6 September 2018 - - US-based Stellar Biotechnologies, Inc. (NASDAQ: SBOT), a manufacturer of a key protein utilized in multiple immunotherapy development pipelines targeting Alzheimer's, autoimmune disease and cancers, among other diseases, has been contracted by the US National Institutes of Health to supply the company's Stellar KLH protein for government-sponsored clinical studies, the company said.

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, utilise 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 personalised anti-tumor vaccinations.

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 US 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.

Based north of Los Angeles at the port of Hueneme, Stellar Biotechnologies, Inc. (NASDAQ: SBOT) is in the manufacture of Keyhole Limpet Hemocyanin, an immune-stimulating protein utilised 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.