iBio - Die Impfstoffmaschine

ISIN: US4510332038 | WKN: A2JNBU | Symbol: 0JVN
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iBio verspricht mit ihrer "green-vax" Plattform iBioLaunch neue Ansätze in der Herstellung von Impfstoffen.

Seit Tagen wieder heiss begehrt.

NEWARK, Del.--(BUSINESS WIRE)-- iBio, Inc. (NYSE AMEX: IBIO) today announced release of results from a series of scientific studies of the breadth of product applicability of its iBioLaunch™ technology. The results were published in a supplemental edition of the scientific journal Human Vaccines. The peer-reviewed scientific manus describe both vaccine applications and monoclonal antibody applications of iBio’s proprietary plant-based protein expression technology.

“iBio’s platform-as-product business strategy is based on a substantial body of peer-reviewed scientific evidence that the iBio technology offers unique commercial advantages over conventional approaches for the development and manufacture of vaccines and therapeutic proteins,” said Robert Erwin, iBio’s President. “These newly published data reflect pre-clinical work completed by our research collaborator, Fraunhofer USA Center for Molecular Biotechnology, more than a year ago that formed the basis for our current clinical trials and ongoing examination of the limits, if any, of our technology for the commercial expression of proteins for vaccines and biotherapeutics.”

iBioLaunch technology has been employed to make vaccines against pandemic H1N1 influenza and avian influenza H5N1 for two ongoing Phase I human clinical trials. One of the newly published papers describes these experimental vaccines and reports their induction of protective immunity in animal models of influenza. Additional papers report the use of iBioLaunch technology for a novel vaccine for malaria and for production of a proprietary monoclonal antibody that offers protection in animal models of anthrax. Links to abstracts of the publications are provided below:

Plant-based rapid production of recombinant subunit hemagglutinin vaccines targeting H1N1 and H5N1 influenza
DOI: 10.4161/hv.7.0.14561 Yoko Shoji, Jessica A. Chichester, Mark Jones, Slobodanka D. Manceva, Emily Damon, Vadim Mett, Konstantin Musiychuk, Hong Bi, Christine Farrance, Moneim Shamloul, Natasha Kushnir, Satish Sharma and Vidadi Yusibov, Pages 41 – 50)

A non-glycosylated, plant-produced human monoclonal antibody against anthrax protective antigen protects mice and non-human primates from B. anthracis spore challenge
DOI: 10.4161/hv.7.0.14586 Vadim Mett, Jessica A. Chichester, Michelle L. Stewart, Konstantin Musiychuk, Hong Bi, Carolyn J. Reifsnyder, Anna K. Hull, Mark T. Albrecht, Stanley Goldman, Les W. J. Baillie and Vidadi Yusibov, Pages 183 – 190

Antibodies to plant-produced Plasmodium falciparum sexual stage protein Pfs25 exhibit transmission blocking activity
DOI: 10.4161/hv.7.0.14588 Christine E. Farrance, Jessica A. Chichester, Konstantin Musiychuk, Moneim Shamloul, Amy Rhee, Slobodanka D. Manceva, R. Mark Jones, Tarlan Mamedov, Satish Sharma, Vadim Mett, Stephen J. Streatfield, Will Roeffen, Marga van de Vegte-Bolmer, Robert W. Sauerwein, Yimin Wu, Olga Muratova, Louis Miller, Patrick Duffy, Robert Sinden and Vidadi Yusibov, Pages 191 – 198

About iBio, Inc.

iBio, Inc. is a biotechnology company offering its proprietary, transformative iBioLaunch technology platform for the production of biologics including therapeutic proteins and vaccines. The iBioLaunch platform uses transient gene expression in green plants for superior efficiency in protein production. Advantages include significantly lower capital and process costs, and the technology is ideally suited for complex proteins and for applications where speed, scalability, and surge capacity are important. The iBioLaunch technology was developed for iBio by the not-for-profit Fraunhofer USA Center for Molecular Biotechnology (FCMB) during the past eight years to overcome the inadequacies of existing technologies. iBio owns the intellectual property and technology developed at FCMB, and continues to sponsor development and application of the technology for biological applications in human health. Further information is available at www.ibioinc.com.

About Fraunhofer USA Center for Molecular Biotechnology

Fraunhofer USA CMB, a division of Fraunhofer USA, Inc., is a not-for-profit research organization whose mission is to develop safe and effective vaccines targeting infectious diseases and autoimmune disorders. The technology CMB developed for iBio, Inc. provides a safe, rapid and economical alternative for both vaccine and therapeutic protein production. The Center conducts research in the area of plant biotechnology, utilizing new, cutting edge technologies applicable to the diagnosis, prevention and treatment of human and animal diseases. The Center houses individuals with expertise and excellence in plant virology, pathology, molecular biology, immunology, vaccinology, protein engineering, and biochemistry. Further information is available at www.fraunhofer-cmb.org.
Wahnsinn dieser Schub.
Bin eher skeptische ab der Technologie. Man kann mitreiten aber Ausstieg nicht verpassen!
iBio rockt ab!

iBio Announces Successful Production of Critical Hookworm Vaccine Antigen
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.
NEWARK, Del,. April 4, 2012 /PRNewswire/ -- iBio, Inc. (NYSE AMEX: IBIO)
today announced issuance of a US patent covering compositions and methods
for generating clonal cell lines and plants for expressing gene products. This
invention, developed by the Fraunhofer USA Center for Molecular Biotechnology,
iBio’s research collaborator, is a part of iBio’s broader iBioLaunch™ platform for
vaccines and therapeutics. The new patent is US Patent 8,148,608 entitled
“Systems and methods for clonal expression in plants.”
..und weiter geht's im Höhenflug

NEWARK, Del., April 10, 2012 /PRNewswire/ -- iBio, Inc. (NYSE AMEX: IBIO) announced that its proprietary iBioLaunch™ technology for the production of biotherapeutic proteins and vaccine antigens in whole green plants has been used to produce a functional monoclonal antibody copy of palivizumab, a humanized monoclonal antibody that binds to respiratory syncytial virus (RSV) glycoprotein fusion protein (F), and inhibits viral entry into cells. Palivizumab is used to reduce RSV associated hospitalizations, but its high cost limits treatment to high-risk infants who receive monthly intramuscular injections throughout the RSV season. Worldwide annual sales of palivizumab exceed $900 million.

Scientists at iBio's research and development partner, Fraunhofer USA Center for Molecular Biotechnology, have expressed the antibody heavy and light chains in green tissues of plants using an iBioLaunch vector system developed for multi-chain proteins such as antibodies. The expression of palivizumab in plants resulted in self-assembly of the appropriate antibody quaternary structure, which was then recovered from the plant tissue.

iBioLaunch-produced palivizumab was shown to bind inactivated RSV, indicating that it recognizes F antigen presented on the virus' surface. Furthermore, plant-produced palivizumab was demonstrated to have a dose-dependent RSV neutralizing activity in a plaque reduction neutralization test. The effective concentration to observe 50% plaque reduction is comparable for plant-produced palivizumab to that reported for palivizumab manufactured in recombinant mammalian cells. The virus neutralizing activity observed is specific to palivizumab, as demonstrated with the use of an unrelated, plant-produced monoclonal antibody as a negative control for any plant-specific activity.

The production of functional palivizumab in plants extends the number of monoclonal antibodies that have been produced using the iBioLaunch™ system. All the monoclonal antibodies manufactured using iBioLaunch technology have been shown to be correctly assembled and fully active in appropriate bioassays.
iBio to receive new patent to add to iBioModulator portfolio
iBio announced notification from the U.S. Patent and Trademark Office that a new patent in the Company's iBioModulator portfolio will issue on March 26. The new patent, number 8,404,252 entitled "Yersinia pestis Antigens, Vaccine Compositions and Related Methods," includes claims covering plague antigens fused to the Company's thermostable immunomodulator -- iBioModulator -- protein, as well as vaccine compositions and a method for producing a protective immune response to the antigen.

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