| PROSPECTUS SUMMARY (S-1 3/16/2004)
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Our Business
We are a biotechnology company developing a new class of therapeutic products designed to enhance the body’s natural immune responses to treat cancer, infectious diseases and other medical conditions associated with weakened immune systems. We derive our therapeutic products from a patient’s own T cells, which are cells of the immune system that orchestrate immune responses and can detect and eliminate cancer cells and infected cells in the body. We use our patented and proprietary Xcellerate Technology to generate activated T cells, which we call Xcellerated T Cells, from blood that is collected from the patient. Activated T cells are T cells that have been stimulated to carry out immune functions. Our Xcellerate Technology is designed to rapidly activate and expand the patient’s T cells outside of the body. These Xcellerated T Cells are then administered to the patient.
We believe, based on clinical trials to date, that our Xcellerate Technology can produce Xcellerated T Cells in sufficient numbers to generate rapid and potent immune responses to treat a variety of medical conditions. In our ongoing clinical studies using our Xcellerate Technology, we have observed an increase in the quantity and a restoration of the diversity of T cells in patients with weakened immune systems. We plan to submit these findings to the FDA for review in our annual report. We believe we can efficiently manufacture Xcellerated T Cells for therapeutic applications. We expect Xcellerated T Cells may be used alone or in combination with other complementary treatments.
Our clinical trials and independent clinical trials using an earlier version of our technology, to date, have involved small numbers of patients and we have not designed nor been required to design such trials to produce statistically significant results as to efficacy. These trials have not been randomized nor double-blinded to ensure that the results are due to the effects of the Xcellerated Technology. Success in early clinical trials does not ensure that large-scale trials will be successful nor does it predict final results. We and other clinical investigators have completed or are conducting clinical trials in the following indications:
· Chronic lymphocytic leukemia, or CLL. In our ongoing Phase I/II clinical trial in CLL, treatment with Xcellerated T Cells resulted in a 50% to 100% reduction in the size of enlarged lymph nodes in 10 of 11 patients evaluated to date. In addition, there was a 50% or greater reduction in spleen size as measured below the rib cage by physical examination in all 10 of the patients with enlarged spleens. We plan to submit these findings to the FDA for review in our annual report.
· Multiple myeloma. In our ongoing Phase I/II clinical trial, we have shown that treatment with Xcellerated T Cells led to rapid recovery of T cells and lymphocytes in all 32 patients evaluated to date with multiple myeloma following treatment with high-dose chemotherapy and transplantation with the patient’s own stem cells, known as autologous stem cell transplantation. Previous independent clinical studies have demonstrated a correlation between patient survival and the speed of recovery of lymphocytes following treatment with chemotherapy and stem cell transplantation. Preliminary results on the first 25 patients evaluated for tumor responses in our clinical trial have documented, in
the majority of patients, a greater than 90% decrease in the tumor marker, which is used to measure disease. We have not yet submitted these data to the FDA and additional follow-up will be required to determine the therapeutic effects of Xcellerated T Cells after transplant. In independent clinical trials, a greater than 90% decrease in the tumor marker has been associated with increased survival in multiple myeloma patients. We have also recently initiated a Phase II trial to treat patients who have advanced disease with Xcellerated T Cells without other anti-tumor therapy.
· Non-Hodgkin’s lymphoma. In an independent clinical trial, conducted by one of our scientific founders under a physician-sponsored investigational new drug application, or IND, 16 non-Hodgkin’s lymphoma patients undergoing high-dose chemotherapy and autologous stem cell transplantation were treated with T cells activated with an earlier version of our proprietary technology. Based on a September 2003 report of the results of this trial in the peer-reviewed journal, Blood, 8 out of these 16 patients with a very poor prognosis were still alive with a median followup of 33 months. These data were derived from an independent clinical trial, which we did not control and which were not designed to produce statistically significant results as to efficacy or to ensure the results were due to the effects of T cells activated using an earlier version of our proprietary technology. We have been advised that these data have been submitted to the FDA for review. We plan to initiate a Phase II clinical trial in the first half of 2004 in patients with non-Hodgkin’s lymphoma who have failed prior therapies.
· Kidney cancer. In our completed Phase I clinical trial in 25 patients with metastatic kidney cancer, treatment with Xcellerated T Cells and low doses of the T cell activating agent, interleukin-2, or IL-2, led to a median survival of 21 months. The results of this study were published in a peer-reviewed journal, Clinical Cancer Research, in September 2003, and have been submitted to the FDA for review. Previous independent clinical studies have demonstrated median survival of patients with metastatic kidney cancer of approximately 12 months.
· Prostate cancer. In our recently completed Phase I/II clinical trial in prostate cancer, treatment with Xcellerated T Cells led to greater than 50% decreases in the serum tumor marker, prostate specific antigen, or PSA, in 2 out of 19 patients. We have not yet submitted these findings to the FDA. In some independent clinical studies, decreases in PSA levels have been shown to correlate with increased patient survival.
· HIV. In an independent clinical trial in HIV patients with low T cell counts, conducted by one of our scientific founders under a physician-sponsored IND, treatment with T cells activated using an earlier version of our proprietary technology increased the patient population’s average T cell count to within normal levels and maintained this normal count for at least one year following therapy. These data were derived from an independent clinical trial, which we did not control and which were not designed to produce statistically significant results as to efficacy or to ensure the results were due to the effects of T cells activated using an earlier version of our proprietary technology. We have been advised that these data have been submitted to the FDA for review. The results of this study were published in a peer-reviewed journal, Nature Medicine, in January 2002. In several independent clinical studies, increased levels of T cells have been shown to correlate with increased patient survival and improved clinical outcome. In addition, Fresenius Biotechnology GmbH initiated a Phase I clinical trial under our collaboration to treat HIV patients with genetically-modified T cells produced using our Xcellerate Technology.
Our Solution
We have developed our proprietary Xcellerate Technology, which consistently activates and grows large numbers of T cells ex vivo, or outside of the body, for multiple potential therapeutic applications.
Benefits of Xcellerated T Cells
We believe Xcellerated T Cells may be an effective treatment for cancer and infectious diseases and may have the following clinical benefits:
· Increased T cell quantity. Using our Xcellerate Technology, we have documented a 100-fold to 300-fold increase in T cells during the manufacturing process. These results were published in the peer-reviewed BioProcessing Journal in November 2003 and have been submitted to the FDA for review.
· Prolonged T cell survival. In an independent clinical trial, T cells activated using an earlier version of our proprietary technology have been documented to survive in the body for more than a year after their administration. We have been advised that these data have been submitted to the FDA for review. We believe the prolonged survival of Xcellerated T Cells may enable less frequent administration than existing therapeutic products for cancer and infectious diseases.
· Improved T cell quality. Xcellerated T Cells have been documented to produce a broad spectrum of chemical messengers, including cytokines and other molecules required to generate an effective immune response. We have submitted these findings to the FDA for review.
· Broadened T cell diversity. We have observed the generation of T cells with a broad diversity of T cell receptors using our Xcellerate Technology and have submitted such findings to the FDA for review. A broad diversity of T cell receptors is important to enable the immune system to recognize and eliminate a wide variety of cancers and infectious diseases.
· Favorable side effect profile. There have been over 115 infusions of Xcellerated T Cells given to more than 90 patients to date in Xcyte-sponsored clinical trials. We have observed few side effects in most patients. Side effects have generally been minor, consisting primarily of fever, chills and nausea associated with the infusions. To date we have had only two serious adverse events that were judged as possibly or probably related to our technology, both of which resolved following treatment. The first of these was a rash that resolved following treatment. The second of these was congestive heart failure in a patient with pre-existing severe anemia that resolved approximately two hours following treatment. We subsequently amended our protocol to identify patients with anemia prior to administering Xcellerated T Cells.
· Complementary to other therapies. We believe that Xcellerated T Cells may be complementary to current therapies, such as chemotherapy, radiation and monoclonal antibodies.
Benefits of our Xcellerate Technology
We believe our Xcellerate Technology may have the following benefits:
· Ex vivo process. We designed our Xcellerate Technology to be used outside of the body in a controlled environment where we can provide optimal conditions for the activation and growth of T cells.
· Broad clinical applications. Based on recent clinical trials, we believe that our Xcellerate Technology can be applied to a variety of medical conditions, including many types of cancer and infectious diseases.
· Ease of administration. Xcellerated T Cells are administered in approximately two hours using a routine intravenous procedure in an outpatient clinic.
· Reproducible and cost-effective manufacturing. We use a standardized process to produce Xcellerated T Cells for all patients. Other than our proprietary components, our Xcellerate Technology incorporates commercially available products and standard clinical and blood bank supplies, which enables us to efficiently manufacture Xcellerated T Cells.
Our Strategy
Our goal is to be a leader in the field of T cell therapy and to leverage our expertise in T cell activation to develop and commercialize products to treat patients with cancer, infectious diseases and other medical conditions associated with weakened immune systems. We plan to initially develop Xcellerated T Cells to treat life-threatening diseases, such as cancer and HIV, which currently have inadequate treatments. Key elements of our strategy include the following:
· Maximize speed to market.
· Expand the therapeutic applications of Xcellerated T Cells.
· Leverage complementary technologies and therapies.
· Retain selected U.S. commercialization rights in cancer.
· Enhance our manufacturing capabilities.
· Expand and enhance our intellectual property.
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Our Corporate Information
We were incorporated in Delaware as MolecuRx, Inc. in January 1996. We changed our name to CDR Therapeutics, Inc. in August 1996 and changed our name to Xcyte Therapies, Inc. in October 1997. Our principal executive offices are located at 1124 Columbia Street, Suite 130, Seattle, Washington 98104, and our telephone number is (206) 262-6200. Our web site address is www.xcytetherapies.com. The information contained on our web site is not incorporated by reference into and does not form any part of this prospectus.
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