iBio receives U.S. patent for iBioModulator platform

iBio, Inc. (NYSE AMEX: IBIO) today announced issuance of a US patent covering compositions of matter and methods of use of modified lichenase B polypeptides comprising the Company's iBioModulator™ platform. The new patent, which provides broad protection of the platform, is US Patent 8,173,408, entitled "Recombinant Carrier Molecule for Expression, Delivery and Purification of Target Polypeptides."

The iBioModulator platform has been shown to significantly modify the immune response to a vaccine in two important ways. It increases the strength of the initial immune response to a vaccine antigen (as measured by antibody titer).  It also extends the duration of the immune response. These results demonstrate that the use of the iBioModulator platform can lower vaccine antigen requirements and enable fewer doses to establish prolonged immunity. The ability to provide better immune response and longer-term protection without booster inoculations adds 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.

"The iBioModulator is another platform, separate and independent from our plant-based biologics technology," said Robert B. Kay, iBio's Chairman and CEO. "Although we recommend its use together with our iBioLaunch platform to achieve maximum efficiency in producing the fused protein, the iBioModulator is usable independently and is applicable to recombinant vaccines made with any system.  We expect strong interest in its use."

Efficacy studies in animals have confirmed the superior performance of certain iBioModulator-based vaccines, and ongoing tests will provide additional data about the further extent to which prolonged immunity is conferred by the iBioModulator technology. On the strength of results obtained to date, iBio has broadened its commercial program to include additional vaccine applications for preclinical evaluation.

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.
   
• 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. 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 plague and anthrax.

The iBioModulator also has been used by scientists at iBio, Inc.'s research and development partner, the Fraunhofer USA Center for Molecular Biotechnology, 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.