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
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