Pevion’s therapeutic Candida vaccine shows robust systemic and mucosal immunogenicity
Pevion Biotech AG announced latest results from the ongoing clinical study of its therapeutic candida vaccine PEV7, showing high levels of specific antibodies and a 100% mucosal immune response rate. The announcement further included the results of the largest, international representative epidemiological survey to date on recurrent vulvovaginal candidiasis (RVVC), confirming that 7% of adult women suffer from the disease.
The newly announced data come from the group of volunteers vaccinated with the intramuscular high dose of PEV7 and showed significantly increased immunogenicity over the previously vaccinated low-dose group, while confirming the excellent safety profile customary for virosome-delivered vaccines. Particularly relevant for the postulated mode-of-action of PEV7 was the strong immune response detected in vaginal and cervical samples. All volunteers showed a mucosal immune response with consistently high titers across the group.
“An immune response of this magnitude in the cervicovaginal compartment is very encouraging with regards to the therapeutic potential of the vaccine”, stated Jean-Paul Prieels, former Head of Vaccine R&D at GlaxoSmithKline and recently elected Board Member at Pevion. “After seeing the first positive immunogenicity data from the low dose group, we defined criteria on what immunogenicity outcome we would regard as best case for the high dose. We are delighted that these criteria have been met in full. We are now following the level of immune response over time and see first promising signs in terms of mucosal antibody persistence”.
In order to further validate the disease burden and the commercial potential of PEV7, Pevion mandated the largest, international representative epidemiological survey on RVVC among 6’000 women, generating robust data on prevalence, incidence and the age structure of the RVVC patient population. The study was performed in the US and the five largest European markets by Ipsos Health, a leader in the field of independent market research.
“The consistency of the Ipsos survey results across countries and with previous studies is very convincing. RVVC is a common problem throughout the Western world.” says Prof. Betsy Foxman, a leading RVVC epidemiologist from the University of Michigan School of Public Health, Ann Arbor, USA. “41% of women surveyed reported a least one episode of vulvovaginal candidiasis. Of those, one in five had a 12-month period with 4 or more yeast infections. Therefore, PEV7 has the potential to address a strong unmet medical need.”
“PEV7 is a first-in-class therapeutic vaccine to address this widespread and highly debilitating disease”, states Evert Kueppers, CEO of Pevion. “Based on the positive data from our clinical study, we advance both product and business development activities for the PEV7 program at full speed”.
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