UPDATE;05-08-2021
IBio Shares Trading Higher After Covid-19 Vaccine Study Results
11:24 am ET May 7, 2021 (Dow Jones) Print

By Stephen Nakrosis

Shares of iBio Inc. are trading higher on the NYSE American exchange Friday, a day after
the company provided an update on its IBIO-201 Covid-19 vaccine candidate.

At 11:17 a.m. ET, the companys shares were trading 16.3% higher,
at $1.61.

Volume at the time topped 77.7 million shares,
above the stocks 65-day average volume of some 11.6 million shares.

After the bell Thursday, the company said IBIO-201,
which combines antigens derived from the spike protein fused with its LicKM booster molecule,
recently completed IND-enabling toxicology studies, adding,
The studies identified no adverse effects at low or high doses.

The companys chairman and chief executive, Tom Isett,
said, Combined with data from previous immune-response studies,
these pathology results help demonstrate the potential value of
LicKM as a useful tool in our vaccine development toolbox.

The company also said it is developing IBIO-202,
a subunit vaccine candidate that targets the
nucleocapsid protein (N protein) of SARS-CoV-2.

Mr. Isett said, In light of the successful global roll-out of
Covid-19 vaccines targeting the S protein and the emergence of
variant strains of the disease,
we decided to focus our efforts on the continued development of
IBIO-202 as a differentiated vaccine candidate.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

May 07, 2021 11:24 ET (15:24 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.

May 07, 2021 11:24 ET (15:24 GMT)

News 05-05-2021 $IBIO huge settlementiBio and Fraunhofer USA Conclude Litigation and Enter License Agreement

IBIO
+12.7907%
iBio, Inc.
Tue, May 4, 2021, 2:00 PM

IBIO
+12.7907%
BRYAN, Texas, May 04, 2021 (GLOBE NEWSWIRE) --
iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a biotech innovator and biologics contract manufacturing organization,
announced today that it has successfully resolved its lawsuit with Fraunhofer USA, Inc. (“Fraunhofer USA”).

The parties’ settlement confirms iBio’s ownership of certain intellectual property related to plant-based biopharmaceutical production.

As part of the settlement, iBio granted Fraunhofer USA a fully
paid-up license to use the recombinant protein manufacturing technologies that were the subject of litigation.

Tom Isett, Chairman and CEO of iBio, said,
“We are pleased to see this matter resolved and to receive compensation for the use our intellectual property.

iBio remains committed to relentlessly innovating in the area of plant-made biologics,
while respecting fair competition and protecting our IP.

As a result, this settlement gives assurance to our licensees and clients that they can continue to depend upon us to develop and
enhance our
FastPharming® Technologies to provide them with the speed,
scalability,
and eco-friendly advantages of plant-based biologics development
and manufacturing from iBio.”

The Settlement concludes the lawsuit that began in March 2015 in the Delaware Court of Chancery.

In addition to an initial payment at signing which will cover iBio’s significant legal fees and expenses,
Fraunhofer USA will make additional cash payments to iBio in
March 2022 and
March 2023. Certain details of the settlement are confidential.

Copyright (c) 2021 Dow Jones & Company, Inc.

UPDATE SETTLEMENT 05-08-2021

https://www.ibioinc.com/technology/glycan-engineering

src=https://investorshub.advfn.com/uimage/uploads/2020/2/28/lpns[ibio-logo.png

(NYSE MKT: IBIO)
https://www.ibioinc.com/

Company Overview

iBio, Inc. (NYSE MKT: IBIO), a leader in the plant-made pharmaceutical field,
develops and offers pharmaceutical product applications using its iBio Technology platform.

The iBio Technology platform is a proprietary,
transformative technology for the production of biologics including monoclonal antibodies, other therapeutic proteins and vaccines.

========================================================================================================================================================================

$IBIO COVID-19 and Unmet Needs: huge read
https://www.ibioinc.com/vaccines/ibio-202/
https://www.ibioinc.com/therapeutics/ibio-100/
https://www.ibioinc.com/vaccines/ibio-202/
https://www.ibioinc.com/vaccines/ibio-400/
https://www.ibioinc.com/research-bioprocess/
https://www.ibioinc.com/cdmo-services/process-development/
https://www.ibioinc.com/cdmo-services/cgmp-manufacturing/

https://www.ibioinc.com/cdmo-services/aseptic-fill-finish/
https://www.ibioinc.com/cdmo-services/bioanalytics/
https://www.ibioinc.com/cdmo-services/factory-solutions/

SARS-CoV-2 is a zoonotic strain of coronavirus that was first detected in human populations in the Chinese province of Hubei in late 2019. The spread of infection has since been driven by human-to-human transmission resulting in the 2020-2021 pandemic.

As a result of unprecedented public and private sector initiatives, 
as well as the advent of mRNA and viral vector technologies, 

new vaccines against COVID-19 disease received regulatory clearance in multiple countries in record time. 

Still, a multi-year track record of safety and efficacy of these 
new platforms has yet to be established with vulnerable populations, especially those most directly impacted by the current pandemic 

– the elderly. Additionally, mRNA vaccines require expensive supply chain support, 

and there may be certain limitations to the viral vector-based products. 

Coupled with new mutations of the SARS-CoV-2 virus identified in 
South Africa 
and the UK for which the new vaccines may or may not provide robust protection, 
there is a need for ongoing research. 

Traditional subunit vaccines or virus-like particle alternatives may have a role in managing the pandemic, 

particularly constructs that can be cost-effectively designed, prototyped, and mass produced in rapid fashion.1

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https://www.otcmarkets.com/stock/IBIO/overview

FastPharming™ Advantages


https://www.ibioinc.com/about/what-we-do
Because the cell line development phase is eliminated, FastPharming offers significant time savings compared to traditional expression platforms.
For instance, iBio produces milligram quantities of protein in as little as 6 weeks, gram quantities in 3 months, and greater than 10g of cGMP material in only 8 months.Additionally, 
FastPharming processes are easily scalable, produce high quality product, are cost efficient, deliver improved safety, and facilitate superior glycosylation control.

IBio uses the FastPharming System to quickly produce biotherapeutic and vaccine candidates for unmet medical needs.
In the area of human disease, IBIO-100 targets fibrosis, a leading world-wide cause of organ failure.
IBIO-200 is a virus-like particle (VLP) vaccine designed as a rapid medical countermeasure solution to the COVID-19 outbreak.

Technology Applications


The FastPharming platform produces a variety of recombinant products including:

  • Biobetter and biosimilar antibodies
    Antigens for subunit vaccine design
    Virus-like particles (VLP)
    Lysosomal enzymes
    Blood factors and cytokines
    Scaffolds, maturogens and materials for 3D Bioprinting and biofabrication

https://www.ibioinc.com/scientific-publications

The COVID-19 pandemic sweeping across the globe is pushing innovation to the cutting edge throughout the biopharma industry.
More rapid development of novel diagnostics, therapeutics,
and vaccines is acutely needed to mitigate further spread of the virus and prevent its reoccurrence in the future.
iBio is offering its FastPharmingTM  Contract Manufacturing Services to vaccine and therapeutic developers to address the need
for speeding time-to-clinic for new antigens, antibodies, and other protein biologics using a plant-based expression system.
In addition, iBio is developing its own proprietary solutions, notably IBIO-200, a virus-like particle (VLP) vaccine candidate for  COVID-19 disease.

Potential Vaccine Platforms

The traditional approach to vaccines is to use live or killed viruses to generate immune responses.
Development, approval, and commercialization of these types of vaccines can take several years, a model that is clearly unfeasible during this pandemic.
New approaches use a reductionist approach by identifying key viral components that can be incorporated into a vaccine that elicits a strong immune response and is also safe and easy to manufacture.1

Such approaches include vaccines that rely on recombinant DNA or messenger RNA (mRNA).
San Diego-based Inovio Pharmaceuticals, the first company to advance a vaccine (INO-4700) against MERS-CoV into human testing,
is developing a DNA-based vaccine against COVID-19, while both Cambridge, Massachusetts-based Moderna and German biotech CureVac are developing mRNA-based vaccines.
There are concerns with many of these approaches, however, particularly DNA and mRNA vaccines.
Questions have been raised about their cold-chain requirements compared with traditional vaccine technology platforms.
These solutions provide great hope but carry significant risk. 

At present, six COVID-19 or SARS-CoV-2 phase I clinical trials are listed in clinicaltrials.gov, although there are likely more in the works, as registration in the database is not mandatory until phase II.

iBio’s VLP Solutions

Virus-like particles (VLPs) represent a promising alternative to soluble antigens, as their shape, size, repetitive antigen structure,
and geometry have been shown to trigger stronger immune response, both humoral and cellular.2 VLPs are artificial
constructs comprising multiple proteins organized to resemble a virus, but without including any viral genetic material, thereby rendering them non-infectious.
Because they have the components and conformation of the native virus, they can engender stronger and broader immune responses than the antigen itself.

In addition, VLPs can be produced as cost-effectively as other novel platform technologies being used for COVID-19 vaccine development
and do not present additional safety concerns compared with those associated with DNA- and mRNA-based solutions.

iBio has extensive capability in this area, having developed plant-based bioprocesses that generate VLPs with the
same structures as more traditional methods but via more efficient manufacturing routes. VLP platforms like iBio’s are advantageous because,
in addition to obtaining high yields of the individual VLP components, the components automatically self-assemble into a spherical VLP,
simplifying both the upstream and downstream purification processes involved in VLP manufacture.

The recent phase III clinical success of a VLP-based influenza vaccine produced in the N. benthamiana system
(NCT03739112, NCT03301051), both in terms of efficacy and safety, demonstrates the potential for plant-based VLP vaccine development.3 

IBio-200: A VLP-Based COVID-19 Vaccine Candidate

IBIO-200 is iBio’s lead COVID-19 vaccine candidate.  iBio uses Woodchuck hepatitis virus and human hepatitis B virus core proteins
fused to COVID-19 receptor-binding motif (RBM), which self-assemble into empty nanoparticles.
The resulting VLPs form 40- to 50-nm diameter nanoparticles. The antigen is displayed in a repetitive structure and geometry,
and the particle is decorated with oligomannose molecules to more closely resemble the structure of naturally occurring viruses.  
Oligomannose glycosylation is thought to lead to better cellular uptake of the VLPs by antigen-presenting cells via the mannose receptor.
As with other VLP-derived vaccines, IBIO-200 is designed to interact with immune cells differently than soluble antigens.

The production of IBIO-200 follows standard and highly optimized protocols. Plants are seeded,
germinated, and grown to 5 weeks of age in environmentally controlled grow rooms.
At 5 weeks, plants are vacuum infiltrated with Agrobacterium containing transient plant-specific expression vectors encoding COVID-19 antigen constructs.
After infiltration, the vector drives vaccine expression for 5–7 days; plant material is shredded, and total soluble protein extracted.
Preliminary scalable downstream processes have been designed, including concentration and buffer exchange of clarified extract capture and polishing chromatography.

For evaluation purposes, the first screenings measured expression and protein stability.
Selected candidates will then be injected into mice for an initial immunization study.
IgG response, cytokine profiling, and results of virus neutralization assays will dictate a second candidate screening.
Subsequently, selected candidates will enter toxicology studies in appropriate animal models to support an IND filling.
A lead candidate and a back-up will then be selected for further in vivo efficacy studies.

In parallel, iBio will develop a process that is scalable to cGMP manufacturing, prepare manufacturing documentation, and develop QC release assays.
The FastPharming manufacturing system delivers a tightly controlled particle size, providing considerable quality and scale-up advantages,
as uniform antigen display enables better dose definition and higher product yields. 

All of this work will be based on technology proven successful for the clinical development of vaccine candidates in iBio’s U.S.-based,
large-scale production facility with all cGMP, QA, QC, scale-up, and regulatory resources;
the facility is self-contained and secure with highly reliable logistics.

Extensive Vaccine Experience at iBio

iBio’s FastPharming facility was originally constructed in 2010 with funding from the Defense Advanced Research Projects Agency (DARPA),
part of the U.S. Department of Defense (DoD), which was exploring a range of technologies that could enable faster responses to outbreaks.
Plant-based expression technology won out, and the facility was one of three commercial sites comprising the “Blue Angel” initiative.

As part of the DARPA Blue Angel H1N1 Program, iBio’s facility was designed and built to manufacture kilogram quantities of
recombinant proteins within months versus the historically longer time frames needed for more traditional systems.
Its rapid launch to production has been designed specifically for medical countermeasure responses.
The iBio facility is among the largest biotherapeutic production facilities in the world for the production of recombinant protein in N. benthamiana,
with a current capacity to produce bulk clinical protein at the scale of approximately 500 million doses per year.

iBio technology has been used to produce a number of prophylactic vaccines, including soluble pathogen antigens formulated with adjuvants against anthrax,
H5N1 influenza, H1N1 influenza and hookworm, and a virus-like particle (VLP) formulated with an adjuvant against malaria.
Phase I clinical studies have been completed for all of these vaccine candidates.

 

02-07-2021
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