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”.

Recurrent vulvovaginal candidiasis (RVVC), also known as chronic recurrent thrush, is a largely unrecognized but highly debilitating condition, which affects 7% of adult women. It is defined as four or more acute episodes of symptomatic vulvovaginal candidiasis within a 12 months period. Clinical symptoms are vulvovaginal inflammation, most often dominated by severe itching, and other symptoms causing extreme discomfort and pain. The quality of life of RVVC patients is strongly impacted, both physically and psychologically. A significant proportion of patients suffer over many years without perspective for any amelioration or cure from permanently present painful disease symptoms, impeded activities including social life and work, partnership problems, and difficulties or impossibility to talk about it. Over time, accumulating frustration leads to loss of self esteem, desperation, and in approximately a third of patients, to depression. Cure rates of RVVC with available antifungal drug therapy remain disappointing and there is no treatment available to prevent recurrencies.

PEV7 is a therapeutic vaccine based on a protein antigen, Sap2, a key virulence factor of vulvovaginal candidiasis, presented on the surface of virosomes. Pevion exclusively in-licensed the Sap2 antigen from its academic partner, the Istituto Superiore di Sanità (ISS) in Rome, Italy.

The ongoing PEV7 Phase I study is designed to assess the safety and immunogenicity of the therapeutic vaccine candidate in healthy volunteers. Half of the subjects will receive intramuscular injections, while the other half will receive capsules, administered intravaginally. In total, the study will enroll 48 healthy women of childbearing age.

Virosomes are a regulatory and market-approved vaccine technology that fulfills carrier and adjuvant functions in one. Essentially, virosomes represent reconstituted empty influenza virus envelopes, devoid of the genetic material of the source virus. As such, virosomes do not replicate and are therefore an ideal combination of carrier plus adjuvant for almost any given antigen, including peptide or protein derived antigens. The technology enables the use of poorly immunogenic antigens and thereby provides access to new indications and markets. Two virosome-based vaccines (Epaxal and Inflexal V, marketed by Crucell Switzerland AG) are licensed in over 40 countries, and more than 70 million doses of these vaccines have been commercially distributed, thereby providing a solid safety and efficacy track record. Pevion has developed and owns the second generation of virosomes that have an excellent stability profile through lyophilization and allow alternative product formulations, such as capsules.

Pevion Biotech AG is a fully independent Swiss vaccine company that develops innovative vaccines for unmet medical needs based on its clinically and commercially validated virosome technology.