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 faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas 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.
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.
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 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/.
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.
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)
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.
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
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.
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
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.
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.