BREAST CANCER
The National Cancer Institute estimates that one in eight U.S. women will develop breast cancer in her lifetime. Annually, over 200,000 American women are diagnosed with breast cancer. Current treatments include surgery, radiation, chemotherapy and Herceptin�, a monoclonal antibody therapy. In the U.S., breast cancer claims the lives of approximately 40,000 women each year.
A Phase I/II trial conducted at Georgetown University's Lombardi Center, testing two cancer vaccines developed by Therion in collaboration with National Cancer Institute and Aventis Pasteur, suggested that human T cell immune responses induced by therapeutic vaccines result in increased survival of patients with late-stage metastatic cancers.
These vaccines, vaccinia-CEA (V) and ALVAC-CEA (A), were used in a combination regimen known as a �prime-boost� protocol in late-stage cancer patients.
COLORECTAL CANCER
Colorectal cancer is the second leading cause of cancer-related death in both men and women in the U.S. It is estimated that over 148,000 new cases of colorectal cancer are reported each year, accounting for more than 56,000 deaths annually. Over 60 % of colorectal cancers are metastatic by the time they are diagnosed. Current treatment options include surgery, radiation and chemotherapy, all of which can result in serious adverse side effects. Over 90% of patients diagnosed and treated for metastatic colorectal cancer die within five years.
Since 1998, Therion and Aventis Pasteur Limited have been engaged in a collaboration to develop pox virus-based vaccines for the treatment of colorectal cancer and melanoma. The collaboration's lead product, ALVAC-CEA/B7.1, is a vaccine intended for the treatment of colorectal cancer, currently in Phase II clinical investigation. This product candidate uses a recombinant pox vector to target carcinoembryonic antigen (CEA) a protein found on a majority of colorectal and cancer cells. In addition to CEA, the vaccine also incorporates a single co-stimulatory component to enhance antigen presentation and activation of cytotoxic T-cells critical for tumor destruction. ALVAC-CEA/B7.1 was found to be safe and well tolerated in Phase I clinical trials in 57 patients, most of whom had late-stage colorectal cancer. Furthermore, these early clinical studies demonstrated the vaccine's ability to elicit critical cell-mediated immune responses to CEA and to stabilize disease in a subset of patients. ALVAC-CEA/B7.1 is expected to enter Phase III trials in 2004.
(von
Mehren et al., Clinical Cancer Research Vol. 7, 1181-1191, May 2001.)
LUNG CANCER
Lung cancer affects over 170,000 new patients each year (American Cancer
Society). Current treatments include surgery, radiation and chemotherapy.
However, these treatments are not very effective an over 150,000 patients die
each year. Lung cancer is the leading cause of cancer death and the second
most common nonskin cancer in the United States. The main risk factors for
developing lung cancer are: Smoking cigarettes, cigars, or pipes; exposure to
second-hand smoke; and exposure to asbestos or radon (National Cancer
Institute).
AIDS
Therion's vaccines combine multiple viral antigens expected to elicit a full range of antibody and cellular immune responses, and are designed to achieve the efficacy of live attenuated HIV vaccines. Leveraging the versatility of pox virus vectors and their historical success in previous viral eradication programs (e.g. small pox), Therion is investigating opportunities to produce vaccines for serious infectious diseases. Therion is currently developing a family of preventive AIDS vaccines in a program supported through grants and contracts with the National Institutes of Health and with the International AIDS Vaccine Initiative (IAVI).
The Company has four vaccine candidates in development. TBC-3B, Therion�s first AIDS vaccine, has exhibited a strong safety profile to date in Phase I studies. Therion is currently developing a new generation of multi-antigen AIDS vaccines based on an additional pox virus vector designated MVA. Therion expects these vaccines to enter Phase I clinical trial in cooperation with the NIH in 2004.
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