iBio (NYSE American:IBIO) has developed an industry-leading plant-based gene-expression technology to rapidly produce high levels of proteins used for making biologics at its contract development and manufacturing organization (CDMO) plant at College Station, Tex.
“Our CDMO business has extensive monoclonal antibody experience that can take a product candidate from lab to launch,” Robert Kay, executive chairman and CEO, says in an interview with BioTuesdays.
“We can take a product from the earliest stages — feasibility and pilot development — through preclinical and clinical support, and all the way to full-scale manufacturing, without going outside our CDMO, eliminating delays, uncertainties and expenses for transfer of technology and other matters commonly required at other CDMOs” he adds.
In addition, iBio can leverage its CDMO business into a “financial interest in the products being developed by collaborators that utilize iBio’s technology platform,” he points out. “This may include revenue, profit sharing, an equity stake and royalties under license agreements.”
iBio’s 139,000-square-foot plant was largely funded by DARPA (the U.S. government’s Defense Advanced Research Projects Agency) in 2011 at a cost of $68-million, to be a rapid manufacturer of therapeutics and vaccines in the event of a bioterrorism attack or pandemic outbreak. “We modified the facility and it can now handle parallel development of multiple products,” he says.
Mr. Kay explains that iBio’s technology platform makes plant-based biopharmaceuticals through a four-step process:
The DNA sequence of the target protein (that will comprise the intended active pharmaceutical ingredient of the drug candidate) is used to produce a DNA molecule called a vector.
The vector, implanted in an agrobacteria, is infiltrated into a Nicotiana plant, which has reached a height of six-to-eight inches in a few weeks.
When the agrobacteria, including the vector, infiltrates the nucleus of plant cells, it highjacks the plant metabolism, causing the plant to rapidly produce target proteins.
And after four-to-seven days, the target proteins are extracted from the plant and purified to pharmaceutical standards.
“This is dramatically different from mammalian cell approaches,” he says, noting that iBio CDMO can reduce time at each stage of development, compared with mammalian cell systems, leading to a potentially speedier product launch.
“We have the capability to conduct early product candidate screening faster, more economically and more broadly than mammalian cell cultures, which gives the candidate a greater likelihood of success,” he adds. “Because each plant operates as a mini-bioreactor, we can scale up simply by growing and transfecting more plants to reach larger scale production rather than suffer the torturous process of growing cell lines and investing in more or larger stainless steel bioreactors.”
Mr. Kay says the total time to a GMP run at iBio CDMO is about 12 months, which is some six months faster than a mammalian cell platform. “The ingenuity of the iBio process provides iBio with higher margins than the mammalian cell approach, without increasing the price to the client,” he adds. “We can have multiple revenue sources at various stages of development, from early lead screening to selection and optimization, to manufacturing product for clinical trials for multiple products in a single year.”
Reduced time at each stage of development speeds product launch
He says iBio does not plan to use its CDMO plant for extended manufacturing to support a single product. “We have the capability to help a client design and build a captive manufacturing plant for a successful product to which we would provide technology transfer services and, if desired, manufacturing services.”
Mr. Kay says, “iBio’s IP is protected by issued patents in various countries and 14 years of know-how and trade secrets, which allows us to service the needs of clients in any plant-based drug production system.”
iBio’s technology has been validated in early-stage studies that were financed by DARPA for an H1N1 influenza vaccine; by the Bill and Melinda Gates Foundation for H5N1 influenza and malaria vaccines; by the Sabin Vaccine Institute for a hookworm vaccine; by the NIH for an anthrax vaccine; and by an agency of Brazil’s Ministry of Health for a yellow fever vaccine.
According to Mr. Kay, at iBio’s request, an affiliate of Kenneth Dart’s Eastern Capital fund was invited to acquire the Texas CDMO facility, with iBio and Eastern Capital forming iBio CDMO LLC. It is 70% owned by iBio and 30% by Eastern Capital, which also has a substantial stake in iBio.
According to industry forecasts, the market for biopharmaceutical outsourced development spending is expected to hit $31-billion by 2019, up from $26-billion in 2016. The market for small- and mid-sized biopharmaceutical company outsourced development is expected to keep pace, reaching an estimated $11-billion in 2019, compared with $8-billion in 2016.
iBio has 124,000 square feet of manufacturing space at its CDMO plant, with a current operating capacity of 2.2 million plants that can generate 150 kg of therapeutic API protein a year. “If all of the capacity were used for production of monoclonal antibodies, the annual commercial manufacturing revenue would be in the range of $120-million to $150-million,” Mr. Kay suggests.
However, the facility was designed to enable expansion of the CDMO in two stages, beginning with increasing its pilot space to essentially double its annual capacity to perform feasibility studies – a six-month project that would cost about $2.9-million, which “we would more than recover in a single year,” he adds.
The second stage of a future expansion, costing about $22-million, would double capacity to 4.4 million plants that would produce 300 kg of API a year. “By doubling the current plant, we could generate annual revenue in the range of $240-million to $300-million,” Mr. Kay suggests.
“If we are successful in continuing to build our pipeline, we are one-to-two years away from exhausting current capacity,” Mr. Kay says.
In its proprietary product segment, Mr. Kay says the company temporarily slowed development of its lead drug candidate, IBIO-CFB03, as it focused on restructuring the business model of the CDMO segment.
IBIO-CFB03 is in development for the treatment of systemic sclerosis, idiopathic pulmonary fibrosis (IPF), and localized scleroderma, and has received orphan drug designation from the FDA. The prevalence of systemic sclerosis is between 123,000 and 245,000 people in the U.S. and EU.
Preclinical data indicate IBIO-CFB03’s potential use for both inhibition and reversal of fibrosis, which would make it a “hugely valuable drug, if successful,” he says.
Mr. Kay points to Roche’s 2014 $8.3-billion acquisition of InterMune in 2014, the developer of the IPF drug Esbriet, and Roche’s subsequent launch of the drug, which ultimately failed to have a meaningful impact on reversing fibrotic disease or increasing overall survival.
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