Adagloxad Simolenin


Adagloxad Simolenin

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 Hakomori 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 Adagloxad simolenin.

Adagloxad Simolenin For Metastatic Breast Cancer

Adagloxad simolenin (formerly 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%. Adagloxad simolenin, 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 Adagloxad simolenin is very safe. It was also shown to induce a strong immune response against cancer cells.

Adagloxad Simolenin Clinical Trial

An active immuno-oncology therapy based on the Globo H antigen, Adagloxad simolenin’s clinical trial for breast cancer was conducted in 45 medical centers worldwide. The trial exceeded its patient recruiting target of 342 subjects (349 subjects recruited in total) in July 2014, and topline data was unblinded in February 2016. Despite not meeting its primary efficacy endpoint of Progression-Free Survival (PFS), the trial demonstrated to a significant degree that subjects who generated enough Globo H antibodies benefited from an extended period of PFS. These results were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2016. The Company held its End of Phase 2 (EOP2) Meeting with the US Food and Drug Administration (FDA) in January 2017, and received a written reply from the European Medicines Agency (EMA) regarding questions related to the Company's design of its global Phase III clinical trial for Adagloxad simolenin. The Company will amend its global Phase III clinical trial accordingly.

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. Adagloxad simolenin is a first-in-class active immunotherapy against breast cancer. For those patients who experience severe side effects from chemotherapy or other therapies, adagloxad simolenin represents a viable alternative that may offer a dramatic improvement in their quality of life.