 Rokote Laboratories Finland Oy is developing a coronavirus vaccine and the clinical trials should start during 2023. The development of the company’s FINCoVac vaccine has been rapid as it is based on knowledge gained from long-term research. Despite this, the journey of a vaccine from innovation to a drug product takes years. The nasally administered FINCoVac 2.0 coronavirus vaccine developed by Rokote Laboratories Finland Oy is based on the expertise and cooperation of Professor Kalle Saksela, Academician Kari Alitalo and Academic Professor Seppo Ylä-Herttuala. After long-term research and development, the vaccine candidate developed by the professors in 2020 has since been refined into a new investigational product version, FINCoVac 2.1, which will soon enter larger-scale production for clinical trials. Vaccine development has been rapid since the basic structure of coronaviruses was already known Developing a vaccine typically takes at least a decade. However, coronavirus vaccines have entered the market at a faster rate than this, since researchers around the world have gathered plenty of information on previous coronaviruses, such as SARS-CoV-1 and MERS, even before the COVID-19 pandemic. Both of these viruses are close relatives of the SARS-CoV-2 virus that causes the COVID-19 disease. Based on this previous knowledge, it could be concluded which structures of SARS-CoV-2 can be used to achieve an immunological response. The vaccine by Rokote Laboratories Finland Oy is vector-based, meaning that it uses the adenovirus, which has been proven to be safe, as its vector. The vector contains a clone of the DNA strand of the coronavirus spike protein, but the vaccine does not contain the SARS-CoV-2 virus itself. In practice, this means that the ‘preparation instructions’ of the virus protein are delivered to the cells like in a COVID-19 infection, but the vector virus in the vaccine is harmless, as opposed to a real infection. With the help of the vaccine, the vaccinated person’s own cells are programmed to produce the virus protein, which activates the immune system to prepare for the virus that causes the disease. “The efficacy of conventional vaccines is based on viruses that have been weakened or inactivated, or they are based on purified surface proteins or parts of them that resemble the structure of the coronavirus spike protein, in the case of COVID-19. This stimulates the cells in the person’s immune system to produce antibodies against the virus or its surface structures. Conversely, the FINCoVac 2.1 vaccine uses a technique in which the cells of a vaccinated person start producing the spike protein themselves, which activates the production of antibodies,” Director of R&D Erkko Ylösmäki explains the mechanisms. Manufacturing vector vaccines is faster than conventional vaccines To prepare conventional vaccines, pathogenic viruses are either attenuated prior manufacture or fully inactivated following the manufacture. These steps require a lot of time to make sure the vaccine preparation is safe and does not cause disease in healthy people. The manufacturing of vector vaccines does not require these steps, which makes the process a bit more streamlined. “The FINCoVac 2.1 coronavirus vaccine is a biological medicinal product that is produced in a production cell line designed for this purpose. Manufacturing the vaccine candidates at laboratory scale is rapid as dozens of them can be made in a few months. However, testing the candidates is slow, since long pre-clinical trials are required to evaluate the efficacy,” Ylösmäki says. The manufacturing process of a biological vaccine requires expertise Now, Rokote Laboratories Finland Oy is ready for the manufacturing of the FINCoVac 2.1 coronavirus vaccine for clinical trial. The company selected a Belgian contract manufacturer that is specialised in biological medicinal products to manufacture its nasal vaccine. “At the moment, the production volume of our vaccine in our own laboratories is a few hundred millilitres, but the scale required for the first clinical trials is ten litres. For clinical trials, the vaccine must be manufactured following the EU’s Good Manufacturing Practice (GMP). This means that the investigational product should be manufactured in similar conditions to the vaccines already on the market. Laboratory conditions are not sufficient,” Ylösmäki explains. Taking the production of a biological vaccine from millilitres to dozens of litres requires experience and accuracy. Its manufacturing process is sensitive to even the smallest changes. This is why the purity of the components, and the stages of the production process must be tested and standardised especially carefully. The batch of vaccines manufactured will be tested with dozens of different tests so that the high quality and safety of the vaccine can be ensured. “Ensuring high quality and safety takes its time, and the process can’t be accelerated. It is important that people can trust that the vaccines are of high quality right from the early clinical trials,” Ylösmäki states. Vaccines are tested on people at many phases before applying marketing authorisation Once a sufficient amount of the vaccine has been manufactured and the tests show that it is clean and safe and has an appropriate shelf-life, the clinical trials begin. They ensure the safety and efficacy of the vaccine. At the first phase, the vaccine and its administration method are tested on a few dozen people.
“In the phase I clinical trial, we study the safety and adequate dose and administration method of the vaccine. In the trial, all criteria must be met before we can proceed to the next phase,” says Clinical Trial Manager Katriina Lavikainen. The clinical trials are strictly monitored, scientifically reliable, ethically conducted, and compliant with regulatory requirements. When all the required clinical trial phases have been completed, a marketing authorisation can be applied for with the European Medicines Agency. The application for marketing authorisation goes through an evaluation lasting several months that involves experts from all EU member countries. Once the marketing authorisation is granted, it is valid in all EU countries. Outside the EU, different countries have different marketing authorisation procedures, and Rokote Laboratories Finland Oy aims to bring its coronavirus vaccine to the global market. Further information: Erkko Ylösmäki Research and Development Director, Rokote Laboratories Finland Oy erkko.ylosmaki(at)rokote.com p. 040 5836604 Text: Anni Turpeinen Image: iStock
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 The nasal COVID-19 vaccine can suppress the infection before the symptoms even appear. People who are not infected would not spread the disease and the pandemic could come to its end. Rokote Laboratories Finland Ltd is one of the few European companies, if not the only one, developing a nasal vaccine. COVID-19 morbidity numbers remain high on a global scale. Even though currently available vaccines prevent the severe form of the disease, they have not been able to prevent the spreading of the coronavirus. “As long as we are unable to keep the coronavirus from spreading, there is a risk of new severe variants of the virus emerging. Moreover, we do not know how reoccurring illness or long covid, impact a person’s immune system. Therefore, it is important to develop a coronavirus vaccine that can prevent individuals from getting the infection and bring an end to the pandemic,” says CEO of Rokote Laboratories Finland Ltd Tuija Keinonen. The Finnish vaccine development company Rokote Laboratories Finland Ltd is a Kuopio and Helsinki based pharmaceutical company, which is developing a nasal COVID-19 vaccine. The vaccine consists of an adenoviral vector to which the spike protein gene of the SARS-CoV-2 virus has been transferred. The vaccine aims to program the cells of the nasopharynx to produce the SARS-CoV-2 virus spike protein that generates the immune response. The FINCoVac vaccine does not contain the SARS-CoV-2 virus itself. The nasal vaccine can prevent infection The administration method of Rokote Laboratories Finland’s vaccine is one of its most important benefits. The vaccine, which is administered into the nose in the form of a spray or drops, is expected to produce sterilizing immunity in the first entry point of the virus in the human body. This enables the virus infection to be suppressed before any symptoms appear. “The coronavirus typically infects the upper airways or, in other words, the nasopharyngeal mucosa. The purpose of the nasal vaccine is to form a strong immune defence in these mucous membranes to keep the virus from reproducing and prevent the infection. People who do not get infected do not spread the virus,” says R&D Director Erkko Ylösmäki. The mechanism of action of the available injectable vaccines is different than the nasal vaccines. Injectable vaccines generate in the bloodstream and in the lower airways an immune response mainly based on immunoglobulin G (IgG) antibodies, which provides protection against the severe form of the disease. “The weakness of injectable vaccines is their inability to form a strong immune defence on the nasopharyngeal mucosa. This enables the virus to reproduce in the nasopharynx of vaccinated individuals, cause symptoms and even spread before the immune system can rectify the situation. The aim of the nasal vaccine is to stop the virus in the first point of entry, specifically on the nasopharyngeal mucosa, by significantly improving the mucosal immunity based on IgA antibodies,” Ylösmäki explains. Easy administration is a benefit of nasal administration Injectable vaccines as primary vaccines have been effective particularly in terms of protection against the severe form of the disease. That said, it might be possible to attain more effective protection with a nasal booster after the primary vaccination. As such, the most important benefit of the nasal spray or drop vaccine is expected to be their ability to preventing the spreading of the pandemic, compared to the injectable vaccines. Nasal administration is also painless and therefore more convenient than injection. “There are still areas and countries in the world that have not even started the first round of vaccinations. In these countries, nasal administration could be an economical, ecological and safer vaccination method – perhaps even the only possible one,” Keinonen says. Clinical assessment of efficacy is challenging Even though the benefits of the nasal vaccine are clear, developing it is not easy. The nasal mucosa has evolved to handle pathogens, and the natural defence mechanisms of the nose effectively expel foreign materials from the upper airways. This makes it challenging to get the vaccine’s spike protein gene through the barrier to activate the immune cells in the nasopharynx. Another development challenge stems from the assessment of clinical correlates of efficacy. In the current clinical trials, the efficacy of nasal vaccines is evaluated using the clinical correlates of efficacy established with injectable vaccines. “This means that even though the nasal vaccine primarily impacts the amount of mucosal IgA antibodies that neutralise the virus, the current clinical trials correlate the clinical efficacy to the amount of the serum IgG antibodies that neutralise the virus and are primarily affected by the injectable vaccines. Even the authorities are currently unsure as to the kinds of indicators and correlations to use for ensuring clinical efficacy of nasal vaccines,” Ylösmäki describes. According to the view of the European Medicines Agency EMA, the nasal vaccine must undergo phase III efficacy studies if a correlation with the effects of approved vaccines cannot be demonstrated. Europe’s vaccine self-sufficiency brings security On a global scale, roughly 50 mucosal COVID-19 vaccines are under development, 20 of which are in the clinical phase. According to the Mucosal Vaccines for SARS-CoV-2: Scientific Gaps and Opportunities workshop (11/2022) organised by NIAID (19, BARDA (2), BMFG (3), The Wellcome Trust and CEPI (4), Rokote Laboratories Finland Ltd is currently the only European pharmaceutical company developing a nasal vaccine. This is significant in terms of Europe’s vaccine self-sufficiency and emergency supply. “There are three nasal vaccines in the world that have been granted marketing authorisation. We do not know when they will be authorised in Europe if applications are submitted or whether authorisation will even be granted upon applications. The coronavirus has proven its adaptability and virulence many times over, and the world will not be able to manage with one or two vaccines. Nasal vaccines will also be needed to prevent new virus epidemics, and that also motivates us to continue our groundbreaking development work,” Keinonen says. Upon release into the market, Rokote Laboratories Finland’s vaccine will be as up to date as possible in terms of variant coverage. The clinical trials of the vaccine is planned to begin in 2023. 1 NIAID: National Institute of Allergy and Infectious Diseases 2 BARDA: Biomedical Advanced Research and Development Authority 3 BMFG: The Bill and Melinda Gates Foundation 4 CEPI: Coalition for Epidemic Preparedness Innovations Further information:Tuija Keinonen CEO, Rokote Laboratories Finland Oy tuija.keinonen(at)rokote.com p. 050 555 1541 Erkko Ylösmäki Research and Development Director, Rokote Laboratories Finland Oy erkko.ylosmaki(at)rokote.com p. 040 5836604 Text: Anni Turpeinen Image: iStock Rokote Laboratories Finland Ltd received funding from Sitra to prepare decentralised clinical trial15/12/2022  The purpose of the funding granted by Sitra is to expedite the popularisation of decentralised and virtual research methods in Finland. Rokote Laboratories Finland Ltd will use the funding to prepare a research plan and application for a phase 1a clinical trial of a nasal COVID-19 vaccine. The efficacy and safety of pharmaceuticals are studied by means of clinical trials. Traditionally trial subjects visit the trial sites multiple times for laboratory and other examinations and to obtain the drugs being studied. Decentralisation and virtuality provide new implementation methods for clinical research, which will facilitate participation, increase the amount and quality of research data and reduce costs. Decentralised clinical trials utilise physical and digital methods that are not dependent on time and place, such as measurements conducted at home. This means that trial subjects do not always need to travel to the trial site and the investigators gain more measurement and research data at an increased frequency. Funding to be used to build basic structures for clinical trialsRokote Laboratories Finland Ltd is developing a nasally administered adenovirus-based COVID-19 vaccine to which the spike protein gene of the SARS-CoV-2 virus has been transferred. The vaccine aims to programme the cells of the nasopharynx to produce the SARS-CoV-2 virus spike protein that generates the immune response. The company will use the Sitra funding to plan a phase 1 a decentralised trial and prepare the permit application documentation for it. “The phase 1a trial is the first time our vaccine will be tested on humans. It will study the functionality and administration method of the vaccine among a smaller group of subjects before the larger phase 1 clinical trial, and it will be used for deciding on the administration methods used in the later clinical trials,” explains Katriina Lavikainen, Clinical Trial Manager at Rokote Laboratories Finland Ltd. The preliminary screening of those interested in participating in the phase 1a clinical trial and the process of requesting their consent will be carried out through online services. In addition to this, the trial subjects can, as an example, record body temperatures and any symptoms brought on by the vaccine in a mobile app, which transfers the data to the trial database. This enables the investigators to stay up to date on the condition of the subjects and contact them if necessary. Only some of the measurements as well as the laboratory tests and regular medical examinations will be conducted physically at the trial site. “There is an increasing number of digital methods and applications for decentralised clinical trials, and they are becoming more commonplace on a global scale. This clinical trial is the first of its kind for Rokote Laboratories Finland Ltd, and we want to take a pioneering approach in designing it from the start,” Lavikainen says. Finland has what it takes to become a trailblazer in health data usageDecentralised clinical trials have long been a hot topic in international discussion, and countries such as Sweden and Denmark are actively promoting the new research methodology. Digital methods are also utilised elsewhere in the world to a substantial degree; for example, consent for participation is usually provided through online services. Finland’s comprehensive health data, digitally literate citizens and innovation-friendly authorities are helping to increase the prevalence of decentralised clinical trials. Successful decentralisation shifts the focus to the research itself, supplements the range of methods and strengthens Finland’s position in the field of clinical trials. “Sitra’s goal is to build the health care and social welfare sector in Finland into a pioneer in the usage of health data. This will provide the population with health benefits and boost society’s economic growth. We also want to promote Finland’s active role in sustainable digital development within the European region,” says Johannes Ahlqvist, specialist for Sitra’s Health Data 2030 project. The funding is significant for Rokote Laboratories Finland LtdThe funding granted by Sitra is very important for Rokote Laboratories Finland Ltd. The use of decentralised and virtual methods in future clinical trials will improve data quality, provide up-to-date information on the condition of the subjects, facilitate recruitment, and increase the convenience to the trial subjects.
“It is great that we can be involved in developing and deploying these new and advanced operating methods,” says Tuija Keinonen, CEO of Rokote Laboratories Finland Ltd. For further information, please contact: info@rokote.com media@rokote.com Text: Anni Turpeinen Rokote Laboratories Finland Ltd has decided to update its intranasal vaccine because the SARS-CoV-2 BA.4 and BA.5 virus variants have become more common. Therefore, the launch of the clinical trials will be moved to 2023.
SARS-CoV-2 appears to be here to stay and able to evolve into new virus variants. Neither any of the currently available vaccines nor a previous SARS-CoV-2 infection gives sufficient protection against infection by the new variants. A preclinical evaluation of the current version of the vaccine developed by Rokote Laboratories Finland Ltd demonstrates comprehensive protection against the most common virus variants as well as the first Omicron BA.1 variant. However, the ability of the latest BA.4 and BA.5 variants to evade the immune response induced by BA.1 has created a new challenge for vaccine development, and Rokote Laboratories Finland Ltd considers it important to respond to this challenge with an updated vaccine. “We believe that the vaccines based on the Omicron BA.1 variant that are being currently developed will already be outdated in terms of the epidemiological situation when they enter the market. Even though the postponement of our clinical trials is regrettable, we believe it is necessary that the variant coverage of our vaccine is as up to date as possible when it enters the market,” say the founders of Rokote Laboratories Finland Ltd, Professors Kalle Saksela and Seppo Ylä-Herttuala. “The original goal of the company was to develop a new generation vaccine, the likes of which is not available on the market yet. Since we have learned during the COVID-19 pandemic that the virus has a substantial ability to transform and to retain its virulence, despite all the measures societies have taken so far, it has become another key goal for us to ensure the efficacy of the vaccine far into the future,” says CEO Tuija Keinonen. For further information, please contact: info@rokote.com media@rokote.com |
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Rokote Laboratories Finland Oy
Y-tunnus: 3155372-4 VAT: FI31553724 |
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Rokote Laboratories Finland Ltd
Business ID: 3155372-4 VAT no: FI31553724 |