a canadian success story: overcoming scientific and logistical problems in the development of...
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![Page 1: A Canadian Success Story: Overcoming scientific and logistical problems in the development of NeisVac-C Dr. Harold J. Jennings NRC-IBS](https://reader035.vdocuments.mx/reader035/viewer/2022062717/56649e4c5503460f94b4130c/html5/thumbnails/1.jpg)
A Canadian Success Story: Overcoming scientific and logistical problems in the
development of NeisVac-C
Dr. Harold J. JenningsNRC-IBS
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Age specific rates for meningococcal infection UK, Public Health Laboratory Services. Compiled by D. Jones
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Structures of The Capsular Polysaccharides of N. meningitidis
O ‖
6)-D-ManpNAc(1-O-P-O- 3 AcO
8)-D-NeupNAc(2
9)-D-NeupNAc(2 8 AcO
9)-D-NeupNAc(2
6)-D-Galp(14)-D-NeupNAc(2
6)-D-Glcp(14)-D-NeupNAc(2(contains OAc groups)
Group Structure
A
B
C
C(OAc-)
W-135
Y
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N. meningitidis O-acetylated Group C polysaccharide
n
O
HO2C
HO
OHO
OH
HOAcHN O
HO2C
HO
O
OAc
HOAcHN O
HO2C
HO
O
OAc
HOAcHN O
HO
HO
CO2H
OAc
HOAcHN
n
O
HO2C
HO
OAcHN O
HO2C
HO
O
OAc
HOAcHN O
HO2C
HO
O
OAc
HOAcHN O
HO
HO
CO2H
OAc
HOAcHN
O
H
NaIO4
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History of the Development of NRC Conjugate Vaccines
1990 NAVA Incorporated in Canada by merging BioChem/ NRC technology with AMVAX (U.S.). BioChem Pharma retained Canadian rights.
1992 NAVA/ NRC vs. American Cyanamid (Praxis). U.S. Courts of Appeal infringement of U.S. Patent 4,356,170.
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N. meningitidis O-deacetylated Group C polysaccharide
n
O
HO2C
HO
OHO
OH
HOAcHN O
HO2C
HO
O
OH
HOAcHN O
HO2C
HO
O
OH
HOAcHN O
HO
HO
CO2H
OH
HOAcHN
O
HO2C
HO
O
O
AcHN O
HO2C
HO
O
HO
HOAcHN
O
H
H
m
NaIO4
N. meningitidis O-acetylated Group C polysaccharide
n
O
HO2C
HO
OHO
OH
HOAcHN O
HO2C
HO
O
OAc
HOAcHN O
HO2C
HO
O
OAc
HOAcHN O
HO
HO
CO2H
OAc
HOAcHN
n
O
HO2C
HO
OAcHN O
HO2C
HO
O
OAc
HOAcHN O
HO2C
HO
O
OAc
HOAcHN O
HO
HO
CO2H
OAc
HOAcHN
O
H
NaIO4
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O
OHO
HO
P
O
O
O
OH
OH
OH
OH
n
H. influenzae type b polysaccharide
m
O
OHO
HO
P
O
O
O
OH
O
H
O
OHO
HO
P
O
O
O
OH
OH
OH
OHO
H
NaIO4
O
HO2C
HO
O
O
AcHN O
HO2C
HO
O
HO
HOAcHN
O
H
H
m
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N. meningitidis O-deacetylated Group C polysaccharide
n
O
HO2C
HO
OHO
OH
HOAcHN O
HO2C
HO
O
OH
HOAcHN O
HO2C
HO
O
OH
HOAcHN O
HO
HO
CO2H
OH
HOAcHN
O
HO2C
HO
O
O
AcHN O
HO2C
HO
O
HO
HOAcHN
O
H
H
m
NaIO4
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HPA (CDSC) E. Miller et al. 2003
Laboratory Confirmed Cases of Meningococcal Disease (by quarter) England & Wales.
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History of the Development of NRC Conjugate Vaccines
2000 Baxter Int. acquired NAVA following marketing of Group C meningococcal vaccine.
2001 Shire acquired BioChem Pharma. Retained Canadian rights on NRC technologies.
2004 ID Biomedical acquired Shire’s vaccine business. Retained Canadian rights on NRC technologies
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Prevalence of Group B Streptococcus disease isolates
Ia38.8%
Ib8.5%
II7.0%
III28.7%
V14.7%
VII0.8%NT
1.6%
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→4)D-Glcp-(1→4)D-Galp-(1→ 3 ↑ 1
D-NeupNAc-(2→3)D-Galp-(1→4)D-GlcpNAc
→4)D-GlcpNAc-(1→3)D-Galp-(1→4)D-Glcp-(1→3)D-Glcp-(1→2)D-Galp-(1→ 6 3 ↑ ↑ 1 2
D-Galp D-NeupNAc
→4)D-Glcp-(1→6)D-GlcpNAc-(1→3)D-Galp-(1→ 4 ↑ 1
D-NeupNAc-(2→3)D-Galp
→4)D-Glcp-(1→4)D-Galp-(1→4)D-Glcp-(1→ 6 4 ↑ ↑ 1 1
D-NeupNAc-(2→3)D-Galp-(1→4)D-GlcpNAc D-Glcp
Structures of The Capsular Polysaccharides of Group B Streptococcus
Ia
Ib
III
II
V
→4)D-Glcp-(1→4)D-Galp-(1→ 3 ↑ 1
D-NeupNAc-(2→3)D-Galp-(1→3)D-GlcpNAc
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Protection of infant mice by placentally transferredpolysaccharide (PS) specific antibody
Vaccine
Tetanus Toxoid (TT)
III PS
III PS and TT
III PS-TT Conjugate
Mothers Vaccinated
1
2
3
3
ProgenyChallenged
12
22
33
29
Survivors
0
0
0
27
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Recent history of the development of Group B meningococcal- conjugate vaccine
1999: Aventis Pasteur sub-licensed NRC technology for the development of a chemically modified group B meningococcal polysaccharide- conjugate vaccine
2002:Aventis Pasteur carried out a limited trial of the conjugate vaccine on a few male volunteers using alum as adjuvant (poor bactericidal activity)
2003:Aventis Pasteur dropped the above sub-license because of perceived safety concerns
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“Further consideration by Aventis-Pasteur experts, in-house, led to the conclusion that there could be sustained difficulties for “proving” safety to licensing authorities and the general public. Moreover, because of the plausibility of the perceived risk, the vaccine could become the focus for anti-vaccine groups with a constant threat of litigation from those who “suspect” they may have been adversely affected.” 1
1: Decision by the Safety Consultation Committee- Aventis-Pasteur SA
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Recent history of the development of Group B meningococcal- conjugate vaccine
2004:
Baxter dropped the license to NRC technology on chemically modified group B meningococcal- conjugate vaccine
2004:
BioVeris licensed NRC technology on chemically modified group B meningococcal- conjugate vaccine
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Royalty RevenuesRoyalties Received - by period (bar) and cumulative (line, x10)
$0.00
$500,000.00
$1,000,000.00
$1,500,000.00
$2,000,000.00
$2,500,000.00
$3,000,000.00
$3,500,000.00
31-Dec-97
30-Jun-98
31-Dec-98
30-Jun-99
31-Dec-99
30-Jun-00
31-Dec-00
30-Jun-01
31-Dec-01
30-Jun-02
31-Dec-02
30-Jun-03
31-Dec-03
30-Jun-04
31-Dec-04
30-Jun-05
31-Dec-05