— Researchers describe rapid, low-cost drug development approach
— The article also reports preclinical and early clinical data for LMN-101
SEATTLE, March 21, 2022 /PRNewswire/ — A common food source has been converted into a biomanufacturing platform that offers a way to rapidly produce massive quantities of biological drugs for common diseases that currently lack effective treatments. Lumen Bioscience researchers report in Natural biotechnology their breakthrough genetic engineering methods to highly express bioactive Spirulina proteins using large-scale cultivation and processing methods suitable for biopharmaceutical manufacturing.
The publication also details favorable preclinical and early-stage clinical testing of these manufactured and orally administered neutralizing antibodies against Campylobacter, a major cause of infant mortality in the developing world and a growing threat of antibiotic resistance. The product, LMN-101, is currently going through Phase 2 clinical trials, and BARDA’s CARB-X program is funding the development of a second-generation version of this product.
The publication, “Development of spirulina for the manufacture and oral administration of therapeutic proteins” is available online here.
“Genetic engineering has transformed biologics manufacturing over the past 50 years, but plant-based biopharmaceutical production has remained an elusive challenge,” said jim robert, MD, Ph.D., lead author and co-founder and chief scientific officer of Lumen Bioscience. “Spirulina-based biomanufacturing combines the safety of food biotechnology with genetic engineering methods to produce biopharmaceuticals that may address medical needs that current drug development tools have failed to address.”
Spirulina, a photosynthetic cyanobacterium, is a highly nutritious food and the only microorganism grown commercially in the world as a food. Previous attempts to convert this safe and scalable food source into a bioproduction platform have proven unsuccessful. In the new paper, Lumen researchers detail methods for constitutive and stable expression of therapeutic proteins in spirulina, with productivities and potencies tens to hundreds of times greater than those achievable in other food platforms. These advances in scalability and potency make orally administered biologics commercially feasible for the first time.
“Delivering therapeutic amounts of biological proteins into the gut presents an enormous challenge, and for this reason targets in the gastrointestinal tract have long been considered nearly unusable,” Roberts said. “The Spirulina platform elegantly meets this challenge. It can be used to produce and deliver the huge amounts of ingestible biotherapeutics that will be needed to both prevent and treat gastrointestinal disease. Preventing and treating diarrheal disease, the example reported in today’s article, provides an excellent case study: these widespread diseases are having devastating effects in the developing world, but traditional drug-making tools have failed to generate a solution despite decades of heavy investment. The approach outlined in today’s post offers new hope for people at risk of these diseases.”
Beyond campylobacter, Lumen is currently applying the technology to a growing list of highly prevalent diseases, including the following publicly disclosed programs:
- LMN-201, a complex biological cocktail for the prevention of It’s hard infection (in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and Rockefeller University)
- LMN-301, an antibody cocktail for Covid-19 for both upper respiratory and gastrointestinal administration (funded in part by the US Army Medical Research and Development Command and the Bill & Melinda Gates Foundation )
- A complex biological cocktail for the treatment of inflammatory bowel diseases (targets not yet disclosed)
- In collaboration with Novo Nordisk, orally administered biologics against gastrointestinal targets relevant to cardiometabolic diseases (targets not yet disclosed)
Lumen Bioscience discovers, develops and manufactures biological drug candidates for widespread diseases, many of which currently lack effective treatments. The company’s unique drug development and manufacturing platform offers the potential to transform the biologics industry with increased speed, mass-market scale and exponentially lower costs than current approaches. Lumen’s clinical pipeline includes investigational biologic drugs for It’s hard infection, Covid-19, cardiometabolic disease, inflammatory bowel disease, norovirus and traveller’s diarrhea. For more information visit: www.lumen.bio.
SOURCE Light Bioscience