浩鼎新藥進度持續超前！張念慈：OBI833 明年人體臨床 鉅亨網記者張旭宏 台北2013-06-26 19:31:00 興櫃新藥廠台灣浩鼎(4174-TW)董事長張念慈樂觀指出，公司新藥進度持續超前！其中獲TFDA核准治療末期轉移性乳癌的疫苗OBI822/821，臨床進度超前，最快明年首季完成收案，並進行歐美3期臨床試驗。而除乳癌外，短期內也將新增卵巢癌適應症，自2期開始啟動。另外在新一代癌症免疫治療的OBI-833部分，第一個適應症鎖定末期胰腺癌，預計明年進入人體臨床。浩鼎除原有治療末期轉移性乳癌的疫苗OBI822/821，去年獲TFDA核准進入3期人體臨床試驗外，確定第二個適應症為卵巢癌。另外，自中研院授權的新一代癌症免疫治療OBI833，也確定第一個適應症為末期胰腺癌，預計明年進入人體臨床，第二個候選適應症則會是肺癌。其中OBI822/821，明年第一季就將完成收案，2016年藥品就可以上市銷售。 張念慈指出，除了乳癌外，OBI822/821短期內將進行卵巢癌的適應症，且因安全性已被證實，將會從2期臨床切入，時間會節省許多，另外未來考量銷售通路，歐洲及日本的銷售可能對外授權。至於經銷美商Optimer的抗生素新藥DIFICID(鼎腹欣)，張念慈表示，去年已取得國內藥證，4月也已獲健保初步核價，希望下半年能夠展開台灣上市營運計畫。
OBI-833 New Generation Cancer Vaccine The expression of carbohydrate antigens can be targeted on the surface of cell cancers. OBI-833/832 is a new generation cancer vaccine licensed to OBI from Academia Sinica [www.sinica.edu.tw]. Globo H is synthesized using the OPopSTM discovery platform [LINK TO OPOPS] and produce into an antigen. Earlier research at Academia Sinica indicates Globo H is highly expressed on the cell surfaces of different cancers, including prostate, pancreatic, gastric, breast and lung cancers. OBI's cancer vaccine is code named OBI-833/832 and it attacks cancer cells and cancer stem cells. It enhances the numerous immune responses on IgG, and induces immune cells to produce large antibodies that target and destroy cancer cells. OBI-833/832 is processing the preclinical test and will start animal model test in 2012. Application for approval of a cancer clinical trial is now planned. OBI-833/832 is a new cancer drug for the treatment of various cancers, and is another promising active immunotherapy that could become the new choice of treatment against cancer.
Taipei, Taiwan – 31 January 2013 – A recent paper published by the Academia Sinica explained that a new generation therapeutic cancer vaccine – Globo H-DT (OBI-833) – can effectively target cancer cells and cancer stem cells. These results have been published in the Proceedings of the National Academy of Sciences of the United States of America (PNAS) in an article entitled, "Carbohydrate-based vaccines with a glycolipid adjuvant for breast cancer." The technology was granted a US patent in 2009, was licensed by the Academia Sinica to OBI Pharma in 2010, and is currently being developed by OBI Pharma. OBI Pharma has conducted intense research in Globo H carbohydrate cancer immunotherapy since 2002. Globo H is expressed on the surface of certain cancer cells, including the following cancer types: breast, ovary, prostate, pancreas, colon, and stomach. Immunotherapy is a novel therapy for cancer and the most advanced progress made to date is OBI Pharma's Phase II/III clinical trial of OBI-822 (Globo H-KLH) for metastatic breast cancer subjects, which is a multinational multi-center randomized controlled clinical trial in Taiwan, Hong, South Korea, India and the US. This study has been granted Phase III status by the Taiwan FDA. Globo H-DT (OBI-833) utilizes a different mechanism than Globo H-KLH, which may be superior to that of Globo H-KLH. Therefore, OBI Pharma will develop OBI-833 for the unmet medical needs of the most aggressive types of cancer. The glycosphingolipid Globo H is highly expressed in various types of cancers, including lung, breast, prostate, ovary, gastric, and colon. Globo H was first isolated by Hakomori and colleagues from a breast cancer cell line by an anti-Globo H IgM antibody. The new synthetic cancer drug demonstrates very high specificity. In addition, this active immunotherapy can stimulate the body's immune system to target cancer cells. Therefore, active immunotherapy is capable of stimulating a specific immune response to target cancer cells, extending the survival time significantly and improving the quality of life of these patients. Dr. Youe-Kong Shue, CEO of OBI Pharma, says OBI-833 will target more aggressive cancer types and expects to initiate a Phase 1 clinical trial in the US and Taiwan in 2014.