NEW YORK, AUGUST 10, 2020 (GLOBE NEWSWIRE) – iBio, Inc. (NYSE AMERICAN: IBIO) (“iBio” as the “Company”), a biotechnology corporation and biology contract organization, today released an update on one of its own vaccine candidates designed to prevent infection by the SARS CoV-2 virus. iBio explores a variety of adjuvants in combination with iBio’s proprietary lichenase carrier molecule (“LicKMTM”) Fused with a subunit coronavirus protein (“ IBIO-201 ”) with the aim of producing a safe and effective vaccine for COVID-19, and especially one for our most vulnerable populations, including the elderly.
Ten distinct preclinical research arms for the IBIO-201 antigen-adjuvant combinations have been concluded. These include combinations delivered via intramuscular and intranasal routes, and datasets are under evaluation.
Anti-SARS-CoV-2 peak titers after IBIO-201 were observed 21 days after immunization. Titers continued to increase over the 42-day study. Distinct, favorable Th1 and Th2 immune profiles were observed.
Early functional tests of mouse antisera from IBIO-201 immunized mice demonstrate the presence of antibodies that interfere with the binding of SARS-CoV-2 spike protein sequences to human ACE2 in ex vivo assays. iBio plans to conduct additional tests of IBIO-201 antisera, including further evaluations of neutralizing titers in multiple assay formats. In addition, significant immune profiling studies are ongoing to evaluate safety and immune protection correlations, including antigen-specific T-cell responses and memory B-cell assays. The additional testing for both IBIO-201 and IBIO-200 takes place in collaboration with the Texas A&M University System (“TAMUS”) laboratories.
“We are encouraged by these pre-clinical data, which demonstrate the ability of IBIO-201 to generate an immune response to SARS-CoV-2 sequences and neutralize protein interaction,” said Tom Isett, President and CEO of iBio. “We expect to gain more insight as we complete data analysis of both of our COVID-19 vaccine candidates.”
About iBio’s COVID-19 fax development programs
On March 11, 2020, the company filed four preliminary patent applications with the U.S. Patent and Trademark Office in support of its COVID-19 fax platforms. The virus-like partition (“VLP”) program (“IBIO-200”) was later announced on March 18, 2020. The LicKM-Subunit program (“IBIO-201”) was announced on June 3, 2020. As the program (s) move to clinical trials, iBio has the potential to rapidly develop and produce on clinical and commercial scales in its 130,000 square feet in Bryan, Texas. Originally built in 2010 with funding from the US Defense Advanced Research Projects Agency [DARPA], iBio’s FastPharming Facility® was part of the “Blue Angel” initiative to set up factories capable of providing rapid medical response in response to a disease pandemic.
About iBio, Inc.
iBio is a global leader in plant-based biology production. Its FastPharming System® combines vertical agriculture, automated hydroponics, and glycan engineering technologies to rapidly deliver high quality monoclonal antibodies, vaccines, bioinks, and other proteins. The company’s subsidiary, iBio CDMO LLC, delivers FastPharming Contract development and manufacturing services. iBio’s FastGlycaneering Development Service ™ includes an array of new glycosylation technologies for high-performance recombinant protein engineering. In addition, iBio develops proprietary products, which include IBIO-100 for the treatment of fibrotic diseases, and vaccines for COVID-19 disease. Visit www.ibioinc.com for more information.
FORWARD VIEWING STATEMENTS
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Federal Securities Act. Words like “may”, “maybe”, “will”, “should”, “believe”, “expect,” “expect,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan”, “of purpose” as similar expressions, as statements regarding intention, belief, as current expectations, are forward-looking statements. These advancing statements are based on current estimates and assumptions and include statements regarding the production of a safe and effective vaccine for COVID-19 disease and in particular one for our most vulnerable populations, including the elderly, are plans for additional testing of IBIO-201 antisera to perform, including further evaluations of neutralizing titers in multiple assay formats, and gain more insight as we complete data analysis of both of our COVID-19 vaccine candidates. While the company believes that these forward-looking statements are reasonable, we do not need to place undue reliance on such forward-looking statements, which are based on information available to us at the date of this release. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions of those stated as implied by any forward-looking statements. Important factors that may cause actual results to differ substantially from current expectations include the company’s ability to schedule additional testing plans for both SARS-CoV-2 vaccine candidates, IBIO-201 and IBIO-200, and to produce a safe and effective vaccine for COVID-19 disease, the ability of the company to obtain regulatory approvals for the commercialization of its product candidates, including its COVID-19 vaccines, or to comply with ongoing regulatory requirements, regulatory constraints regarding its capabilities to promote or commercialize their product for specific indications, acceptance of their product candidates in the market and the successful development, marketing or sale of products, their ability to maintain its licensing agreements, the continued maintenance and growth of its patent estates, its ability to establish and maintain collaborations, its ability to capitalize d or obtain or retain grants necessary to fund their research and development activities, competition, as well as the ability to retain their key employees and the other factors discussed in the Company’s annual report on Form 10-K for the year ended June 30, 2019 and the Company’s subsequent applications to the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. The information in this release is provided only as of the date of this release, and we make no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
Contacts:
Stephen Kilmer
iBio, Inc.
Investor Relations
(646) 274-3580
[email protected]
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