LOS ANGELES, Sept. 5, 2018 /PRNewswire/ -- Stellar
Biotechnologies, Inc. (Nasdaq: SBOT), a leading manufacturer of a
key protein utilized in multiple immunotherapy development
pipelines targeting Alzheimer's, autoimmune disease and cancers,
among other diseases, announced today that it has been contracted
by the U.S. National Institutes of Health (NIH) to supply the
company's Stellar KLH protein for government-sponsored clinical
studies.
The company reported that it has initiated product manufacturing
for the NIH's National Cancer Institute, which plans to use a
vialed formulation of Stellar KLH in dendritic cell-based cancer
therapies. These experimental therapies, now in Phase 1 and Phase 2
clinical studies, utilize cells from a patient's own immune system
to mount a response against tumors. To produce the vaccine,
mononuclear cells are extracted from a patient, primed with tumor
antigens and KLH and matured into dendritic cells before being
administered back to the patient. According to scientists at the
NCI Vaccine Branch's clinical research program, the use of
KLH-loaded dendritic cells enhances the immune response and
improves the efficacy of these personalized anti-tumor
vaccinations.
Frank R. Oakes, Stellar Chief
Executive Officer and President, said that the NIH has been a
longtime supporter of aquaculture-produced KLH, due in part to the
greater control and reliability of domesticated sources. "The
adjuvant and immune-stimulating properties of KLH are well
established and we are excited to see our products being utilized
in this promising area of cancer research," said Mr. Oakes. "The
critical role of KLH in dendritic cell vaccines demonstrates just
how versatile this unique protein can be. This contract opens a new
potential growth opportunity for KLH outside the KLH-conjugate
vaccines clinical studies that we are currently supporting."
The National Institutes of Health, which operates as the
nation's leading biomedical research agency, includes 27 research
institutes and centers and is a component of the U.S. Department of
Health and Human Services. The mission of NCI Vaccine Branch's
clinical research program is to develop vaccines and immune-based
therapies that harness the immune response to control, eradicate or
prevent cancer and HIV infection.
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 immune-stimulating protein utilized as a
carrier molecule in therapeutic vaccine pipelines (targeting
cancers, immune disorders, Alzheimer's and inflammatory diseases)
and for assessing immune system function. KLH can also be used in
immunotoxicology studies for monitoring the immunomodulatory
effects of drug candidates. Stellar is committed to meeting the
growing demand for commercial-scale supplies of GMP grade KLH,
ensuring environmentally sound KLH production, and supporting the
development of KLH-based active immunotherapies. Stellar KLH is a
trademark of Stellar Biotechnologies.
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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.
