Product Development Approach Cancer Research - AIDS Research Therion's unique development approach enables rapid generation and clinical evaluation of multiple product candidates for a variety of disease targets. Therion has established a powerful proprietary technology that allows simultaneous in vivo expression of those components known to be necessary to stimulate potent and specific immune responses against cancer cells. The Company's therapeutic vaccines are based on three key elements that can be combined easily to generate multiple products: A versatile set of pox virus vectors that have an established safety profile in humans and can simultaneously express multiple antigens, co-stimulatory molecules, and immune-modulating proteins Genes encoding tumor-specific antigens that stimulate and direct the immune system to specifically target cancer cells Genes encoding co-stimulatory molecules and immune-modulating proteins that enhance immune responses Therion's technology and development approach together with its strong partnership with NCI provide a rapid pathway to the clinic, allowing early testing of multiple products and protocols in human subjects. This early clinical evaluation is critical to efficient product development, as data generated using animal models have proven to be insufficient for predicting the effects of anti-cancer products in humans. Therion's use of common development, manufacturing, and testing procedures enables efficient product generation and advancement from tumor antigen identification to an IND-approvable therapeutic vaccine in as little as 12 months. By inserting genes for new antigens, co-stimulatory molecules and immune-modulating proteins into its pox virus vectors, the Company can readily improve and expand its product pipeline. Product Development Programs To date, Therion has built a substantial portfolio of products aimed at major cancers and AIDS, with eight currently in Phase I and II clinical trials. Up to ten clinical studies with new products/protocols are expected to be initiated in 1999. Cancer Research Therion is developing two classes of therapeutics designed to enlist a specific and potent immune system attack on cancer cells: antigen-specific therapeutic cancer vaccines and proprietary gene therapy products. The Company's therapeutic cancer vaccines which incorporate genes coding for tumor associated antigens have built-in specificity to direct an immune attack against target cancers. Therion has seven therapeutic cancer vaccines in clinical trials, including PROSTVAC for prostate cancer and TBC-CEA for colorectal and lung cancers. The Company has additional vaccines in clinical trials for melanoma and breast cancers. Therion's proprietary gene therapy products introduce key co-stimulatory or immune modulating genes directly into solid tumors to promote and enhance specific immune responses against those tumors. Because these agents leverage the tumor antigens expressed by the tumor cells themselves for specificity, they have potential utility across a wide range of cancers, including those for which tumor antigens have not yet been identified. The Company expects to initiate clinical trials with two of its proprietary gene therapy products in 1999. AIDS Research Therion is developing a family of preventive AIDS vaccines in a program supported entirely by NIAID. Therion's vaccines combine multiple viral antigens to elicit a full range of antibody and cellular immune responses, and are designed to achieve the efficacy of live attenuated HIV vaccines with the safety of Therion's recombinant pox virus based products. The Company has four vaccine candidates in development, led by TBC-3B. TBC-3B was the first multi-antigen AIDS vaccine to enter clinical trials and has exhibited a strong safety profile to date in Phase I studies. A second vaccine is expected to enter clinical trials in 2000. Back to the top