Seattle, WA—November 26, 2018—Lumen Bioscience, a Seattle biotechnology company focused on orally delivered antibody therapeutics and other biologics, announced today that the US Patent and Trademark Office has issued Patent no. 10,131,870, entitled “Targeted Mutagenesis in Spirulina.” 

Spirulina is a common variety of photosynthetic microalgae consumed all over the world, from US grocery outlets to remote locations in Africa, because of its high nutritional content, safety, and ease of cultivation. It’s also widely used as an animal feedstock, and is being developed as a food for astronauts to grow in space. It is the only microorganism farmed at commercial scale worldwide.

Like many single-cell organisms, spirulina reproduces asexually, which means that it is not possible to improve it by using traditional plant breeding approaches. Despite intense effort and widespread recognition of its potential importance, spirulina has resisted all attempts to enhance its biology using biotechnology tools that are widely used in drug development for biological systems such as yeast and CHO (Chinese hamster ovary cells, the cell line used to make most antibody drugs on the market today). As a consequence, essentially no work has been done to improve the productivity or nutritional profile of this inexpensive, vitamin-rich protein source, nor has the opportunity to use spirulina for synthesis of high-value products been realized.

With the issuance of this patent, Lumen’s researchers now announce that they have developed a novel set of bioengineering tools and methods that finally allow researchers to introduce targeted, highly stable genetic modifications into spirulina. The breakthrough opens the door to converting this global foodstock into a platform for producing a wide range of novel chemical and biologic products, especially medical therapeutics and vaccines. 

With Lumen’s technology, researchers can now edit or remove existing spirulina genes, or insert completely new genes directly into any desired location in the spirulina chromosome, and see those changes persist indefinitely. Lumen itself is using this new technology to develop high-value proteins and other molecules for foods, cosmetics, medicine and industry. 

“The history of the biotechnology industry can be written as the story of new platform organisms–––from E. coli to yeast to mammalian cells–––that suddenly enable products that were previously impractical or impossible. Our discovery of spirulina genetic engineering is the next chapter in that book,” said Jim Roberts, MD, PhD, Lumen’s CSO and a co-inventor on the patent. “Our goal is to make this breakthrough technology as widely available as possible, through interactions, licenses and collaborations with companies and academic researchers worldwide."

For drug development, this means faster timelines, higher chances of clinical success, and lower costs compared to traditional production systems. While  tremendously successful for many applications, these older workhorses of the biotechnology industry have proven unsuitable for the large-scale production of certain classes of proteins and other biologics. Moreover, the cost of producing therapeutics in spirulina is 100fold less expensive than previously possible using the older biotechnology platforms. The new spirulina platform is also a significant advance over plant-based biotechnology platforms that have been evaluated in the past, that have failed to gain commercial traction despite showing initial promise. Spirulina can make 100 times more active therapeutic protein than food crop or tobacco-plant-based expression systems, and the resulting drugs can be administered without expensive processing and purification. This makes the Lumen spirulina platform an ideal system for making orally delivered biologics such as antibody therapeutics, a long-unmet need in health care.

The great potential of Lumen’s technology has already led to collaborative efforts with groups all over the world, including the Bill & Melinda Gates Foundation, the National Institutes of Health, and several leading US research universities, to address such critical targets as ultra-low-cost antibody therapeutics for children in developing countries, oral vaccines against infectious viruses, and other new biologics. Among other programs, Lumen announced earlier this year that the NIH had awarded Lumen a grant to develop a new oral malaria vaccine that will not require refrigerated distribution, and also previously announced that the USDA awarded another grant to Lumen to develop an oral vaccine for farmed fish.

To date, Lumen has been granted 20 composition-of-matter and pathway patents, and 41 new applications are currently pending, all of which relate to novel approaches to engineering spirulina and other cyanobacteria to create novel bio-based products. The new patent announced today also covers the proprietary strains used to produce Lumen’s first product, RioBlue™, which is a natural replacement for the petroleum-derived, artificial food color called “FD&C Blue #1.” Lumen produces RioBlue in its state-of-the-art cGMP production facility in Seattle, Washington. The broad composition-of-matter claims in the patent announced today cover all engineered versions of this microorganism, and therefore indirectly cover all of Lumen’s planned biologics products

“This patent forms the cornerstone of Lumen’s comprehensive intellectual property strategy,” said Brian Finrow, Lumen’s CEO. “Aside from Columbia University’s patents in mammalian cell culture, and the University of Washington’s ‘Hall’ patents in yeast, it’s hard to think of another case where such broad protection was obtained for a novel platform biology. We look forward to working with our current collaborators and new potential licensees to explore the broad potential of this technology.”

The law firms Cooley LLP and Lee & Hayes PLLC advised Lumen throughout the successful prosecution process.