There was a lot of profit-taking and selling in many COVID-19 plays in August. Some names did get ahead of themselves and rally too far. One name that got hit the hardest is iBio Inc. We feel this is a market over-reaction as while iBio Inc is a COVID-19 play, it is so much more than that.
The biggest hurdle these vaccine players face is not in developing the vaccine but in manufacturing hundreds of millions of doses. Moderna can only produce 100 million doses. The US needs 300 million. The entire world needs 7 billion. iBio’s FastPharming System positions the company to be involved in any company that comes to market with a COVID-19 vaccine or treatment. In this article, we take a look at iBio Inc and why smart investors should BTFD before the next move higher.
First up, here’s a little background on iBio Inc for those not familiar with the company. 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 gram quantities of high-quality monoclonal antibodies, vaccines, bioinks, and other proteins. The Company’s subsidiary, iBio CDMO LLC, provides FastPharming Contract Development and Manufacturing Services via 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. 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 IBIO-200, a COVID-19 vaccine.
Ibio Inc COVID-19 Vaccine 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.
IBIO-201 COVID-19 Vaccine
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-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 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 the 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 laboratories.
The latest news from iBio Inc is an exclusive worldwide license agreement with Planet Biotechnology Inc. for the development of Planet’s COVID-19 therapeutic candidate, ACE2-Fc. Under the terms of the agreement, iBio obtained an exclusive license to Planet’s ACE2-Fc. Planet is eligible to receive certain pre-specified payments upon achievement of clinical development milestones. Tom Isett, Chairman & CEO of iBio, said:
“We see tremendous opportunity in our partnership with Planet to develop this novel immunoadhesin molecule as a potential COVID-19 disease treatment. We believe the molecule may be effective against SARS-CoV-2 infection, and that it has the potential to be rapidly re-designed in the FastPharming® System to address mutations in the current virus, if any, as well as future coronaviral diseases.”
ACE2-Fc is a recombinant protein comprised of human angiotensin converting enzyme 2 (ACE2) fused to a human immunoglobulin G Fc fragment (Fc). As an immunoadhesin, ACE2-Fc targets the coronavirus virions directly by using the ACE2 extracellular domain as a decoy to bind the spike protein and block infection of healthy cells, while the fused Fc domain prolongs the life of the protein in circulation. The design is expected to bring the benefit of a traditional neutralizing antibody while prospectively limiting the potential for “viral escape” given that ACE2 is also the target receptor for coronavirus for cell entry. Planet’s in vitro studies demonstrated that its ACE2-Fc blocks SARS-CoV-2 virus from infecting Vero E6 cells.
President Trump has touted the use of convalescent plasma for treating COVID-19. Last week, President Trump announced emergency authorization to treat COVID-19 patients with convalescent plasma — a move he called “a breakthrough,” one of his top health officials called “promising” and other health experts said needs more study before it’s celebrated.
The announcement came after White House officials complained there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease that has upended Trump’s reelection chances.
Earlier this month, Mayo Clinic researchers reported a strong hint that blood plasma from COVID-19 survivors helps other infected patients recover. The Mayo Clinic reported preliminary data from 35,000 coronavirus patients treated with plasma, and said there were fewer deaths among people given plasma within three days of diagnosis, and also among those given plasma containing the highest levels of virus-fighting antibodies.
iBio Inc does not derive plasma products directly but its contract development and manufacturing unit leverages its FastPharming platform to produce vaccine antigens, enzymes, blood factors, and cytokines, among others.
It also develops its own products including a COVID-19 vaccine and lead asset IBIO-100, a fusion protein for the potential treatment of fibrotic diseases.
iBio Inc Bottom Line
We know many iBio Inc bulls are frustrated with the recent selloff. Further complicating things is that Tom Isett, Chairman & CEO of iBio, is under numerous NDAs. He cannot come out and say everything the company is working on. Bulls just need to be patient and wait for the PRs to drop. We believe big news is just around the corner with the election just two months away and the Orange Man needing a win. We like how CEO Tom Isett has positioned the company and believe iBio Inc is a discount entry opportunity at these levels.
As always, good luck to all (except the shorts)!
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Disclosure: We have no position in NYSEMKT:IBIO or any of the securities mentioned. We wrote this article ourselves and it expresses our own opinions. We are not receiving compensation for it. We have no business relationship with any company whose stock is mentioned in this article. Insider Financial is not an investment advisor and does not provide investment advice. Always do your own research and make your own investment decisions. This article is not a solicitation or recommendation to buy, sell, or hold securities. This article is meant for informational and educational purposes only and does not provide investment advice.