REG - GSK PLC - GSK completes acquisition of Affinivax, Inc.

GSKAnnouncement

16/08/2022 07:16

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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
(https://www.gsk.com/en-gb/company/)

 

 GSK enquiries
 Media:               Tim Foley        +44 (0) 20 8047 5502  (London)
                      Simon Moore      +44 (0) 20 8047 5502  (London)
                      Kathleen Quinn   +1 202 603 5003       (Washington DC)

 Investor Relations:  Nick Stone       +44 (0) 7717 618834   (London)
                      James Dodwell    +44 (0) 20 8047 2406  (London)
                      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
(https://www.cdc.gov/pneumococcal/about/facts.html)

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