GSK PLC GSK completes acquisition of Affinivax, Inc. (1480W)
16 August 2022 - 4:06PM
UK Regulatory
TIDMGSK
RNS Number : 1480W
GSK PLC
16 August 2022
Issued: 16 August 2022, London UK
GSK completes acquisition of Affinivax, Inc.
GSK plc (LSE/NYSE: GSK) today announced it has completed the
acquisition of Affinivax, Inc (Affinivax), a clinical-stage
biopharmaceutical company based in Cambridge (Boston,
Massachusetts). Affinivax has pioneered the development of a novel
class of vaccines, the most advanced of which are next-generation
pneumococcal vaccines.
As previously announced, the acquisition of Affinivax aligns
with GSK's strategy of building a strong portfolio of specialty
medicines and vaccines. It includes a next-generation 24-valent
pneumococcal vaccine candidate (AFX3772), currently in phase II
development, which is based on the highly innovative Multiple
Antigen Presenting System (MAPS(TM) ) platform technology . A
30-plus valent pneumococcal candidate vaccine is also in
pre-clinical development.
The MAPS(TM) technology supports higher valency than
conventional conjugation technologies, potentially enabling broader
coverage against prevalent pneumococcal serotypes and generating
higher antibody responses against many individual serotypes than
current pneumococcal vaccines.
Tony Wood, Chief Scientific Officer, GSK , said: "Affinivax's
exciting pneumococcal vaccine candidates, the potentially
disruptive MAPs technology and their fantastic scientific talent,
further strengthen our pipeline of novel vaccines and presence in
the Boston area".
In the adult phase I/II clinical trials, AFX3772 was well
tolerated in participants and demonstrated good immune responses
compared to the current standard of care. In July 2021, the US Food
and Drug Administration granted Breakthrough Therapy designation
for AFX3772 to prevent S. pneumoniae invasive disease and pneumonia
in adults 50 years and above. Preparations for the start of the
phase III program are underway. Phase II clinical trials started in
June 2022 to assess the use of the vaccine in the paediatric
population.
Financial considerations
Under the terms of the agreement, GSK has acquired 100% of the
outstanding shares of Affinivax. The acquisition comprised an
upfront payment of $2.1 billion paid upon closing and two potential
milestone payments of $0.6 billion to be paid upon the achievement
of certain paediatric clinical development milestones. The
transaction was subject to customary closing conditions, including
the expiration or early termination of the waiting period under the
Hart-Scott- Rodino Anti-Trust Improvements Act of 1976. GSK will
account for the transaction as a business combination.
Pneumococcal disease
Pneumococcal disease is an umbrella term used to describe any
infection caused by the bacteria Streptococcus pneumoniae, a
leading cause of acute bacterial infections worldwide. It has a
broad clinical spectrum including bloodstream infections (sepsis),
pneumonia, meningitis, and other milder diseases such as sinusitis
and otitis media. A broadly recognized unmet medical need remains
despite the availability of current vaccines. Pneumococcal
pneumonia causes an estimated 150,000 hospitalisations each year in
the United States; pneumococcal meningitis and bacteremia killed
approximately 3,250 people in the United States in 2019[1].
MAPS (TM) technology platform
Multiple Antigen Presenting System (MAPS) is a novel and highly
efficient vaccine technology platform that enables the precise,
high-affinity binding of pathogen-derived polysaccharides and
proteins of immune-relevance into a single vaccine. Immunisation
with the resulting polysaccharide-protein complexes induces a broad
and potentially protective B-cell (antibody) response to the
polysaccharides and a separate B-cell and T-cell immune response to
the proteins. The distinctive plug-and-play nature of MAPS (TM)
enables the targeting of a broad range of infectious diseases.
The initial use of the technology has been directed primarily
toward preventing pneumococcal disease. Applicability of the
technology has also been demonstrated for additional infectious
disease pathogens, including those that cause hospital-acquired
infections.
About GSK
GSK is a global biopharma company with a purpose to unite
science, technology, and talent to get ahead of disease together.
Find out more at gsk.com/company
GSK enquiries
Media: Tim Foley +44 (0) 20 8047 (London)
5502
Simon Moore +44 (0) 20 8047 (London)
5502
Kathleen Quinn +1 202 603 5003 (Washington DC)
Investor Relations: Nick Stone +44 (0) 7717 618834 (London)
James Dodwell +44 (0) 20 8047 (London)
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Mick Readey +44 (0) 7990 339653 (London)
Josh Williams +44 (0) 7385 415719 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described in the Company's
Annual Report on Form 20-F for 2021, GSK's Q2 Results for 2022 and
any impacts of the COVID-19 pandemic.
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[1] US Centers for Disease Control and Prevention, Fact facts -
pneumococcal disease. Available here:
https://www.cdc.gov/pneumococcal/about/facts.html
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