Freeze-dried version of vaccine would boost availability to the world, save lives and help fight the spread of drug resistance

(BOSTON: August 15, 2019) – CARB-X, a global partnership led by Boston University, is awarding Integrated Biotherapeutics (IBT) of Rockville, Maryland, USA, $1.6 million to expand the development of its vaccine against Staphylococcus aureus,  including  Methicillin-resistant Staphylococcus aureus (MRSA) superbugs, so that the vaccine can be used to prevent infections in developing nations, as well as in the developed world. Under this initiative, IBT will expand its R&D to evaluate the efficacy of its vaccine, IBT-V02, against strains of the bacteria found in developing nations, and will also explore development of a freeze-dried version of the vaccine so that it can be used where cold storage systems are not available.

This funding is in addition to an award of up to $8.5 million announced by CARB-X in 2017 to support the development of the IBT’s innovative vaccine. The extra support announced today by CARB-X is possible because of funds from CARB-X partners – UK government’s Global Antimicrobial Resistance Innovation Fund (GAMRIF) for antibacterial products, and the Bill & Melinda Gates Foundation earmarked specifically for the development of antibacterial preventative approaches that can be used in low- and middle-income countries (LMICs).

“A vaccine to prevent infections caused by Staphylococcus aureus, including drug-resistant strains, could save the lives of thousands, including infants, and curb the spread of the bacteria and drug resistance,” said Kevin Outterson, Executive Director of CARB-X and Professor of Law at Boston University. “IBT’s plan to develop its vaccine to prevent these infections in all corners of the world reflects the kind of creative thinking we need in the global fight against drug resistance.”

“Effective vaccines can prevent life-threatening bacterial infections and help reduce overuse and misuse of antibiotics, which is a particular problem in many developing nations and a threat to global health security as it fuels the spread of antibiotic resistance,” said M. Javad Aman, IBT President and CSO. “CARB-X’s vision and new funding opens up new doors to better global approaches and solutions to battle drug resistant bacterial infections. We would not be able to develop this new vaccine without the support of CARB-X, its funders, as well as National Institute of Allergy and Infectious Diseases (NIAID).”

The science of preventing bacterial infection is challenging. Vaccines have been developed to prevent bacterial infections such as diphtheria and tetanus. But past efforts to develop a vaccine to prevent S. aureus have failed. S. aureus bacteria secrete a wide range of toxins that can destroy tissue, disable the patient’s immune system and help bacteria spread through the body. IBT-V02 is the first multivalent S. aureus vaccine entirely based on rationally designed toxoids that collectively enable the body to neutralize and provide protection against major families of toxins secreted by the S. aureus pathogen.

MRSA bacteria a growing global threat

MRSA bacteria cause a range of serious illnesses, from skin and wound infections to pneumonia and serious bloodstream infections that can cause sepsis and death. Sepsis, which occurs when the body’s response to an infection injures its own tissues and organs, is a leading cause of death, particularly in the developing world among infants and children. An estimated 3 million newborns and 1.2 million children suffer from sepsis globally every year. Recently published studies indicate that resistant pathogens, including MRSA, are increasingly common causes of newborn sepsis in particular, and likely contribute to excess mortality in this most vulnerable population.

Global data on the impact of S. aureus bacteria is lacking. In the US alone, the US Centers for Disease Control and Prevention (CDC) estimates that 80,461 MRSA infections and 11,285 related deaths occurred in 2011.

Expansion of IBT’s research

The IBT team is focusing on two main areas of research to expand its current vaccine development activities.

• Collaborate with health research organizations active in LMICs in Africa, Southeast Asia and South America to collect circulating strains of aureus for testing and also to potentially collaborate on future clinical trials in LMICs.
• Develop a freeze-dried version of the vaccine for use in regions where temperature-controlled supply chains are unreliable or do not exist. This involves developing a freeze-dried powder formulation for distribution that would not be affected by changes in room temperature. The formulation would be mixed with a saline-type liquid prior to administration to patients.

Driving innovation to address the growing global superbug crisis

According to the World Health Organization, an estimated 700,000 people die each year worldwide from drug-resistant bacterial infections. The CARB-X portfolio is the world’s largest antibacterial early development portfolio. It currently has 30 active projects in five countries, and is expected to grow significantly this year.

Since its launch in 2016, CARB-X has announced 45 awards exceeding $130.5 million, with the potential of additional funds if project milestones are met, to accelerate the development of antibacterial products. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and graduate from CARB-X and others fail for a variety of reasons.

Partnership driving antibacterial innovation

CARB-X is investing more than $500 million in antibacterial R&D between 2016-2021. The goal is to support therapeutic projects in the early phases of development through Phase 1, and diagnostic development from feasibility through development and into the early phases of product verification and validation, so that they will attract additional private or public support for further clinical development and approval for use in patients. CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the Centers for Disease Control and Prevention (CDC)’s 2013 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 led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic 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 headquartered in the Boston University School of Law.

This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and awards from Wellcome Trust, the German and UK governments and the Bill & Melinda Gates Foundation, as administrated by CARB-X. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Health and Human Services Administration for Strategic Preparedness and Response, other funders, or CARB-X. 

Media Contacts:

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

Integrated Biotherapeutics Inc.
Javad Aman
javad@integratedbiotherapeutics.com
O:  +1.240.454.8940
M: +1.301.512.8921

About CARB-X
CARB-X is a global non-profit partnership led by Boston University and dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic 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). A non-profit partnership, CARB-X is investing more than $500 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, rapid diagnostics and devices. CARB-X supports 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 headquartered at Boston University School of Law. https://carb-x.org/.  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 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 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 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 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 Sue Desmond-Hellmann and Co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.

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.