(BOSTON: July 31, 2018) – CARB-X is awarding SciBac of San Francisco, CA, USA, $0.68 million in non-dilutive funding, with the possibility of up to $3.08 million more in two additional stages if certain project milestones are met, to develop a novel biotherapeutic to fight deadly Clostridium difficile infections (CDI). SciBac’s SCB-102 project, if it succeeds, has the potential to effectively treat and prevent C. difficile infections.
“The world urgently needs antibiotic alternatives, like those that SciBac is developing, as well as other life-saving products to treat and prevent deadly infections,” said Kevin Outterson, Executive Director of CARB-X. “The microbiome is providing exciting new approaches to the prevention and treatment of life-threatening infections. The projects in the Powered by CARB-X portfolio are in the early stages of development, but if successful, they offer tremendous potential in the global fight against superbugs.”
“SciBac has essentially created a new class of drugs. Our patented platform technology allows us to mate different species of microbes. This means we can harness the microbiome to both treat and prevent antibiotic resistant disease, with targeted modes of action” said Jeanette Mucha, CEO of SciBac. “We are honoured to receive this CARB-X award, it is a tremendous validation of our approach and our growing pipeline.”
The CARB-X award will support the early stage development of SCB-102, an antibiotic alternative for the prevention and treatment of recurrent CDI, commonly known as deadly diarrhea. C. difficile infections are designated as an urgent antibiotic-resistant threat by the Centers of Disease Control and Prevention (CDC). The infection causes an estimated 15,000 deaths each year in the US, many among seniors, and it represents the most common microbial cause of healthcare-associated infections in US hospitals. The CDC cites a recent study that found that 1 in 5 patients with healthcare-associated C. difficile infection experienced a recurrence of the infection, and 1 in 11 aged 65 or older died within 30 days of diagnosis.
SCB-102 consists of microbes specifically designed to target the disease and is constructed with SciBac’s proprietary gene transfer technology platform. The technology mates microbes into a single hybrid with the best genetic traits of each parent microbe, thereby allowing SciBac to design these hybrids to target specific diseases through multiple modes of action, and at the same time, to bolster the microbiome for fast recovery.
SCB-102 is under development as an oral therapy and consists of three hybrid microbes. The drug kills C. difficile, stops its colonization of the colon, neutralizes its toxins, and prevents spore formation. The CARB-X award will advance its development in three stages, with the first providing full genetic characterization and extensive in vitro studies to determine dosing rationale, the second focusing on manufacturing and safety testing, and the third stage supporting a first-in-human clinical trial.
CARB-X support for the SciBac project is possible thanks to funding from the Wellcome Trust, a global charity based in the UK working to improve health globally, and the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR).
CARB-X’s expanding portfolio
New antibiotics, diagnostics and other products are needed urgently to treat bacteria that are increasingly resistant to existing antibiotics. According to the World Health Organization, an estimated 700,000 people die each year worldwide from bacterial infections. In the United States, an estimated 23,000 people die each year from drug-resistant bacterial infections, according to the CDC.
CARB-X is currently funding 35 R&D projects that target the most serious drug resistant bacteria, including antibiotics, rapid diagnostics and other innovative non-traditional products. The SciBac project is the third microbiome project in the portfolio. CARB-X, which stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, supports projects in seven countries and is working to expand its pipeline with great science from around the world.
Since it was established in 2016, CARB-X has announced awards totaling $90.1 million, plus an additional $123.8 million if project milestones are met, to accelerate the development of antibacterial products. These funds are in addition to investments made by the companies themselves.
Partnership to drive antibacterial innovation globally
CARB-X has more than $500 million to invest in antibacterial R&D from 2016-2021. The goal is to support projects through the early phases of development through Phase 1, so that they will attract additional private or public support for further clinical development and approval for use in patients. The scope of CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the CDC’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO in 2017 – with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.
CARB-X is a non-profit partnership funded by BARDA, the Wellcome Trust, the UK Government’s Global Antimicrobial Resistance Innovation Fund (UK GAMRIF), and the Bill & Melinda Gates Foundation, 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 based at the Boston University School of Law.
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust. The contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Administration for Strategic Preparedness and Response, Wellcome Trust, or other CARB-X funders.
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CARB-X is a non-profit public-private partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is investing more than $500 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, rapid diagnostics and devices. In its first two years, CARB-X has built the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X focuses exclusively on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is funded by US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR), the Wellcome Trust, a global charity based in the UK working to improve health globally, the UK Government’s Global Antimicrobial Resistance Innovation Fund (UK GAMRIF), the Bill & Melinda Gates Foundation, 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 based at Boston University in the School of Law. Other partners include RTI International, the Broad Institute of Harvard and MIT, MassBio, and the California Life Sciences Institute (CLSI). https://carb-x.org/. Follow us on Twitter @CARB_X.
SciBac creates rEvolutionary live biotherapeutics that treat and prevent antibiotic resistant disease, while fortifying the microbiome. Using their proprietary platform technology, SciBac mates beneficial microbes to create hybrid strains with traits meticulously selected to target disease through multiple modes of action. SciBac has an expanding pipeline that includes biotherapeutics for Clostridium difficile infections and chronic Pseudomonas in cystic fibrosis patients. For more information, visit www.scibac.com.
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 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.
The partnership with CARB-X is part of DHSC’s Global Antimicrobial Resistance 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 AMR. GAMRIF is a £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 visit www.bu.edu, or contact Suzanne Otte at email@example.com.
About the Broad Institute of MIT and Harvard
Broad Institute of MIT and Harvard was launched in 2004 to empower this generation of creative scientists to transform medicine. The Broad Institute seeks to describe all the molecular components of life and their connections; discover the molecular basis of major human diseases; develop effective new approaches to diagnostics and therapeutics; and disseminate discoveries, tools, methods, and data openly to the entire scientific community. Founded by MIT, Harvard, Harvard-affiliated hospitals, and the visionary Los Angeles philanthropists Eli and Edythe L. Broad, the Broad Institute includes faculty, professional staff, and students from throughout the MIT and Harvard biomedical research communities and beyond, with collaborations spanning over a hundred private and public institutions in more than 40 countries worldwide. For further information about the Broad Institute, http://www.broadinstitute.org. In support of CARB-X, the Broad Institute created the Collaborative Hub for Early Antibiotic Discovery (CHEAD), which serves an interdisciplinary center that partners with academic investigators engaged in antibiotic development and/or resistance research to accelerate their early-stage, small molecule therapeutics toward Investigational New Drug (IND) application.
MassBio is a not-for-profit organization founded in 1985 that represents and provides services and support for the world’s leading life sciences supercluster. MassBio is committed to advancing Massachusetts’ leadership in the life sciences to grow the industry, add value to the healthcare system and improve patient lives. Representing 1000+ biotechnology companies, academic institutions, disease foundations and other organizations involved in life sciences and healthcare, MassBio leverages its unparalleled network of innovative companies and industry thought leaders to advance policy and promote education, while providing member programs, events, industry information, and services. Learn more at MassBio.
About the California Life Sciences Institute (CLSI)
The mission of the California Life Sciences Institute (CLSI) is to maintain California’s leadership in life sciences innovation through support of entrepreneurship, education and career development. Located in the birthplace of biotechnology, CLSI strives to ensure that the economic and intellectual power of the region’s life sciences industry and its employees remains strong. By maintaining its focus on entrepreneurship, education and career development programs, CLSI supports the foundations of innovation that have made California home to the world’s most prominent life sciences ecosystem. As a non-profit 501(c)(3), CLSI’s objectives are met through collaborations, partnerships, and the generosity of individuals, sponsors and foundations. CLSI is a member of the CARB-X consortium, serving as an accelerator. Learn more at http://califesciencesinstitute.org.
About RTI International
RTI International is an independent, non-profit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach – one that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world. For more information, visit www.rti.org.