Affinivax, Inc. Announces Initiation of Phase 1/2 Clinical Study of ASP3772, Its Novel Pneumococcal MAPS Vaccine, in Collaboration with Astellas

Clinical study will evaluate safety, tolerability, and immunogenicity
in adults

Initiation of clinical study triggers milestone payment to Affinivax

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Affinivax,
Inc.
(“Affinivax”) today announced that the first subject has been
dosed with ASP3772, its novel MAPS vaccine targeting Streptococcus
pneumoniae
(pneumococcus). The clinical study protocol – “A Phase
1/2, Randomized, Single Ascending Dose Study in Adults (Stage 1) and
Randomized, Single Ascending Dose-Finding Study in Elderly Subjects
(Stage 2) with ASP3772, a Pneumococcal Vaccine” – was initiated by
Affinivax’s development partner, Astellas Pharma, Inc. (“Astellas”)
following the successful submission of an Investigational New Drug (IND)
application to the U.S. Food and Drug Administration in December 2018.
The study is posted on Clinicaltrials.gov.

Affinivax and Astellas entered into an exclusive worldwide license
agreement in February 2017. The strategic partnership leverages
Affinivax’s proprietary MAPS vaccine technology platform utilizing
Affinivax’s process development and analytical expertise to advance a
novel pneumococcal MAPS vaccine, with Astellas playing a leadership role
in development and commercialization. This has resulted in the
development of ASP3772, a novel vaccine which offers the potential to
provide broader protection against pneumococcal disease. The initiation
of clinical testing for ASP3772 triggered a milestone payment of $10
million to Affinivax from Astellas.

“Advancing this program from the labs at Boston Children’s Hospital to
clinical testing in less than 5 years realizes our vision to utilize the
MAPS technology platform to offer a range of safe and effective vaccines
targeting multiple bacterial pathogens,“ said Richard Malley, MD,
Affinivax’s Scientific Founder, Professor of Pediatrics at Harvard
Medical School, and the Kenneth McIntosh Chair in Pediatric Infectious
Diseases at Boston Children’s Hospital. “We believe that MAPS, in
contrast to traditional vaccines, offers a unique way to present the key
epitopes of the desired antigens (polysaccharides and/or proteins) to
induce a robust and broad immune response. We now look forward to
confirming this in clinical trials.”

“The initiation of clinical testing of ASP3772 is a major milestone for
the development of our MAPS technology platform and for our company”
said Steven B. Brugger, CEO of Affinivax, Inc. “I want to recognize the
tremendous effort on the part of the entire Affinivax team, in
collaboration with our Astellas colleagues, to achieve this important
milestone. We now look forward to advancing this important vaccine
towards clinical proof of concept and continuing to work to bring an
improved pneumococcal vaccine to patients.”

About the Global Impact of Pneumococcal Disease

Streptococcus pneumoniae (pneumococcus) is a bacterium frequently
found in the upper respiratory tract of healthy children and adults, and
can cause serious infections ranging from pneumonia, meningitis, and
sepsis, representing a major global health problem. The World Health
Organization (WHO) estimates that half a million deaths in children
under 5 years old occur each year worldwide due to infection by this
bacterium. In the United States, there are over 900,000 cases of
pneumococcal pneumonia each year, leading to 400,000 hospitalizations
with an associated 5-7% mortality rate in hospitalized patients.
Streptococcus pneumoniae is the leading cause of lower respiratory
infection morbidity and mortality globally, contributing to more deaths
than all other etiologies combined in 2016.1 Prevnar 13® is
currently the top selling vaccine worldwide, generating more than $5.6
billion in sales in 2017.2

About Multiple Antigen Presenting System (MAPS)

The MAPS technology platform uses proprietary chemistry that capitalizes
on the highly specific and durable non-covalent, affinity binding
between biotin and rhizavidin, a biotin-binding protein. The highly
stable complex created by this affinity binding contributes to a simple,
modular, and efficient approach to the development of MAPS vaccines. In
stark contrast to the highly complex chemistry of conventional vaccine
conjugation (which is optimized to induce protective antibody responses
to only the polysaccharide antigen with the protein antigen serving
primarily as a carrier), a MAPS vaccine can present both the
polysaccharide antigen and the protein antigen to induce a broad and
potent immune response.

About Affinivax, Inc.

Affinivax is advancing a next generation vaccine technology platform to
enable the development of vaccines that provide the highest level of
protection against challenging infectious diseases. Backed by an initial
investment from the Bill
& Melinda Gates Foundation
, and working with world experts in
vaccine discovery and development, Affinivax is focused on creating a
pipeline of vaccines for children and adults in both the developed and
developing worlds. The company’s proprietary vaccine platform, called
Multiple Antigen Presentation System (MAPS), enables the high affinity
binding of protective polysaccharides and proteins in a single vaccine
and uniquely induces a broad and protective immune response. The MAPS
technology provides a highly stable, modular, and efficient approach to
develop vaccines against a wide range of diseases. The company has
achieved preliminary preclinical proof-of-concept for several MAPS
vaccines and is currently advancing its lead vaccine candidate against Streptococcus
pneumoniae
in clinical trials. For more information, visit www.affinivax.com.

About Affinivax – Astellas Strategic Partnership

Affinivax and Astellas entered into an exclusive worldwide license
agreement in February 2017 to develop and commercialize a vaccine
targeting Streptococcus pneumoniae (pneumococcus). The
partnership will utilize Affinivax’s proprietary MAPS vaccine technology
platform to advance a novel MAPS vaccine targeted to prevent and reduce
the spread of pneumococcal disease. Astellas will lead and fully fund
the development program and obtain worldwide rights to commercialize the
MAPS vaccine for pneumococcal disease. Affinivax is eligible to receive
a range of development milestones and commercial milestones, as well as
tiered royalties on any future product sales.

1   GBD 2016 Lower Respiratory Infections Collaborators. Estimates of
the global, regional, and national morbidity, mortality, and
aetiologies of lower respiratory infections in 195 countries,
1990-2016: A systematic analysis for the Global Burden of Disease
Study 2016. Lancet Infect Dis. 2018 Sep 19. pii:
S1473-3099(18)30310-4. doi: 10.1016/S1473-3099(18)30310-4.
2

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® Prevnar 13 is a registered trademark of Wyeth LLC.

Contacts

The Yates Network
Kathryn Morris, 914-204-6412
[email protected]

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