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.
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.; Amaran Biotechnology, Inc.