Stellar Biotechnologies, Inc. and Neovacs S.A. have announced that the Companies have entered into an expanded supply agreement to meet Neovacs' requirements for Keyhole Limpet Hemocyanin (KLH), a primary component of Neovacs' proprietary Kinoid immunotherapy technology.
The new agreement extends and expands the supply contracts previously in place between the Companies, in order to ensure the continued supply of Stellar KLH™ to Neovacs during its Kinoid clinical trials and to support the expected commercial roll-out of Neovacs' lead product candidate IFNα-Kinoid, an immunotherapy being developed for the treatment of systemic lupus erythematosus ("lupus").
Stellar is a leader in the sustainable manufacture of KLH, an immune-stimulating protein widely used as a carrier molecule in immunotherapies under development for a variety of disease indications. Immunotherapy uses a patient's own immune system to target and treat diseases. KLH can only be produced from a scarce marine source. Stellar believes it is the only company with the proprietary technology to manage sustainable, scalable production of GMP quality KLH to meet future pharmaceutical industry demands.
Neovacs is a leader in the development of active immunotherapies for the treatment of chronic autoimmune diseases. Neovacs' patented Kinoid technology combines a select cytokine of interest attached to KLH as the immune-stimulating carrier protein. The resulting immunotherapy uses the patient's immune system to generate antibodies against the targeted disease.
Neovacs' lead product candidate, IFNa-Kinoid, has successfully completed a Phase I/IIa clinical trial for lupus. The Company's Scientific Advisory Board (SAB) members have announced their full support for the planned Phase IIb trial of IFNα-Kinoid in approximately 160 patients in Europe, Latin America and Asia. This Phase IIb study is expected to begin mid-2015. A U.S. Phase IIa trial of IFNα-Kinoid for the treatment of lupus in the U.S. is expected to commence by early 2016.
"We have enjoyed a long-standing and successful relationship with Stellar Biotechnologies as our key KLH supplier," said Miguel Sieler, Chief Executive Officer of Neovacs. "This new agreement with Stellar comes at a pivotal point for Neovacs, as we are preparing to launch multicenter clinical trials with IFNα-Kinoid and are strengthening our U.S. operations through the recent formation of a wholly-owned subsidiary, Neovacs, Inc. The new supply agreement will ensure that Neovacs has access to a scalable, stable supply of GMP grade KLH as our Kinoid products advance through clinical development and we prepare for the expected commercial launch."
"Expanding our supply commitment to Neovacs to include late-stage clinical trials and expected initial commercialization is an excellent demonstration of the growing commercial prospects for our core KLH business," said Frank Oakes, President and CEO of Stellar Biotechnologies. "We also see this is as positive validation for the use of Stellar KLH™ in the development of new immunotherapy treatments."
Under the terms of the agreement, Neovacs will purchase Stellar KLH™ for use in its proprietary KLH-based Kinoid immunotherapies in the European Union, Latin America, Asia, the U.S. and Canada. Neovacs will use Stellar KLH™ for its planned Phase II and Phase III clinical trials and for expected commercial manufacturing of its products for up to one year following market approval.
Neovacs will manage and fund all product development and regulatory submissions for its immunotherapy products and act as the sponsor company for the future clinical trials. Stellar will supply GMP grade KLH to Neovacs according to agreed specifications, quantities, and pricing, as well as maintain a master file with the U.S. FDA for the KLH product. Stellar will also provide professional, technical, and regulatory support to Neovacs. The agreement has an initial five-year term, which may be renewed by Neovacs in one-year increments.