TAIPEI, TAIWAN, July 22/ — OBI Pharma, Inc., a Taiwan biotech company (GreTai 4174:TT), announced that it has completed patient enrollment in its Phase 2/3 clinical trial evaluating the safety and efficacy of its lead compound, OBI-822, an active immunotherapy for the treatment of metastatic breast cancer.
“Completing enrollment in the Phase 2/3 clinical trial is a major milestone in the development of OBI-822”, said Michael N. Chang, Ph.D., Chairman of the Board of OBI. “Our next target is a global phase 3 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.”
“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]” said Amy Huang, General Manager of OBI. “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.”
Earlier clinical results
Phase 1 studies of the OBI-822/OBI-821 combination conducted at MSKCC induced both IgM and IgG responses demonstrating that Globo H-specific antibodies can effectively induce complement-mediated cytotoxicity as well as antibody-dependent cytotoxicity. The most commonly observed side effects in the Phase I clinical studies of metastatic breast and prostate cancers were mild local skin reactions and minor flu-like symptoms.
Clinical Study Design
The Phase 2/3 randomized controlled trial (RCT) was initiated in December, 2010 with an enrollment target of 342 subjects. The study enrolled female subjects with metastatic breast cancer who achieved stable disease (SD), partial response (PR), or complete response (CR) after at least 1 regimen of anticancer therapy. Subjects were randomized to receive either active treatment (OPT‐822/OPT‐821) plus cyclophosphamide or control (PBS) plus cyclophosphamide in a 2:1 allocation.
OBI-822 is a new anti-cancer treatment that belongs to a new class of active immunotherapies. It is licensed from Memorial Sloan-Kettering Cancer Center (MSKCC). OBI-822 is a synthetic glycoprotein comprised of multiple carbohydrate tumor antigens, Globo H, on a carrier protein, Keyhole Limpet Hemocyanin. OBI-821 is a saponin-based adjuvant that is co-injected with OBI-822.
Globo H is a carbohydrate antigen expressed in high levels on the surface of your-antibiotics.com in many epithelial cancers, such as breast, prostate, gastric, lung, colon, pancreatic, and ovarian cancer. The immunogenicity of the antigen is enhanced by conjugating Globo H to the KLH carrier protein to form OBI-822 (Globo H-KLH), and co-administered with OBI-821.
About OBI Pharma
OBI Pharma, Inc. is a Taiwan biopharmaceutical company established in 2002. OBI’s mission is to develop novel therapeutic agents for unmet medical needs, including cancer & infectious diseases. The company’s flagship product is OBI-822, a first-in-class active immunotherapy for metastatic breast cancer. OBI is also developing next generation active immunotherapies for difficult to treat cancers, including lung, prostate, pancreatic, stomach, and ovarian. The company is the license holder for DIFICID™ in Taiwan and owns the commercial rights to the product, a novel antibiotic indicated for C. difficile-associated diarrhea. Additional information can be found at www.obipharma.com/en
Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma’s reports and presentations, including OBI Pharma’s most recent filings with the Taiwan Securities and Exchange Commission.
OBI Pharma, Inc.
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