PORT HUENEME, CA -- (Marketwired) -- 10/01/15 -- Stellar Biotechnologies, Inc. ("Stellar" or "the Company") (OTCQB: SBOTF) (TSX VENTURE: KLH), the leader in sustainable manufacture of Keyhole Limpet Hemocyanin ("KLH"), is pleased to provide an update on the Company's ongoing collaboration with privately-held Taiwan biopharmaceuticals manufacturer Amaran Biotechnology, Inc. ("Amaran").
The alliance between Stellar and Amaran was formed in 2013 to develop and evaluate methods for the manufacture of the OBI-822 immunotherapy, which incorporates Stellar KLH™ as the immune-stimulating carrier molecule. OBI-822 is the flagship product of OBI Pharma, Inc., a publicly-listed Taiwan biotech company. The product is currently in a late-stage multinational clinical trial for the treatment of metastatic breast cancer. Enrollment for this Phase II/III trial was completed in 2014 and OBI Pharma expects its topline results to be announced by March, 2016. OBI-822 is also in a physician-initiated Phase II clinical trial in Taiwan for the treatment of ovarian cancer. Recruitment for that trial is expected to be completed by the end of this year.
Stellar and Amaran have now completed all primary objectives of the collaboration, which include method development, formulation, and process qualification for GMP-grade Stellar KLH™ and meeting the specifications needed for the production of OBI-822. The next stage of the collaboration will involve scale-up and optimization of processes to commercial manufacturing levels, with the focus on production, quality, and regulatory requirements to support OBI Pharma's planned global Phase III trial and potential future market launch.
Additionally, Amaran recently commissioned a new state-of-the-art biological manufacturing and research center in Taiwan's Hsinchu Biomedical Science Park in Hsinchu County, Taiwan, anticipating expanded capacity for the production of active immunotherapies, such as OBI-822.
"We are very pleased with the success of our alliance with Stellar Biotechnologies, and the progress made towards commercial scale production of KLH for OBI-822," said Tessie Che, General Manager and Chair of Amaran's Board of Directors. "All of the programs that support OBI-822 and that will move this important immunotherapy closer to market launch are on track."
"Stellar's collaboration with Amaran is an exciting clinical project," said Catherine Brisson, Ph.D., Chief Operating Office for Stellar Biotechnologies, Inc. "Through close cooperation with the Amaran team, we achieved each primary objective on-time and to the particular specifications required. We look forward to the scale-up stage with Amaran and to providing our partners with GMP Stellar KLH™ for their immunotherapy programs."
About Amaran Biotechnology, Inc.
Amaran Biotechnology, Inc. is a privately-held Taiwan biopharmaceuticals manufacturer. Amaran is engaged in the business of designing, developing, and manufacturing pharmaceuticals and biotechnology products. It is expected that Amaran will manufacture KLH-conjugated active immunotherapies, such as OBI-822, the lead immunotherapy product of OBI Pharma, Inc. Visit www.amaran.com.tw to learn more about Amaran.
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 atwww.obipharma.com/en.
About Stellar Biotechnologies, Inc.
Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH) is the leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), an important immune-stimulating protein used in wide-ranging therapeutic and diagnostic markets. KLH is both an active pharmaceutical ingredient (API) in many new immunotherapies (targeting cancer, immune disorders, Alzheimer's, and inflammatory diseases) as well as a finished product for measuring immune status. Stellar Biotechnologies is unique in its proprietary methods, facilities, and KLH technology. We are committed to meeting the growing demand for commercial-scale supplies of GMP grade KLH, ensuring environmentally sound KLH production, and developing KLH-based active immunotherapies.