Stellar Biotechnologies, Inc., 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.

For more details, go to: http://www.stellarbiotechnologies.com/media/press-releases/detail/314/first-fda-breakthrough-therapy-designation-for