|[December 05, 2013]
Genocea Biosciences Initiates Phase 1 Study of Vaccine Candidate GEN-004 to Prevent Infections Caused by Pneumococcus
CAMBRIDGE, Mass. --(Business Wire)--
Biosciences, Inc., a clinical-stage company pioneering novel T cell
vaccines, announced today that it has initiated a Phase 1 study of
GEN-004, an investigational vaccine candidate for pneumococcus (Streptococcus
pneumoniae), a major cause of infectious disease-related death
globally. GEN-004 is the first vaccine candidate designed to prevent
infections caused by all strains of pneumococcus through a novel T
cell-mediated mechanism of action.
According to The World Health Organization, roughly half a million
children less than five years of age die of pneumococcal disease
annually. Pneumococcus naturally colonizes the nasopharynx, or nose and
throat. The bacterium can become dangerous, especially to the very young
and the elderly, if it is not cleared from the nasopharynx and enters
the lungs and bloodstream, where it can be responsible for
life-threatening illnesses such as bacteremic pneumonia, meningitis and
Several publications have indicated that TH17 responses are a
natural mechanism to clear pneumococcus from the nasopharynx. GEN-004
contains three unique protein antigens, SP0148, SP1912, and SP2108,
shown by Genocea's proprietary antigen discovery platform, ATLAS™, to be
associated with protective TH17 T cell responses against
pneumococcus in humans. In preclinical studies presented at the
International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD)
in 2012, GEN-004 significantly reduced nasopharyngeal colonization by
stimulating TH17 immune responses.
Each protein in GEN-004 is also conserved across all sequenced strains
of pneumococcus, meaning that GEN-004 could represent a universal
vaccine against pneumococcus working through a novelmechanism of
action. There are more than 90 known strains of pneumococcus. Approved
vaccines prevent disease caused by the most prevalent strains of
pneumococcus, but do not prevent disease caused by strains not in the
vaccines. Emerging evidence suggests that strains not in the existing
vaccines play an increased role in causing pneumococcal disease.
"Despite the availability of safe and effective vaccines to prevent
pneumococcal infection, pneumococcus continues to evolve away from our
defenses. The potential to use a T cell-directed vaccine covering all
pneumococcal strains to combat the bacterium in the nasopharynx, where
its evolution takes place, may enable the next-generation of
pneumococcal vaccines," noted George Siber, M.D., executive director of
the Genocea board and chairman of its scientific advisory board. Dr.
Siber is the former CSO of Wyeth Vaccines, where he led the development
of Prevnar-7®, the first commercial vaccine in the market-leading
Prevnar franchise of pneumococcal vaccines from Pfizer, Inc.
The Phase 1 study is a randomized, double-blind, dose-escalation,
placebo-controlled clinical trial enrolling approximately 90 healthy
adult volunteers. The study will seek to evaluate the safety and
immunogenicity of GEN-004 across a range of doses. Genocea expects
initial results in the second quarter of 2014.
GEN-004 is the second clinical candidate designed with insights from
Genocea's ATLASTM antigen discovery platform, which
identifies vaccine targets by profiling the T cell responses to a
pathogen in large populations of humans exposed to that pathogen. The
program to develop this product received support from PATH, an
international non-profit organization. Genocea's lead program is
GEN-003, a therapeutic vaccine candidate designed to treat people
infected with Herpes Simplex Virus type 2 (HSV-2). Genocea recently
reported positive interim Phase 1/2a data for GEN-003, including a
statistically significant 51 percent reduction in viral shedding
frequency. These data were presented in a late-breaker oral presentation
at the Interscience Conference on Antimicrobial Agents and Chemotherapy
(ICAAC) in September 2013.
To learn more please visit www.genocea.com.
About Genocea Biosciences, Inc.
Genocea is harnessing the power of T cell immunity to develop the next
generation of vaccines. T cells are increasingly recognized as a
critical element of protective immune responses to a wide range of
infectious disease pathogens, but are difficult to target using
traditional vaccine discovery methods. Genocea is able to identify
protective T cell antigens in humans exposed to a pathogen using ATLAS™,
its proprietary technology platform, potentially enabling vaccines
against pathogens for which vaccine solutions do not exist or are
sub-optimal. Genocea's pipeline of novel T cell vaccines includes
GEN-003 for HSV-2 therapy, GEN-004, and earlier-stage programs in
chlamydia, HSV-2 prophylaxis and malaria.
PATH is an international nonprofit organization that transforms global
health through innovation. PATH takes an entrepreneurial approach to
developing and delivering high-impact, low-cost solutions, from
lifesaving vaccines, drugs, diagnostics, and devices to collaborative
programs with communities. Through its work in more than 70 countries,
PATH and its partners empower people to achieve their full potential.
For more information, please visit www.path.org.
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