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iBio European Patent on iBioModulator Technology Emerges From Opposition Period

June 9, 2014

The patent (European patent EP 1664322) covers iBio's carrier molecule fusion protein technology (iBioModulator™) for therapeutic proteins and vaccines.

"This is an important extension of intellectual property protection for our commercial technology platform," said Robert B. Kay, iBio's chairman and CEO. "We are pursuing applications of this technology for both therapeutic and preventive vaccines. We expect the iBioModulator platform will significantly enhance interest in licenses for superior vaccine products."

An immunomodulator is a substance that alters the immune response. Animal studies have shown that the iBioModulator platform can increase the strength of the immune response specific to a vaccine antigen (as measured by antibody titer). Commercial applications of this proprietary platform include the development of more effective vaccines.

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 human papillomavirus (HPV) 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, plague, sleeping sickness and influenza.

• The iBioModulator also has been used by scientists at 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.

"Europe is certainly among the most important markets for our technology and products," said Robert Erwin, iBio's president. "Expanding our intellectual property portfolio in European countries is an important part of our global strategy to deliver more efficient technology to meet the growing demand for affordable, high-quality biologic products."

The patent, entitled "RECOMBINANT CARRIER MOLECULE FOR EXPRESSION, DELIVERY AND PURIFICATION OF TARGET POLYPEPTIDES," is based on an invention developed by scientists at the company's research and technology collaborator, the Fraunhofer USA Center for Molecular Biotechnology, and is owned by iBio. This patent joins the company's fusion protein and iBioModulator allowed or issued patents in the U.S., Australia, Canada, China and India.

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Source: Global Data Point

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