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November 30, 1999 ANTIGENICS INC (AGEN) S-1 Filing (SEC form S1) Antigenics is engaged in the discovery and development of a family of novel immunotherapeutics for the treatment of life threatening and chronic medical conditions. Immunotherapeutics are drugs that work by modulating the immune system to fight disease. We are currently evaluating our lead immunotherapeutic, Oncophage, in six separate phase II or phase I/II clinical trials in four different cancers, and we expect to start a pivotal phase III trial by mid-2000. We are also developing immunotherapeutics to treat infectious diseases, such as genital herpes, and autoimmune disorders, such as diabetes and multiple sclerosis. Based upon our scientific and drug development skills, our technology platform and our strategic expertise, we intend to become a leader in drug discovery, development and commercialization. Our immunotherapeutics are based on a specific class of proteins known as heat shock proteins. Heat shock proteins are present in all cells throughout the body and published research suggests that they play a central role in the generation of immune responses. We believe that when we inject our heat shock protein-based immunotherapeutics into patients, they elicit a powerful immune response. We believe this immune response is capable of systemically targeting and killing cancers or other diseased cells from which the specific heat shock proteins were derived. We believe our heat shock protein technology can be used broadly for the treatment of a wide variety of diseases. Each of our heat shock protein-based immunotherapeutics includes a heat shock protein that is constant and a repertoire of peptides that varies depending on the target disease. For diseases such as cancer, which vary among individuals, we use heat shock protein-peptide complexes derived from a patient's own cancer and therefore our immunotherapeutics are patient-specific, or autologous. For each infectious disease which is generally caused by a common pathogen, we intend to produce a disease-specific immunotherapeutic using that same common pathogen. Our heat shock protein technology has been shown to stimulate the immune system to treat cancers in a wide range of preclinical studies. In addition, over one dozen scientific institutions world-wide have independently confirmed various aspects of our technology platform. Our lead immunotherapeutic, Oncophage, consists of purified, patient-specific heat shock protein-peptide complexes and is designed to elicit an immune response to a patient's cancer. The manufacturing process for Oncophage begins when a patient's tumor is surgically removed and shipped frozen by overnight courier to our manufacturing facility. Using our proprietary methods, we purify Oncophage from the tumor tissue in a process that takes less than 10 hours. We then ship Oncophage frozen to the hospital for administration to the patient. A patient is initially injected with Oncophage four to six weeks after surgery. The typical course of treatment involves a series of injections into the skin once per week for four to six weeks. To date, we have treated approximately 140 advanced stage cancer patients with Oncophage in our clinical trial programs. We have initially targeted cancers for which there are limited or no treatment alternatives and tumor types and stages of disease that involve resectable tumors. Further, we have targeted cancers and stages of disease that we believe can be evaluated in clinical trials with near term endpoints to permit rapid and efficient completion of clinical trials and submission of regulatory filings. We are currently conducting separate phase II or phase I/II clinical trials with Oncophage for the treatment of: - renal cell carcinoma, a type of kidney cancer; - metastatic melanoma, a type of skin cancer; - colorectal cancer, or cancer of the colon and rectum; and - gastric cancer, or stomach cancer. In addition, we are planning to start phase II clinical trials evaluating Oncophage as a treatment for sarcoma, a type of soft tissue cancer, and low grade indolent non-Hodgkin's lymphoma, a type of cancer that originates in the lymph tissue. We also expect to begin a pivotal phase III trial for Oncophage as a treatment for renal cell carcinoma by mid-2000. Preliminary results from our completed and ongoing clinical trials indicate that Oncophage is generally safe and well tolerated. These results also demonstrate preliminary indications of clinical benefit in a number of patients. For example, in renal cell carcinoma, we have shown that Oncophage has achieved a response rate, a common measure of clinical benefit, comparable to that of the existing approved treatment without the significant side effects associated with that treatment. We have also shown that in all patients who responded clinically, the number of immune cells increased after treatment with Oncophage. Moreover, we have shown that we can manufacture Oncophage consistently and in sufficient quantities from most tumor types. In addition to cancer, we believe our heat shock protein derived immunotherapeutics may be effective in treating various infectious diseases and autoimmune disorders. Our immunotherapeutics for treating infectious diseases will consist of heat shock proteins complexed to peptides that are produced by disease-causing pathogens. We have targeted genital herpes as our first infectious disease indication and are conducting preclinical studies. We anticipate filing an Investigational New Drug Application, or IND, with the United States Food and Drug Administration, or FDA, for genital herpes in 2000. We are also researching the applicability of heat shock proteins to treat autoimmune disorders like diabetes and multiple sclerosis. We have demonstrated in a number of animal models that heat shock proteins administered in high doses can turn off the misguided immune responses responsible for several autoimmune disorders. | ||||||||||||
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