ID Biomedical (NASDAQ:IDBE)
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ID Biomedical receives positive data from clinical testing of its
Group-Common Pneumococcal Vaccine
- Company receives clearance to move testing of vaccine to infants
VANCOUVER, March 22 /PRNewswire-FirstCall/ -- ID Biomedical Corporation (TSX:
IDB; NASDAQ: IDBE) announced today that it has completed analysis of data
obtained from several Phase 1 clinical studies of its Pneumococcal Group-
Common Vaccine, PGCvax(TM), in adults, elderly and toddlers. PGCvax is being
developed to prevent invasive diseases, including meningitis, caused by the
bacteria Streptococcus pneumoniae (also known as the pneumococcus).
These studies enrolled over 300 subjects, who received the vaccine in a series
of four different clinical trials conducted in young adults, the elderly, and
toddlers in 2003 and 2004. The results demonstrated that PGCvax was
well-tolerated and immunogenic in different age-groups. The 1-dose study in
toddlers primarily addressed safety, but the trials in adults included a 2-dose
regimen and yielded detailed immunogenicity data. Significant (greater than
four-fold) antibody responses to the protein antigen in the vaccine were
demonstrated in 92% of young adults and 85% of elderly (65 years and over)
subjects receiving optimal doses of the vaccine, whereas no recipients of
control products had such responses. Young adults and elderly persons had
nearly identical 9.0-fold increases (95% confidence interval 6.7 to 12.1-fold)
in their geometric mean antibody levels (p less than 0.0001 by paired sample
t-test for both groups). Importantly, human antibodies induced in the clinical
studies were able to protect against lethal disease caused by pneumococci when
transferred to animals, and also could be shown to bind to the surface of
pneumococci. The induction of cell-surface-binding antibodies is a key finding,
since such antibodies can attach to the outer surface of pneumococci, where
they could interact with other components of the immune system to destroy the
bacteria before they induce disease.
Based on these promising results, ID Biomedical has now received clearance from
the Canadian regulatory authorities to initiate a Phase 1 study in infants, the
major target population for this vaccine.
The initial Canadian study of PGCvax in infants will enroll 75 infants. It will
use a randomized, comparator-controlled, double-blind, dose-escalation design
to evaluate the safety, local and systemic tolerance, and immunogenicity of
PGCvax. Each child will receive four vaccine injections: at 2, 4 and 6 months
of age and a booster dose at one year. ID Biomedical plans to begin enrollment
this month. A similar protocol will be carried out in Israel in order to
provide data in a population where pneumococcal carriage is acquired early in
infancy; this trial is expected to begin later in the spring.
While pneumococcal vaccines exist, there is currently no vaccine available that
can protect universally against all 90 serotypes. Available pneumococcal
vaccines are strain- (serotype) specific and cover only a minority of the 90
pneumococcal serotypes. One polysaccharide vaccine available for high-risk
adults and the elderly covers 23 different serotypes. Unfortunately, this
vaccine is not reliably protective against pneumococcal pneumonia and also does
not induce any significant antibody response in very young children, where the
burden of disease is the highest. A polysaccharide conjugate vaccine was
developed specifically for children under 5 years of age, and has been highly
effective at preventing diseases caused by the seven serotypes that have been
the most common disease-causing serotypes to date in young children. This
vaccine has been widely used in the United States since its introduction in
2000. Recently, however, it has been observed that other serotypes not included
in that vaccine have infected children immunized with this vaccine at a higher
rate than non-vaccinated children, a phenomenon known as 'serotype
replacement'.
"The emerging evidence for serotype replacement highlights the need for a new
vaccine that is protective against all serotypes of pneumococci. Our candidate
vaccine elicits antibodies that bind to the surface of pneumococci and that
recognize strains from all 90 known serotypes. This lends support to the
concept that PGCvax could protect against diseases caused by all known strains
of pneumococcus. Also important is that Streptococcus pneumoniae is a major
cause of serious illness and mortality worldwide, thereby leaving a clear unmet
medical need that PGCvax has the potential to address," said Ronald W. Ellis,
Ph.D., Senior Vice President, Development for ID Biomedical. "Like many
important pathogens, pneumococci cause a significant morbidity and mortality at
the extremes of the age spectrum. PGCvax offers potential advantages in both
the very young and elderly populations, and our clinical development strategy
will address needs in both groups," Dr. Ellis added.
Unlike existing pneumococcal vaccines, which are based on bacterial
polysaccharides, PGCvax is a subunit vaccine based on two novel proteins found
on the cell surface of pneumococci. These two proteins are found in strains
from all 90 known pneumococcal serotypes, and the immune response to these
proteins has been shown to be protective in preclinical models.
ID Biomedical's development of innovative, protein-based vaccines, including
PGCvax, is supported, in part, through a Technology Partnerships Canada (TPC)
conditionally repayable investment of up to $80 million. "We are very proud to
have Industry Canada's participation in this program. We are working jointly
with the Canadian Government in many sectors, and we are very appreciative of
their support. Such collaborations allow us to go one step further in becoming
a leading vaccine company," said Anthony Holler, MD, Chief Executive Officer of
ID Biomedical.
About Streptococcus pneumoniae
S. pneumoniae is a leading cause of bacterial meningitis, sepsis, pneumonia,
and otitis media in infants and young children, and of pneumonia and invasive
diseases in the elderly and immunocompromised individuals. S. pneumoniae is a
major cause of morbidity and mortality worldwide. The burden of disease and
mortality in children is significant. Invasive pneumococcal disease accounts
for approximately 200 deaths annually in the United States in children less
than 5 years of age. In this same group, over 700 cases of meningitis, 13,000
blood infections and over 5 million cases of otitis media were reported
annually. Worldwide, approximately 1,800,000 deaths per year are caused by
acute respiratory infections in children under 5 years old, and most of these
are due to S. pneumoniae.
The current market for pneumococcal vaccines exceeds US$1 billion per year, and
is expected to continue to show strong growth during the coming decade.
About ID Biomedical
ID Biomedical is an integrated biotechnology company dedicated to the
development of innovative vaccine products. It operates in research,
development, manufacturing, sales and marketing from its facilities in Canada
and in the United States. ID Biomedical is dedicated to becoming a premier
vaccine company with significant marketed products worldwide and an extensive
pipeline in both clinical and preclinical development.
ID Biomedical has a leading position in the Canadian influenza market. It
received a ten-year mandate from the Government of Canada in 2001 to assure a
state of readiness in the case of an influenza pandemic and provide influenza
vaccine for all Canadians in such an event. It also currently supplies
approximately 75% of the Canadian government's influenza vaccine purchases.
For further information on ID Biomedical, please visit the Company's website at
http://www.idbiomedical.com/.
The information in this news release contains so-called "forward-looking"
statements. These include statements regarding ID Biomedical's expectations and
plans relating to the integration of the vaccine business acquired from Shire,
statements about ID Biomedical's expectations, beliefs, intentions or
strategies for the future, which may be indicated by words or phrases such as
"anticipate", "expect", "intend", "plan", "will", "we believe", "ID Biomedical
believes", "management believes", and similar language. All forward-looking
statements are based on ID Biomedical's current expectations and are subject to
risks and uncertainties and to assumptions made. Important factors that could
cause actual results to differ materially from those expressed or implied by
such forward-looking statements include: (i) the company's ability to
successfully integrate the Shire vaccine business; (ii) the company's ability
to successfully complete preclinical and clinical development of its products;
(iii) the company's ability to manufacture its products; (iv) the seasonality
of the flu-vaccine business and related fluctuations in the company's revenues
from quarter to quarter; (v) decisions, and the timing of decisions, made by
the health regulatory agencies regarding approval of its products for human
testing; (vi) the company's ability to enter into distribution agreements for
its products, and to complete and maintain corporate alliances relating to the
development and commercialization of its technology and products; (vii) market
acceptance of its technologies and products; and (viii) the competitive
environment and impact of technological change and other risks detailed in the
company's filings with the Securities and Exchange Commission. ID Biomedical
bases its forward-looking statements on information currently available to it,
and assumes no obligation to update them.
For more information, please contact:
Investor Relations/Media
Dean Linden Michele Roy,
(604) 431-9314 (450) 978-6313
DATASOURCE: ID Biomedical Corporation
CONTACT: Investor Relations/Media - Dean Linden, (604) 431-9314,
; Michele Roy, (450) 978-6313,
;
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