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CARB-X announces award to Achaogen to advance the development of next-generation aminoglycoside antibiotic to treat highly-resistant gram-negative pathogens

CARB-X announces award to Achaogen to advance the development of next-generation aminoglycoside antibiotic to treat highly-resistant gram-negative pathogens

(BOSTON, MA) – April 26, 2018 – CARB-X is funding Achaogen, Inc. (NASDAQ: AKAO) of South San Francisco, CA, to support the development of a next-generation broad-spectrum aminoglycoside antibiotic capable of overcoming resistance mechanisms and potentially treating highly-resistant pathogens such as Pseudomonas aeruginosa and Acinetobacter baumannii. Under the agreement, Achaogen will receive an initial award of up to $2.4 million with the possibility of up to $9.6 million more in two additional stages based on the achievement of certain project milestones.

“Achaogen’s research reflects important advances in the battle to overcome drug-resistance mechanisms. The world urgently needs new antibiotics, rapid diagnostics, vaccines and entirely new approaches to protect us from drug-resistant bacteria,” said Kevin Outterson, Executive Director of CARB-X. “The projects in the Powered by CARB-X portfolio are in the early stages of research, but if successful, these innovative projects hold great potential to treat serious infections and fight against the rise of drug-resistant bacteria.”

“We are honored to have CARB-X’s support in advancing our novel aminoglycoside program, which we believe has significant potential to address the growing multi-drug resistance problem in gram-negative bacteria,” said Lee Swem, Ph.D., Achaogen’s Chief Scientific Officer. “The race to develop innovative antibiotics is an ongoing fight against bacterial evolution, which continuously evolve to develop resistance to current therapies. We believe that CARB-X’s financial support is vital to advancing research programs, like ours, that have the potential to impact the lives of patients with serious bacterial infections.”

Aminoglycosides have been a cornerstone of antibiotic treatments for over 70 years but face growing resistance. Achaogen has focused on engineering aminoglycosides to overcome resistance mechanisms. With CARB-X support, Achaogen will pursue a next-generation aminoglycoside with the aim of overcoming clinically-relevant resistance mechanisms and potentially treating pathogens such as Enterobacteriaceae, P. aeruginosa and A. baumannii, for which there are few new agents in development.

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 worldwide 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. Antibacterial innovation has declined over past decades while resistance has been on the rise.

Expanding portfolio
The CARB-X portfolio is the world’s largest and most scientifically diverse portfolio of early development antibacterial projects with 31 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, funds projects in 7 countries and is working to expand its pipeline with the best science from around the world.

Since it was established in 2016, CARB-X has announced awards totaling $79.8 million, plus an additional $107.5 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.

Partnership to drive antibacterial innovation
CARB-X is a partnership between the UK charity Wellcome Trust, 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 a commitment of up to $455m by the US government and Wellcome Trust from 2016-2021. The goal is to support projects through the early phases of development through Phase 1, so that they will attract additional private or public support for further clinical development and approval for use in patients. The scope of CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the ‘Antibiotic Resistant Threats in the United States’ report published by the Centers for Disease Control and Prevention (CDC) in 2013 or the Priority Bacterial Pathogens list published by the World Health Organization (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.
Responsible use of existing antibiotics and equitable access, particularly in low-income countries where need is greatest, is also vital to addressing the global health problem. Both are a condition of CARB-X funding.
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust, as administered by CARB-X. The contents are solely the responsibility of the authors and do not necessarily represent the official views of 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
Achaogen:
Denise Powell
510.703.9491
dpowell@achaogen.com
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 Achaogen
Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterial treatments for multidrug resistant (MDR) gram-negative infections. Achaogen is developing plazomicin, its lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. The Food and Drug Administration has granted plazomicin Breakthrough Therapy designation for the treatment of bloodstream infections caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. The Company’s second product candidate is C-Scape, an orally-administered beta-lactam/beta-lactamase inhibitor combination. Achaogen’s plazomicin program has been funded, and its C-Scape program is funded, in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA). Achaogen has received funding from the Wellcome Trust to support aspects of of plazomicin development.
Achaogen has other programs in early and late preclinical stages of development focused on other MDR gram-negative infections and additional disease areas. All product candidates, including plazomicin, are investigational only and have not been approved for commercialization. For more information about Achaogen, please visit www.achaogen.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
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.