News

CARB-X is funding Seattle-based Lumen Bioscience to develop a new oral monoclonal antibody cocktail to prevent serious diarrheal diseases

CARB-X is funding Seattle-based Lumen Bioscience to develop a new oral monoclonal antibody cocktail to prevent serious diarrheal diseases

Lumen’s immunotherapy (mAb) targets pathogens that are a major cause of death of infants and children in low- and middle-income countries (LMICs)

(BOSTON) – CARB-X is awarding up to US$5.35 million to Lumen Bioscience, in Seattle, WA, USA, to develop a new immunotherapy to prevent diarrheal diseases caused by two deadly pathogens, Campylobacter jejuni and enterotoxigenic E. coli. The project could be eligible for up to $8.26 million more in non-dilutive funding from CARB-X if project milestones are met, subject to available funds.

Diarrheal diseases are often referred to as traveller’s diarrhea – intestinal infections caused by contaminated food or water. While unpleasant, most healthy adults survive. However, in low- and middle-income countries (LMICs), diarrhea is a leading cause of death and disease among infants and children.

Diarrhea kills 2,195 children every day—more than AIDS, malaria, and measles combined, according to the US Centers for Disease Control and Prevention (CDC). Diarrheal diseases account for 1 in 9 child deaths worldwide, making diarrhea the second leading cause of death among children under the age of 5. It causes death by depleting body fluids, resulting in profound dehydration.

“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.”

“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,” said Jim Roberts, M.D., Ph.D., co-founder and Chief Scientific Officer of Lumen Bioscience. “Our unique approach offers the potential to provide an effective approach at a low cost and mass scale, and we are grateful for the support from CARB-X to help advance this promising approach.”

The project, LMN-GI-EEC-401, is an oral antibiotic-alternative biologic developed with Lumen’s proprietary manufacturing process that utilizes spirulina expression. The goal is to produce a food-grade immuno-prophylactic drug at low cost for use around the world, including in areas where health-care temperature control is not available.

The Lumen work is being done in collaboration with 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.

CARB-X receives its funding from the US Biomedical Advanced Research and Development Authority (BARDA), the Wellcome Trust in the UK, the UK Global Antimicrobial Resistance (AMR) Innovation Fund (GAMRIF), Germany’s Federal Ministry of Education and Research (BMBF), and the Bill & Melinda Gates Foundation. The funding contributions by GAMRIF and the Gates Foundation are earmarked by CARB-X to fund projects that focus on specific antibacterial priorities, and the Lumen project is one such project. Gates Foundation funds received by CARB-X are allocated to the development of vaccines and novel biologics to avert drug-resistant diseases and protect the lives of children and infants, especially in LMICs. GAMRIF funding allocated to CARB-X is focused on innovative research and development in the field of AMR, specifically in neglected and underinvested areas for LMICs, where the burden of AMR is greatest.

Supporting global antibacterial innovation to address drug resistance  

The World Health Organization (WHO) estimates that 700,000 people die each year from drug-resistant infections, including 35,000 in the US and 33,000 in Europe. CARB-X funds only projects that target drug-resistant bacteria highlighted on the Center for Disease Control and Prevention (CDC)’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list, or ranked Critical or High on the WHO list.

The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 50 active projects focused exclusively on drug-resistant bacteria. CARB-X is investing up to $480 million in non-dilutive funding between 2016-2022 to support the early development of new antibiotics and other therapeutics, vaccines and other preventatives, rapid diagnostics. The goal is to support therapeutics projects through the early phases of development including Phase 1 so that they will attract additional private or public support for further clinical development and regulatory approval for use in patients.

Since its launch in 2016, CARB-X has announced 76 awards and has committed more than $260 million, with the potential of additional funds if project milestones are met. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and others fail for a variety of reasons.

This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from the Wellcome Trust, Germany’s Federal Ministry of Education and Research (BMBF), the UK Global AMR Innovation Fund (GAMRIF), and the Bill & Melinda Gates Foundation. The contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Office of the Assistant Secretary for Preparedness and Response, or other CARB-X funders.

Contacts:

CARB-X:
Jennifer Robinson
+1.514.914.8974
carbxpr@bu.edu

Lumen Bioscience:
Julie Rathbun
+1.206.769.9219
jrathbun@lumen.bio

About CARB-X
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 funded 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 (HHS), 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 other prevention approaches, 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.

About Lumen Bioscience
Lumen Bioscience discovers, develops and manufactures biologic drugs and vaccine 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. For more information, visit: www.lumen.bio.

About BARDA and NIAID
The US Department of Health and Human Services works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. Within HHS, ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases. NIH is the primary US federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.

About Wellcome Trust
Wellcome exists to improve health for everyone by helping great ideas to thrive. We’re a global charitable foundation, both politically and financially independent. We support scientists and researchers, take on big problems, fuel imaginations and spark debate. The Wellcome Trust is a charity registered in England and Wales, no. 210183. Its sole trustee is The Wellcome Trust Limited, a company registered in England and Wales, no. 2711000 (whose registered office is at 215 Euston Road, London NW1 2BE, UK).

About BMBF
Education and research are the foundations for our future. The promotion of education, science and research by the German Federal Ministry of Education and Research (BMBF) represents an important contribution to securing Germany’s prosperity. Education and research are a Federal Government policy priority, which is reflected in the development of the funding it is making available to these fields. 

About the Bill & Melinda Gates Foundation
Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Mark Suzman, under the direction of Bill and Melinda Gates and Warren Buffett.

About the Global AMR Innovation Fund (GAMRIF)
The Department for Health and Social Care (DHSC) is the UK Government department which is responsible for helping people to live more independent, healthier lives for longer.

This research is co-funded by DHSC’s Global AMR Innovation Fund (GAMRIF). GAMRIF was established to provide seed funding for innovative research and development, specifically in neglected and underinvested areas, in the field of antimicrobial resistance (AMR). GAMRIF is a c.£50m UK aid investment, which means all projects funded must support research primarily and directly for the benefit of people in low- and middle-income countries (LMICs). The Fund takes a ‘One Health’ approach, seeking to invest in potential solutions to reduce the threat of AMR in humans, animals, fish and the environment. The Fund seeks to leverage additional global funding through interaction with international government bodies, public-private partnerships, product development partnerships, global funding mechanisms and global fora.

About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With more than 33,000 students, it is the fourth-largest independent university in the United States. BU consists of 17 schools and colleges, along with a number of multi-disciplinary centers and institutes integral to the University’s research and teaching mission. In 2012, BU joined the Association of American Universities (AAU), a consortium of 62 leading research universities in the United States and Canada. For further information, please contact Jeremy Thompson at jeremy22@bu.edu. www.bu.edu.