Seattle, WA, January 27, 2021 – Lumen Bioscience, a clinical-stage biopharmaceutical company developing biologic drug candidates for highly prevalent diseases, today announced initiation of an up to $14.5 million project funded by CARB-X to develop an oral monoclonal antibody cocktail to prevent serious diarrheal diseases. Separately, the company simultaneously published pre-clinical and clinical research describing for the first time how its novel spirulina platform is used to rapidly develop, produce, and deliver edible antibody drugs.
The CARB-X project will develop an antibiotic-alternative that targets two key pathogens behind the diarrheal diseases that kill thousands of infants and children in the developing world: Campylobacter jejuni and enterotoxigenic E. coli. The intended product is a low-cost, edible antibody cocktail that can be easily shipped, stored, and used worldwide, including in regions like Africa and parts of SE Asia that lack refrigerated (“cold-chain”) distribution. With an initial funding commitment of $5.2 million, the project is eligible for an additional $8.26 million if project milestones are met, subject to available funds at CARB-X.
“Preventatives are urgently needed for deadly infections,” said Erin Duffy, R&D Chief of CARB-X, a global non-profit partnership led by Boston University and dedicated to funding and supporting the development of innovative products to address antibiotic-resistant bacterial infections. “The Lumen project is an extremely innovative immunotherapy in the early phases of development, and if successful, could potentially transform the way we prevent deadly infections in infants and children, and save precious lives.”
In newly published research, Lumen describes its discovery of novel methods to engineer spirulina for production of targeted therapeutic proteins and a low-cost system to manufacture them at large-scale under biopharmaceutical-grade cGMP controls. The paper also details preclinical and clinical studies funded in part by the Bill & Melinda Gates Foundation that show how the Lumen platform can address widespread diseases for which conventional drug development tools have failed to find solutions. Pending peer-review, the research titled “Expression and Manufacturing of Protein Therapeutics in Spirulina” has been posted on the online preprint server bioRxiv.
“We are pleased to publish findings detailing our unique drug discovery and production technologies that promise to broadly impact many devastating diseases,” said Jim Roberts, M.D., Ph.D., co-founder and Chief Scientific Officer of Lumen Bioscience. “The ability to effectively prevent and treat diarrheal diseases, which have devastating impacts in the developing world, has been compounded by the sheer scale and costs inherent in traditional drug development. Our unique approach offers the potential to provide an effective approach at a low cost and mass scale. We are grateful for the support from CARB-X to help advance our approach for diarrheal diseases.”
In the CARB-X project, Lumen leads a research consortium that includes the US Naval Medical Research Center (led by Frederic Poly), Tufts University in Boston (led by Charles Shoemaker), the University of Virginia (led by Jim Nataro), and A-Alpha Bio, Inc., a Seattle-based biotechnology start-up.
Lumen Bioscience discovers, develops, and manufactures biologic drug candidates for several prevalent, worldwide diseases—many of which currently lack any effective treatments. The company’s unique drug development and manufacturing platform offers the potential to transform the biologics industry through increased speed, mass-market scale, and exponentially lower costs than current approaches. Lumen’s clinical pipeline includes investigational biologic drugs for C. difficile infection, Covid-19, norovirus, and traveler’s diarrhea. For more information, visit: www.lumen.bio.
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services, the Wellcome Trust, a global charity based in the UK working to improve health globally, Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). CARB-X is investing up to $480 million from 2016-2022 to support innovative antibiotics and other therapeutics, vaccines, and rapid diagnostics. CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X is headquartered at Boston University School of Law. carb-x.org/. Follow us on Twitter @CARB_X.