Stellar and Amaran Provide Update on Collaboration
News Oct 06, 2015
Stellar Biotechnologies, Inc. has provided 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 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."