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CARB-X announces $3.8M award to Entasis Therapeutics to speed the development of Entasis’ non beta-lactam PBP inhibitor

CARB-X announces $3.8M award to Entasis Therapeutics to speed the development of Entasis’ non beta-lactam PBP inhibitor

CARB-X portfolio grows to 19 early development projects aimed at treating drug-resistant bacterial infections and battling the growing global threat of drug-resistance

Scientific diversity of CARB-X portfolio enriched by Entasis’ ground-breaking research

BOSTON, MA – October 12, 2017 – CARB-X announced today an award worth $3.8 million to Entasis Therapeutics to accelerate the development of a new antibiotic class to treat serious drug-resistant Gram-negative bacterial infections. The award commits funding of up to $3.8 million in an initial period, with the possibility of up to $6.3 million more based on the achievement of milestones.

“The addition of Entasis’ PBP inhibitor program to the CARB-X portfolio expands the rich diversity of our pipeline and reflects a novel approach against drug-resistant infections,” said Kevin Outterson, Executive Director of CARB-X. “The Powered by CARB-X portfolio now has 19 projects including the Entasis project. These projects are in the early stages of research, and there is always a high risk of failure. But if successful, they hold exciting potential in the fight against the deadliest drug-resistant bacteria.”

Entasis’ PBP inhibitor project, which is currently in lead optimization, is a novel antibiotic class targeting the penicillin-binding proteins (PBPs), cell wall targets unique to bacteria. Unlike beta-lactam antibiotics, which also kill bacteria by binding to PBPs, Entasis’ PBP inhibitors stand out because they are unaffected by all four classes of beta-lactamases, while demonstrating potent antibacterial activity. This is the second award for Entasis, a Waltham, MA-based Biotech. The first award was announced in March 2017 for ETX0282CPDP, Entasis’ oral beta-lactamase inhibitor in combination with cefpodoxime targeting Enterobacteriaceae infections

“We are delighted to partner with CARB-X for a second time and look forward to working with the CARB-X team on our novel PBP inhibitor program,” said Manos Perros, CEO of Entasis. “As antibiotic resistance continues to rise, it is crucial to identify new classes of effective, well tolerated agents with activity against multi-drug resistant infections. With CARB-X’s valuable support, we hope to address this need through the development of our growing portfolio of investigational antibiotics, including our new PBP inhibitor program.”

CARB-X’s portfolio is the world’s largest and most scientifically diverse portfolio of early development antibiotics and rapid diagnostics to treat the most serious drug-resistant bacterial infections, often referred to as superbugs. CARB-X, which stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, was launched in July 2016. It currently funds projects in 6 countries and is working to expand its pipeline with the best science from around the world.

Drug-resistant infections currently cause an estimated 700,000 deaths worldwide annually, according to the World Health Organization. If antibiotic resistance continues at its current rate, that number could rise significantly. In the US alone, the Center for Disease Control and Prevention (CDC) estimates that 23,000 people die each year from drug-resistant bacterial infections, many of which occur in hospitals and health care settings.

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 global support from other governments, industry and civil society to expand its ability to fund the best science around the world to get the new life-saving treatments so urgently needed.

BARDA’s Director Rick Bright, Ph.D., said: “The support announced today will help speed development of a new antibacterial product with the potential to treat patients with life-threatening infections. Antibiotic resistant infections not only pose a day-to-day public health concern but also complicate our response to national security threats, which is why at BARDA we working to revitalize the antibacterial pipeline. Today’s announcement is another example of our commitment to promote and accelerate medical countermeasure innovation through novel public-private partnerships like CARB-X.”

Tim Jinks, Head of Drug-Resistant Infections at Wellcome Trust, said: “Antibiotics are fundamental to modern medicine but overuse and inappropriate use have led to dangerous bacteria developing deadly resistance. Wellcome is committed to helping ensure we get urgently needed new treatments to tackle this urgent global health threat. Drug discovery must also go hand-in-hand with concerted action to ensure antibiotics are used responsibly and that existing and new treatments are made available in all countries for those who need them.”

The Entasis project was selected from among 202 applications received from companies around the world in CARB-X’s most recent round of funding.

The funding is part of an overall commitment of up to US$455m by the US government and Wellcome Trust over a five-year period from 2016-2021. So far this year, including the Entasis award, CARB-X has announced $44.9 million to help fund 19 projects plus an additional $58.6 million if project milestones are met. These funds are in addition to the companies’ own investments in their programs. Responsible use of existing antibiotics and equitable access, particularly in low-income countries where need is greatest, are 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.

The last new class of antibiotics approved for treatment against Gram-negative bacteria was discovered in 1962. Antibiotic discovery is challenging because bacteria are able to genetically modify and become resistant to medicines. As well, large pharmaceutical companies have significantly scaled back investment in antibiotic research in the past decades because it has not been sufficiently profitable.

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

About Entasis Therapeutics Inc.
Entasis Therapeutics is developing a portfolio of innovative cures for serious drug-resistant bacterial infections, a global health crisis affecting the lives of millions of patients. Entasis’ anti-infective discovery platform has produced a pipeline of meaningfully differentiated programs which target serious bacterial infections, including ETX2514SUL (targeting Acinetobacter baumannii infections), ETX0282CPDP (targeting infections caused by Enterobacteriaceae), Non-Beta-lactam PBP inhibitor (targeting Gram-negative infections), and zoliflodacin (targeting Neisseria gonorrhoeae). www.entasistx.com

About Non Beta-lactam PBP Inhibitor
Entasis Therapeutics is developing a novel antibiotic class targeting the penicillin-binding proteins (PBPs), cell wall targets unique to bacteria. While beta-lactams kill bacteria by binding to PBPs, bacteria have evolved to produce beta-lactamases which inactivate these agents. Entasis’ non-beta-lactam PBP inhibitors are unaffected by all four classes of beta-lactamases while demonstrating remarkable antibacterial activity. The program is currently in the lead optimization stage of development. Current leads demonstrate potent in vitro and in vivo antibacterial activity against some of the toughest to treat Gram-negative pathogens, including MDR Pseudomonas aeruginosa, carbapenem-resistant Enterobacteriaceae, and MDR Acinetobacter baumannii.

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, we will spend up to $455 million from 2016-2021 to support innovative products 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 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.

Contacts:

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

Entasis Therapeutics:

Entasis Company Contact
Kyle Dow
Entasis Therapeutics
(781) 810-0114
kyle.dow@entasistx.com

Entasis Media Contact
Kari Watson or Stefanie Tuck
MacDougall Biomedical Communications
(781) 235-3060
kwatson@macbiocom.com
stuck@macbiocom.com