宇越生醫(鑫品) &高榮 進行CD19免疫治療 _Chimeric Antigen Receptor (CAR) T-Cell Immunotherapy)

鑫品生醫：本公司轉投資公司宇越生醫科技股份有限公司與高雄榮民總醫院簽訂合約，執行Car-T技術平台於血癌治療之開發研究(補充公告) 鉅亨網新聞中心　　2015-06-29 17:13:10　第三十四條　第8款1.事實發生日:104/06/26 2.契約或承諾相對人:高雄榮民總醫院3.與公司關係:非關係人4.契約或承諾起迄日期(或解除日期):104/06/15~106/06/145.主要內容(解除者不適用):宇越生醫公司委託高雄榮總，執行嵌合抗原受體T細胞CD19-Car-T技術平台於血癌治療之開發研究。宇越生醫公司將取得本研究產出之研發成果之專利申請權及專利權、著作權或其他相關之智慧財產權等相關權利及義務。6.限制條款(解除者不適用):無7.對公司財務、業務之影響(解除者不適用):增加本公司生醫產品與技術服務項目，進而擴大整體營運規模。8.具體目的(解除者不適用):經由轉投資公司進入CAR-T新藥的開發領域。9.其他應敘明事項:宇越生醫於6/26(五)獲高雄榮總通知完成合約用印簽署。

 Chimeric Antigen Receptor (CAR) T-Cell Immunotherapy for Leukemia and Beyond Sagar B. Kudchodkar, PhD, and Marcela V. Maus, MD, PhD Published Online: Friday, August 29, 2014 Abstract  Chimeric antigen receptor (CAR) T-cell therapy is an immunotherapy in which the patient's own T cells are isolated in the laboratory, redirected with a synthetic receptor to recognize a particular antigen or protein, and reinfused into the patient. Clinical trials of CAR T cells directed to the CD19 antigen have shown impressive results in advanced B-cell malignancies at multiple academic centers over the last 3 years. We describe the technology of CAR T cells, findings at 5 academic centers, and toxicities associated with CAR T cell-treatment and their management. Although CAR T cells for B-cell malignancies are the most advanced in terms of clinical testing, CAR T cells are the basis of a new platform technology that is poised to be expanded to other hematologic and nonhematologic malignancies, especially as new targets are identified and manufacturing processes are streamlined. Introduction  Chimeric antigen receptor (CAR) T-cell therapy is an immunotherapy in which the patient's own T cells are isolated in the lab, redirected with a synthetic receptor to recognize a particular antigen or protein, and re-infused into the patient (Figure). Over the last 5 years, at least 15 clinical trials of CAR T cell therapy have been published. A new wave of excitement surrounding CAR T cell therapy began in August 2011, when investigators from the University of Pennsylvania (Penn) published a report on 3 patients with refractory chronic lymphocytic leukemia (CLL) who had long-lasting remissions after a single dose of CAR T cells directed to CD19.1,2 Since then, the enthusiasm has only increased as investigators from the National Cancer Institute (NCI),3,4 Memorial Sloan Kettering Cancer Center (MSKCC),5 which allowed us to transition most of these patients to a standard- of-care allogeneic hematopoietic stem cell transplant (allo- SCT), and Penn6 have published impressive results in lymphoma and acute lymphoblastic leukemia (ALL). At large meetings, including those of the American Society of Hematology (ASH) and the American Association for Cancer Research (AACR), new sessions devoted to CAR T cell therapies have been organized and well attended, and all the major centers developing CAR T cells, including also Baylor College of Medicine, Fred Hutchinson Cancer Research Center, City of Hope National Medical Center, and MD Anderson Cancer Center, have discussed their latest results. Tellingly, what was considered a fringe field only 5 years ago has recently attracted investors, and several new partnerships and biotechnology companies have been formed around CAR T cell therapies (Table). What Exactly Is a CAR-Modified T Cell?  CARs are synthetic molecules that minimally contain: (1) an antigen-binding region, typically derived from an antibody, (2) a transmembrane domain to anchor the CAR into the T cells, and (3) 1 or more intracellular T cell signaling domains.7 A CAR redirects T cell specificity to an antigen in a human leukocyte antigen (HLA)-independent fashion, and overcomes issues related to T cell tolerance. Thus far, CAR T cells directed against CD19 are the only ones that have achieved a clinical proof-of-concept and are in later stages of clinical development. However, CAR-modified T cells are a platform for a therapy that could be extended to other hematologic and nonhematologic tumors, provided the CAR is specific to the desired proteins on the surface of the tumor cell. The CAR can be introduced into the T cells by a variety of techniques, some of which permanently modify the genome of the T cell (integrating vectors) and have the potential for long-term effects, and some of which are transient (nonintegrating). Examples of integrating methods are retroviral, lentiviral, and transposase-based vectors; examples of nonintegrating methods are adenoviral vectors and plasmid or RNA electroporation. Each method carries unique benefits and concerns related to cost of development, safety, and the durability of CAR expression. The intracellular domains included in the CAR (ie, CD28-z or 4-1BB-z) can modulate T cell properties, such as their ability to survive and proliferate.