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CARB-X partners with T2 Biosystems to develop tests to identify and diagnose drug-resistant bacteria direct from blood

CARB-X partners with T2 Biosystems to develop tests to identify and diagnose drug-resistant bacteria direct from blood

T2 Biosystems Diagnostic Tests Aim to Save Valuable Time By Enabling Doctors to Identify a Broad Range of Life-Threatening Bacterial Infections in a Patient’s Bloodstream

(BOSTON, MA) – March 6, 2018 – CARB-X is funding T2 Biosystems, Inc. of Lexington, MA (NASDAQ: TTOO) to support the development of new tests using the company’s T2 Magnetic Resonance technology that would enable doctors to quickly diagnose and treat life-threatening, drug-resistant bacterial infections in whole blood. The technology could be a game-changer in the way certain infections are diagnosed and treated, by providing doctors with information they need to treat patients with targeted therapy.

This collaboration with T2 Biosystems is the second diagnostic project in the Powered by CARB-X pipeline. Under the terms of the funding agreement between CARB-X and T2 Biosystems, T2 Biosystems will receive an initial award of up to $1.1 million, with the possibility of up to $0.9 million more based on the achievement of certain project milestones.

“The ability to rapidly diagnose and treat drug-resistant bacteria will save lives by enabling doctors to treat patients more quickly and effectively than is possible with today’s diagnostic tools,” said Kevin Outterson, Executive Director of CARB-X. “Our collaboration with T2 Biosystems enhances the diversity of our pipeline with exciting technology. These products are not ready for use in patients yet, but if approved, they offer great potential to fight against life-threatening, drug-resistant bacteria.”

“The collaboration with CARB-X will accelerate the development of diagnostic tests to identify major bacterial species and resistance genes faster than ever,” said John McDonough, president and chief executive officer of T2 Biosystems. “Identifying these infections directly from whole blood with T2MR technology will help patients receive the right therapy faster – improving patient outcomes and reducing healthcare costs. We believe these diagnostic advances will also support the development of new antibiotics by accelerating clinical trials, attacking the problem of resistance on all fronts.”

Rapid diagnosis means better and faster treatment with fewer deaths

Bacterial bloodstream infections can be deadly even at low concentrations. If bacterial infections are identified quickly, patients can be placed on effective antibiotic therapy faster. The T2 Biosystems collaboration builds on T2 Biosystems’ T2MR technology and FDA-cleared T2Dx Instrument, focusing on the development of new tests to identify bacterial pathogens and resistance markers directly in whole blood. Existing diagnostics rely primarily on blood cultures conducted in laboratories, which can take days and do not always produce reliable results. As a result, physicians are often unable to treat infections quickly with the appropriate antibiotics, leading to higher mortality and overuse of unnecessary antibiotics.

The new tests aim to address the most serious superbugs and resistance genes on the antibiotic-resistance threat list published by the Centers for Disease Control and Prevention (CDC). In total, the tests delivered by T2 Biosystems with support from CARB-X will aim to identify 20 infectious species and resistance genes directly from whole blood, including Carbapenem-resistant Enterobacteriaceae (CRE) and Methicillin-resistant Staphylococcus aureus (MRSA). The 20 infectious species and resistance genes are among more than 25 targets that T2 is working to detect with its tests.

In addition to speeding diagnosis and treatment of patients, these tests could be used to accelerate clinical trials for new antibiotics and reduce time to market.

CARB-X portfolio expanding

The CARB-X portfolio is the world’s largest and most scientifically diverse portfolio of early development antibacterial projects with 26 projects including antibiotics and other therapeutics, vaccines and diagnostics to respond to the threat of drug-resistant bacteria. CARB-X, which stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, currently funds projects in 6 countries and is working to expand its pipeline with the best science from around the world. CARB-X expects to make further funding announcements later this year.

Since it was established in 2016, CARB-X has announced awards totaling $68.2 million, plus an additional $85.1 million if project milestones are met, to accelerate the development of antibiotics and other products. These funds are in addition to investments made by the companies themselves.

New antibiotics, diagnostics and other products are needed urgently to treat bacteria that are becoming increasingly resistant to existing antibiotics. According to the World Health Organization (WHO), an estimated 700,000 people die each year around the world from bacterial infections. According to the CDC, in the United States alone, an estimated 23,000 people die each year from drug-resistant bacterial infections.

Partnership to drive antibacterial innovation

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 (ASPR), and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

CARB-X funding is part of an overall commitment of up to $455m by the United States government and Wellcome Trust over a five-year period from 2016-2021. CARB-X is actively seeking global support from other governments, industry and civil society to expand its ability to fund the best science projects around the world to support new life-saving treatments that are urgently needed.

BARDA’s Director Rick Bright, Ph.D., said: “The support announced today aims to speed development of a new tool to enable doctors to quickly diagnose and treat life-threatening bacterial bloodstream infections, including those associated with sepsis, to enhance national security and global health security. At BARDA, we are committed to innovation and revitalizing the antibacterial pipeline of drug candidates, diagnostics, and devices through a combination of incentives. Today we add another product to the Powered by CARB-X portfolio, furthering our commitment to promote and accelerate medical countermeasure innovation through novel public-private partnerships like CARB-X.”

Dr. Tim Jinks, head of Drug-Resistant Infections at Wellcome Trust said: “Addressing the rapidly rising global superbug problem requires urgent development not only of new drugs, but also innovative diagnostics. Healthcare workers need effective tests and devices that provide timely and accurate detection of drug-resistant infections that inform treatment decisions to ensure patients are given the best and most appropriate care. The T2 project offers exciting potential and is an important addition to the CARB-X portfolio, which Wellcome funds.”

Additionally, the CARB-X partnership leverages NIAID’s long-standing preclinical services program established to facilitate product development for new drugs, vaccines and diagnostics. CARB-X is representative of the innovative new types of strategies encouraged by NIAID in recent years. NIAID also funds projects directly.

CARB-X identifies and funds promising early development research to treat the most serious bacteria. The goal is to support projects through the early phases so that they will attract additional private or public support for clinical development. To be considered for CARB-X support, projects must target antibiotic-resistant bacteria on the Serious or Urgent Threat List prepared by the CDC or on the Priority Pathogens list published by the WHO.

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 Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health or Wellcome Trust.

Media Contacts:

CARB-X: Jennifer Robinson
514.914.8974
carbxpr@bu.edu

T2 Biosystems: Amy Phillips, Feinstein Kean Healthcare
amy.phillips@fkhealth.com
412-327-9499

About CARB-X

CARB-X is the world’s largest public-private partnership devoted solely to accelerating early development antibacterial R&D. Funded by ASPR/BARDA and Wellcome Trust, with in-kind support from NIAID, CARB-X is investing up to $455 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, rapid diagnostics and devices to treat drug-resistant bacterial infections. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X operates through Boston University. Other partners include RTI International, the Broad Institute of Harvard and MIT, MassBio, and the California Life Sciences Institute (CLSI). http://www.carb-x.org/.

About T2 Biosystems

T2 Biosystems, an emerging leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, is dedicated to saving lives and reducing the cost of healthcare by empowering clinicians to effectively treat patients faster than ever before. T2 Biosystems is focused on addressing critical unmet needs in healthcare starting with sepsis, one of the deadliest and most expensive conditions in hospitals today. The T2Sepsis Solution™ is a unique approach that combines the standard of care for the management of sepsis patients with T2 Biosystems’ products, including the T2Dx® Instrument and T2Candida® Panel, and the T2Bacteria® Panel, which is commercially available in Europe and other countries that accept the CE mark and available for research use only in the U.S. Powered by the proprietary T2 Magnetic Resonance technology, or T2MR®, the T2Sepsis Solution is proven to deliver better patient care and greater cost savings. Hospital customer experience has demonstrated faster time to effective treatment, shortened ICU and hospital lengths of stay, reduced use of unnecessary antifungals, and millions of dollars in savings. T2 Biosystems has an active pipeline of future sepsis products including additional species and antibiotic resistance, as well as tests for Lyme disease and hemostasis. For more information, please visit www.t2biosystems.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’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the federal public health and medical preparedness and response to disasters and other emergencies, on behalf of the Secretary of HHS. 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.

NIAID is one of the 27 Centers and Institutes of the National Institutes of Health (NIH) a component of the U.S. Department of Health and Human Services. NIH is the nation’s medical research agency, and 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, 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.

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. 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, 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.