SOURCE: Stellar Biotechnologies, Inc.

Stellar Biotechnologies, Inc.

March 10, 2015 17:31 ET

First FDA Breakthrough Therapy Designation for KLH-Conjugate Immunotherapy Signals Key Step for Novel Carrier Molecule

PORT HUENEME, CA--(Marketwired - Mar 10, 2015) - Stellar Biotechnologies, Inc. ("Stellar" or "the Company") (OTCQB: SBOTF) (TSX VENTURE: KLH), the leader in sustainable manufacture of Keyhole Limpet Hemocyanin ("KLH") is encouraged that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for a KLH-based immunotherapy compound in the treatment of adult patients with EGFRvIII-positive glioblastoma being developed by Celldex Therapeutics, Inc. 

This important designation by the FDA is a first for a KLH-based immunotherapy. Stellar KLH™ is not being used by Celldex, however, there are a number of KLH-conjugate immunotherapies that are currently in clinical trial development in the U.S., Europe, or Asia for a variety of disease indications including cancers, autoimmune disorders, Alzheimer's, and inflammatory diseases, which are using Stellar KLH™. 

"We believe this represents an important validating event for the KLH-conjugate approach in immunotherapy," said Frank Oakes, President and CEO of Stellar Biotechnologies. "This fast track designation provides a positive signal from the FDA for companies developing immunotherapies that use the KLH molecule as a carrier protein component."

Stellar developed the proprietary ability to sustainably produce KLH while protecting its natural marine source and the Company is strategically focused on ensuring long-term, scalable supply of this essential molecule for pharmaceutical use. Stellar believes that, should the pipeline of KLH-based immunotherapies lead to approved new drug products, the Company will be positioned to take advantage of the emerging KLH market opportunity.

Read more about KLH at: http://www.klhsite.org/
Learn about Stellar Biotechnologies' sustainable KLH manufacturing advantage: http://www.stellarbiotechnologies.com/stellar-klh/sustainable-advantage

About Stellar Biotechnologies, Inc.

Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH) is the leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), an important immune-stimulating protein used in wide-ranging therapeutic and diagnostic markets. KLH is both an active pharmaceutical ingredient (API) in many new immunotherapies (targeting cancer, immune disorders, Alzheimer's and inflammatory diseases) as well as a finished product for measuring immune status. Stellar Biotechnologies is unique in its proprietary methods, facilities, and KLH technology. We are committed to meeting the growing demand for commercial-scale supplies of GMP grade KLH, ensuring environmentally sound KLH production, and developing KLH-based active immunotherapies.

Visit www.stellarbiotech.com and the KLH knowledge base www.KLHsite.org.

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