SOURCE: iBio, Inc.

iBio, Inc.

December 10, 2014 08:31 ET

iBio Provides Updates on Its IBIO-CFB03 Fibrosis Drug Candidate and Other Activities for the 2014 Annual Shareholders Meeting

NEWARK, DE--(Marketwired - Dec 10, 2014) - iBio, Inc. (NYSE MKT: IBIO), a leader in biotechnology for developing and manufacturing plant-made pharmaceutical products, will provide shareholders and attendees at its Annual Meeting today with an update on current activities including progress in developing IBIO-CFB03 to address significant unmet medical need for the treatment of idiopathic pulmonary fibrosis (IPF), systemic sclerosis (SSc), and other fibrotic diseases.

In addition to reviewing IBIO-CFB03, senior management will provide the following information to shareholders at the meeting:

1. Opportunities for vaccine and antibody products using the iBioLaunch™ platform. The efficiency and flexibility of iBioLaunch™ technology and the company's issued patent portfolio have attracted increasing commercial and scientific interest in light of serious challenges such as the Ebola virus disease outbreak in West Africa.

In addition, the finding reported by the Centers for Disease Control that approximately half of the H3N2 influenza viruses analyzed during the early weeks of the current flu season are sequence drift variants, against which this year's vaccines are less efficacious, highlights the importance of the much greater speed with which iBiolaunch™ technology can produce large quantities of vaccine, enabling identity of active viral sequences to be largely known instead of guessed prior to initiation of production. Influenza vaccines are currently produced with time-consuming traditional methods that are poorly suited for rapid and practical manufacturing responses to new viral strains.

Management will discuss the previously disclosed and ongoing collaboration with Caliber Therapeutics LLC and Novici Biotech LLC to develop novel antibody products for oncology applications and to improve the expression yield of antibodies for application to disease pathogens such as influenza and Ebola virus.

2. Opportunities for iBio's subsidiary operations and business relationships in Brazil. The iBioLaunch™-based recombinant yellow fever vaccine continues development with collaborators in Brazil. Management will discuss previously announced product candidates under review for potential development for the Brazilian market.

3. Opportunities in Japan. iBio has extended business development activities into Japan in collaboration with Kanematsu Chemicals Corporation, and will discuss the company's general approach to developing opportunities in non-U.S. markets.

4. Programs involving government and NGO sponsorship. Phase 1 clinical trials of a malaria transmission-blocking vaccine and a hookworm vaccine are underway, both of which are non-commercial products fully funded by third parties. These and potential new programs provide valuable data on medically important applications of iBio's proprietary technology.

Overview of iBio's development of IBIO-CFB03. iBio has collaborated with Dr. Feghali-Bostwick, the inventor of IBIO-CFB03, at the Medical University of South Carolina (MUSC) during 2014 to develop this drug candidate for clinical trials. Dr. Feghali-Bostwick previously published data demonstrating that specific endostatin-derived peptides inhibit and reverse fibrosis in preclinical mouse models of fibrosis as well as in human skin. iBio obtained an exclusive, worldwide license to the patents and pending patents underlying these discoveries and inventions, and initiated an aggressive and now successful program to produce the active pharmaceutical ingredient, and potentially valuable derivatives, in plants using its iBioLaunch™ technology. Several lead formulations are under evaluation for clinical development, and work necessary to file an investigational new drug application (IND) with the FDA is being conducted, a process the company expects to complete by mid-2015.

iBio has determined that preclinical efficacy results and lack of significant toxicity in experiments conducted to date justify high priority advancement of the product into clinical trials. The serious unmet medical need potentially addressed by this breakthrough product justify investment in a Phase 1 clinical trial that will not only evaluate safety in healthy volunteers, but also seek evidence of efficacy on a preliminary basis in patient volunteers. In consultation with its clinical advisory board, iBio believes that such a strategy will not only accelerate overall clinical development of IBIO-CFB03, but also provide the basis for pursuing at least two clinical indications in parallel in subsequent clinical trials.

The development program will be assisted by a world-class clinical advisory board established by the company during 2014. The board includes Dr. Thomas A. Medsger, Jr., an internationally recognized expert on the epidemiology, clinical and laboratory features and natural history of systemic sclerosis and localized forms of scleroderma, Raynaud disease and polymyositis/dermatomyositis. Richard M. Silver, M.D., one of the world's leaders in clinical care and investigation of systemic sclerosis, Timothy Blackwell, M.D., an internationally recognized expert in IPF and other lung diseases, and Dr. J. Terrill Huggins, a leading clinical investigator in the field of IPF.

About Idiopathic Pulmonary Fibrosis and Systemic Sclerosis
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 worse survival rate than most cancers except for pancreatic cancer and certain lung cancers. Although both Esbriet® (pirfenidone) and Ofev® (nintedanib) were approved by the FDA for IPF in late 2014 on the basis of statistically significant reductions in the rate of disease progression observed in a portion of clinical trial participants, neither drug has been proven to extend life, neither drug reverses the course of disease, and neither drug is likely to provide sufficient benefit to improve ongoing patient quality of life. Nevertheless, according to GlobalData, the market across the U.S. and European Union for already-existing IPF therapy is expected to grow from $49 million in 2012 to more than $1.1 billion by 2017.

Systemic sclerosis 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 sclerosis 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. Organ fibrosis is responsible for health care costs exceeding $10 billion per year, and it is estimated that the number of deaths due to fibrosis is twice the number of deaths 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.

About iBio, Inc.
iBio is developing a proprietary product, IBIO-CFB03, for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis, and other fibrotic diseases using its iBioLaunch™ platform. The company also offers proprietary products and product licenses to others, based on its proprietary iBioLaunch™ and iBioModulator™ platforms, providing collaborators full support for turn-key implementation of its technology for protein therapeutics and vaccines. In Brazil, iBio has formed a subsidiary company, iBio do Brasil Biofarmacêutica Ltda., and has been collaborating with Oswaldo Cruz Foundation (Fiocruz) since 2011 to develop a recombinant yellow fever vaccine based upon iBio technology.

The iBioLaunch™ platform is a proprietary, transformative technology for development and production of biologics using transient gene expression in unmodified green plants. The iBioModulator platform is complementary to the iBioLaunch™ platform and designed to significantly improve vaccine products with both higher potency and greater duration of effect. Further information is available at: www.ibioinc.com.

FORWARD-LOOKING STATEMENTS
STATEMENTS INCLUDED IN THIS NEWS RELEASE RELATED TO IBIO, INC. MAY CONSTITUTE FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. SUCH STATEMENTS INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES SUCH AS COMPETITIVE FACTORS, TECHNOLOGICAL DEVELOPMENT, MARKET DEMAND, AND THE COMPANY'S ABILITY TO OBTAIN NEW CONTRACTS AND ACCURATELY ESTIMATE NET REVENUES DUE TO VARIABILITY IN SIZE, SCOPE AND DURATION OF PROJECTS. FURTHER INFORMATION ON POTENTIAL RISK FACTORS THAT COULD AFFECT THE COMPANY'S FINANCIAL RESULTS CAN BE FOUND IN THE COMPANY'S REPORTS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.