Sequella Global Tuberculosis Foundation Partners Development of the First New TB Vaccines in More Than 80 Years.

Business Editors/Health & Medical Writers

BIOWIRE2K

ROCKVILLE, Md.--(BW HealthWire)--March 22, 2002

The Sequella Global Tuberculosis Foundation (SGTBF) announced landmark progress in field-testing the first new tuberculosis (TB) vaccines in more than 80 years.

Through its Tuberculosis Vaccine Collaboration (TBVC) program, a program funded with $25M from the Bill and Melinda Gates Foundation, the SGTBF reached agreement on three clinical partnerships to develop TB vaccines that will intervene at three different phases of the disease.

The TBVC program is composed of several interrelated initiatives that foster dialogue between researchers, field clinicians, global regulatory and governmental agencies, and the pharmaceutical industry.

The clinical development agreements reflect the consensus reached among public health officials that TB will only be contained and ultimately eradicated through the synergistic efforts of public and private institutions in partnership and represent a first step forward in the eradication of TB.

According to the World Health Organization (WHO), 2-3 million people die annually from TB and 70-90 million people will die from the disease in the next three decades. Despite these dismal statistics, the world has not seen a new TB vaccine since the 1920s, when the original BCG vaccine (currently used to vaccinate 85% of newborns in the world) was discovered.

The SGTBF has teamed up with three corporate partners, University of California, LA (UCLA, Los Angeles, CA, USA), Intercell, AG (Vienna, Austria), and Sequella, Inc.(Rockville, MD, USA), to develop new TB vaccines that use different mechanisms of action and address different disease stages.

The clinical agreement with UCLA is to develop an 'improved' BCG vaccine, a recombinant BCG that over-expresses a major TB protein that has, itself, demonstrated efficacy in animal models of TB: Antigen 85.

The research underpinning the selection of this vaccine for preparation for clinical trials was led by Marcus Horwitz, M.D., at UCLA, and demonstrated that this new vaccine provokes a stronger immune response in vaccinated animals than BCG, and is more protective.

This discovery suggests that the recombinant BCG may supplant the current vaccine as a prophylactic vaccine for children if its safety and efficacy in humans is as good as in animals. The Korean TB Institute has produced the first batch of clinical grade vaccine, and preclinical studies in preparation for Phase I safety tests in humans will commence in the next several months.

This potentially more effective vaccine is slated to enter human Phase I clinical trials in mid 2002 and marks the first Phase I test of a new TB vaccine in more than 80 years.

The SGTBF will also develop another pre-infection vaccine, the TransVax TB Epitope vaccine, which resulted from collaboration between EpiVax, Inc, a bioinformatics company in RI, USA, and Intercell AG, a biotechnology company in Vienna, Austria.

EpiVax used its proprietary bioinformatics programs to scan TB proteins known to protect animals for regions (epitopes) of the proteins that would stimulate human immune responses from a wide variety of genetic backgrounds. Intercell, Inc. synthesized these peptides and combined them with their proprietary adjuvant, TransVax.

The indication for this vaccine is as a boost to the current BCG vaccine to stimulate recall immune responses in adolescent children vaccinated with BCG as newborns. This vaccine is being manufactured by Good Manufacturing Practice (GMP) in Intercell facilities in Europe, and is expected to begin preclinical toxicity studies in late summer 2002.

The TransVax TB vaccine is expected to begin human Phase I safety and immunogenicity studies in early 2003.

In a similar public-private partnership, the SGTBF is working with Sequella, Inc. (both co-founded by Dr. Carol A. Nacy) to develop a post-exposure vaccine that may decrease reactivation disease and may shorten the time (currently 6-24 months) patients must take their TB drugs.

This result, demonstrated in animal models of TB, could help decrease the incidence of drug-resistant TB in humans who find it difficult to comply with the current long drug regimen.

This vaccine is also being manufactured according to GMP in Europe, by Cobra Pharmaceuticals in the UK, and will be tested for potency in several laboratories around the world before it begins its preclinical toxicity testing. SGTBF anticipates that this vaccine could begin Phase I safety and immunogenicity tests in humans in 2003.

Through its current three clinical development agreements, SGTBF has ensured that any effective TB vaccine developed with its assistance will be marketed in all countries in which there is a need.

A new and effective TB vaccine that can prevent or facilitate treatment of infectious pulmonary TB could substantially reduce the economic hardship endured by developing nations as a result of epidemic TB. Thus SGTBF contributes through its vaccine clinical development agreements to the overall theme for World TB Day 24 March 2002, - "Stop TB, fight poverty."

The need for new tools to combat this global infectious disease has never been so obvious as it is today: over 2 billion people infected with the causative agent of TB, more than two million deaths each year, and a rising incidence of drug resistant TB threatens public health in every corner of the world.

While Directly Observed Therapy Short Course (DOTS) with the existing anti-TB drugs, recommended by the WHO and the cornerstone of the Stop TB movement, will help to reduce TB in areas where it is rigorously practiced, new and more effective vaccines, diagnostics and drugs must be developed to truly achieve a significant level of control over the global TB epidemic.

SGTBF mission is to assist the development of new tools for the control of TB through creative partnerships with academia, governments, and industry. The three new Clinical Development Agreements for new TB vaccines with UCLA, Intercell, and Sequella demonstrate the effectiveness of this mission.

About the Sequella Global Tuberculosis Foundation

SGTBF is a non-profit organization created in response to the critical need for new diagnostics, drugs, and vaccines to stem the rising tide of TB deaths.

With generous support from the Bill & Melinda Gates Foundation, the SGTBF facilitates the development of new TB vaccines and fosters bi-directional dialogue between basic researchers, field clinicians, global regulatory and governmental agencies, and the pharmaceutical industry to accelerate development of new tools to control TB.