LOS ANGELES, March 1, 2017 /PRNewswire/ -- Stellar
Biotechnologies, Inc. (Nasdaq: SBOT), a leading manufacturer of a
key protein utilized in immunotherapy development pipelines, and
biopharmaceuticals manufacturer Amaran Biotechnology, Inc., have
entered into an exclusive multi-year supply agreement in connection
with clinical development studies of immunotherapies for metastatic
breast cancer and other cancers.
The agreement follows a two-year development collaboration
between the companies involving the optimization of manufacturing
processes for a KLH-conjugated vaccine known as Adagloxad Simolenin
(formerly OBI-822), now in late-stage clinical studies. Adagloxad
Simolenin is part of a new class of treatments, known as active
immunotherapies, which are designed to stimulate a patient's own
immune system to recognize and attack targeted tumor cells.
"This supply agreement with Stellar secures sustainable access
to KLH, a key ingredient required to manufacture Adagloxad
Simolenin, a therapeutic cancer vaccine which Amaran
is producing for its client, OBI Pharma, Inc.," said
Tessie Che, Amaran General Manager
and Chair of its Board of Directors. Brian Stamper, Director
of Business Development at Amaran, further highlighted that this
agreement strongly supports the joint effort of all three companies
to move this valuable immunotherapy closer to regulatory approval
and commercial launch.
Stellar President and CEO Frank
Oakes said that he was pleased to build on the success of
the collaboration. "This new agreement with Amaran provides us with
another validation of the Stellar KLH carrier platform and marks an
important step in the development of new treatment options for
devastating cancers," said Mr Oakes.
Under the terms of the supply agreement, Amaran has committed to
purchase Stellar KLH in amounts necessary to meet its requirements
for vaccine production. Stellar will maintain a master file with
the U.S. FDA for the KLH product used by Amaran. In addition to
Adagloxad Simolenin, the exclusive supply agreement covers cancer
immunotherapies and vaccines that combine tumor antigens known as
Globo H to one of Stellar's KLH product formulations.
About Amaran Biotechnology, Inc.
Founded in 2010, Amaran Biotechnology, Inc. is a privately-held
biopharmaceuticals manufacturer engaged in the design, development
and manufacture of pharmaceutical and biotechnology products,
including KLH-conjugated active immunotherapies such as Adagloxad
Simolenin, the lead immunotherapy product of OBI Pharma, Inc., a
publicly-traded Taiwan biotech
company. Amaran corporate headquarters are based in Zhubei City,
Taiwan.
Adagloxad Simolenin is in ongoing Phase 2 and Phase 3
multinational clinical studies for metastatic breast cancer and a
Phase 2 clinical trial in Taiwan
for the treatment of ovarian cancer. In January 2017, OBI Pharma announced that the
company met with the US Food and Drug Administration and plans to
prepare its Phase 3 protocol for submission to regulators. OBI
Pharma also received formal approval from the China Food and Drug
Administration to conduct a proposed Phase 3 clinical study of its
anticancer vaccine.
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 an active
pharmaceutical ingredient (API) 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.
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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
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"might," "potential," or "continue" and variations or similar
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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
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jurisdiction, including the United
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SOURCE Stellar Biotechnologies, Inc.; Amaran Biotechnology,
Inc.