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DoD Funds Covid-19 G.I. Infection Therapy

Spirulina powder

Spirulina powder (Music4thekids, Wikimedia Commons)

24 Sept. 2020. A biotechnology company is developing biologic treatments for Covid-19 infections in the gastrointestinal tract and to block further disease transmission. The work by Lumen Bioscience in Seattle is funded by a nearly $4 million award from the U.S. Army Medical Research and Development Command that supports research on filling medical needs affecting military readiness.

While Covid-19 infections are often associated with respiratory symptoms, the infections can also affect the gastrointestinal or G.I. tract causing vomiting, diarrhea, or abdominal pain during the early phases of the disease. Once in the G.I. tract, the SARS-CoV-2 viruses can also induce changes in intestinal microbes, as well as generate inflammatory enzymes in the gut. The company cites data showing a majority of Covid-19 patients express both respiratory and G.I. symptoms, and as many as a quarter of patients show only G.I. symptoms.

Lumen Bioscience designs biologic therapies, including antibodies, for G.I. disorders with a technology it says is faster, less expensive, and less risky than most other biologic therapies. The company’s platform is based on genetically engineered spirulina, a blue-green algae used for centuries as a food source and today as a nutritional supplement. The spirulina chromosome is altered with an added molecule, such as an antibody, which the spirulina cells then produce as the algae grows.

Lumen says the genetically altered spirulina grows in the company’s lab and production facility meeting current good manufacturing practice or cGMP pharmaceutical industry standards. The company says growing the spirulina requires only water, salt, light, and carbon dioxide, making it an inexpensive and scalable process. The algae are then dried, leaving a powder with the therapeutic molecules that Lumen formulates into capsules. The spirulina do not survive the drying process, but according to the company their cell membranes protect the therapeutic molecules through the stomach and the molecular payloads are released in the small intestine.

The Army project calls for Lumen to produce a biologic drug cocktail to treat Covid-19 gut infections with small-scale antibodies, similar to those produced by camelid mammals, such as llamas and alpacas. These scaled-down antibodies, also known as nanobodies, have a smaller size and lighter weight that enables them to hit smaller targets more precisely than full-sized antibodies, and are also more thermally and chemically stable.

The project funds R&D on the Covid-19 treatments through an investigational new drug application with FDA, in effect, a request to begin clinical trials, as well as gearing up Lumen’s manufacturing facilities. The company says it plans to begin mid-stage clinical trials in the spring of 2021 and start full-scale manufacturing the following summer.

Brian Finrow, Lumen Bioscience’s co-founder and CEO, says in a company statement, “This platform builds on 25 years of research by others in the field of camelid antibody engineering, and our unique cGMP manufacturing system makes an important contribution to this legacy: a scalable, cost-effective way to make and deliver these biologic drugs to disease targets in the G.I. tract.”

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