FDA approves the first autologous dendritic cell therapy product, applicable to four types of cancer such as lung cancer

• by EVOMT
• 2017-06-05

　　APAC Biotech, a leading Indian biotechnology company, has been granted a commercial license by the Indian FDA to sell the product APCEDEN, a dendritic cell based autoimmune therapy product for four cancer indicators, namely prostate cancer, ovarian cancer, rectal cancer, and non small cell lung cancer

　　The Food and Drug Administration of India has approved the use of this application after rigorous review

　　"Over the past few decades, the development and application of cellular and genetic engineering have made revolutionary progress, committed to personalized treatment of cancer. We are now confident that during clinical trials in India, we have observed good results in the treatment of cancer using this method. Oncologist Dr. Ashok Vaid said that the results are encouraging and mark the possibility of treating patients with solid tumors that do not meet standard treatment."

　　APCEDEN is a mature dendritic cell derived from autologous monocytes that, when loaded with tumor antigens, can generate an effective immune response against tumors In 2011, an ATTEST trial was conducted in which multiple patients with advanced solid tumors who had failed chemotherapy were recruited for APCEDEN treatment. The results of the study were published in the International Journal of Cell Therapy in 2014. The trial was aimed at understanding the potential benefits and risks of treatment. In the trial, 28.9% of cases demonstrated good quality of life and disease stability, and survival benefits of over 200 days were observed

　　In addition, the company has also received a marketing license from Mumbai for three other products. These three products are STEMPEUCEL obtained from allogeneic cultured bone marrow mesenchymal cells, autologous cultured osteoblasts, and autologous adult chondrocytes, OSSORON

　　DC therapy involves using patients' autologous mononuclear cells to induce the generation of DC in vitro, then loading the corresponding tumor antigen to make DC cells loaded with tumor antigen, and injecting these DC cells into the patient's body to stimulate the proliferation of tumor killing lymphocytes in the body, thereby achieving long-term monitoring of tumor and tumor killing effects, To achieve the goal of eliminating tumors. Dendritic cells (DC) were first discovered by Canadian scholar Steinman in 1973

　　Dr. Ralph Marvin Steinman is an internationally renowned immunologist and cell biologist. In 1973, he and Dr. Zanville. A. Cohn discovered "dendritic cells" and their basic mechanisms, and was awarded the Nobel Prize in Physiology and Medicine on October 3, 2011

　　Note: Dendritic cells used for immunotherapy are derived from monocytes in autologous blood. They undertake the task of discovering "cancer cells" in the immune cell population and conveying information, which instructs other immune cells to attack "cancer cells"

　　Ralph? Dr. Steinman was diagnosed as pancreatic cancer in 2007. Using the dendritic cell mechanism he studied, Dr. Ralph gave himself immunotherapy, and he continued to live for four years. Dr. Ralph used the method of reinjection after culturing dendritic cells in vitro for his immunotherapy. At the same time, Japanese medical institutions are also using similar methods to immunotherapy patients, mastering the core technology and constantly upgrading, For example, globally forward-looking immunosuppressant (PD-1)+dendritic cell vaccine combination therapy, cell immunotherapy+high-dose vitamin C intravenous drip therapy, and other research achievements have attracted worldwide attention

　　At present, immunocyte therapy cannot replace standard treatment (surgery, chemotherapy, and radiotherapy). Patients need to combine their own conditions, and if they have a certain economic ability, they can receive formal standard treatment with adjuvant immunotherapy to activate the immune system, extend survival, and prevent cancer recurrence