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CARB-X awards Amicrobe $2.48M to accelerate the development of Amicidin-β topical antimicrobial

CARB-X awards Amicrobe $2.48M to accelerate the development of Amicidin-β topical antimicrobial

Scientific diversity of CARB-X portfolio boosted with Amicrobe’s ground-breaking research on topically applied antimicrobials for use on infected tissue in surgical, emergency and post-disaster settings

BOSTON, MA – October 24, 2017 – CARB-X announced today an award of up to $2.48 million to Amicrobe Inc. to accelerate the development of a new bioengineered antimicrobial designed for direct application to contaminated and infected tissues, including those of surgery and trauma. The award commits funding of up to $2.48 million in an initial period, with the possibility of up to $3.76 million more based on the achievement of milestones to the satisfaction of CARB-X.

“The addition of the Amicidin-β program, which represents the first topically applied antimicrobial in the CARB-X portfolio, expands the 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 20 projects including the Amicrobe 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 global fight against the deadliest drug-resistant bacteria.”

Amicrobe’s Amicidin-β project, which is currently in preclinical development, stands out because it represents a new generation of topically applied antimicrobials designed to combine broad, rapid microbicidal activity with beneficial physical properties to enhance intrawound performance and safety. If successful in reaching the market, the Amicidin-β project could potentially be used to treat infected tissue in surgical and emergency settings, and also in post-disaster scenarios involving large numbers of injured people.

“The era of antimicrobial resistance challenges all of us to bring forward new technologies and products to prevent and treat life-threatening infections” said Michael P. Bevilacqua, M.D., Ph.D., CEO and CSO at Amicrobe, a Carlsbad, CA-based firm. “At Amicrobe, we are very pleased to receive the recognition and support of CARB-X to accelerate our Amicidin-β 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. Projects include 9 new classes of antibiotics, non-traditional approaches like the Amicrobe project, and a rapid diagnostic for lung infections. 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, with more than 25,000 deaths in the European Union.

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: “Wellcome is committed to addressing this urgent global health threat. With drug-resistant infections spreading rapidly it’s vital we speed discovery of new and innovative treatments. The addition of this exciting project to the CARB-X portfolio is another important step in achieving this. Drug discovery must also go hand-in-hand with concerted action to ensure responsible use of antibiotics and availability of existing and new treatments for patients in all countries.”

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 Amicrobe award, CARB-X has announced $47.4 million to fund 20 projects plus an additional $62.4 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.

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’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.

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 Amicrobe Inc.

Amicrobe is using bioengineering principles to produce a new generation of locally applied antimicrobials that combine broad microbicidal activity, beneficial physical properties, and safety. Two of its product candidates, Amicidin-α and Amicidin-β, are large-molecule biological therapeutics designed for the prevention and treatment of life-threatening infections, especially in the fields of surgery and trauma. Amicrobe’s technology platform is expected to produce multiple innovative products for the fight against antibiotic resistance. Amicrobe is headquartered in Carlsbad, California. For more information, please visit www.amicrobe.com.

About Amicrobe’s Amicidin-β project

Amicidin-β is a novel biological therapeutic (single chain amino acid polymer) that combines microbicidal activity and surfactant properties within the same molecule for enhanced intrawound performance. Built by iterative design and testing, Amicidin-β is being developed for treatment of life-threatening focal infections, especially those involving foreign bodies and biofilms. High-impact applications may include infections associated with orthopedic implants, surgical procedures, and traumatic wounds. Key design features include: (1) Broad and rapid microbicidal activity against Gram-positive and Gram-negative bacteria (including multidrug resistant strains), as well as yeast; (2) Surfactant properties for enhanced anti-biofilm activity; and (3) Easy removal by irrigation and bioresorbability when left in place. Amicidin-β is produced using robust polymer methods, which should enable large-scale, cost-effective manufacturing. It is protected by multiple US and international issued and pending patents.

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, CARB-X will spend up to $455 million from 2016-2021 to support innovative antibiotics, vaccines and rapid diagnostics 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

Amicrobe: Daniel Huang
Director of Operations
dhuang@amicrobe.com