iBio Provides Update on IBIO-201 COVID-19 Vaccine Program
iBio Inc. (NYSE AMERICAN: IBIO) provided a promising update on its COVID-19 vaccine candidate, IBIO-201. Preclinical studies demonstrated its ability to generate immune responses against SARS-CoV-2, with increasing antibody titers observed over 42 days. The company is collaborating with Texas A&M University System to conduct additional testing focused on neutralizing titers and immune profiling. iBio highlighted its capability to advance vaccine candidates rapidly, leveraging its FastPharming Facility for scale-up production.
- Successful preclinical results for IBIO-201, showing an increasing immune response over 42 days.
- Collaboration with Texas A&M University System for further testing and evaluation.
- Established capability to rapidly develop and manufacture vaccines at clinical scales.
- None.
NEW YORK, Aug. 10, 2020 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSE AMERICAN:IBIO) (“iBio” or the “Company”), a biotechnology corporation and biologics contract manufacturing organization, today provided an update on one of its proprietary vaccine candidates being designed to prevent infection from the SARS-CoV-2 virus. iBio is investigating an array of adjuvants in combination with iBio’s proprietary lichenase carrier molecule (“LicKMTM”) fused to a coronavirus subunit protein (“IBIO-201”) with the goal of producing a safe and effective vaccine for COVID-19 disease, and especially one for our most vulnerable populations, including the elderly.
Ten distinct preclinical study 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 spike titers to IBIO-201were 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 testing of mouse antisera from IBIO-201 immunized mice demonstrates 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 testing 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 correlates, including antigen-specific T cell responses and memory B cell testing. The additional testing for both IBIO-201 and IBIO-200 is occurring in collaboration with the Texas A&M University System (“TAMUS”) laboratories.
“We are encouraged by these pre-clinical data, which demonstrate IBIO-201’s ability to generate an immune response to SARS-CoV-2 sequences and neutralize protein interaction,” said Tom Isett, Chairman & 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 Vaccine Development Programs
On March 11, 2020, the Company filed four provisional patent applications with the U.S. Patent and Trademark Office in support of its COVID-19 vaccine platforms. The virus-like particle (“VLP”) program (“IBIO-200”) was subsequently announced on March 18, 2020. The LicKM-Subunit program (“IBIO-201”) was announced on June 3, 2020. If the program(s) move into clinical trials, iBio has the capability to rapidly develop and manufacture at clinical and commercial scales in its 130,000 square foot facility in Bryan, Texas. Originally built in 2010 with funding from the U.S. Defense Advanced Research Projects Agency [DARPA], iBio’s FastPharming Facility® was part of the “Blue Angel” initiative to establish factories capable of rapid delivery of medical countermeasures in response to a disease pandemic.
About iBio, Inc.
iBio is a global leader in plant-based biologics manufacturing. Its FastPharming System® combines vertical farming, 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, provides FastPharming Contract Development and Manufacturing Services. iBio’s FastGlycaneering Development Service™ includes an array of new glycosylation technologies for engineering high-performance recombinant proteins. Additionally, iBio is developing proprietary products, which include IBIO-100 for the treatment of fibrotic diseases, and vaccines for COVID-19 disease. For more information, visit www.ibioinc.com.
FORWARD-LOOKING STATEMENTS
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding producing a safe and effective vaccine for COVID-19 disease and especially one for our most vulnerable populations, including the elderly, plans to conduct additional testing of IBIO-201 antisera, including further evaluations of neutralizing titers in multiple assay formats, and gaining more insight as we complete data analysis of both of our COVID-19 vaccine candidates. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on 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 from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to successfully complete additional testing planned 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 Company’s ability to obtain regulatory approvals for commercialization of its product candidates, including its COVID-19 vaccines, or to comply with ongoing regulatory requirements, regulatory limitations relating to its ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, its ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, competition, or its ability to retain its 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 filings with 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 undertake 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
skilmer@ibioinc.com
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