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Stellar Biotechnologies, Inc. (SBOTF) Applauds FDA’s First Breakthrough Therapy Designation for KLH-Conjugate
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for Celldex Therapeutics, Inc.’s immunotherapy compound for the treatment of glioblastoma, the most common and aggressive cancerous brain tumor which typically results in death in the first 15 months following diagnosis.
Celldex’s compound is based on keyhole limpet hemocyanin (KLH), a large matelloprotein found in the herbivore keyhole limpet snail found off the coast of California. KLH is an active pharmaceutical ingredient in many new immunotherapies as well as a finished product for measuring immune status.
The FDA’s designation is the first for a KLH-based immunotherapy and signals the emerging value of KLHs in the medical field.
As a manufacturer of KLH, California-based Stellar Biotechnologies says it is “encouraged” by the news as confirmation of the potential of KLH-based immunotherapies.
“We believe this represents an important validating event for the KLH-conjugate approach in immunotherapy,” Frank Oakes, president and CEO of Stellar Biotechnologies, stated in a news release. “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.”
Though Celldex is not using Stellar KLH™, there are a number of KLH-conjugate immunotherapies using Stellar’s KLHs 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.
Strategically focused on ensuring long-term, scalable supply of this essential molecule for pharmaceutical use, Stellar developed the proprietary ability to sustainably produce KLH while protecting its natural marine source. Stellar says it has confidence that if the pipeline of KLH-based immunotherapies lead to approved new drug products, the company is primed to take advantage of KLH market opportunities.
For more information visit, www.stellarbiotech.com
