Stellar
Biotechnologies is powering and improving the swiftly-evolving field of
immunotherapy. The California-based company is a leader in the sustainable
manufacture of Keyhole Limpet Hemocyanin (KLH), and committed to applying its
KLH platform to the creation and enhancement of drug therapies that activate
the body’s immune system in order to treat disease.
KLH is a
multipurpose molecule that can be joined with a disease-targeting agent to
create a new immunotherapy, or used alone to measure the body’s immune response
to drugs. It is a high molecular weight (HMW) and an important
immune-stimulating protein with a history of safe, effective use in therapeutic
vaccine development. KLH is used in immunotherapy and diagnostic markets to
target cancers, infectious diseases, and immune disorders (including Crohn’s
disease, rheumatoid arthritis, systemic lupus erythematosus, lymphoma,
metastatic breast cancer and prostate cancer).
Stellar
Biotech has made a breakthrough in the science and supply of KLH. To support
its commitment to excellence in targeted immune therapies and
immunodiagnostics, it has developed the proprietary ability to sustainably
produce the vital KLH molecule, and set new benchmarks for its manufacture as
well as the protection of its natural marine source. KLH can only be obtained
from a rare marine source, the Giant Keyhole Limpet, but the company’s landmark
achievements in aquaculture science ensure the production of quality KLH while
protecting its source.
Stellar
Biotech’s proprietary methods, facilities, and KLH technology make it unique
and allow it to meet the rising demand for the commercial-scale supply of good
manufacturing practice (GMP) grade KLH to ensure environmentally-sound KLH
production as well as develop KLH-based active immunotherapies. The company’s
current product offerings include: KLH pharmaceutical intermediates; HMW and
subunit KLH protein in various grades, formulations, and configurations; and
preclinical in vitro diagnostic kits.
Stellar
Biotech has a number of active collaborations in the works:
• In June 2014, Neovacs, a French
biotech company and long-time customer of Stellar Biotechnologies, shared an
update on its immunotherapy programs and pipeline for autoimmune disease.
During an interview with Neovacs’ CEO Miguel Sieler, Mr. Sieler discussed the
company’s use of Stellar KLH as the carrier molecule in three of its products
now in clinical development. Neovacs develops vaccines that stimulate a
patient’s immune system and allow it to produce monoclonal antibodies to target
a pre-specified autoimmune disease; in this case, the products are set to
target Rheumatoid Arthritis, Crohn’s Disease, and Lupus.
• Stellar is also working with OBI
Pharma, a Taiwanese biopharmaceuticals manufacturer, to develop and evaluate
manufacturing methods for an active immunotherapy that targets metastatic
breast cancer and uses Stellar’s GMP-grade KLH. The concept behind the therapy,
designated OBI-822, is to use the human body’s immune system to fight cancer
with few side effects, unlike chemotherapy and radiation therapy that harm good
cells along with cancerous cells. In late July 2014, OBI Pharma announced that
its phase 2/3 stage clinical trial for OBI-822 has met the goal of collecting
342 patients. The clinical test project was designed as a multinational,
randomized control trial, with 45 medical centers in Taiwan, Hong Kong, South
Korea, India and the United States participating. The company’s chairman
Michael N. Chang commented that the OBI-822 project is progressing smoothly and
the completion of the patient collection was a major milestone. The next step
is to analyze the data from the clinical test after the last patient completes
the treatment process.
For more
information on the company or other collaborations, visit www.stellarbiotech.com
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