OBI Pharma, Inc., a Taiwan-based biotech company developing novel therapeutic agents for unmet medical needs, has completed patient enrollment in its Phase 2/3 randomized double-blind controlled trial assessing the safety and efficacy of OBI-822, an active immunotherapy for the treatment of metastatic breast cancer. The compound is exclusively licensed to OBI by the Memorial Sloan-Kettering Cancer Center.
This experimental drug consists of a synthetic glycoprotein composed of several carbohydrate tumor-antigens, Globo H, an antigen highly expressed on the surface of several different tumors, including breast cancer.
Globo H has its immunogenicity enhanced upon conjugation with the Keyhole Limpet Hemocyanin (KLH) carrier protein, this way forming OBI-822, which is administered in conjugation with OBI-822, a saponin-based adjuvant.
“Completing enrollment in the Phase II/III clinical trial is a major milestone in the development of OBI-822,” said Michael N. Chang, Ph.D., Chairman of the Board of OBI, in a company’s press release. “Our next target is a global phase III trial — now that there is a current IND with the US FDA and an IND application already submitted in China. We look forward to the results of this trial being confirmed once the course of treatment is completed in all enrolled patients early next year.”
Previous Phase I clinical studies of the OBI-822/OBI-821 in metastatic breast and prostate cancers revealed the compound induced specific antibody responses, indicating a complement as well as antibody-dependent cytotoxicity with only mild side effects.
Following the promising data, the company initiated the current Phase II/III trial, enrolling 342 female patients suffering from metastatic breast cancer who were able to achieve stable disease, partial response or complete response after at least 1 regimen of anticancer therapy. Patients will receive either active OPT-822/OPT-821 plus cyclophosphamide, a prodrug used in chemotherapy regimens, or control plus cyclophosphamide. Additionally, the study has defined progression free survival and overall survival as its primary and secondary outcome measures, respectively.
“The cancer active immunotherapy OBI-822 guides the immune system to attack breast cancer cells, with minimal side effects, as observed in the OBI’s Phase 1 and Phase 2/3 clinical trials” added Amy Huang, General Manager of OBI in the press release. “OBI-822’s anti-cancer potential goes beyond breast cancer. All tumor cells expressing Globo series glycan (Globo H, SSEA-3 and SSEA-4) are possible treatment targets for OBI-822. According to the latest research findings reported by Taiwan’s Academia Sinica, the Globo H vaccine can potentially treat up to 16 different types of cancer. In fact, OBI Pharma and Mackay Memorial Hospital jointly initiated a Phase 2 ovarian cancer trial in November 2013 which is currently on-going,” she concluded.
The final results from the trial, conducted in over 40 sites in multiple countries, are estimated to be out by the end of 2016, and if proven effective, OBI-822 can represent a real alternative for patients who develop serious side effects from chemotherapy or other types of therapies, significantly improving their quality of life.