Phase IIb Proof of Concept Trial Planned for Kenya, India
and South Africa
ROCKVILLE, Md., Oct. 10, 2012 /PRNewswire-USNewswire/
-- Aeras announces that it has signed an agreement with
GlaxoSmithKline Vaccines, S.A. (GSK) to jointly advance the
clinical development of an investigational tuberculosis (TB)
vaccine containing GSK's proprietary M72 antigen and
AS01E* adjuvant. This novel research
and resource-sharing agreement between the largest non-profit TB
vaccine biotech and one of the world's leading research-based
pharmaceutical and healthcare companies marks advancement in the
race to develop new vaccines against TB, a global infectious
disease killer.
"This partnership signals our commitment to building innovative
collaborations to develop and deliver new TB vaccines," said
Jim Connolly, President and Chief
Executive Officer of Aeras. "We will never reverse the spread
of the global TB epidemic without new vaccines as part of the
solution."
The new agreement comes after promising results from early stage
clinical trials showed that the GSK TB vaccine candidate known as
M72/AS01E* has an acceptable safety and
reactogenicity profile and demonstrated an immune response.
Under the new agreement, Aeras and GSK will each provide resources
to run a multi-center proof of concept clinical trial to test the
vaccine candidate in healthy adults between 18 and 50 years of
age. The Phase IIb trial is scheduled to begin in
Kenya, India and South
Africa next year pending approvals from authorities.
"When considering the massive public health impact and costs to
society of neglected diseases including tuberculosis, global
financing for R&D remains critically low in this area," said
Jim Connolly. "Working in
partnership with GSK – sharing resources, capabilities and know-how
– affords us the opportunity to conduct this pivotal, multi-country
proof of concept trial, getting us that much closer to potentially
one day having a TB vaccine that could protect adolescents and
adults from one of the world's deadliest infectious diseases."
TB continues to kill 1.4 million men, women and children
annually, despite the widespread use of the currently available TB
vaccine, Bacille Calmette-Guerin (BCG), in TB endemic
countries. BCG prevents some forms of TB in infants but does
not prevent pulmonary TB, which accounts for the majority of
infections and deaths among adolescents and adults. The GSK
vaccine candidate developed under this new agreement is being
designed to be used in addition to BCG.
*Contains QS-21 Stimulon® adjuvant licensed from
Antigenics Inc, a wholly owned subsidiary of Agenus Inc. (NASDAQ:
AGEN).
About Tuberculosis
Tuberculosis is the world's second deadliest infectious
disease, with 8.8 million new cases in 2010. Current guidelines
require a minimum of six to nine months of treatment. TB is
changing and evolving, making new vaccines more crucial for
controlling the pandemic. Tuberculosis is the leading cause of
death for people living with HIV/AIDS, particularly in
Africa. Multidrug-resistant TB (MDR-TB) and extensively
drug-resistant TB (XDR-TB) are hampering treatment and control
efforts.
About Aeras
Aeras is the world's largest and only fully integrated
tuberculosis vaccine development organization dedicated to
addressing a disease that has chronically infected almost a third
of the world's population. In collaboration with global partners in
Africa, Asia, North
America and Europe, Aeras
is supporting the clinical testing of six vaccine candidates as
well as a robust portfolio of preclinical candidates. Aeras is a
nonprofit organization and receives funding from the Bill &
Melinda Gates Foundation and other private foundations as well as a
wide range of governments. Aeras is based in Rockville, Maryland, USA where it operates a
state-of-the-art manufacturing and laboratory facility, and
Cape Town, South Africa. For more
information, see www.aeras.org.
SOURCE Aeras