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CARB-X is funding Phico Therapeutics to develop an engineered bacteriophage drug to treat ventilator-associated pneumonia caused by drug-resistant Pseudomonas aeruginosa

CARB-X is funding Phico Therapeutics to develop an engineered bacteriophage drug to treat ventilator-associated pneumonia caused by drug-resistant Pseudomonas aeruginosa

Breakthrough technology combines engineered bacterial viruses and antibacterial protein to inactivate bacterial DNA

(BOSTON) – CARB-X is funding Phico Therapeutics, in Cambridge, UK, to develop a new intravenous engineered bacteriophage drug to treat ventilator-associated pneumonia caused by Pseudomonas aeruginosa, a serious problem in hospitals, intensive-care units and health-care settings. P. aeruginosa is one of the top three antibiotic-resistant bacteria listed by the World Health Organization (WHO) as ‘priority pathogens’ posing the greatest threat to human health.

The CARB-X award provides up to $5.3 million to support preclinical development of Phico’s SASPject PT3.9 project, plus up to $12.86 million more if the project progresses successfully through safety to Phase 1 first-in-human clinical studies, subject to available funding.

Phico’s SASPject technology is ground-breaking in that it uses engineered bacterial viruses (bacteriophages) combined with antibacterial small acid-soluble spore proteins (SASPs) to precisely target the P. aeruginosa bacteria and inactivate the bacteria’s DNA, stopping them from reproducing and spreading. Additionally, SASPs are unaffected by the sequence of bacterial DNA, making it unlikely that bacteria could develop resistance, and are therefore effective against multidrug-resistant bacteria.

“Phico’s innovative approach delivers the antibiotic effect of SASPs by using engineered bacteriophages to precisely target P. aeruginosa infections,” said Erin Duffy, R&D Chief of CARB-X, a global non-profit partnership led by Boston University and dedicated to funding and supporting the development of innovative products to address antibiotic-resistant bacterial infections. “This approach has the potential to target the bacteria without damaging other cells or contributing to the rise of resistance. If successful, this new intravenous drug could transform the way patients with ventilator-associated pneumonia are treated in hospitals, and save lives.”

Patients on ventilators in hospitals and intensive-care units settings often develop pneumonia, which can be life-threatening particularly among intensive-care patients. The US Centers for Disease Control and Prevention (CDC) estimates that in 2017, multidrug-resistant P. aeruginosa caused 32,600 infections in US hospitals, and 2,700 patients died as a result. P. aeruginosa is also a significant problem in low- and middle-income countries (LMICs); Phico aims to produce a therapy that is accessible to resource-poor settings.

Dr. Heather Fairhead, Phico Founder and CEO, said: “To receive funding from CARB-X is important validation for our SASPject technology platform and its potential in fighting bacterial resistance. It has been awarded at the end of a due diligence process which reinforces the credibility of the company and our team – I am delighted to now look forward to progressing our lead product to clinical trials and developing a product pipeline that will advance the science of antibacterial therapy and in time, save millions of lives round the world.”

Click here to see a video on Phico’s innovative approach 

Supporting global innovation to address antibiotic resistance

CARB-X is investing up to $480 million in non-dilutive funding between 2016-2022 to support the early development of new therapeutics, preventatives and rapid diagnostics.

The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 55 active projects focused exclusively on drug-resistant bacteria. The goal is to support products through the early phases of development so that they will attract additional private or public support for further clinical development and regulatory approval for use in patients.  Since its launch in 2016, CARB-X has announced 84 awards worth more than $318 million in 11 countries, with the potential of additional funds if project milestones are met, subject to available funding.

A non-profit partnership, CARB-X receives its funding from the US Biomedical Advanced Research and Development Authority (BARDA), the Wellcome Trust, the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF), Germany’s Federal Ministry of Education and Research (BMBF), and the Bill & Melinda Gates Foundation. The funding contributions from GAMRIF are earmarked by CARB-X to fund projects that focus on specific antibacterial priorities, and the Phico project is one such project. GAMRIF funding allocated to CARB-X is focused on innovative research and development in the field of AMR, specifically in neglected and underinvested areas for low- and middle-income countries (LMICs), where the burden of AMR is greatest.

Each year, an estimated 700,000 people die each year from antibiotic-resistant infections, including 35,000 in the US and 33,000 in Europe. CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.

CARB-X funding for this project is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from the Wellcome Trust, Germany’s Federal Ministry of Education and Research (BMBF), and the UK Global AMR Innovation Fund (GAMRIF). 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, or other CARB-X funders.

Contacts:

CARB-X
Jennifer Robinson
+1 514 914 8974
carbxpr@bu.edu

Phico Therapeutics
Sarah Jeffery
Zyme Communications
+44 (0)7771 730919
sarah.jeffery@zymecommunications.com

About CARB-X
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services, the Wellcome Trust, a global charity based in the UK working to improve health globally, Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).  CARB-X is investing up to $480 million from 2016-2022 to support innovative antibiotics and other therapeutics, vaccines, and rapid diagnostics. CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X is headquartered at Boston University School of Law. carb-x.org/.  Follow us on Twitter @CARB_X. 

About Phico Therapeutics 
Phico Therapeutics (Phico) is a biotechnology company developing engineered phage technology as the basis of a new generation of antibiotics to overcome antibacterial resistance, particularly those caused by multi-drug resistant bacteria.

Phico’s SASPject™ platform technology utilises engineered bacterial viruses, or phages, to deliver a gene encoding a unique antibacterial small acid-soluble spore protein (SASP) that inactivates bacterial DNA. This stops the bacteria from metabolising or reproducing, whilst the SASP remains unaffected by the sequence of the bacterial DNA, including mutations, making resistance unlikely to develop. SASPject can target any chosen bacteria including those that are treatment resistant.

Founded in Cambridge, UK, by Dr Heather Fairhead, Phico is building an innovative intravenous antibacterials pipeline focused on serious infections with few existing treatment options and targeting key superbug threats including a Pseudomonas aeruginosa, Klebsiella pneumoniae and Escherichia coli. The company has previously received backing from independent investors, the Wellcome Trust and UK Government grants, and has a clear path to take lead intravenous product, P. aeruginosa targeted, SASPject PT3.9 through a study in patients. www.phicotx.co.uk/ 

About SASPject™
SASPject™ is a pan-spectrum antibacterial  technology that can target selected bacterial species  by using  engineered bacteriophages. SASPject™ works by injecting a gene that encodes small acid-soluble spore proteins, or SASPs, directly into the targeted bacteria. The injected gene then produces SASPs, which bind to bacterial DNA and inactivate it. SASPs “turn off” DNA so the targeted bacterial cell cannot metabolise or reproduce. The immune system can then remove the bacteria from the body. SASPs bind to all bacterial DNA, irrespective of the sequence of that DNA. Spontaneous mutations in DNA, or the import of new DNA that gives new characteristics to the bacterial cell, are key ways in which bacteria develop resistance to antibiotics. Neither of these strategies affects the ability of SASP to bind to and inactivate bacterial DNA.

About BARDA and NIAID
The US Department of Health and Human Services works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. Within HHS, ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases. NIH is the primary US 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.

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 BMBF
Education and research are the foundations for our future. The promotion of education, science and research by the German Federal Ministry of Education and Research (BMBF) represents an important contribution to securing Germany’s prosperity. Education and research are a Federal Government policy priority, which is reflected in the development of the funding it is making available to these fields. 

About the Global AMR Innovation Fund (GAMRIF)
The Department for Health and Social Care (DHSC) is the UK Government department which is responsible for helping people to live more independent, healthier lives for longer.

This research is co-funded by DHSC’s Global AMR Innovation Fund (GAMRIF). GAMRIF was established to provide seed funding for innovative research and development, specifically in neglected and underinvested areas, in the field of antimicrobial resistance (AMR). GAMRIF is a c.£50m UK aid investment, which means all projects funded must support research primarily and directly for the benefit of people in low- and middle-income countries (LMICs). The Fund takes a ‘One Health’ approach, seeking to invest in potential solutions to reduce the threat of AMR in humans, animals, fish and the environment. The Fund seeks to leverage additional global funding through interaction with international government bodies, public-private partnerships, product development partnerships, global funding mechanisms and global fora.

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 contact Jeremy Thompson at jeremy22@bu.edu. www.bu.edu.