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2021-12-08

Analysis ExpreS2ion Biotech: Solid data open for final phase

Detta är en betald analys på uppdrag av ExpreS2ion Biotech Holding utförd av Analysguiden

Bavarian Nordic releases first phase 2 data
In a first readout from Bavarian Nordic’s phase 2 study of ABNCoV2, the COVID vaccine candidate licensed from AdaptVac, 103 tested subjects showed a variety of responses to a single-shot booster dose. In one of the groups receiving the 100-microgram dose, antibody levels to the Wuhan virus variant increased by a substantial 40 times (40-fold) two weeks after injection of the vaccine.

In another group receiving the same dose, levels of antibodies only doubled. These different reactions to ABNCoV2 are related to the baseline values, i.e. how antibody levels were on day 0 before receiving and reacting to the shot. As for patients infected with the Delta variant, the currently dominating strain of the virus, the boost to the immune system was less pronounced, but still a solid 21-fold increase in patients with no protection to the virus.

Solid comparison to competitors
After the initial COUGH-1 trial with ABNCoV2, sponsored by a consortium including ExpreS2ion Biotechnologies, a very potent profile was communicated suggesting potential for a superior potency to the currently marketed mRNA vaccines. However, as the program progresses, we are now looking more for a non-inferior profile.

We would speculate that the edge of the ABNCoV2 vaccine candidate is to be found outside short-term efficacy, such as the possibility of long-term immunogenicity and safety. No serious adverse events have been observed in the human trials with ABNCoV2.

Design of phase 3 still pending, fair value unchanged
The latest spreading variant of the SARS CoV2 virus, named omicron, has so far not been tested in a vaccine study. If this variant becomes dominant in 2022, we believe it may impact the design of the upcoming phase 3 study of ABNCoV2, potentially providing the Bavarian candidate with another edge. However, CEO Paul Chaplin also referred to potential difficulties finding an active comparator for the pivotal phase 3 study.

Bavarian Nordic expects starting a phase 3 trial in first half of next year and, assuming everything goes well, submit the product for approval before year-end. This may allow the company to receive preorders for 2023, booked in 2022. We still find this scenario a bit stretched and stick to a first order in 2023. Our fair value for ExpreS2ion Biotechnologies remains unchanged at SEK 60.

Författare Analysguiden