CARB-X Backs Integrated Biotherapeutics to Prevent Drug-Resistant MRSA Infections

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

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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, BU Law professor and 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. aureus pathogen.

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 six 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 healthcare 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 Office of the Assistant Secretary for 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 to 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.

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