DALLAS, Nov. 1 /PRNewswire/ -- Baylor Health Care System announced today its formation of a cancer immunotherapy company, known as ODC Therapy Inc. ODC will develop, produce and distribute customized cancer vaccines, including a melanoma vaccine, to individual patients and monitor their immune response after treatment.
"ODC will bring personalized therapies from early-stage clinical trials to marketing approval and commercial distribution," said Joel Allison, president and chief executive officer, Baylor Health Care System. "For 100 years, Baylor Health Care System has been bringing important innovations to health care. We know that the development of new therapies begins with the needs of individual patients. Through ODC we will bring outstanding clinically relevant research to wide public access."
Jacques Banchereau, Ph.D., director, Baylor Institute for Immunology Research, and Karolina Palucka, M.D., Ph.D., chair, Cancer Immunology Research at Baylor, and their team are using dendritic cells to develop these novel therapies. Dendritic cells play a crucial role in identifying and capturing foreign antigens -- molecules that can induce a specific immune response and direct other immune cells to destroy the tumor cells that they represent. ODC cancer vaccines are produced by removing dendritic cell precursors from a patient, culturing and loading these cells with the tumor antigens and then reintroducing them back into the same patient.
"The goal of these therapies is to stimulate the immune system to destroy tumor cells where ever they have spread (metastasized) in the body. This vaccination approach is being developed to provide a therapy where conventional treatments, such as surgery, radiation and chemotherapy, have limited or no effect and is designed to extend and maintain the patient's quality of life," said Michael Ramsay, M.D., president, Baylor Research Institute.
For further clinical, regulatory and process development, ODC will fund vaccination therapies that show safety and efficacy by supporting rigorous clinical trials. Researchers at the Baylor Institute for Immunology Research have invented and optimized processes for the production of personalized cancer vaccines and tested these novel therapies in Phase I clinical trials. Since 1998, more than 375 personalized vaccines have been manufactured and used to treat 63 patients diagnosed with late-stage metastatic melanoma.
"Studies in these patients treated at Baylor University Medical Center with personalized vaccines that we've produced have established that dendritic cells loaded with tumor antigens can induce tumor-specific immune responses and clinical responses. ODC has selected a protocol for further development wherein dendritic cells generated from patient's blood monocytes are loaded with a killed allogeneic tumor cell line as a source of tumor antigens," said Dr. Banchereau. "In a recent Phase I dose escalation trial, 20 patients with metastatic melanoma were treated with this first generation vaccine. While the results of this trial are still being analyzed, one patient has demonstrated a complete remission and another remarkable partial remission. At 22 months since the beginning of the trial 14 of the patients are still alive."
"Therapies selected for further development by ODC initially will include a melanoma vaccine for late-stage melanoma patients. ODC also will measure immune cell production and cytokine release in response to tumor specific antigens as a service for clinical and research applications," said Tom Turpen, Ph.D., president, ODC Therapy Inc. "These assays provide valuable insights for the discovery of mechanisms of disease and healing. This information may be used to develop prognostic and diagnostic markers for health management and surrogate markers for clinical trial endpoints."
ODC Therapy Inc. is a privately held company owned by Baylor Health Care System and initially will lease facilities in the Zelig H. Lieberman Research Building, home to Baylor Institute for Immunology Research, on the Baylor University Medical Center campus. Baylor Health Care System provided $4 million in seed financing in July 2004. Prior investments in technology development and clinical trials include more than $20 million in funding at the Baylor Institute for Immunology Research, a component of Baylor Research Institute. The board of directors of ODC is composed of experienced leaders in the Dallas business, financial and health care communities. ODC has licensed a portfolio of intellectual property from Baylor Research Institute and Rockefeller University in the fields of cancer immunotherapy and immunomonitoring. Technology Innovation Group Inc. served as a consultant to Baylor Health Care System during the establishment of ODC.
Baylor Health Care System is a not-for-profit, faith-based network of hospitals, primary care centers and practices, rehabilitation clinics, senior health centers and affiliated ambulatory surgery centers. Baylor also operates the Baylor Research Institute, which promotes and supports clinically relevant research, bringing innovative treatments from the laboratory workbench to the patient bedside. Investigators at Baylor are conducting more than 500 active research protocols spanning more than 20 medical specialties. Baylor Health Care System will report $240 million in community benefit to the Texas Department of Health for its fiscal year 2004.
For more information about Baylor Health Care System, visit http://www.baylorhealth.com/ .
SIDEBAR: Dendritic Cells
Dendritic cells are a class of white blood cells found in every individual's nose, lungs, skin and stomach lining. They lie in wait, ready to capture germs that we may inhale, touch or swallow. They reel in invaders, such as bacteria or viruses, chop them into pieces called antigens, and display the antigens on their surfaces. Antigen-bearing dendritic cells travel to lymph nodes or the spleen, where they tell the cells of the immune system -- B cells, which make antibodies, and killer T cells, which attack infected cells -- how to respond. Some cells educated by dendritic cells become "memory" cells that remain in the body for years -- perhaps decades -- to combat the invader in case it returns.
Manipulation of dendritic cells may provide cures for a range of immune system diseases, including cancer; autoimmune diseases such as lupus, rheumatoid arthritis and Type 1 diabetes; rejection of transplanted organs; and infectious diseases such as AIDS.
Baylor Health Care SystemCONTACT: Wendy Walker of Baylor Health Care System, +1-214-820-4581, orwendyw@baylorhealth.edu
Web site: http://www.baylorhealth.com/
