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Novo Annual Report 2015
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a seed investment in
minervax
t he danish biotech company,
minervax
is developing a
vaccine
for the prevention of infection with group b streptococcus (
gbs
), a gram-positive bacterium that causes lethal infections or critical illness in newborns. these
gbs
infections occur as a result of mother-to-child transmission or from environmental sources. the introduction of screening for
gbs
during pregnancy, as well as extensive use of antibiotics during labour, has greatly reduced the incidence of
gbs
infections. however, despite these efforts,
gbs
infection still remains a significant unmet need. an estimated 15 to 20 per cent of women carry
gbs
and run the risk of transmitting the infection to their unborn child ? in the womb, during birth, or during the first months of the baby?s life. successful clinical testing
minervax
was founded in 2010, based on research into
gbs
immunology at lund university. at the end of 2013, novo seeds led the investment in
minervax
, supported by sunstone capital and lauritzen fonden. in addition,
minervax
received a grant from the european commission?s 7th framework programme (fp7), as part of a consortium of academic and sme partners, to fund clinical testing of the
gbs
vaccine
. these investments allowed
minervax
to start clinical testing in 240 healthy volunteers in the summer of 2015. the phase 1 trial represents a significant milestone for the company towards achieving clinical proof of concept by late 2016. ?we have excellent data for the
vaccine
in mice,? explains per fischer, d.phil. and ceo of
minervax
. ?so we know that the
vaccine
works conceptually and protects against
gbs
infections, and we?re expecting a high effect on immune response. by vaccinating with an antigen, we can measure how strong the immune response is, and thereby determine the therapeutic effect.? the initial part of the phase 1 clinical study, conducted in healthy, non-pregnant women, has shown that the
vaccine
is not only safe and well tolerated; it also generates a dose- dependent increase in antibodies against the bacteria. the next part of the trial will study the
vaccine
in a larger group of women, and explore how long lasting the immune response is. this is important to know in order to determine when the
vaccine
should be administered, to give the baby the best protection during the critical time before and after birth. nanna lüneborg, investment director in novo seeds, is impressed by
minervax
? progress ? particularly that they?ve managed to take their
vaccine
candidate to the point of clinical testing already. ?it?s an enormous credit to the team to have developed the project, which started out as academic research at lund university, to a point where it can be tested in humans. this
vaccine
has the potential to dramatically reduce the disease burden from
gbs
infection, and it?s going to be really exciting to see the results from the trial next year.?
vaccine
is key
minervax
is not alone in trying to develop a
gbs
vaccine
. but per fisher is unfazed by the competition. ?
minervax
?s technology is superior and likely to cover a higher percentage of bacterial strains than the other
vaccine
s in development. our
vaccine
candidate is based on an innovative fusion protein, which induces a strong protective immune response against
gbs
infections.? vaccination of pregnant women is a controversial issue, but the
minervax
team is convinced that it is the best way to address the disease burden of
gbs
infections. the current practice of using widespread, broad- spectrum antibiotics will eventually lead to the emergence of resistant strains of
gbs
, which will significantly impair the effectiveness of current preventive strategies and treatment options in the remaining
gbs
infections. that?s why per fischer believes that all pregnant women should be vaccinated to prevent serious disabilities, and, in worse cases, death among infected newborns. group b streptococcal infection represents 50 per cent of life-threatening infections in newborns worldwide. there is an urgent need for an effective
vaccine
that can prevent these infections. copenhagen-based biotech,
minervax
is addressing this need. and novo seeds is on board as leading investor. fast facts on group b streptococcus (
gbs
)
gbs
infection in the unborn child may lead to premature delivery or stillbirth, and
gbs
infection in the newborn child may result in sepsis, pneumonia or meningitis, all of which carry a significant risk of severe morbidity, long- term disability or death. annually,
gbs
is responsible for some 8,000 infections in newborns, 800 deaths and 1,000 life-long disabilities in europe and us. novo a/s 48 novo seeds
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