R&D

OBI-822

The Globo H Story

The surfaces of cancer cells frequently express specific types of carbohydrate antigens, like Globo H. Healthy cells do not express or, if at all, express these antigens to a lesser extent. Therefore, such antigens may be used as potential targets for stimulating an active immune response against tumor cells.

Globo H was first isolated as a glycolipid with a ceramide backbone from the human breast cancer cell line MCF-7 by Hakamori and colleagues in 1983. It is highly expressed in various types of cancer, such as breast, prostate, and lung. Therefore, it is a potential target for the development of a novel immunotherapeutic treatment against various cancers.

Globo H is a complex hexasaccharide. The lack of an efficient synthesis method hindered further clinical development until the development of the One-Pot Synthesis (OPopS™) platform. The platform was developed by Professor Chi-Huey Wong, Distinguished Research Fellow and President of Academia Sinica, when he was at The Scripps Research Institute (TSRI). OBI has rights to the OPopS™ platform, which enables the commercialization of OBI-822.

OBI-822 For Metastatic Breast Cancer

OBI-822 is a conjugate of Globo H and KLH. It is exclusively licensed to OBI from Memorial Sloan-Kettering Cancer Center (MSKCC).

Breast cancer is the most prevalent form of cancer in women. The 5-year survival rate for metastatic breast cancer is as low as 24.3%. OBI-822, a first-in-class active immunotherapy in development for metastatic breast cancer, may fulfill this unmet medical need.

Two Phase I studies in metastatic breast cancer and relapsed prostate cancer patients, which were conducted by MSKCC, showed that OBI-822 is very safe. It was also shown to induce a strong immune response against cancer cells.

Today, OBI has advanced this development into an on-going Global Phase 2/3 randomized controlled trial.

OBI-822 Clinical Trial

The ongoing OBI-822 Clinical Trial is presently conducted in over 40 sites in multiple countries including: the US, Taiwan, Korea, India, and Hong Kong.

To learn more about the trial, visit ClinicalTrials.gov NCT01516307

Immunotherapy: Principles and Mechanisms

Cancer immunotherapy is the use of a patient's own immune system against cancer cells. There are two major types of cancer immunotherapy:

(a) Passive immunotherapy - This approach uses special antibodies, which are produced outside of the patient's body. Examples of passive immunotherapy include the monoclonal antibody therapy Herceptin and Avastin.

(b) Active immunotherapy – This approach uses a patient's own immune system by activating and training it to recognize and kill tumor cells. OBI-822 is a first-in-class active immunotherapy against breast cancer. For those patients who experience severe side effects from chemotherapy or other therapies, OBI-822 represents a viable alternative that may offer a dramatic improvement in their quality of life.