If Lumen Bioscience achieves its goals, patients will be able to take its drugs the same way some people supplement breakfast: a spoonful heaped onto a bowl of cereal or mixed into juice. The startup harnesses spirulina, protein-rich cyanobacteria touted by many health enthusiasts as a “superfood.”
Lumen CEO Brian Finrow (pictured above, right) acknowledges spirulina’s health benefits, but that’s not why his company embraces it. Seattle-based Lumen turns spirulina into tiny factories that churn out therapeutic antibodies. Finrow says the Lumen technology overcomes many of the challenges of working with cyanobacteria. Research has yielded a crop of gastrointestinal disorder drug candidates, the most advanced of which is on track to Phase 2 testing. Now Lumen has $16 million in financing to develop its biologic drugs that don’t need to be injected but instead are taken like food.
“Think of it as an edible drug,” Finrow says.
Antibodies are designed to bind to an antigen on the surface of a target cell. That specificity spares healthy cells from side effects, which makes antibodies attractive as drugs, says Finrow, a former senior vice president at Seattle-based Adaptive Biotechnologies (NASDAQ: ADPT). But antibodies are large molecules—too big and complex to be made by chemical synthesis. Manufacturing them in a lab is time consuming and expensive, which limits the applications of these medicines.
Lumen builds on the work of co-founder Jim Roberts (above, left), a longtime scientist at the Fred Hutchinson Cancer Research Center (and a former Xconomist). Earlier in his career, he was credited as a co-inventor of technology that coaxes mammalian cells into making monoclonal antibodies, research conducted at Columbia University. At Lumen, Roberts takes a similar approach to spirulina.
Engineering a food product to produce a biologic drug is not a new idea. Earlier efforts failed, mostly because it’s hard to produce enough of the biologic. If a patient must eat the equivalent of an acre of a crop a day to receive therapeutic benefit, it’s just not feasible as a drug, Finrow says. Spirulina has been grown at scale in the US since the 1970s, which means that it has a long track record and plenty of safety data, Finrow says. Furthermore, sprirulina is packed with protein so a little sprinkle goes a long way. The biggest challenge is figuring out a way to make those protein stores therapeutic.
Antibodies are proteins. Lumen gets spirulina to produce them by engineering the cyanobacteria’s genome. But the company doesn’t use CRISPR or some other gene-editing technique, which Finrow says would only make antibody production more complex and more expensive. The Lumen technology takes a gene that codes for a desired protein and inserts it into one or more designated locations in the spirulina genome. As spirulina grow and divide, they make the antibodies and pack them inside their cell membranes. Engineering also controls how much of a desired protein is produced in each cell.
Spirulina only need water and light to grow. The spirulina that’s sold by grocers and health food stores is grown in outdoor ponds, then dried. Lumen produces its spirulina much the same way, though it does so in a controlled 20,000 square-foot-indoor facility in Seattle’s Fremont neighborhood. The end product is a greenish powder of dead, desiccated cells.
“Once you solve the manufacturing problem, you can go after diseases,” Finrow says.
Traveler’s diarrhea is Lumen’s lead disease target. The company aims to prevent the condition from developing in the first place. The Lumen drug, a capsule filled with the green powder, is intended to be taken by a traveler once a day, Finrow says. In the gut, the cell membrane breaks down, releasing its antibody payload. Those antibodies stand ready to bind to and neutralize toxic bacteria they encounter. The antibodies and pathogens are then swept from the gastrointestinal tract with bodily waste. In Phase 1 testing, the drug candidate was shown to be safe and well tolerated by patients. It’s now being readied for a Phase 2 test expected to start in early 2021.
The FDA initially didn’t even require a Phase 1 test, partly because of … Next Page »