Stellar Biotechnologies and
Spain-based Araclon Biotech SL have entered into a definitive exclusive supply
agreement designed to enable Araclon to meet its Phase 2 and Phase 3 clinical
trial requirements for Keyhole Limpet Hemocyanin (KLH) for use in Araclon’s
active immunotherapies against Alzheimer’s disease.
Stellar is a leader in sustainable
manufacture of KLH, an immune-stimulating protein commonly used as a carrier
molecule in immunotherapy development. KLH can only be produced from a scare
marine source, which limits the manufacture of this important molecule.
However, Stellar believes it is the only company that has the technology to
manage the controlled production of this resource.
Spain-based Araclon is developing
beta amyloid-targeting active immunotherapies for neurodegenerative diseases
with a primary focus on Alzheimer’s disease. The company’s patented technology
against the disease involves immunization against amyloid-beta (Aβ) together
with KLH as a carrier protein.
The purpose of the exclusive supply
agreement is to ensure that Araclon has access to a stable supply of Stellar
KLH™ for the ongoing clinical development of Araclon’s Alzheimer’s drugs,
including the development of manufacturing processes, production capacity and
regulatory support. Per the agreement, Araclon will manage and fund all product
development and regulatory submissions for its products; Stellar will supply
GMP-grade Stellar KLH™ protein and will provide technical and regulatory
support to Araclon.
“This new collaboration with
Araclon Biotech is an excellent demonstration of Stellar’s core business model
which is to partner with the companies and organizations developing the many
KLH-based immunotherapies now in clinical development,” Frank Oakes, president
and CEO of Stellar, stated in the news release. “Stellar has the technology to
deliver a reliable source of KLH today that can also be scaled up sustainably
to address the industry’s future KLH demand as promising immunotherapy products
reach commercial markets.”
Per the agreement, Stellar is
obligated to deliver the first batch of Stellar KLH™ to Araclon by December 31,
2014. The parties have agreed upon first negotiation rights for the exclusive
supply of Stellar KLH™ in connection with the potential future commercialization
by Araclon of its beta amyloid-targeting immunotherapy products. The agreement
has an initial five-year term, which may be renewed by Araclon for additional
one-year periods.
“An agreement with Stellar
Biotechnologies is very important to Araclon. A stable supply of GMP grade KLH
is needed to advance in our Alzheimer’s immunotherapy program through Phase II
and III clinical trials,” commented a source at Araclon.
For more information, visit
www.stellarbiotech.com
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