iBio uses the FastPharming System to quickly produce biotherapeutic and vaccine candidates for unmet medical needs. In the area of human disease, IBIO-100 targets fibrosis, a leading world-wide cause of organ failure. IBIO-200 is a virus-like particle (VLP) vaccine designed as a rapid medical countermeasure solution to the COVID-19 outbreak.
Additionally, iBio has developed a candidate vaccine for Classical Swine Fever, an agricultural disease so severe that infected pig herds are destroyed to prevent spread. The IBIO-400 program has demonstrated complete protection in live-virus challenge studies while providing an ability to discriminate between infected and vaccinated animals (DIVA).
IBIO-100 is iBio's therapeutic candidate for the treatment of systemic scleroderma, pulmonary fibrosis, and other fibrotic diseases. It has been granted orphan-drug designation by the FDA for treatment of systemic sclerosis.
Based upon the work (Science translational medicine vol. 4,136 (2012): 136ra72. doi:10.1126/scitranslmed.3003421) by iBio's collaborator Dr. Carol Feghali-Bostwick, IBIO-100 is a fusion of the endostatin derived E4 antifibrotic peptide to the hinge and heavy chain of human IgG1.
This fusion protein is produced using iBio's proprietary FastPharming transient plant expression technology and has achieved significant reductions in fibrotic symptoms in both cellular and animal models.
Bleomycin induction of lung fibrosis in mice
as measured by both hydroxyproline content assay and Modified Ashcroft histopathology scoring
Reduction of skin thickening and collagen content in mice
produced by osmotic pump delivery bleomycin and subsequent pump delivery of IBIO-100
Reduction of hydroxyproline content of human lung tissue
obtained after transplant of diseased, terminal-stage organs. Tissue fragments exhibited significant reduction of fibrotic content when cultured in the presence of IBIO-100 after only 72 hours. This final result demonstrates IBIO-100 efficacy in highly diseased human tissue in addition to its efficacy in animal models.
IBIO-100’s unusual biophysical properties allow it to be effective using infusion and oral administration schemes in animal models, a novel aspect of a biotherapeutic protein of its type.
Further studies are being conducted to support an Investigational New Drug (IND) application and to provide methods for Good Manufacturing Practice (GMP) production in our Bryan, Texas facility.
SARS-CoV-2 is a strain of coronaviruses that was introduced to human populations from an animal source in the Chinese province of Hubei in late 2019. The spread of infection has since been driven by human-to-human transmission. Efficient medical countermeasures to block the progress of a disease, about which little is known, are central to global health. Vaccines represent one strategy and can now be aligned with a rapid production method, iBio’s FastPharming capability. iBio is developing two SARS-CoV-2 vaccine candidates using its proprietary FastPharming manufacturing system and vaccine design technologies for rapid production of recombinant proteins in its cGMP-compliant manufacturing facility.
Unlike traditional cell-culture bioprocesses that are performed in stainless-steel or single-use bioreactors, iBio’s FastPharming system uses plants as bioreactors, saving months in initial setup time and reducing the risks and delays associated with scale-up. During a pandemic, having the ability to rapidly scale and manufacture a vaccine with consistent properties from batch to batch is invaluable.
IBIO-200 is a virus-like particle (VLP) based vaccine for the COVID-19 disease caused by the SARS-CoV-2 strain of coronavirus. VLP based vaccines are known to interact with immune cells differently than soluble antigens and can trigger both humoral and cellular responses.
IBIO-200 has been designed to maximize uptake by antigen presenting cells in order to increase the overall immune response. A SARS-CoV-2 derived antigen is fused to a self-assembling protein partner to generate the VLP. The antigen is displayed in a repetitive structure and geometry, and the particle is decorated with oligomannose molecules to resemble the structure of a naturally occurring virus.
As evidenced in the electron micrographs shown here, the FastPharming Manufacturing System delivers a tightly controlled particle size. This offers many quality and scale-up advantages given that the uniform antigen display enables better dose definition and higher product yields. Overall, IBIO-200 is a promising vaccine candidate for the COVID-19 disease, given its designed immunostimulatory properties, quality, and fast scalability to tens of millions of doses.
IBIO-201 is a second SARS-CoV-2 vaccine candidate, based on a subunit platform that combines antigens derived from the SARS-CoV-2 spike protein fused with iBio’s patented lichenase booster molecule (“LicKM”), which is designed to enhance immune response. Subunit vaccines have a proven track-record in protecting humans against deadly diseases, however, one of the challenges is that they often require the use of an adjuvant to boost their immunogenicity. Additionally, they are often insufficiently stable to be formulated into a vaccine.
iBio has addressed both of these issues with the use of LicKM, a modified thermostable variant of the lichenase protein from Clostridium thermocellum. LicKM fusion proteins can strengthen the initial immune response to the antigen (as measured by antibody titer) and extend the duration of the immune response, thus lowering vaccine antigen dose requirements or enabling fewer doses to establish prolonged immunity. As a result, antigens fused to LicKM generally demonstrate stronger immune responses and promote long-lasting immunity. Fusing the SARS-CoV-2 spike protein antigens with iBio’s LicKM technology may be advantageous in achieving prolonged immune response against COVID-19, while enabling unmatched scalability for a population-wide immunization program through FastPharming capabilities.
Classical Swine Fever Vaccine
Classical swine fever (CSF) is a contagious, often fatal, disease affecting both feral and domesticated pigs. Outbreaks in Europe, Asia, Africa and South America have not only adversely impacted animal health and food security but have also had severe socio-economic impacts on both the pig industry worldwide and small scale pig farming.
In collaboration with the Institute of Infectious Animal Diseases (IIAD) at Texas A&M University and Kansas State University, iBio used the FastPharming system to develop a safe and effective DIVA-capable subunit vaccine. (Plant Biotechnol J. 2019 Feb;17(2):410-420. dol: 10.1111/pbi.12986)
Formulated in novel oil-in-water emulsion adjuvants, IBIO-400 studies have shown that after single-dose vaccination, the adjuvanted, plant-made CSF E2 subunit vaccine provides complete protection in challenged pigs and is accompanied by strong virus neutralization antibody responses.
Producing a subunit vaccine in plants saves time and money
Studies showed protection after a single dose
All vaccinated animals were protected from CSF clinical signs
Provided through the absence of Ems response
Potential for use in bait for feral hogs (natural virus reservoirs) without substantial purification, unlike live attenuated vaccines
Possible rapid adaptation to regional strain variations and emerging novel subgenotypes