CARB-X portfolio gains first vaccine project – a highly innovative approach to the prevention of life-threatening infections often contracted in hospitals

(BOSTON: November 1, 2017) – CARB-X is awarding up to $168,000 to Integrated Biotherapeutics of Rockville, Maryland, with the possibility of up to $8.3 million more based on achievement of milestones, to develop a novel and innovative vaccine for the prevention of serious drug-resistant infections known as MRSA.

“This is the first vaccine project in the CARB-X portfolio, increasing the diversity of the pipeline and bringing a novel approach that could potentially prevent drug-resistant infection and save lives,” said Kevin Outterson, Executive Director of CARB-X, the world’s leading non-profit partnership dedicated to accelerating the development of products to treat infections caused by superbugs. “The Powered by CARB-X portfolio now has 22 antibiotics, vaccine and diagnostics projects, with more than $52 million committed in initial awards. These projects are in the early stages of research, and there is always a risk of failure in these stages. But if successful, these projects hold real potential in the fight against the deadliest drug-resistant bacteria.”

“This CARB-X award will help us complete the preclinical studies and the Phase I clinical trial for IBT-V02, the first entirely toxoid-based multivalent vaccine for prevention of infections with Staphylococcus aureus,” said Dr. M. Javad Aman, President and Chief Scientific Officer of Integrated Biotherapeutics. “Antibiotic resistant S. aureus is a major public health threat causing numerous cases of invasive disease with high mortality rates in the hospitals and communities across the globe and billions of dollars in health care costs.”

Methicillin-resistant Staphylococcus aureus, better known as MRSA, causes a range of illnesses, from skin and wound infections to pneumonia and bloodstream infections that can cause sepsis and death, usually in people with weakened immune systems. The US Centers for Disease Control and Prevention (CDC) estimates that more than 11,000 people die each year in the US from S. aureus infections. These infections, including MRSA, are among the most common causes of healthcare-associated infections.

New approach to preventing MRSA infections

The IBT-V02 project, which has completed the discovery stage and proof of concept efficacy in animal models of MRSA infection, represents a new and potentially game-changing approach to preventing MRSA infections. Previous efforts had primarily targeted the surface of S. aureus bacteria, however, none were successful. S. aureus is challenging because it has a large arsenal of secreted toxins that cause tissue destruction, disable the patient’s immune system, and help bacteria disseminate in the body. IBT-V02 is the first multivalent S. aureus vaccine entirely based on rationally designed toxoids. They include seven attenuated toxoids that collectively provide protection against three large families of toxins secreted by the S. aureuspathogen.

CARB-X’s portfolio is the world’s largest portfolio of early development antibiotics, vaccines and rapid diagnostics to treat the most serious drug-resistant bacterial infections. CARB-X stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator. Launched in July 2016, CARB-X funds companies in 6 countries and is working to expand its pipeline with the best science from around the world.

Drug-resistant infections cause an estimated 700,000 deaths worldwide annually, according to the World Health Organization. In the US alone, the CDC estimates that 23,000 people die each year from drug-resistant bacterial infections, many of which occur in hospitals and health care settings.

Public-private partnership

CARB-X is a partnership between the UK charity Wellcome Trust 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, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). CARB-X is actively seeking support from other governments, industry and civil society to expand its ability to fund promising projects and deliver new life-saving treatments so urgently needed.

BARDA’s Director Rick Bright, PhD., said: “The support announced today aims to speed development of a novel vaccine candidate to prevent life-threatening infections. At BARDA, we know countering national security threats includes preventing secondary bacterial infections from dangerous pathogens like MRSA. We are expanding the antimicrobial pipeline through a combination of incentives. Today’s announcement is another example of our commitment to promote and accelerate medical countermeasure innovation through public-private partnerships like CARB-X.”

Tim Jinks, Head of Drug-Resistant Infections at Wellcome Trust, said: “Wellcome is committed to addressing this urgent global health threat. With drug-resistant infections spreading rapidly it’s vital we speed discovery of new preventative measures as well as innovative treatments. This includes supporting research into vaccines to prevent bacterial infections and taking hold in the first place. The addition of this exciting project to the CARB-X portfolio is the first step in achieving this. Incentives to promote new product development must go hand-in-hand with concerted action to ensure responsible use of antibiotics and availability of new healthcare tools for patients in all countries.”

More than $52 million for 22 projects in pipeline

The funding is part of an overall commitment of up to US$455 million by the US government and Wellcome Trust over a five-year period from 2016-2021. So far this year, including the Integrated Biotherapeutics award, CARB-X has announced $52.1 million to fund 22 projects plus an additional $72.15 million if project milestones are met. These funds are in addition to the companies’ own investments in their projects. Responsible use of existing antibiotics and equitable access, particularly in low-income countries where need is greatest, is also vital to address the global health problem. Both are a condition of CARB-X funding.

CARB-X’s role is to identify and fund promising early research in antibiotics, vaccines, rapid diagnostics, devices and alternative approaches to prevent, diagnose and treat the most serious drug-resistant Gram-negative bacterial infections. Projects funded by CARB-X receive non-dilutive funding as well as drug development and business support services. It is in the early phases of research that most projects are abandoned often because of lack of funding. The goal is to progress these Powered by CARB-X projects to a stage where they may attract additional private or public support for clinical development.

CARB-X expects to make further funding announcements later this year.

This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust, as administrated by CARB-X. The contents are solely the responsibility of the authors and do not necessarily represent the official views of CARB-X, the HHS Administration for Strategic Preparedness and Response, the National Institutes of Health or Wellcome Trust.

About CARB-X
CARB-X is the world’s largest public-private partnership devoted to early stage antibacterial R&D. Funded by BARDA and Wellcome Trust, with in-kind support from NIAID, CARB-X will spend up to $455 million from 2016-2021 to support innovative antibiotics, vaccines and rapid diagnostics from ‘hit-to-lead’ stage through to Phase 1 clinical trials. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is led by Boston University. Other partners include the Broad Institute of Harvard and MIT, MassBio, the California Life Sciences Institute and RTI International. For more information, please visit www.carb-x.org and follow us on Twitter @CARB_X.

About Integrated Biotherapeutics
IBT is a biotechnology company focused on the discovery of novel vaccines and therapies for emerging infectious diseases with a pipeline that includes promising product candidates for bacterial and viral infections including vaccines for Staphylococcal infections, unique pan-filovirus immunotherapeutics and vaccines, and a variety of other product candidates for emerging pathogens. Located in Rockville, MD, IBT has a close working relationship with United States Government agencies including the National Institute of Allergy and Infectious Diseases (NIAID/NIH). National Cancer Research Institute (NCI), Department of Defense (DOD), United States Army Medical Research Institute of Infection Diseases (USAMRIID) as well as many biotechnology and pharmaceutical companies and academic laboratories. For more information, visit www.integratedbiotherapeutics.com.

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 HHS, ASPR and NIH
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

ASPR leads HHS’s efforts to prepare the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. Within ASPR, BARDA provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threat agents, pandemic influenza, and emerging infectious diseases.

NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary 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. For more information about NIH and its programs, visit www.nih.gov. News releases, fact sheets and other NIAID-related materials are available on the NIAID website: https://www.niaid.nih.gov.

About Boston University
A leading research university with over 33,000 undergraduate and graduate students from more than 130 countries, nearly 10,000 faculty and staff, 17 schools and colleges, and 250 fields of study. Boston University is consistently ranked among the world’s best research universities and is a member of the American Association of Universities. For further information, see www.bu.edu or contact Ann Comer-Woods anncomer@bu.edu

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, go to 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. For further information about CHEAD, go to https://www.broadinstitute.org/infectious-disease-and-microbiome/carb-x-collaborative-hub-early-antibiotic-discovery.

About MassBio
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.

About the California Life Sciences Institute (CLSI)
The California Life Sciences Institute (CLSI) supports the foundations of innovation that have made California home to the world’s most prominent life sciences ecosystem. CLSI’s mission is to maintain California’s leadership in life sciences innovation through support of entrepreneurship, education and career development. CLSI is a member of the CARB-X consortium, serving as an accelerator. CLSI is an affiliate of the California Life Sciences Association (CLSA), which represents California’s leading life sciences organizations. The California Life Sciences Institute is a non-profit 501(c)(3), and was established in 1990 as the BayBio Institute. Learn more at http://califesciencesinstitute.org.

About RTI International
RTI International is an independent, nonprofit 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.

Media Contacts:

CARB-X: Jennifer Robinson
+1-514-914-8974
jcrobinson119@icloud.com

Integrated Biotherapeutics: Robert Blackwell III
240-778-6513
rblackwell@integratedbiotherapeutics.com