Phase 1 Clinical Trial Begins for Malaria Vaccine Candidate Based on iBio's Proprietary Technology
NEWARK, DE--(Marketwired - Feb 10, 2014) - iBio, Inc. (NYSE MKT: IBIO), a leader in plant-based biotechnology for developing and manufacturing biological products, reported the initiation of a Phase 1 human safety and immunogenicity clinical study of a transmission-blocking malaria vaccine candidate. The vaccine candidate was produced on the company's proprietary iBioLaunch™ platform by the Fraunhofer USA Center for Molecular Biotechnology.
The text describing the program, released by the Fraunhofer USA Center for Molecular Biotechnology, follows:
'Fraunhofer USA Center for Molecular Biotechnology (FhCMB) announced today that clearance was obtained from the U.S. Food and Drug Administration (FDA) for an investigational new drug (IND), Fraunhofer's plant-derived malaria transmission-blocking vaccine (TBV), which targets the Pfs25 antigen, to proceed into the clinic in a Phase 1 safety and immunogenicity study.
Antibodies directed at Pfs25 can block transmission of the malaria parasite from mosquitoes to humans by preventing the parasite from developing in the mosquito. In preclinical models, purified plant-derived virus-like particles containing Pfs25, in combination with the adjuvant Alhydrogel®, have been shown to induce antibodies that effectively block infection of mosquitoes that have fed on an infectious blood meal. If these results can be reproduced in humans, the vaccine approach may provide a strategy to interrupt malaria transmission and thereby contribute to reduction of the P. falciparum disease burden.
"Entering this clinical trial is an important milestone," said Dr. Yusibov, Executive Director of FhCMB. "We have moved targets from molecular engineering all the way through to pilot scale manufacturing in plants under good manufacturing practices and evaluation in a Phase 1 clinical trial."
Development of this malaria TBV is an effort to improve global health by supporting the development of critical platform technologies for delivering vaccines to malaria-endemic countries. As part of the planned collaboration strategy, FhCMB, the PATH Malaria Vaccine Initiative (MVI) and Accelovance entered into an agreement to conduct a Phase 1 clinical trial.
"We are excited to see this promising new vaccine approach advance to clinical testing," says Ashley J. Birkett, PhD, Director of MVI. "Vaccines that can induce immunity to break the cycle malaria parasite transmission between humans and mosquitoes have the potential important interventions to accelerate future elimination and eradication efforts."
This Phase 1 clinical trial was initiated in early November and is being conducted by Accelovance.'
This clinical trial is the third human study of vaccine candidates produced on the iBioLaunch platform under license from iBio. The completion of two Phase 1 clinical trials of influenza vaccine candidates, one for H1N1 influenza and one for H5N1 influenza, have previously been announced. iBio owns the technology used in this program, and has the right of reference and the right to use and incorporate information from this clinical trial in additional applications for regulatory approval of products or processes and for the manufacture and commercialization of products.
About iBio, Inc.
iBio develops and offers proprietary products and product licenses, based on its proprietary iBioLaunch and iBioModulator™ platforms, providing collaborators full support for turn-key implementation of its technology for protein therapeutics and vaccines. In Brazil, iBio has been collaborating with Oswaldo Cruz Foundation (Fiocruz) and Fraunhofer Center for Molecular Biotechnology since 2011 to develop a recombinant yellow fever vaccine based upon iBio technology.
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 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.