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




(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.


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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.

 




 

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IBIO News: Despite narrower fiscal Q2 2021 loss, iBio expenses grow; shares fall after hours 02/16/2021 04:54:50 PM
IBIO News: Current Report Filing (8-k) 02/16/2021 04:21:25 PM
IBIO News: Quarterly Report (10-q) 02/16/2021 04:19:34 PM
IBIO News: iBio beats on revenue 02/16/2021 04:07:50 PM
IBIO News: iBio Reports Fiscal Second Quarter 2021 Financial Results and Provides Corporate Update 02/16/2021 04:05:00 PM
PostSubject
#25758   Merck will help J&J produce vaccine....not iBio...see link https://finance.yaho trade2brich 03/02/21 08:58:42 AM
#25757   Your very welcome...enjoy... georgie18 02/23/21 09:13:58 AM
#25756   Great TA Georgie! alvaroc2 02/23/21 09:02:36 AM
#25755   Thank you...lets see where she goes... georgie18 02/23/21 07:56:38 AM
#25754   Nice work, adding more $1.90s and if it doebop 02/23/21 07:28:26 AM
#25753   IBIO...$1.64...in the P/M...Hitting my buy range this morning... georgie18 02/23/21 05:38:05 AM
#25752   IBIO...$1.99...Bullish Pole N Flag Reversal pattern to the georgie18 02/22/21 06:13:31 AM
#25751   These guys need to get something on the JPetroInc 02/21/21 08:53:47 PM
#25750   iBio Inc (IBIO) mick 02/21/21 07:48:29 PM
#25749   because some people become self aware they have JPetroInc 02/21/21 07:32:43 AM
#25748   Also COVID infections dropped by 77% in last guay 02/21/21 05:47:00 AM
#25747   This is done. I was in but sold trade2brich 02/20/21 06:38:31 PM
#25746   I’m hoping for a 52 week high in YJ4LIFE 02/20/21 05:28:21 PM
#25745   $6 sounds great to me. Nebuchadnezzar 02/20/21 05:21:59 PM
#25744   genuinely hope to see $6.00 pps and above JPetroInc 02/20/21 05:18:19 PM
#25743   IBIO has been quite a tricky stock. Nebuchadnezzar 02/20/21 02:25:10 PM
#25742   $ibio $2.06 ^ 0.0289 (1.42%) Taurus69 02/20/21 02:10:07 PM
#25741   That’s a lot nickels. Hehehe!!! YJ4LIFE 02/20/21 12:12:08 AM
#25740   20m nickels? Mmkay Nebuchadnezzar 02/20/21 12:01:58 AM
#25739   ...I'd be a millionaire. frankyahoo 02/19/21 11:56:09 PM
#25738   You worry about nickels while I worry about Nebuchadnezzar 02/19/21 11:52:08 PM
#25737   $ibio $2.11 ^ 0.0789 (3.88%) Taurus69 02/19/21 07:13:57 PM
#25736   Nice score and I agree on a potential JPetroInc 02/19/21 07:00:36 PM
#25735   If I only had a nickel for every frankyahoo 02/19/21 05:46:36 PM
#25734   1 of March litigation against Fraunhofer, the boom alvaroc2 02/19/21 05:25:28 PM
#25733   I think bottom is in now Nebuchadnezzar 02/19/21 05:09:50 PM
#25732   I added 150k shares under $2 but it doebop 02/19/21 05:08:46 PM
#25731   Did some find take a stake? News? Nebuchadnezzar 02/19/21 04:31:12 PM
#25730   Volumn is picking up AH trading. YJ4LIFE 02/19/21 04:13:29 PM
#25729   Yup a lot of buying. I got some YJ4LIFE 02/19/21 04:04:06 PM
#25728   almost 4 million vol in last 5 minutes Nebuchadnezzar 02/19/21 04:02:31 PM
#25727   added 5000 more just now. volume just picked up Nebuchadnezzar 02/19/21 03:58:48 PM
#25726   iBio needs FDA's nod on 201 JPetroInc 02/18/21 08:37:06 AM
#25725   Adding here today! Top Penny 02/18/21 07:52:21 AM
#25724   There is definitely potential here with $IBIO, the Nebuchadnezzar 02/17/21 09:46:48 PM
#25723   well if there's 1 pot that needs stirring, JPetroInc 02/17/21 09:08:10 PM
#25722   i dont know. lol you know I am Nebuchadnezzar 02/17/21 08:22:20 PM
#25721   why do I bother... JPetroInc 02/17/21 08:16:22 PM
#25720   I don't know anything about stocks. This is Nebuchadnezzar 02/17/21 06:32:57 PM
#25719   correct - but you also are aware of JPetroInc 02/17/21 06:26:58 PM
#25718   however you want to slice it, it still Nebuchadnezzar 02/17/21 06:06:03 PM
#25717   those are offerings via capital lifts JPetroInc 02/17/21 05:54:20 PM
#25716   https://www.globenewswire.com/news-release/2020/12/08/2141381/0/en/iBio-Announces-Pricing-of-35-Mill Nebuchadnezzar 02/17/21 03:44:52 PM
#25715   what are you talking about...? JPetroInc 02/17/21 03:43:04 PM
#25714   not anymore, but they did. they better not Nebuchadnezzar 02/17/21 03:40:44 PM
#25713   iBio is not diluting JPetroInc 02/17/21 03:38:49 PM
#25712   its only a good move if they stop Nebuchadnezzar 02/17/21 11:40:02 AM
#25711   Good move, imo YJ4LIFE 02/17/21 11:36:57 AM
#25710   just added 10,000 @ $2.03 for swing trade Nebuchadnezzar 02/17/21 11:08:05 AM
#25709   I don’t think this is going to reach bennn000 02/17/21 10:19:17 AM
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