NEWARK, Del., March 13, 2013 /PRNewswire/ -- iBio, Inc. (NYSE MKT: IBIO) today announced notification from the U.S. Patent and Trademark Office that a new patent in the Company's iBioModulator™ portfolio will issue on March 26, 2013. The new patent, number 8,404,252 entitled "Yersinia pestis Antigens, Vaccine Compositions and Related Methods," includes claims covering plague antigens fused to the Company's thermostable immunomodulator -- iBioModulator ™-- protein, as well as vaccine compositions and a method for producing a protective immune response to the antigen. The invention was developed by scientists at the Fraunhofer USA Center for Molecular Biotechnology (FhCMB), iBio's research collaborator and is owned by iBio.
Plague is considered a potential bioterrorism weapon. There is no plague vaccine currently approved for use in the U.S. Although killed whole-cell plague vaccines have been reported to protect against bubonic plague in animal models, such vaccines were not effective against pneumonic plague. By contrast, data previously published in the peer-reviewed scientific journal, Vaccine, demonstrated that a recombinant plague vaccine incorporating the iBioModulator protein, and produced via the iBioLaunch™ platform in green plants, provided full protection of non-human primates against aerosolized Y. pestis (pneumonic plague).
An immunomodulator is a substance that alters the immune response. The iBioModulator platform has been shown in animal models to significantly modify the immune response to a vaccine in two important ways. It increased the strength of the initial immune response to a vaccine antigen (as measured by antibody titer). It also extended the duration of the immune response. These results demonstrate that the use of the iBioModulator platform may lower vaccine antigen requirements and enable fewer doses to establish prolonged immunity. The ability to improve immune response and provide longer-term protection without the necessity of booster inoculations would add significant value to a vaccine by reducing the overall costs and logistical difficulties of its use while effectively reaching a higher proportion of the target population.
Among the positive tests completed to demonstrate the ability of the iBioModulator platform to improve the performance of vaccines are the following:
- An iBioModulator-Pfs 25 antigen malaria vaccine candidate in advanced pre-IND testing elicited transmission blocking activity at lower doses and for a longer period of time following immunization compared to a vaccine candidate containing the antigen alone; titers of specific immunoglobulins to Pfs 25 were approximately ten-fold higher across dose levels when the iBioModulator was used.
- Therapeutic HPV (human papilloma virus) vaccine candidates constructed with iBioModulator provided superior protection from HPV-16 E7-induced tumors and extended survival in a mouse model when compared with vaccination with native E7 protein alone. The HPV tumor protection was both prophylactic and therapeutic. It produced tumor-free survival of mice immunized with the E7 iBioModulator antigen. Effective therapeutic vaccination to treat HPV-induced cancer has been a long-desired but difficult to achieve objective of healthcare professionals. The iBioModulator platform offers a new and promising approach to addressing this important goal.
- iBioModulator has been used as a fusion to express peptide or protein domain antigens in a number of other successful vaccine candidates, including those for anthrax.
- The iBioModulator also has been used by scientists at FhCMB to improve the solubility and stability not only of recombinant vaccine antigens, but other proteins as well. Ongoing studies will include evaluation of the benefits of using the iBioModulator in the development and production of therapeutic product candidates.
"The benefits of the iBioModulator platform are available by separate license to those who license product candidates developed by iBio and also for products developed independently by licensees," said Robert B. Kay, Chairman and CEO of iBio. "Our success in broadening patent protection for product applications of the iBioModulator technology should expand interest in its commercial use."
About iBio, Inc.
iBio develops and offers product applications of its iBioLaunch™ and iBioModulator™ platforms, providing collaborators full support for turn-key implementation of its technology for both proprietary and biosimilar products. 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 is designed to significantly improve vaccine products with both higher potency and greater duration of effect. The iBioModulator platform can be used with any recombinant expression technology for vaccine development and production. 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.
Robert Erwin, President
SOURCE iBio, Inc.