Date: 2015-04-01
Type of information: Services contract
Compound: Keyhole Limpet Hemocyanin (KLH)
Company: Neovacs (France) Stellar Biotechnologies (USA - CA)
Therapeutic area: Technology - Services
Type agreement: services contract/supply agreement
Action mechanism:
Disease:
Details: * On April 1st, 2015, Stellar Biotechnologies and Neovacs 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. 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. 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.
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