iBio, Inc. Provides Corporate Update at Annual Shareholders Meeting
NEW YORK, NY -- (Marketwired) -- 05/04/17 -- iBio, Inc. (NYSE MKT: IBIO), a leader in developing plant-based biopharmaceuticals, announced today that it provided a corporate update at its Annual Shareholders Meeting held in Bryan, TX.
Robert B. Kay, iBio's Chairman and CEO, stated, "Our achievements over the past year have transformed iBio's business. In this period, we completed the acquisition, recommissioning and expansion of our Texas plant and equipment for development and cGMP biopharmaceutical manufacturing. This enables advancement of our lead proprietary therapeutic candidate for fibrotic diseases toward human clinical trials. It also enables us to operate the facility as a contract development and manufacturing organization (CDMO), constituting a separate line of revenues for the Company. The CDMO is capable of using our proprietary technology to move projects from feasibility confirmation, through development, clinical trial support, and full-scale manufacture, for our collaborators and biotech clients."
Development and Manufacturing Operations
Barry Holtz, PhD, President of iBio CMO LLC, reviewed the Company's recommissioning and expansion of its pilot and large-scale manufacturing facility.
Dr. Holtz reported, "We are now capable of operating under cGMP compliance and moving biopharmaceutical product candidates toward full-scale engineering batches to support clinical development activities. We completed construction of a new product/process development laboratory that tripled our capacity to provide proteins to current and potential clients who engage iBio CMO in early stage feasibility studies."
iBio's pilot scale plant production capacity has been doubled. All large-scale automated systems have been commissioned or recommissioned, and new staff members have been added to fill out the CDMO team. Multiple new proteins are under development for several clients.
IBIO-CFB03 Fibrosis Therapeutic Product Candidate
Terry Ryan, PhD, iBio's Chief Scientific Officer, outlined the progress made during the year on IBIO-CFB03, the Company's lead proprietary therapeutic candidate for fibrotic diseases.
Dr. Ryan remarked, "We are working steadily towards filing an IND for IBIO-CFB03, and are encouraged by our progress. During this year, we obtained Orphan Drug Designation from the FDA. We also achieved key development milestones with regard to the Company's lead candidate CFB03, including:
- development of an improved cGMP manufacturing process allowing iBio to move forward on completing the CMC (Chemistry, Manufacturing, and Controls) section for its upcoming Investigational New Drug (IND) application to the FDA;
- completion of initial preclinical pharmacokinetic and toxicology studies; and
- expansion of preclinical research beyond previously announced systemic scleroderma and pulmonary fibrosis models to include liver, kidney, corneal, and cardiac fibrosis as potential additional clinical indications."
Robert Erwin, iBio's President, discussed recent business strategy developments and provided the following update on client commitments for use of the Company's technology and CDMO services:
Collaboration with Bio-Manguinhos/Fiocruz
Bio-Manguinhos, the unit of the Oswaldo Cruz Foundation (Fiocruz) in Brazil responsible for the development and production of vaccines, reagents and biopharmaceuticals suitable to meet the demands of public health and linked to the Health Ministry of Brazil, is extending and broadening its commitment to work with iBio. iBio and Bio-Manguinhos/Fiocruz have agreed in principle to enter into a collaborative relationship for the mutual development of certain products and facilities utilizing iBio and Bio-Manguinhos/Fiocruz intellectual property and services, and are working together to develop formal agreements to govern their relationship. The first such agreement is planned to be a Master Services Agreement to provide a general infrastructure for the overall relationship between iBio and Bio-Manguinhos/Fiocruz. The separate product and facilities projects will be described in detailed addenda to be attached to and governed by the Master Services Agreement.
The first project is expected to address development of a new Yellow Fever Vaccine based upon iBio's recombinant, plant-based technologies. A prior agreement governing early-stage, pre-clinical work expired in March 2017. Bio-Manguinhos/Fiocruz and iBio intend to collaborate on further development of the antigen, production of vaccine material for clinical trials, supervision of execution of Phase I clinical trials in the United States and further activities based upon the results of such trials.
The need for a new Yellow Fever vaccine is accentuated by the current outbreak of Yellow Fever that has killed at least 240 people in Brazil in recent months, according to the Brazilian Health Ministry. The disease has already spread to Brazil's most populous states: Minas Gerais, Rio de Janeiro, and Sao Paulo, and U.S. infectious disease specialists have expressed concern that the virus might "jump the Panama Canal" and also reach Puerto Rico and the continental United States. Meanwhile, the CDC warned of a shortage of the current Yellow Fever vaccine in the United States because of recent manufacturing problems.
Other joint project plans include the development of a bio-better monoclonal antibody product aimed principally for the Brazilian market, and the design and implementation of a Brazil-based manufacturing facility owned by Bio-Manguinhos/Fiocruz, in both cases utilizing iBio intellectual property in addition to Bio-Manguinhos/Fiocruz intellectual property. The planned activities can become legally binding on iBio and Bio-Manguinhos/Fiocruz only after detailed definitive agreements have been executed by the parties.
Collaboration with AzarGen Biotechnologies
AzarGen Biotechnologies (Pty) Ltd, has expanded its collaboration with iBio under a newly agreed Memorandum of Understanding. Based in South Africa, AzarGen is a biotechnology company focused on developing human therapeutic proteins using advanced genetic engineering and synthetic biology techniques in plants. iBio and AzarGen will continue development of AzarGen's surfactant protein therapeutic and initiate development of a "bio-better" version of a therapeutic monoclonal antibody therapeutic product for the South African market.
Mr. Erwin noted, "Projects are underway for several additional clients based on iBio's ability to rapidly achieve early production of multiple product variants and save time on the execution of preclinical product down-selection processes. These clients and their product candidates are currently confidential, but include several antibody candidates and growth factor proteins. We expect current work on some or all of these product candidates to lead to expanded opportunities for both commercial license agreements and significantly higher service-based revenue."
About iBio, Inc.
iBio, a leader in developing plant-based biopharmaceuticals, provides a range of product and process development, analytical, and manufacturing services at the large-scale development and manufacturing facility of its subsidiary iBio CMO LLC in Bryan, Texas. The facility houses laboratory and pilot-scale operations, as well as large-scale automated hydroponic systems capable of growing over four million plants as "in process inventory" and delivering over 300 kilograms of therapeutic protein pharmaceutical active ingredient per year. Facility capacity can be doubled by adding additional plant growth equipment in a space already reserved for that purpose.
iBio applies its technology for the benefit of its clients and the advancement of its own product interests. The Company's pipeline is comprised of proprietary candidates for the treatment of a range of fibrotic diseases including idiopathic pulmonary fibrosis, systemic sclerosis, and scleroderma. IBIO-CFB03, based on the Company's proprietary gene expression technology, is the Company's lead therapeutic candidate being advanced for IND development.
Further information is available at: www.ibioinc.com
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.
Source: iBio, Inc.
Released May 4, 2017