iBio Technology is the manufacturing platform of choice when rapid response to pandemic threats is paramount

Vaccines are increasingly being developed from recombinant proteins representing highly immunogenic proteins of the natural pathogen. In contrast to earlier vaccine technologies which used killed or weakened pathogens to stimulate an immune response, the newer "subunit" vaccines offer an improved safety profile, as well as the potential for a significantly simplified manufacturing and quality process. The iBio Technology delivers the improved safety and manufacturing profile demonstrated with subunit vaccines, but unlike competitor technologies, iBio's extremely rapid gene sequence-to-manufacturing timeline (as little as one month) makes the iBio Technology the manufacturing platform of choice when rapid response to pandemic threats is paramount.

Hookworms are parasitic nematodes that cause anemia and child development complications in infected individuals, most commonly in tropical and subtropical environments. iBio Technology is being used to produce a vaccine antigen to an enzyme found in the gut of the hookworm. Antibodies to this gut enzyme block its action, which normally acts to break down hemoglobin in the blood as a source of iron for the hookworm. When this gut enzyme is blocked, the hookworm dies, allowing infected patients to resume a healthier life. The antigenic form of this hookworm gut enzyme has proven to be impossible to manufacture efficiently using bacterial, yeast, or animal cell expression systems. However, commercially useful amounts of the antigen can be manufactured using the iBio Technology plant expression technology, and development of a vaccine in partnership with the Sabin Vaccine Research Institute is proceeding towards human safety and efficacy studies.

iBio Technology offers a breadth of application that is unmatched

The iBio Technology expression platform has been used to manufacture vaccine candidates that represent a broad range of viral, bacterial and parasitic threats to human health. The technology has been used to successfully produce vaccine components that could not be manufactured using bacterial, yeast or animal cell expression systems, demonstrating a breadth of application that is unmatched.

Each of these vaccines is available to be licensed from iBio along with the iBio Technology manufacturing platform, providing a turnkey entry into vaccine development and manufacturing

Yellow fever was the first human disease to be proven to be caused by a virus and is transmitted via a mosquito bite.

A highly effective vaccine (17D) was developed in 1937 by Max Theiler, for which he was later awarded the Nobel Prize. This vaccine is a weakened, but live version, of the virus and is produced in embryonated chicken eggs. However, like other vaccines produced in eggs, individuals who are allergic to eggs cannot receive the vaccine and others risk side effects, including neurologic effects and organ failure. Children, the elderly and immunocompromised individuals should not receive the 17D yellow fever vaccine.

The side-effect profile has been increasingly unacceptable in regions of the world where yellow fever is present but acceptably managed. Because of these reasons, a next-generation yellow fever vaccine is of high importance in tropical nations and a subunit vaccine made in plants is likely to have an improved safety profile while at the same time being highly effective in protection.

In partnership with Fiocruz/Bio-Manguinhos of Brazil, iBio and its research collaborator, the Fraunhofer USA Center for Molecular Biotechnology, have undertaken the development of this next-generation yellow fever vaccine. A license agreement for the iBio Technology manufacturing platform applied to the yellow fever vaccine has been established with Fiocruz/Bio-Manguinhos and, by mutual agreement, may be expanded to include other product applications.

As part of its collaboration with external agencies such as the Bill & Melinda Gates Foundation Global Health Initiative and the U.S. Department of Defense Advanced Research Projects Agency, subunit vaccines for avian influenza (H5N1) and pandemic influenza (H1N1) have been created and advanced into human safety and immunogenicity clinical studies. These vaccines consist of the viral hemagglutinin (HA) antigen, which is known to produce a protective immune response in humans.

A vaccine for malaria has been elusive, since the malaria parasite changes body forms during its life cycle and is kept hidden from the human immune system for much of its life.

The iBio-manufactured vaccine candidate is novel in that it is directed against a malaria parasite antigen. This is commonly displayed on the parasite forms present in the gut of transmitting mosquitos. Individuals immunized against this mosquito-borne form of the parasite share anti-malaria antibodies with the mosquito when the insect takes a blood meal, and these antibodies block the maturation of the parasites in the insect gut, ending the transmission cycle from mosquito to man and back to mosquito. This vaccine candidate, which has shown great promise in laboratory studies of malaria transmission, was developed in a partnership with the Bill & Melinda Gates Foundation Global Health initiative.

Hookworms are parasitic nematodes that cause anemia and child development complications and retardation in infected individuals, most commonly in tropical and subtropical environments. iBio Technology is being used to produce a vaccine antigen to an enzyme found in the gut of the hookworm. Antibodies to this gut enzyme block its action, which normally acts to break down hemoglobin in the blood as a source of iron for the hookworm. When this gut enzyme is blocked, the hookworm dies, allowing infected patients to resume a healthier life. The antigenic form of this hookworm gut enzyme has proven to be impossible to manufacture efficiently using bacterial, yeast, or animal cell expression systems. However, commercially useful amounts of the antigen can be manufactured using the iBio Technology plant expression technology, and development of a vaccine in partnership with the Sabin Vaccine Research Institute is proceeding towards human safety and efficacy studies.

Human papilloma virus (HPV) has been shown to cause a number of human cancers, chiefly cervical cancer, but also increasingly anogenital and oral cancers. There are multiple oncogenic serotypes of HPV and extensive efforts have been made to produce effective vaccines to prevent HPV infection. However, the iBio Technology has been used to produce an experimental vaccine to one serotype of HPV (HPV-16) which causes the regression and loss of established HPV tumors in an animal model. Such a vaccine in humans has the potential to treat patients with established HPV-related cancers, for which current therapeutic options involve surgical resection followed by chemotherapy and/or radiation treatment.

The iBio Technology has been used to produce vaccines against plague (Yersinia pestis) and anthrax (Bacillus anthracis). The plague vaccine consists of two bacterial antigens (F1 and LcrV) and has been demonstrated in primates to provide complete protection against inhaled plague challenges when administered with an adjuvant.

A vaccine candidate to prevent anthrax infection has been manufactured and comprises a portion of the pathogen’s Protective Antigen and Lethal Factor proteins. Mice immunized with this dual-antigen vaccine made antibodies to anthrax which were successful in neutralizing bacterial infectivity in laboratory tests.