Fra Pareto - oppdatering i kveld;
Positive phase 2 data from vaccine partner
ReiThera today announced the preliminary safety and immunogenicity data from the phase 2 part of the phase 2/3 COVITAR trial with its Covid-19 vaccine. The adenoviral vector-based vaccine was well tolerated and induced a clear immune response in trial subjects. Antibody response against the SARS-CoV-2 spike protein was generated in 93% of volunteers after the first dose, reaching 99% after the second dose. These results are in line with both other adenovirus vector-based and mRNA vaccines and only indicates that the vaccine is doing what it is supposed to do. It says nothing about vaccine efficacy as this will be tested in the upcoming phase lll part of the study, involving close to 10,000 subjects. The phase lll part will be a non-inferiourity study against one of the viral vectored vaccines already on the market, i.e. probably AstraZeneca´s or JNJ´s (vaccines from Russian Gamaleya and Chinese Sinopharm are also adenoviral based but probably unlikely objects for comparison). So far, the viral vector-based vaccines have shown lower efficacy vs mRNA based vaccines, so it is difficult to address any commercial value for ReiThera´s candidate if they “only” are to show inferiourity to existing vaccines based on similar technology. ArcticZymes is delivering its SAN HQ enzyme to ReiThera for use in the manufacturing process. If the vaccine reaches the market, the volumes to be delivered by AZT could be very large. We view this deal as nice to have and icing on the ArcticZyme investment case. We have a Buy recommendation and a target price of NOK 135.
Phase ll positive, but does not say anything about the commercial prospect
The phase ll part of COVITAR enrolled 917 volunteers over the age of 18 with 25% of subjects being over the age of 65 and/or with conditions associated with an increased risk of severe disease in case of SARS-CoV-1 infection. Volunteers were randomized in three regimes (1:1:1), receiving either a single vaccine dose followed by a placebo dose, or two vaccine doses or two doses of placebo, with a three-week interval between the two administrations. The preliminary results showed that the vaccine was doing the trick and generated antibody responses (seroconversions) against the SARS.CoV-2 spike protein in over 93% of volunteers after the first dose, climbing to 99% after the second dose.
Phase lll part to commence shortly
According to clinicaltrials.gov, Reithera originally had three options for the design of the phase lll part; two superiority designs vs placebo and one non-inferiourity design. Everything hinged on the evolution of the pandemic and availability on the market of alternative vaccines. Given the fact that we now have a handful of vaccines on the market, the non-inferiourity design had to be chosen. The phase lll program will measure non-inferiority on a primary immunological end-point in comparison with a viral vectored vaccine already on the market. This means that this study will be completely different vs the ones conducted originally by, Pfizer/Bionthech, Moderna, JNJ, AZT and others. The study has received a positive opinion from the EMA and other important regulatory agencies. ReiThera hopes to start the phase lll trial shortly. We currently do not know how many countries and sites to be involved in the phase lll part of COVITAR. Showing non-inferiority could be seen as an easy task, but we have to remind investors of the changing landscape: existing viral-based vaccines were tested in an environment with different virus variants, while COVITAR will recruit subjects in an environment dominated by new variants, e.g. the fast-spreading delta variant.
