LOS ANGELES, June 21, 2018 /PRNewswire/ -- Stellar
Biotechnologies, Inc. (Nasdaq: SBOT), a leading manufacturer of a
key protein utilized in multiple immunotherapy development
pipelines targeting Alzheimer's, lupus and cancer, among other
diseases, today announced the successful completion of a research
study focused on the molecular composition of the company's KLH
products. The quality analysis was completed as part of Stellar's
initiatives to support later stage clinical trials of drug
candidates that utilize KLH as a carrier molecule and
immunostimulant.
As part of the study, third party researchers analyzed the
patterns of carbohydrates that attach to the KLH protein through a
biologic process known as glycosylation. The compositional profile
of these glycans, as they are known, are believed to enhance the
immunogenicity of KLH. Due in part to the large size and complexity
of this glycosylation, KLH has never been synthesized.
Stellar Executive Vice President of Corporate Development,
Gregory T. Baxter, PhD reported that
study results demonstrated highly consistent molecular structure
from batch to batch, a key attribute for a biologically sourced
protein.
"These results confirm that our production and manufacturing
processes are able to reliably produce a consistent product. The
data showed that glycan site occupancy and site-specific
glycosylation were equivalent among the production lots tested,
among other findings," said Dr. Baxter. He noted that the research
study also provided greater insight into the characteristics of the
KLH molecule that may be useful in better understanding conjugation
efficiency, a metric important to therapeutic vaccine developers.
Stellar is planning additional product development studies to
support its customers and partners.
To produce Stellar KLH, hemocyanin protein is extracted from its
native source using Stellar's patented process and then purified
and manufactured into various grades and formulations. Due in part
to its controlled aquaculture source and manufacturing methods,
Stellar KLH has been shown to produce vigorous primary and
secondary immune responses. Researchers interested in obtaining
Stellar KLH, or obtaining technical specifications for research or
GMP-grade KLH, may contact Stellar business development department
at (805)488-2800 or KLHinfo@stellarbiotech.com.
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About Stellar Biotechnologies
Based north of
Los Angeles at the Port of
Hueneme, Stellar Biotechnologies, Inc. (Nasdaq: SBOT) 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 a key
pharmaceutical ingredient in many new immunotherapies (targeting
cancer, immune disorders, Alzheimer's and inflammatory diseases) as
well as a finished product for measuring immune status. Stellar is
unique in its proprietary methods, facilities, and KLH technology.
The company is 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. Stellar KLH is a trademark of Stellar
Biotechnologies.
Stellar Forward-Looking Statements
This press
release may contain forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements may be identified by the use of words
such as "anticipate," "believe," "plan," "estimate," "expect,"
"intend," "may," "will," "would," "could," "should," "might,"
"potential," or "continue" and variations or similar expressions.
Readers should not unduly rely on these forward-looking statements,
which are not a guarantee of future performance. There can be no
assurance that forward-looking statements will prove to be
accurate, as all such forward-looking statements involve known and
unknown risks, uncertainties and other factors which may cause
actual results or future events to differ materially from the
forward-looking statements. Such risks include, but may not be
limited to: general economic and business conditions; technology
changes; competition; changes in strategy or development plans;
availability of funds and resources; anticipated requirements for
operating capital; governmental regulations and the ability or
failure to comply with governmental regulations; changes in trade
policy and international law; the timing of Stellar's or its
partners' anticipated results, including in connection with
clinical trials; the ability to meet the goals of Stellar's joint
ventures and strategic partnerships; and other factors referenced
in Stellar's filings with securities regulators. For a discussion
of further risks and uncertainties related to the Stellar's
business, please refer to Stellar's public company reports filed
with the U.S. Securities and Exchange Commission and the British
Columbia Securities Commission. All forward-looking statements are
made as of the date hereof and are subject to change. Except as
required by law, Stellar assumes no obligation to update such
statements. This press release does not constitute an offer or
solicitation of an offer for sale of any securities in any
jurisdiction, including the United
States.
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SOURCE Stellar Biotechnologies, Inc.
