A Look At Ibio’s Latest Developments And Roadmap
The pharmaceutical industry, and especially the biologics segment, has been the center of attention this year as biopharma across the world joins the race to develop a working COVID19 cure or vaccine. Some companies have so far made significant strides and are closer to a breakthrough now more than ever. It is, therefore, important for investors to choose their pick now. One of the best candidates for growth in the segment is Ibio. Here is a look at its latest development, which will help paint a picture of whether it is a good investment.
Ibio’s files key patents for technologies to be used in developing treatments against the SARS-CoV-2 virus
Ibio submitted a provisional patent filing with the U.S Patent and Trademark Office on March 11 this year. The provisional filing was for its VLP platform and other technologies there were to be used to develop treatments to fight the coronavirus pandemic. The company was also adequately prepared for rapid research activities to combat the ongoing pandemic thanks to its FastPharming Facility, built in 2010 with funding from DARPA. The facility features vertical farming and hydroponics systems to create a variety of biological treatments through a bioreactor plant.
Ibio followed up the patent announcement a few days later on March 18 with the announcement that it was already making significant progress in vaccine candidates' development activities to combat the coronavirus. It also revealed that the vaccine was developed using the FastPharming system. They were able to develop nanoparticles similar to its SARS-CoV-2 to be used for research purposes in creating the vaccine or cure. The system enables the company to generate large quantities of material for research and also for commercial purposes.
The launch of testing activities
The Biologics company announced on March 26 the launch of two immunization studies involving IBIO-200, its SARS-CoV-2 Virus-Like Particle. The studies were to be conducted at the Texas A&M University System (“TAMUS”) laboratories. Ibio signed a Master Joint Development agreement with TAMUS in 2016, and this agreement has been critical for the studies.
Ibio also announced on the same day on March 26 that it had signed a second Statement of Work with AzarGen Biotechnologies that was part of their previous Master Joint Development Agreement which they signed in 2018. The initial agreement between the two companies facilitated AzarGen’s biosimilars' production to be made at Ibio’s facility in Bryan, Texas. The company also mentioned that it had plans to move its FastPharming Manufacturing System to South Africa, helping AzarGen produce critical medicines for the African continent.
Ibio signs two more Master Services Agreements and an MOU
On April 9 this year, the company announced that it signed two new Master Services Agreements, as well as a memorandum of understanding with the Infectious Disease Research Institute (IDRI). The MSAs and MOU were supposed to facilitate vaccine development using SARS-CoV-2 Virus-Like Particle from Ibio. IDRI would provide support in terms of clinical trial oversight and preclinical development as part of the MSAs.
The MOU between the two entities was aimed at facilitating another separate agreement within 60 days after the MOU, where Ibio had the opportunity to select a novel adjuvant from IDRI as part of IBIO-200’s development program. The MOU and MSAs were also critical in bringing IDRI into the fold for the biologics company’s partnership with the Texas A&M University System. The idea was to enable deeper capabilities, advanced technologies, and experience in IBIO-200’s clinical use.
COVID-19 vaccine development update
Ibio announced on April 19 that it became a member of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Thirteen other companies are part of the organization, and the announcement was critical for investors. NIIMBL was set up as a private partnership whose aim is to fast-track the manufacturing of biomedical innovations. It also focuses on developing an international network that aims to strengthen the U.S pharmaceutical industry's performance.
NIIMBL already boasts of more than 140 industry and academic partners in the U.S. This means that it has been working with key organizations and companies with a similar goal. Ibio hopes that joining NIIMBL will allow it to speed up its development. The company has already been moving rapidly considering the announcements and progress made with its coronavirus vaccine pursuits. The company revealed that the vaccine development efforts were already on track, and the announcement about joining NIIMBL means that it will be expedited even more.
Preclinical immunization studies
June was an exciting month for Ibio and its investors because the company announced its preclinical immunization program, which involved its second coronavirus vaccine platform. The latter is called IBIO-201, and it is a subunit vaccine that combines the company’s lichenase booster molecule (LicKM) with antigens sourced from the SARS-CoV-2 spike protein. The company was excited about this approach because matching a LicKM booster with a subunit antigen increased the probability of creating a single-dose vaccine that will provide prolonged immunity. It also promises to deliver higher manufacturing efficiency courtesy of the higher potency.
Ibio’s extensive research also shows that lichenase thermostable immunomodulator protein technology can potentially boost the durability of the vaccine while at the same time delivering higher potency. Previous peer-reviewed data that the company published shows that its lichenase-based developmental vaccine successfully combat the aerosolized pneumonic plague in non-human primate subjects. The data also highlighted the importance of lichenase technology in pursuing potential vaccines for the yellow fever virus and anthrax virus. The data means more potential vaccines can be made using the technology other than coronavirus vaccines, which means more commercial opportunities.
Ibio is leveraging IBM’s clinical trial management system
Ibio also announced on July 24 that it was granted the right to use IBM Clinical Development (ICD) solution free of charge for 18 months. ICD is part of IBM Watson Health’s offerings that IBM announced earlier this year. It would start offering to the medical community to boost their efforts in combatting the coronavirus pandemic. Numerous research organizations, sponsors, and hospital placed their bids for eligibility to receive the free trial.
ICD is an electronic data capture method used to achieve end-to-end visibility. It is often used to achieve more time and costs efficiency in clinical trials, among other benefits. These benefits build further onto Ibio’s rapid efforts to achieve desired results with its IBIO-200 and IBIO-201 covid19 vaccine candidates.
Ibio announced on June 26 that it was added onto the Russell 3000 and Russell 2000 indexes.
IBIO-201 preclinical studies achieve anti- SARS-CoV-2 response
Ibio provided an update on August 10, revealing that its COVID-19 vaccine candidate IBIO-201's preclinical studies demonstrated that it had a significant ability to counteract the SARS-CoV-2 virus. The data was revealed after the company’s researchers concluded 10 preclinical study arms in which they tested the COVID-19 vaccine candidate. This includes drug combos to be delivered in various ways, including intranasal and intramuscular routes.
The anti-SARS-CoV-2 responses were observed in subjects 21 days after immunization. This was from a 42-day study, and the overall findings indicate that the Th1 and Th2 immune profiles were favorable. The vaccine promoted antibodies that blocked the SARS-CoV-2 spike protein sequences from binding with the ACE2 in ex vivo assays in humans. The company also revealed its preclinical studies' continued evaluation to determine the immune protection and safety profile. The additional testing has been taking place at TAMUS labs.
Ibio and Planet Biotechnology Inc sign exclusive global license agreement for ACE2-Fc
Ibio’s latest announcement on August 28 revealed that it entered into an exclusive global license deal with Planet Biotechnology Inc. The agreement will facilitate the development of Planet’s ACE2-Fc coronavirus treatment candidate. The treatment is a recombinant protein that consists of human angiotensin converting enzyme 2 (ACE2) merged with a human immunoglobulin G Fc fragment (Fc). Ibio will have the exclusive rights to ACE2-Fc as part of the agreement. It will also provide various specified payments to Planet Biotechnology, which will be paid out as milestone payments.