product alone and showed that it modulates the inflammatory response and improves the patients’ quality of life. The Phase II clinical study is more comprehensive, more controlled, and the product was combined with methotrexate (which is the gold standard product for the treatment of rheumatoid arthritis) and is how it is generally used. The products that are on the market are almost always used in combination with these disease-modifying compounds.
And now we are already in clinical phase III?
The results of the Phase II clinical studies were very positive; several doses of the product were even tested. The Cuban regulatory entity for medicines and medical equipment (CECMED) had granted a very important conditional registration to Jusvinza, which allows the controlled use of the product. It is controlled because it can be used specifically by those patients who most closely resemble the patients who used it during the clinical studies. That is why it is a very controlled and conditioned study, because it is conditioned to the completion of a Phase III clinical study, which is currently taking place in the western and central provinces of the country. Once this phase III clinical study is completed, we can obtain a definitive registration of the product for its massive use throughout the country.
What has been the impact of Jusvinza internationally?
Before talking about the impact of Jusvinza at international level, I would also like to refer to an intervention study, specifically in this indication of rheumatoid arthritis, which is taking place at the same time as the Phase III clinical study in the western and central regions, and in the eastern provinces and Camagüey. It is an intervention study, whose design was endorsed by the CECMED which is our regulatory entity. The data are real world evidence that contribute with useful information so that later a definitive registration of the product can be granted. The role of physicians and patients was very important for the success of this study. It is culminating in Santiago de Cuba, and the results are very positive, because the patients show an improvement of 88 % in relation to the patients before receiving the treatment. These are very interesting data that validate all this action.
With one of the most important companies in China, we hope that this year or next year, clinical studies will begin in China in the indication of rheumatoid arthritis, and we are also making great efforts to introduce this product in Europe and other countries that have shown interest in the results obtained with the application of the product.
Exactly, with COVID-19 it was necessary to scale up the active ingredient of this product. We have reached a production capacity of 1 kg per year and we have expectations of reaching up to 5 kg; but we have also developed and manufactured batches under Good Manufacturing Practices (GMP) conditions; in other words, ready to use the product with standards valid for the first world, standards that make it easier for us to start a clinical study with Jusvinza in the world due to the quality with which it has been produced in our facilities in Europe.
Source: Jusvinza, otro logro de la biotecnología de Cuba. En Tiempo Real Television Program.
Date: February 8, 2024
Conductor: Esther Lilian González
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