Treating Fibrotic Diseases with IBIO-CFB03

iBio’s proprietary therapeutic product, IBIO-CFB03, is intended to treat systemic scleroderma, idiopathic pulmonary fibrosis (IPF), and other fibrotic diseases.

iBio has produced the active pharmaceutical ingredient using its patented iBio Technology and has made the clinical development of this promising product a key priority.

Collaborating with Dr. Carol Feghali-Bostwick at the Medical University of South Carolina

Data published in 2012 by Dr. Feghali-Bostwick demonstrates that specific endostatin-derived peptides are useful for both in inhibition and reversal of fibrosis in preclinical mouse models of fibrosis as well as in human skin.

Organ fibrosis is responsible for health care costs exceeding $10 billion per year, and the number of deaths due to fibrosis is estimated to be double those due to cancer. Organ fibrosis is responsible for nearly half of deaths in developed countries and results in significant physical, emotional, and financial burdens as well.

Systemic scleroderma is a disorder that affects connective tissue of skin and internal organs as well as the walls of blood vessels. Early diagnosis and individualized therapy can be helpful, but treatment of systemic scleroderma is limited to symptom management. No currently approved drug has been proven to arrest the underlying process or processes that drive progression of the disease.

Idiopathic pulmonary fibrosis, or IPF, is a life-shortening lung disease with a rapidly progressing negative impact on quality of life leading to death within an average of three to five years after diagnosis.

IPF has a lower survival rate than most cancers except for pancreatic cancer and certain lung cancers.

iBio Technology benefit: Monoclonal antibodies

Monoclonal antibodies are usually manufactured in engineered mouse or hamster cells, but they can be manufactured at a significantly lower cost in whole plants using the iBio Technology.

Production of monoclonal antibodies in plants results in high yields of biologically active antibody without contaminating animal cell products. In addition to antibody therapies for chronic disease, monoclonal antibodies have been developed to treat infectious diseases.

The iBio Technology expression platform has produced a monoclonal antibody that protects against respiratory anthrax in a non-human primate model, as well as an anti-influenza neuraminidase monoclonal antibody that is active against Tamiflu™-resistant virus strains.

iBio Technology benefit: Replacement proteins from human blood

Many proteins have been purified from human blood or plasma to compensate for genetic defects in individuals who cannot make these proteins for themselves. As was seen in the case of hemophilia, patients receiving replacement proteins purified from blood or plasma run the risk of infection from viruses or other pathogens found in blood. Because of this risk, clotting factors for hemophiliacs are now supplied as recombinant proteins manufactured from engineered animal cells; however, there are still several genetic diseases for which the current source of replacement protein therapy continues to use human blood or plasma as the starting material.

Production of these replacement proteins using the iBio Technology would remove this risk of disease transmission, since the technology uses no animal cells or animal products, and there is no risk of transmission of viruses to patients from plant material.

iBio Technology benefit: Enzyme replacement therapy

The iBio Technology plant expression system can dramatically lower the cost of important recombinant proteins used in enzyme replacement therapy for certain genetic disorders, putting these life-saving treatments in easier reach of patients. In addition, supply disruptions resulting from problems with complex cell-based manufacturing methods, such as the recent shortages of some replacement therapies caused by viral contamination of the recombinant protein manufacturing process, would be obviated by the adoption of iBio’s plant expression technology.

Human viral pathogens cannot replicate in plant cells, and no human or animal components are used in the iBio Technology process, providing an additional product safety and production reliability margin.