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CARB-X partners with Melinta Therapeutics to accelerate the development of a new class of antibiotic to battle multiple life-threatening superbugs

CARB-X partners with Melinta Therapeutics to accelerate the development of a new class of antibiotic to battle multiple life-threatening superbugs

Melinta’s innovative project brings to 10 the number of new classes in the CARB-X portfolio; it has been more than half a century since the last new class was approved

(BOSTON, MA) – May 7, 2018 – CARB-X is teaming up with Melinta Therapeutics (NASDAQ: MLNT) to support the development of a new class of antibiotic called pyrrolocytosine to treat the most serious drug-resistant bacterial infections. Melinta will receive an initial award of up to $2.3M, with the possibility of $3.9M more from CARB-X based on the achievement of certain project milestones.

“This funding aims to speed the development of an exciting new class of antibiotics to treat patients with life-threatening Gram-negative infections and to enhance global health security. It’s vital we accelerate the discovery of new and innovative approaches to address the rising threat of drug resistance; it has been more than half a century since the last new class was approved,” said Kevin Outterson, Executive Director of CARB-X. “The projects in the portfolio are in the early stages of research. But if successful, these innovative projects hold great potential in the treatment of serious infections and in the fight against the rise of drug-resistant bacteria.”

“Our structure-based design efforts to create and optimize the pyrrolocytosine class of antibiotics have shown exciting promise, with several compounds demonstrating comprehensive activity and preclinical effect across the full set of bacterial “superbugs”,” said Erin Duffy, Ph.D., Chief Scientific Officer at Melinta. “We believe this new class of antibiotics could be transformational in the fight against these urgent threats. The support and resources available through CARB-X will provide important assistance as we move to advance one or more pyrrolocytosines into clinical development.”

Melinta’s novel pyrrolocytosine compounds are part of the company’s ESKAPE Pathogen Program, a program based on Melinta’s proprietary drug discovery platform focused on developing breakthrough antibiotics for bacterial “superbugs” by targeting the bacterial ribosome. The pyrrolocytosines have been designed de novo, from the ground up, in a site not previously exploited by the many successful classes of antibiotics that target the ribosome. They are being developed to optimize properties that allow them to get in and stay in bacterial cells. The novelty in chemistry and binding, combined with the optimized properties, have translated to date into an in vitro activity profile that is not affected by current resistance mechanisms of concern. The pyrrolocytosines have also been shown in preclinical studies to be active against multidrug-resistant pathogens on the Antibiotic Resistant Threats in the United States report published by the Centers for Disease Control and Prevention (CDC) in 2013, including all of the ESKAPE pathogens (Enterococcus faeciumStaphylococcus aureusKlebsiella pneumoniaeAcinetobacter baumanniiPseudomonas aeruginosa and Enterobacter species).

The CARB-X award will help Melinta advance the most promising pyrrolocytosine compounds through preclinical optimization and into clinical development, where ultimately their efficacy and safety in humans may be examined.

Expanding portfolio
The CARB-X portfolio is the world’s largest and most scientifically diverse portfolio of early development products, including new classes of antibiotics and other therapeutics, vaccines, diagnostics and devises, to address serious drug-resistant bacterial infections and other difficult-to-treat infections. There are 10 new classes of antibiotics in the portfolio, and if only one of them successfully reaches patients, it could potentially be the first new class of antibiotic to be approved for the treatment of Gram-negative bacteria since 1962. CARB-X, which stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, funds 32 projects in 7 countries and is working to expand its pipeline with great science from around the world.

Since it was established in 2016, CARB-X has announced awards totaling $82.1 million, plus an additional $111.4 million if project milestones are met, to speed the development of life-saving products. These funds are in addition to investments made by the companies themselves.

The world urgently needs new antibiotics to treat drug-resistant bacteria. According to the World Health Organization (WHO), an estimated 700,000 people die each year around the world from bacterial infections – and that number is on the rise. The last new class of antibiotics approved to treat Gram-negative bacteria was discovered in the early 1960s. Since then, resistance to antibiotics has been on the rise.

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 CDC’s Antibiotic Resistant Threats list, 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
Melinta Therapeutics:
David Belian
(203) 848-6276
Lyn Baranowski
(203) 848-3346
About CARB-X
CARB-X is one of the world’s largest public-private partnership devoted to 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 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 Melinta Therapeutics
Melinta Therapeutics, Inc. is the largest pure-play antibiotics company, dedicated to saving lives threatened by the global public health crisis of bacterial infections through the development and commercialization of novel antibiotics that provide new therapeutic solutions. Its four marketed products include Baxdela® (delafloxacin), Vabomere™ (meropenem and vaborbactam), Orbactiv® (oritavancin), and Minocin® (minocycline) for Injection. It also has an extensive pipeline of preclinical and clinical-stage products representing many important classes of antibiotics, each targeted at a different segment of the anti-infective market. Together, this portfolio provides Melinta with the unique ability to provide providers and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. Visit www.melinta.comfor more information.
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

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 visit www.bu.edu, or contact Suzanne Otte at otte@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.