Corixa and GSK Biologicals Announce Plans to Initiate a Human Clinical Study in the U.S. for a Novel Tuberculosis Vaccine

Business Wire,  Jan 14, 2004  

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Business Editors/Health/Medical Writers

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SEATTLE & RIXENSART, Belgium--(BUSINESS WIRE)--Jan. 14, 2004

Corixa Corp. (Nasdaq:CRXA), a developer of immunotherapeutics, and GlaxoSmithKline Biologicals (GSK Bio), a developer of vaccines and biologicals, today announced that the FDA is allowing the initiation of a Phase I clinical study to evaluate the safety and immunogenicity of a novel, proprietary prophylactic vaccine designed to induce protection against tuberculosis (TB). The trial will be conducted in the United States under the Investigational New Drug Application (IND), currently held by Corixa, and will be the first study of this TB vaccine to be conducted in human volunteers.

The vaccine combines a proprietary, recombinant tuberculosis protein antigen and a GSK Bio proprietary formulation that incorporates several adjuvants including Corixa's MPL(R) adjuvant. MPL is Corixa's flagship adjuvant, which is present in multiple GSK Bio vaccines now in late-stage clinical development. The recombinant tuberculosis antigen is a fusion protein of antigenic domains taken from different Mycobacterium tuberculosis gene products that are recognized by immune system cells harvested from patients that had been infected with tuberculosis but who never showed signs of disease. The fusion protein adjuvant combination appears to have demonstrated protection against tuberculosis infection in a number of relevant animal species including mice, guinea pigs and monkeys.

The vaccine is the first recombinant tuberculosis protein vaccine ever to be tested in humans and is the result of a long-standing collaboration between GSK Bio and Corixa to develop vaccines for certain infectious diseases.

"Tuberculosis represents a significant public health problem," said Jean Stephenne, president and general manager of GSK Bio. "We believe that a recombinant tuberculosis vaccine holds great promise for protection of patients around the world against TB and we look forward to the initiation of the clinical program for this vaccine."

"This trial initiation underscores the productivity of our development partnerships with GSK Bio," said Steven Gillis, Ph.D., chairman and chief executive officer of Corixa. "Pursuing the clinical development of novel vaccines that contain both proprietary antigens and adjuvants from our discovery pipeline remains a key area of growth for Corixa. We look forward to the continued progress of the TB vaccine program in 2004."

About the Trial

The trial will enroll 20 volunteers at one clinical center in the United States. The trial will be a standard dose escalation study in which different cohorts of patients receive escalating doses of recombinant vaccine together with a constant dose of adjuvant. Patients will be evaluated for safety, and serum and immune cells will be collected post-vaccination to determine which dose of vaccine promotes the greatest anti-TB immune response.

About Tuberculosis

Mycobacterium tuberculosis, or Mtb, infection causes more deaths than any other infectious disease in the world. According to the World Health Organization (WHO), each year approximately 8 million people worldwide become sick with tuberculosis and an estimated 2 million die annually from the disease. The WHO estimates that between the years 2000 and 2020 nearly 1 billion people will be newly infected with Mtb, 150 million people will get sick and 36 million will die. According to the National Institute of Allergy and Infectious Diseases, an estimated 2 billion people are infected with Mtb, including approximately 15 million people in the United States. The WHO estimates that up to 50 million persons worldwide may be infected with drug-resistant strains of Mtb.

About GlaxoSmithKline Biologicals

GlaxoSmithKline Biologicals (GSK Biologicals), the world's leading vaccine manufacturer, is located in Rixensart, Belgium. Belgium is the centre of all GlaxoSmithKline's activities in the field of vaccine research, development and production. GSK Biologicals employs more than 1,000 research scientists who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. Last year, an average of 25 GSK Biologicals vaccine doses per second were delivered to 156 countries in both the developed and developing world. One hundred million of the 800 million plus vaccine doses delivered last year were combined paediatric vaccines that protect the world's children against a minimum of 3 and up to 6 diseases. For information, visit GSK Biologicals' vaccines website at www.gsk-bio.com. GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

About Corixa

Corixa is a developer of immunotherapeutics with a commitment to treating and preventing cancer and infectious diseases by understanding and directing the immune system. On June 30, 2003, Corixa announced that the FDA approved BEXXAR for the treatment of patients with CD20-positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy.