- MinervaX scaling up supply of novel GBS vaccine, ahead of
phase III studies
- Wacker Biotech to manufacture active vaccine protein
ingredients and prepare for commercial supply after regulatory
approval
- Vaccine to address the unmet medical burden of GBS, both by
maternal vaccination to prevent adverse pregnancy outcomes and
life-threatening infections in infants and by vaccination of
older/at risk adults
COPENHAGEN, Denmark and MUNICH, Sept. 17,
2024 /PRNewswire/ -- MinervaX ApS, a privately held
Danish biotechnology company developing a novel, prophylactic
vaccine against Group B Streptococcus (GBS) and Wacker Biotech, a
contract development and manufacturing organization (CDMO), wholly
owned subsidiary of Wacker Chemie AG, today announce a
collaboration to manufacture MinervaX's active protein ingredients
of its GBS vaccine.
GBS is responsible for nearly 50 percent of all life-threatening
infections in newborns. At any given time, some 15-25 percent of
the population, including pregnant people are spontaneously
colonized with GBS, and during pregnancy they run the risk of
transmitting the bacteria to their child in the womb, during birth
and/or during the first months of life. GBS colonization may lead
to late abortions, premature delivery, or stillbirth and 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. With no general implemented and fully
protective preventative treatment available for GBS, this
underlines the unmet medical need of developing and providing a
vaccine to prevent adverse pregnancy outcomes and life- threatening
infections in infants caused by GBS. Furthermore, older adults and
adults with certain co-morbidities such as diabetes or obesity are
also at an increased risk of severe GBS infections and form a
second population which would benefit from a prophylactic vaccine
against this potentially fatal disease.
MinervaX's lead vaccine candidate, is a novel protein-only
vaccine, based on fusions of highly immunogenic and proactive
protein domains from selected surface proteins of GBS. The company
is strongly committed and dedicated to advancing its novel vaccine
and has successfully completed two Phase II clinical trials of its
maternal vaccine against GBS and is in preparation to commence
Phase III clinical trials in this indication. Data from MinervaX's
GBS vaccine is very positive, demonstrating an acceptable safety
profile in pregnant people and their infants, with high
immunogenicity, leading to functionally active antibodies, with the
potential for broad coverage and protection, alleviating the need
for excessive use of antibiotics.
Wacker Biotech will manufacture the active ingredients of
MinervaX's novel vaccine candidate, alongside performing the
technology transfer, process validation and process
characterization activities for later commercial manufacturing.
Subsequently, Wacker Biotech will perform all key functions
critical to ensure stable commercial supply at its site in
Amsterdam, The Netherlands.
Per Fischer, CEO of MinervaX,
said: "GBS can be life-threatening for newborn babies and
is linked to over half a million preterm births annually. Following
the EUR 54 million financing last
year, our team is advancing the development of our novel
prophylactic vaccine against GBS for the benefit of all populations
at risk, worldwide. Wacker Biotech is a robust manufacturing
partner with a strong track record in late clinical and commercial
supply and we look forward to collaborating with the team ahead of
commencing Phase III studies."
Ronald Eulenberger, Managing Director of Wacker Biotech B.V.
in Amsterdam,
stated: "With our strong background in E. coli processes,
process characterization, and process validation experiences, we at
Wacker Biotech are perfectly suited to support MinervaX with its
ongoing program for the prevention of invasive GBS disease."
Details of MinervaX's completed Phase II clinical trials in
pregnant people can be found at https://clinicaltrials.gov/ under
the identifiers NCT04596878 and NCT05154578. In addition to
pregnant people, MinervaX is also pursuing Phase I development of
its novel GBS vaccine in older adults, under identifier
NCT05782179.
Notes to Editors:
About MinervaX
MinervaX is a Danish biotechnology company, established in 2010
to develop a prophylactic vaccine against Group B Streptococcus
(GBS), based on research from Lund
University. MinervaX is developing a GBS vaccine for maternal
immunization, and also for vaccination of older/at risk adults.
Phase II clinical data from its maternal vaccination program
suggest a high efficacy, based on the preliminary Correlate of
Protection data from a natural history study. MinervaX's GBS
vaccine is a protein-only vaccine based on fusions of highly
immunogenic and protective protein domains from selected surface
proteins of GBS, the Alpha-like protein family (AIpN). Given the
broad distribution of proteins contained in the vaccine on GBS
strains globally, it is expected that MinervaX's GBS vaccine will
confer protection against virtually 100% of all GBS isolates.
www.minervax.com
About Wacker Biotech
Wacker Biotech is a full-service contract manufacturer of
therapeutic proteins, live biopharmaceutical products (LBPs),
plasmid DNA (pDNA), messenger ribonucleic acid (mRNA) and vaccines
based on microbial systems. Wacker Biotech's portfolio extends from
strain/process development and analytical testing through to
production for clinical and commercial applications. Wacker Biotech
operates three GMP-compliant, FDA- and EMA-certified production
plants at its Jena and Halle sites in Germany and in Amsterdam in the
Netherlands. In addition, Wacker Biotech has had a plant in
San Diego (Wacker Biotech US Inc.)
since February 2021. Wacker Biotech
GmbH, Wacker Biotech B.V. and Wacker Biotech US Inc. are wholly
owned subsidiaries of Munich-based
Wacker Chemie AG.
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SOURCE MinervaX