ROCKVILLE, Md.—Aeras, a nonprofit biotech focused ondeveloping tuberculosis vaccines, has announced the establishment of anagreement with GlaxoSmithKline Vaccines, S.A. (GSK) for the advancement of aninvestigational tuberculosis vaccine containing GSK's proprietary M72 antigenand AS01E adjuvant. Financial details were not disclosed.
"This partnership signals our commitment to buildinginnovative collaborations to develop and deliver new TB vaccines," JimConnolly, president and CEO of Aeras, said in a press release regarding thedeal. "We will never reverse the spread of the global TB epidemic without newvaccines as part of the solution."
Per the terms of the agreement, Aeras and GSK will eachprovide resources to conduct a multi-center proof-of-concept clinical trial toevaluate GSK's vaccine candidate in healthy adults between 18 and 50 years ofage. The Phase IIb trial is slated to begin in 2013 in Kenya, India and SouthAfrica, pending approval from authorities.
The only tuberculosis vaccination available currently isBacille Calmette-Guèrin (BCG). Unfortunately, while BCG prevents some forms ofthe disease in infants, it does not prevent pulmonary tuberculosis, which isthe cause of the majority of tuberculosis infections and death in adolescentsand adults. Under the new agreement, GSK's vaccine candidate is being developedto be used in addition to BCG. Early-stage clinical trials have demonstratedthat M72 has an acceptable safety and reactogenicity profile, as well as ademonstrated immune response.
"When considering the massive public health impact and coststo society of neglected diseases including tuberculosis, global financing forR&D remains critically low in this area," said Connolly in a statement."Working in partnership with GSK—sharing resources, capabilities andknow-how—affords us the opportunity to conduct this pivotal, multi-countryproof-of-concept trial, getting us that much closer to potentially one dayhaving a TB vaccine that could protect adolescents and adults from one of theworld's deadliest infectious diseases."
The announcement is followed by additional tuberculosis newsfrom GSK. The company announced that its tuberculosis compound library would bemade freely available to the public. GSK researchers have screened thecompany's pharmaceutical compound library for any candidates that might inhibittuberculosis bacteria, and plans to publish the results in a scientificjournal, which will shed light on approximately 200 promising candidates thatcould provide new targets for additional tuberculosis medicines. The move isone of several made by GSK in recent years to be more open in the sharing ofits intellectual property, and follows a similar move in 2009 when the companyput all of its malaria compounds in the public domain.
According to the U.S. Centers for Disease Control andPrevention, one-third of the world's population is infected with tuberculosis,with nearly nine million people contracting the disease worldwide in 2011,10,528 of which were reported in the United States. Approximately 1.5 milliontuberculosis-related deaths were recorded in 2011 worldwide, and it is aleading killer of HIV-infected individuals. Tuberculosis is still endemic inseveral countries, with 22 countries listed as being high burden countries forthe disease.
