Stellar Biotechnologies and Neovacs
S.A. have expanded their existing supply agreement under which Stellar will
meet Neovacs’ requirements for Keyhole Limpet Hemocyanin (KLH), a primary
component of Neovacs’ proprietary Kinoid immunotherapy technology.
Stellar is a leading manufacturer of
KLH, an immune-stimulating protein produced from a scarce marine source and
widely used as a carrier molecule in immunotherapies being developed for a
variety of disease indications. 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, similar to its
support of Neovacs’ development of active immunotherapies for the treatment of
chronic autoimmune diseases.
The extended agreement is structured
to ensure the continued supply of Stellar KLH™ during Neovacs’ 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.
“We have enjoyed a long-standing and
successful relationship with Stellar Biotechnologies as our key KLH supplier,”
Miguel Sieler, CEO of Neovacs, stated in the news release. “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.”
Stellar’s Scientific Advisory Board
(SAB) has announced its full support for Neovacs’ planned phase 2b trial of IFNα-Kinoid
in approximately 160 patients in Europe, Latin America and Asia. The study is
slated to begin mid-2015. A phase 2a trial of IFNα-Kinoid for the treatment of
lupus in the U.S. is expected to commence by early 2016.
Per the agreement, 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.
“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. “We also see this is as positive validation for the use of Stellar
KLH™ in the development of new immunotherapy treatments.”
For more information visit
www.stellarbiotech.com, the Stellar KLH knowledge base at www.klhsite.org, or the
Neovacs website at www.neovacs.fr
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