Pevion's Therapeutic Candida Vaccine Generates Functional B Cell Memory in all Vaccinees

BERN, Switzerland, January 17, 2012 /PRNewswire/ --

Pevion Biotech AG today announced further data from the ongoing clinical study of its therapeutic Candida vaccine PEV7, demonstrating the generation of specific and functional B cell memory in 100% of vaccinees. Furthermore, the results again confirm the capability of Pevion's second generation virosomal vaccine platform to induce strong and long-lasting immunity in humans against otherwise weak antigens.

Following the previously announced positive safety and immunogenicity results of PEV7, the Company further investigated the vaccine-induced generation of B cell memory. To this end, half of the group of volunteers vaccinated with the intramuscular low dose of PEV7 received a single booster immunization fourteen months after the primary vaccination course. All vaccinees showed a rapid, specific response either in serum or in cervicovaginal secretion or in both, after antibody titers had come down to baseline six months prior to the boost in this low-dose group.

"Based on analyses of antibody functionality, as monitored by competitive target inhibition, and antigen specific reactivity, we have evidence for an affinity maturation of these antibodies," explained Christian Moser, Head of Research at Pevion. "We are very satisfied to see such an excellent induction of memory by the PEV7 vaccine even at low dose, and we are now looking forward to obtain the results from the high-dose group. Moreover, this is the first time for a second generation virosome-based vaccine that we verified the generation of memory in humans by means of a booster immunization."

The follow-up of the group of volunteers vaccinated with the intramuscular high dose of PEV7 is ongoing and so far has shown high and persistent antibody titers until six months after completion of the vaccination course. In order to evaluate the intravaginal application of PEV7 in capsule form, an additional study arm is ongoing. First volunteers have already been safely vaccinated.

About PEV7 therapeutic Candida vaccine

PEV7 is a clinical-stage, therapeutic vaccine being developed for the treatment of recurrent vulvovaginal candidiasis (RVVC), a moderate-to-severe disease affecting 7% of all adult women. To date, there is no appropriate treatment for RVVC available. PEV7 is based on a protein antigen, Sap2, a key virulence factor of vulvovaginal candidiasis that is 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.

About Virosomes

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, which have an excellent stability profile through lyophilization and allow alternative product formulations, such as capsules.

About Pevion Biotech AG

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. Its proprietary clinical pipeline includes a first-in-class candidiasis vaccine. A clinical stage malaria vaccine candidate has been successfully out-licensed, and the Company's technology has been out-licensed for use as an HIV vaccine currently in human trials. Pevion has in-house development capability and expertise, including a state-of-the-art and industrially scalable GMP manufacturing process. Located near Bern, Pevion was established by two founding companies, Bachem AG (SWX: BANB) and Berna Biotech (now Crucell, a Johnson & Johnson subsidiary). To date, Pevion has raised a total of CHF 45 million from its founders and investors, BZ Bank, Bachem, BB Biotech Ventures and private investors.

For more information, please visit http://www.pevion.com

For further information, please contact:
Christian Moser, DVM, PhD, Head of Research
Phone: +41-31-550-44-44, info@pevion.com