Adagloxad Simolenin (Vaccine)

Adagloxad Simolenin For Early-Stage Triple Negative Breast Cancer

Among breast cancer subtypes, triple nagative breast cancer (TNBC) exhibits the worst clinical outcome, with more than 30% of early-stage patients developing relapses during the first 2–3 years from diagnosis. Adagloxad simolenin, a first-in-class active immunotherapy in development for TNBC, may address this unmet medical need.

Adagloxad simolenin (formerly OBI-822) is exclusively licensed to OBI from Merck & Co. (Merck Sharp & Dohme, MSD). It is a conjugate of Globo H and keyhole limpet hemocyanin (KLH).

Two Phase I studies in relapsed prostate cancer and metastatic breast 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 the tumor surface. The current trial is enrolling TNBC patients who have a high risk of recurrence after surgery. It has been assessed that this group is of high unmet medical needs. This trial uses an immunohistochemistry (IHC) method, approved by the US FDA, to screen and recruit patients who have high Globo H expression on the 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.

In 2020, a 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 FDA and regulatory agencies of other countries have approved this protocol amendment. Global clinical trials were suspended or slowed due to the COVID-19 and Russia-Ukraine war impact. Despite the impact, OBI decided to add more sites to accelerate patient enrollment. Currently, this study has recruited more than half of the estimated patients.  To learn more about the trial, visit NCT01516307

Immunotherapy: Principles and Mechanisms

Cancer immunotherapy is to boost a patient’s own immune system to fight against cancer cells. There are two major types of cancer immunotherapy:

1. 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.

2. 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