Pevion's Therapeutic Candida Vaccine Shows Robust Systemic and Mucosal Immunogenicity, While Epidemiological Survey Confirms Excellent Market Potential
BERN, Switzerland,
October 11, 2011/PRNewswire/ --
Pevion Biotech AG
today 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."
About RVVC
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.
About PEV7
therapeutic Candida vaccine
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 Sanita (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(R) and Inflexal(R)
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.
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
outlicensed, and the Company's technology has been 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 its founding fathers, 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
visit http://www.pevion.com
For further
information, please contact: Julian Wagner, PhD, Business
Development, Phone: +41-31-550-44-44, info@pevion.com
Source: Pevion Biotech AG
Posted: October 2011
