# GSK to acquire clinical-stage biopharmaceutical company Affinivax

- Link: https://www.directorstalkinterviews.com/gsk-to-acquire-clinical-stage-biopharmaceutical-company-affinivax/4121066799
- Published: 2022-05-31T07:19:54+01:00
- Author: Amilia Stone

**[GSK plc](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l)**(
[LON:GSK](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l))
has announced that it has entered into a definitive agreement to acquire Affinivax,
Inc., a clinical-stage biopharmaceutical company based in Cambridge, Boston, Massachusetts,
for a $2.1 billion upfront payment and up to $1.2 billion in potential development
milestones. Affinivax is pioneering the development of a novel class of vaccines,
the most advanced of which are next-generation pneumococcal vaccines.

·   GSK to pay $2.1 billion upfront and up to $1.2 billion in potential development
milestones

·   Proposed acquisition provides access to next-generation 24-valent pneumococcal
vaccine candidate in phase II development and highly innovative, MAPS^(TM) technology

·   Supports development of a strong portfolio of innovative vaccines and specialty
medicines

Pneumococcal disease includes pneumonia, meningitis, bloodstream infections, and
milder diseases such as sinusitis and otitis media and remains a significant unmet
medical need despite the availability of current pneumococcal vaccines. There are
many different pneumococcal serotypes. The number of serotypes in current vaccines
is limited due to the degree of immunological interference observed when using existing
conjugation technologies.

Affinivax has developed the Multiple Antigen Presenting System (MAPS), a novel technology
that supports higher valency than conventional conjugation technologies, enabling
broader coverage against prevalent pneumococcal serotypes and potentially creating
higher immunogenicity than current vaccines. Affinivax’s most advanced vaccine candidate(
AFX3772) includes 24 pneumococcal polysaccharides plus two conserved pneumococcal
proteins (compared to up to 20 serotypes in currently approved vaccines). A 30-plus
valent pneumococcal candidate vaccine is also in pre-clinical development.

**Financial considerations**

Under the terms of the agreement, GSK will acquire 100% of the outstanding shares
of Affinivax. The consideration for the acquisition comprises an upfront payment
of $2.1 billion to be 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 is 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. The transaction is expected to close
in the third quarter of 2022.

GSK will account for the transaction as a business combination.

New GSK reaffirms its full-year 2022 guidance and the medium-term outlook for 2021-
2026 of more than 5% sales and 10% adjusted operating profit CAGR* at CER**.

* CAGR: Compound Annual Growth Rate; **CER: Constant Exchange Rate

**Pneumococcal disease**

The bacterium Streptococcus pneumoniae causes pneumococcal disease. There are multiple
types of pneumococcal disease, including bloodstream infections (sepsis), pneumonia,
meningitis, and other milder diseases such as sinusitis and otitis media. A significant
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^([[i]](https://www.londonstockexchange.com/#_edn1)).

**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 disease-relevant
polysaccharides to disease-relevant protein antigens in 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 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.

> **Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said**: “The
> proposed acquisition further strengthens our vaccines R&D pipeline, provides access
> to a new, potentially disruptive technology, and broadens GSK’s existing scientific
> footprint in the Boston area. We look forward to working with the many talented
> people at Affinivax to combine our industry-leading development, manufacturing,
> and commercialisation capabilities to make this exciting new technology available
> to those in need.”
> 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. Phase III is expected to start in the short term.
> Phase I/II clinical trials to assess the use of the vaccine in paediatrics are
> planned to begin later this year.
> “Affinivax grew out of our founders’ scientific and personal vision to drive vaccine
> innovation to make a meaningful impact on people’s lives, in both developed and
> developing countries,” **said Steven Brugger, CEO of Affinivax, Inc**. “Over the
> past eight years, we have taken that vision from the initial development of our
> MAPS™ vaccine platform at Boston Children’s Hospital to a pipeline of novel vaccines
> with our lead vaccine candidate in late-stage clinical studies. We are proud that
> GSK has recognized our team’s accomplishments and are confident that GSK is an
> ideal new home for our MAPS platform and the team behind its success. GSK’s significant
> capabilities will enable continued advances with MAPS to improve existing vaccines–
> as is the case with our lead Streptococcus pneumoniae MAPS vaccine program – and
> develop vaccines that combat novel and resistant infectious diseases for which
> there are no effective immunization strategies available today.”

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