Wednesday, April 1, 2015

Stellar Biotechnologies, Inc. (SBOTF) Expands KLY Supply Relationship with Neovacs S.A.

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

About QualityStocks

QualityStocks is committed to connecting subscribers with companies that have huge potential to succeed in the short and long-term future. We offer several ways for investors to find, evaluate, and learn more about investing in these companies.

Sign up for “The QualityStocks Daily Newsletter” at www.QualityStocks.net

The Quality Stocks Daily Blog http://blog.qualitystocks.net

The Quality Stocks Daily Videos http://videocharts.qualitystocks.net

 The Quality Stocks “Ones to Watch” http://gotstocks.qualitystocks.net

Please see disclaimer on the QualityStocks website: http://disclaimer.qualitystocks.net

No comments: