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Stellar Biotechnologies to Supply KLH to National Institutes of Health

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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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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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