Adagloxad simolenin (previously OBI-822) is an investigational immunotherapy being developed by OBI Pharma of Taiwan to treat certain types of cancer, including breast cancer. Called an immunostimulant, or compound that activates the immune system, Adagloxad simolenin combines a carbohydrate and a protein to stimulate the immune system to more effectively fight cancer cells.
How Adagloxad simolenin works
Adagloxad simolenin is made up of a carbohydrate called globo H hexasaccharide that is linked to keyhole limpet hemocyanin (KLH), a type of carrier protein. Globo H, found on the surface of many types of cancer cells, may help stimulate T-cells to recognize and attack cancer cells expressing globo H. KLH is used to carry globo H, and designed to bolster T-cells recognition of cancer cells and response against them.
Adagloxad simolenin in clinical trials
A Phase 2/3 clinical trial (NCT01516307) is testing the effects of Adagloxad simolenin in 349 women with metastatic breast cancer in the U.S., China, India, Korea, and Taiwan. The women are randomized to receive Adagloxad simolenin plus Cytoxan (cyclophosphamide), a chemotherapy drug, or Cytoxan plus a placebo. Results presented at the American Society of Clinical Oncology (ASCO) annual meeting, in 2016, showed that the trial did not meet its primary endpoint — progression-free survival — but PFS was significantly improved in a subgroup of women who developed a strong antibody response to Globo H.
Investigators are using study data to design a global Phase 3 trial. In January 2017, the China Food and Drug Administration (CFDA) approved a clinical trial application, submitted by OBI for formal review in 2015, for such a Phase 3 trial to take place, and the company reports that feedback has also been received from the U.S. FDA and European Medicines Agency. Findings from this study, if positive, could be used to support a request for treatment approval.
A Phase 2 clinical trial (NCT02132988) is evaluating if Adaglaxod simolenin improves progression-free survival in women with stable ovarian cancer, or cancers of the fallopian tube or peritoneum (the inner lining of the abdomen, which also covers the surface of the uterus). The trial, taking place at Mackay Hospital in Taiwan, aims to enroll 110 women whose cancer has not progressed after being treated with platinum-based chemotherapy and is still recruiting participants. It began in 2013 and is set to finish in November 2018.
In March 2017, OBI Pharma partnered with Stellar Biotechnologies, the supplier of KLH. The partnership follows a two-year collaboration between the companies, honing the process of manufacturing Adagloxad simolenin conjugated vaccine.
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