Candidate: IBIO-201

Category: VAX

Type: Subunit vaccine combining antigens derived from the SARS-CoV-2 spike protein fused with the company’s patented lichenase booster molecule (LicKM™), designed to enhance immune response.

2021 Status: iBio said May 6 that it completed IND-enabling toxicology studies that identified no adverse effects at low or high doses. The company offered no further development details. “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,” said Tom Isett, iBio’s Chairman and CEO.

2020 Status: iBio said June 4 that it has begun preclinical immunization studies for its second COVID-19 vaccine program, which combines the company’s plant-based FastPharming System™ with LicKM. By adding the LicKM booster to a subunit antigen, the vaccine is expected to improve the likelihood of achieving single-dose, prolonged immunity while also increasing manufacturing capacity through increased potency, iBio said.

IBIO-201 will be tested at Texas A&M University System (TAMUS) laboratories as part of a Master Joint Development Agreement established between TAMUS and iBio in 2016, as well as a Memorandum of Understanding between iBio and Infectious Disease Research Institute (IDRI) signed in April. The company said it will decide whether to exercise its option to include one of IDRI’s novel adjuvants in any COVID-19 vaccine programs within 60 days of completing immunization studies.

If IBIO-201 advances to clinical trials, iBio said, it can rapidly develop and manufacture at clinical and commercial scales in its 130,000-square-foot facility in Bryan, TX. iBio’s FastPharming Manufacturing Facility was built in 2010 with funding from the Defense Advanced Research Projects Agency (DARPA) as part of the “Blue Angel” initiative to establish factories capable of rapid delivery of medical countermeasures in response to a disease pandemic. The facility is equipped with automated hydroponics and vertical farming systems designed to produce biologics, using a relative of the tobacco plant.


COVID-19: 300 Candidates and Counting

To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:

● ANTIVIRAL
● VAX
● ANTIBODY
● RNA