– Nasal vaccine against influenza
Eurocine Vaccines is a publicly listed, clinical-stage company developing nasal vaccines that meet important medical needs. The vaccines are developed up to proof of concept (clinical phase I/II) and licensed to partners for further development and commercialization. The company’s proprietary vaccine adjuvant technology Endocine™, which is a key element of the nasal vaccines, is also offered to license partners for development in various indications.
The company is currently focusing on the nasal influenza vaccine program, Immunose™ FLU, and plans to start a clinical study in the autumn of 2016.
Immunose™ FLU is being developed as convenient nose drops in single dose plastic pipettes.
Immunose™ FLU – an influenza vaccine candidate for children and adults
Immunose™ FLU is Eurocine Vaccines´ lead development program. It is a nasal inactivated influenza vaccine adjuvanted with Endocine™. Immunose™ FLU is profiled as a safe and effective influenza vaccine candidate for children from 6 months. The pediatric segment is the fastest growing segment of the influenza vaccines market with a clear unmet medical need for a safe and effective vaccine. Young children have recently been identified as a risk group for severe influenza infection but the vaccines approved for use in children from 6 months have this far shown limited protective effect.
Immunose™ FLU has been tested in a phase I/II study where it showed good safety results and an immunological response. The vaccine has also been studied in a ferret challenge model to evaluate protection. The ferrets in the study were naïve, i.e. have not been exposed to influenza infection or influenza vaccines previously. It is more difficult to induce a sufficient immune response in naïve individuals than in someone with a preexisting immunity. Young children are often naïve for influenza and this is believed to be a reason for the limited efficacy of the injected vaccines in this population. Immunose™ FLU gave complete protection from influenza challenge and significantly higher HAI and virus neutralization titers than the injectable control vaccine in the ferret study previously mentioned. The results indicate that Immunose™ FLU could have a better protective effect in children than today’s injectable vaccines.
Eurocine Vaccines plans to out-license Immunose™ FLU for further clinical development and commercialization.
The pediatric influenza vaccines market
Immunose™ FLU is profiled as a safe and effective influenza vaccine for children from 6 months. The pediatric segment is the fastest growing segment of the influenza vaccines market with a clear unmet medical need for a safe and effective vaccine.
The market driver for the pediatric influenza vaccine segment is a recommendation from WHO to vaccinate children aged 6 months to 5 years against influenza. This is based on evidence that children in this age group often contract influenza and that also healthy children have an increased risk of hospitalization due to influenza. With the new recommendation, Datamonitor estimates that vaccine coverage of children aged 6 months-18 years in the EU will reach 50% in 2019. The US has a general recommendation that everyone above six months of age should be vaccinated against seasonal influenza and the UK is implementing influenza immunization of all children 2-17 years of age.
Injected influenza vaccines have a lower efficacy in children than in adults since children are often naïve, i.e. have not been exposed to influenza infection or influenza vaccines. The live, attenuated influenza vaccine FluMist (Fluenz in the EU) has shown a superior protective effect in children compared to an injected influenza vaccine but is not approved for use in children under two years of age or children with severe asthma, due to side effects in those groups. At the same time, children under two and severe asthmatics are two of the most important risk groups for severe influenza infection among children. FluMist is priced at a price premium compared to other influenza vaccines.
Based on the efficacy data in ferrets and safety data from the Phase I/II study, Eurocine Vaccines believes that Immunose™ FLU has a potential to provide similar efficacy as FluMist but still be safe for children under two years of age and severe asthmatics. Immunose™ FLU should be able to demand a price premium compared to the injectable vaccines and generate increased revenues in the pediatric segment compared to the adults segment, provided that efficacy and safety can be demonstrated in clinical studies.