Novel project aims to combine immediate treatment with long-term immune protection

(BOSTON: August 26, 2025) – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has awarded PHIOGEN US$1.1M to evaluate PHI-BI-01, its novel, dual-action therapeutic designed to treat and prevent extraintestinal pathogenic Escherichia coli (ExPEC) bloodstream infections, particularly those caused by multidrug-resistant strains.

This next-generation phage-based project aims to reduce mortality and recurrence in patients suffering from life-threatening bacterial sepsis by combining immediate bacterial killing with long-term immune protection from subsequent infections.

PHI-BI-01 has the potential to represent a new class of phage therapy designed to do more than clear infections. This candidate product offers the long-term protection against reinfection by incorporating phages enhanced through directed evolution to overcome bacterial resistance and stimulate a protective immune response. Through its discovery platform, PHIOGEN applies evolutionary selection, high-throughput screening, and human-relevant immune models to develop phages with both potent antibacterial and immunogenic properties. In partnership with CARB-X, upcoming studies will explore the immune mechanisms behind this protection to optimize dosing, scheduling, and durability.

“Bacteriophages offer a unique opportunity to address infections caused by multidrug-resistant bacteria, particularly when conventional antibiotics fail,” said Erin Duffy, PhD, R&D Chief of CARB-X. “PHIOGEN offers a potential novel approach to the prevention of invasive disease caused by E. coli. We are excited to evaluate the immune harnessing potential of this project.”

Bacteremia, the presence of bacteria in the bloodstream, is a critical event, often occurring in hospitalized or immunocompromised patients. Bacteremia carries a high risk of sepsis, organ failure, and death. Infections caused by drug-resistant E. coli are becoming more frequent, often stemming from invasive ExPEC strains that originate in the gastrointestinal or urinary tract and spread systemically.

Current therapies to address sepsis rely on broad-spectrum antibiotics, which are increasingly ineffective and can compromise the patient’s microbiome and immune defenses. With its dual function approach, PHIOGEN proposes a new strategy in infectious disease therapy that relies on the use of bacteriophages to eliminate pathogenic ExPEC and at the same time activate a targeted immune response that helps prevent recurrence.

“Our team’s discovery redefines what phages can do, opening the door to a new class of live biologics capable of addressing both acute infection and recurrent disease,” said Amanda Burkardt, CEO of PHIOGEN.  “Partnering with CARB-X allows us to accelerate this innovation, generating the data needed to advance our dual-function phages toward the clinic and ultimately provide new options for patients with life-threatening infections where antibiotics fail.”

In March 2024, CARB-X launched a new funding solicitation to fill major R&D gaps in the global antibacterial development pipeline. More than 300 initial applications were accepted in four distinct product themes: therapeutics for infections caused by Gram-negative pathogens, novel approaches to the prevention of invasive disease caused by Staphylococcus aureus or Escherichia coli, diagnostics for neonatal sepsis, proof-of-concept for novel sample types for diagnosing lower-respiratory tract infections. Ten awards were announced from the first cycle of the 2024 funding round. Additional projects from the second cycle will be announced this year. CARB-X will begin accepting applications for the second cycle of the 2025 funding round from December 1 to December 12.  Register for the CARB-X newsletter to receive updates.

When CARB-X was founded in 2016, the early-stage antibiotic pipeline was stalled. Since its inception, CARB-X has supported 116 R&D projects in 14 countries, and CARB-X product developers have made significant progress: 22 projects have advanced into or completed clinical trials; 14 remain active in clinical development, including late-stage clinical trials; and 3 products have reached the market. Additionally, more than 10 product developers with active R&D projects have already secured advanced development partnerships to support their clinical development after leaving the CARB-X portfolio. All CARB-X-funded product developers are contractually obligated to develop a Stewardship and Access Plan for their product, outlining strategies to ensure responsible stewardship and appropriate access in low- and middle-income countries.

CARB-X is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Gates Foundation, Germany’s Federal Ministry of Research, Technology and Space (BMFTR), the Public Health Agency of Canada (PHAC), the Novo Nordisk Foundation, Italy’s Ministry of Economy and Finance (MEF), and Japan’s Ministry of Health. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this publication is solely the responsibility of the authors and does not necessarily represent the official views of any CARB-X funders.

CARB-X Contact: Marissa Novel, carbxpr@bu.edu

PHIOGEN Contact: Amanda Burkardt, amanda@phiogenpharma.com

About CARB-X

CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X funds only projects that target the most serious, resistant bacteria identified on global priority lists, syndromes with the greatest global morbidity and mortality, and performance characteristics necessary for patients. https://carb-x.org/ | X (formerly Twitter) @CARB_X

About PHIOGEN

PHIOGEN is a preclinical-stage biotechnology company pioneering a next-generation phage platform to treat and prevent drug-resistant and recurrent bacterial infections. A spin-out from Baylor College of Medicine, PHIOGEN operates from its dedicated lab at Helix Park within the Texas Medical Center, the world’s largest medical complex. The company’s proprietary platform integrates advanced screening, human-relevant models, and evolutionary selection to develop dual-function bacteriophages that both eliminate bacterial pathogens and stimulate protective immunity. PHIOGEN is advancing a pipeline of targeted phage therapies designed to redefine infectious disease treatment where conventional antibiotics fail. To learn more please visit www.phiogen-pharma.com

About BARDA and NIAID

The U.S. Department of Health and Human Services (HHS) 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. The Administration for Strategic Preparedness and Response (ASPR) leads the nation’s medical and public health preparedness for, response to and recovery from disaster and other public health emergencies. Within ASPR, the Biomedical Advanced Research and Development Authority (BARDA) invests in innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures needed to combat health security threats. BARDA is one of the leading public sector funders of advanced development of antimicrobial therapeutics and diagnostics worldwide, having invested more than $2.4 billion in antimicrobial products since 2010. This investment has supported the development of over 160 antimicrobial products and led to the U.S. Food and Drug Administration (FDA) approval of four new antibiotics and FDA 510(k) clearance of eight diagnostics.

As part of HHS, NIH is the primary U.S. 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

Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.

About the German Federal Ministry of Research, Technology, and Space and Research (BMFTR)

Research and technology are crucial foundations for our future. Thus, the promotion of science and research is a policy priority of the German Federal Government. The Federal Ministry of Research, Technology and Space (BMFTR) provides support for scientific re-search and innovation.

About the Global AMR Innovation Fund (GAMRIF)

The Global AMR Innovation Fund (GAMRIF) is a One Health aid fund that supports research and development around the world to reduce the threat of antimicrobial resistance (AMR) in humans, animals and the environment for the benefit of people in low- and middle-income countries (LMICs). GAMRIF core objectives are to develop innovative One Health solutions to tackle AMR; increase availability of context-specific, accessible, and affordable innovations for LMICs; establish international research partnerships with industry, academia, and governments; and collaborate with and leverage additional funding from other global donors.

About the Public Health Agency of Canada

The Public Health Agency of Canada (PHAC), established in 2004, is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention.  Its mission is to improve the health of all people and communities in Canada by addressing public health priorities through science, innovation, service delivery, and collaborative action. The Agency collaborates closely with all levels of government, non-government organizations, and international partners to build an effective public health system. PHAC has a strong history of addressing health threats, including collaboration on a One Health approach to antimicrobial resistance (AMR). As part of the recently launched Pan-Canadian Action Plan on AMR 2023-2027, PHAC is piloting an economic pull-incentive project to increase access to essential antimicrobial drugs not yet authorized in Canada to address priority unmet public health needs.

About the Novo Nordisk Foundation

Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society. www.novonordiskfonden.dk/en

Ministry of Economy and Finance of Italy

The Italian Ministry of Economy and Finance (MEF) performs the functions and tasks incumbent on the State in matters of economic and financial policy, budgeting, public investment planning and public debt management. The Ministry’s activities include coordinating and monitoring public spending and its trends, tax policies and the tax system and state assets. Moreover, the Ministry represents the Italian Government in the main European and international economic and financial fora, performs functions related to global governance and international financial cooperation, maintains relations with international economic, monetary, and financial institutions (such as the IMF, OECD, and Multilateral Development Banks), and negotiates and concludes international agreements and treaties with economic and financial content.

Japan’s Ministry of Health, Labour and Welfare (MHLW)

MHLW is a ministry of the Government of Japan whose missions are to improve and promote social welfare, social security, and public health in order to secure and improve the livelihoods of the people and contribute to economic development. Recognizing the urgent global public health threat posed by AMR, MHLW has been supporting various domestic and international efforts to advance research and development of antimicrobials. MHLW has committed to providing contributions to CARB-X from 2024 to 2026.

About Boston University

Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With nearly 37,000 students, it is one of the largest private residential universities in the United States. BU consists of 17 schools and colleges, along with the Faculty of Computing & Data Sciences and 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 leading research universities in the United States and Canada. For further information, please contact Kim Miragliuolo at kmira@bu.edu. www.bu.edu