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CARB-X is funding Cellics Therapeutics to develop a novel macrophage nanosponge to prevent and treat sepsis

CARB-X is funding Cellics Therapeutics to develop a novel macrophage nanosponge to prevent and treat sepsis

Cellics’ innovative nanosponge technology is designed to trap and neutralize toxins and cytokines that underlie sepsis

(BOSTON) – CARB-X announced today that it is awarding up to US$3.94 million to Cellics Therapeutics, based in San Diego, CA, USA, to develop a new treatment for sepsis caused by drug-resistant Gram-positive and Gram-negative bacteria. Cellics will be eligible for an additional $11.05 million for a total up to $15 million in non-dilutive funding from CARB-X if project milestones are met, subject to available funds.

Cellics’ innovative nanosponge project uses the natural receptors on human macrophage membranes – a type of white blood cell in the immune system – to soak up and neutralize bacterial toxins and inflammatory cytokines that can cause sepsis. The project, CTI-111, is designed as an adjunct in combination with antibiotics and other medicines.

“Sepsis is a leading cause of death around the world that is made worse by the lack of effective preventatives and treatments for drug-resistant bacterial infections. Effective treatments are urgently needed,” said Erin Duffy, CARB-X R&D Chief. “CARB-X funds and supports early development of innovative antibiotics and other treatments that target the most dangerous drug-resistant bacteria. Cellics’ nanosponge product, if successful, could potentially transform the treatment of sepsis and save lives.”

Each year, at least 1.7 million adults in America develop sepsis, according to the Centers for Disease Prevention and Control (CDC). Nearly 270,000 Americans die as a result of sepsis. Globally, the precise epidemiological burden of sepsis is difficult to ascertain. Some scientific reports estimate that sepsis affects more than 30 million people worldwide every year, potentially leading to 6 million deaths.

“Cellics is dedicated to the development of biomimetic nanomedicines to treat life threatening diseases. Our macrophage nanosponge technology leverages the natural receptors on human macrophage membranes to neutralize bacterial pore-forming toxins, endotoxins, and inflammatory cytokines that underlie sepsis,” said Steve Chen, MD, President and Chief Medical Officer, at Cellics. “CARB-X funding represents a validation of the novel Cellular Nanosponge platform. We look forward to working with CARB-X as we continue to advance this technology.”

Nanosponges stop the cascade that leads to sepsis by trapping endotoxins and pro-inflammatory cytokines onto their macrophage cell membranes, neutralizing them. The nanosponges are injected in such large quantities that they vastly outnumber the organism’s own macrophages, ensuring that sepsis and a cytokine storm can be avoided. Since the nanosponges are covered in actual macrophage cell membranes, they can pass as the body’s own immune cells and circulate in the bloodstream without being seen as foreign and removed.

The CARB-X funds will support the development of an appropriate animal model for bacterial sepsis to carefully assess the therapeutic potential of the nanosponges. Researchers also aim to identify the appropriate cell line to be used for manufacturing the nanosponges. The ultimate goal is to advance Cellics’ manufacturing capabilities and scale up production of the nanosponges.

Sepsis-fighting nanosponges are one example of the cell membrane cloaking technology pioneered by UC San Diego nanoengineering Professor Liangfang Zhang. His group develops new nanomedicine therapies by disguising nanoparticles as the body’s own cells. Previous examples include red blood cell nanosponges to combat and prevent MRSA infections;  nanoparticles cloaked in platelet cell membranes to repair wounded blood vessels; and cancer cell membrane-cloaked nanoparticles to elicit multi-antigenic antitumor immunity for cancer immunotherapy.

Sepsis a major killer around the world

Sepsis is the body’s extreme response to an infection. Sepsis happens when an infection you already have —in your skin, lungs, urinary tract, or somewhere else—triggers a chain reaction and inflammation throughout your body. Without timely treatment, sepsis can rapidly lead to tissue damage, organ failure, and death.

Anyone can get an infection, and almost any infection can lead to sepsis. People with chronic conditions such as diabetes, lung disease, cancer, and kidney disease, are at higher risk of developing infections that can lead to sepsis. The most frequently identified bacteria that cause infections that can develop into sepsis include Staphylococcus aureus, Escherichia coli, and some types of Streptococcus.

Effective diagnostics and treatments for sepsis are urgently needed. In addition to lives lost, sepsis incurs staggering costs. US health-care studies show that country spends nearly $24 billion each year to treat sepsis.

Supporting global antibacterial innovation

The World Health Organization (WHO) estimates that 700,000 people die each year from drug-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 Centers for Disease Control and Prevention (CDC)’s 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.

The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 45 active projects focused exclusively on drug-resistant bacteria. CARB-X is investing up to $480 million in non-dilutive funding between 2016-2022 to support the early development of new antibiotics, vaccines, rapid diagnostics and other life-saving products. 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 regulatory approval for use in patients.

Since its launch in 2016, CARB-X has announced 71 awards worth $256.64 million, with the potential of additional funds if project milestones are met. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and others fail for a variety of reasons.

This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by award from Wellcome Trust and Germany’s Federal Ministry of Education and Research (BMBF). 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

Cellics Therapeutics:
Steve Chen, MD
President and Chief Medical Officer
+1.858.412.6148
schen@cellics.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 Cellics Therapeutics
Cellics Therapeutics, Inc. is a privately held development stage biopharmaceutical company founded in 2014 by UC San Diego professor Liangfang Zhang based on his award-winning Cellular Nanosponge Platform Technology. Cellics was created with the goal of applying this platform technology to treat and prevent diseases. The mission of Cellics is to employ innovative biomimetic nanomedicines to address serious diseases with a high unmet medical need. The Company’s initial primary focus at this time is on autoimmune and inflammatory diseases and difficult-to-treat infectious diseases. Cellics also aims to develop best-in-class vaccines for various diseases. The Company is currently on schedule to advance its lead product candidate CTI-005 to human clinical trials for the treatment of MRSA pneumonia. Visit the company at cellics.com. 

About Cellular Nanosponge Platform Technology
Cellics’ proprietary platform technology strips cell membranes of their intracellular contents and creates cellular nanosponges from these membranes to be leveraged as a therapeutic product. These nanosponges are designed to counteract diverse disease pathologies by acting as biomimetic decoys to sequester and neutralize biological molecules that would otherwise attack host cells. Examples of such harmful agents include toxins, inflammatory cytokines and viruses. The cell membrane forming the outer layer of the nanosponges is selected based on the disease pathology – specifically, which host cells are under attack. Cellular nanosponges leverage the natural bioactivity of human cell membrane receptors for therapeutic efficacy. Featuring small size and large quantity, the nanosponges outcompete host cells to bind and sequester biological molecules.

Product development currently emphasizes using nanosponges made of human red blood cell membranes and white blood cell membranes for the treatment of bacterial infections and inflammatory diseases. A similar working principle can be applied with membranes of other cell types, making cellular nanosponges suitable for large and diverse disease areas. We have achieved proof of concept in a range of disease areas such as MRSA, sepsis, COVID-19, and cytokine storm.

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 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 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.