Adagloxad Simolenin (Vaccine)

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 Merck & Co. (Merck Sharp & Dohme, MSD).

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 Memorial Sloan-Kettering Cancer Center (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

Adagloxad simolenin is a novel active immuno-oncologic therapy that targets Globo H on tumor surface. During the second quarter of 2020, its associated Global Phase III clinical trial was suspended due to the COVID-19 pandemic. Nonetheless, the trial was resumed in Taiwan, the United States, Australia, Hong Kong, Ukraine, and Russia by the year end. Clinical trial clearance was also granted in South Korea and China.

Since the start of the trial, recruitment rate has been suboptimal. In 2020, protocol amendment was requested to the FDA to update the study from a randomized, double-blinded, placebo-controlled trial to a randomized, open-labelled, standard-of-care (SOC) controlled design. The proposal has been approved by the FDA and regulatory agencies of other countries. The current trial is based on triple negative breast cancer (TNBC) patients of whom have a high risk of recurrence after surgery. It has been assessed that this group is of high unmet medical needs. The trial uses an immunohistochemistry (IHC) method, approved by the FDA, to screen and recruit patients who have high Globo H expression on the tumor surface.

To learn more about the trial, visit 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.

Last Updated: July 25, 2022