iBio, Inc. (NYSE AMEX: IBIO) today announced positive interim results from a Phase 1 clinical trial of an iBioLaunch™ platform-produced subunit vaccine directed against Influenza A/California/04/09 (H1N1). The vaccine demonstrated strong induction of dose correlated immune responses, with or without adjuvant, as assessed by virus microneutralization antibody assays and hemagglutination inhibition (HAI) responses. The vaccine was safe and well tolerated at all doses when administered with and without adjuvant.
“These expected positive results are an important confirmation of the utility of the iBioLaunch platform, not only for rapid response to infectious disease challenges such as influenza, but also as a preferred approach to a broad range of vaccine and therapeutic products,” said Robert Kay, iBio’s Chairman and Chief Executive Officer.
The clinical trial was sponsored by iBio’s research collaborator, the Fraunhofer USA Center for Molecular Biotechnology (CMB) and the experimental vaccine was manufactured in the pilot plant operating the iBioLaunch platform located at CMB’s Newark, Delaware facility. The clinical trial was conducted at the Walter Reed Army Institute of Research Clinical Trials Center (WRAIR-CTC). Safety and reactogenicity assessments were completed at WRAIR-CTC, and immunogenicity evaluation was performed by the Influenza Division of the Centers for Disease Control and Prevention.
The study was a single center, placebo-controlled, single blinded dose escalation study to preliminarily assess the safety, reactogenicity, and immunogenicity of different vaccine formulations and doses. The study evaluated eighty healthy volunteers from 18 to 50 years of age who received two intramuscular injections of 15 micrograms (mcg), 45 mcg, or 90 mcg of vaccine with or without adjuvant; placebo; or reference vaccine on study days 0 and 21. Final results of the study are expected to be available by the end of the year.About iBio, Inc. iBio develops and offers product applications of its iBioLaunch™ platform, 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. Advantages over other systems include: success with proteins difficult or impossible to produce with other methods; broadly applicable to biologics, including monoclonal antibodies, other therapeutic proteins and vaccines; enables rapid development and validation of modular, scalable, and optionally robotic, multi-product manufacturing facilities; production time measured in weeks instead of months or more. Additional benefits include a practically unlimited surge capacity for remedial action against bioterrorism and pandemic disease; product entry that is unconstrained by traditional process patents, and significantly lower capital and operating costs for comparable production. Further information is available at: www.ibioinc.com. Forward-Looking Statements 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.