Candidate: Terra Cov-2
Type: Vaccine designed to provide specific immunity from SARS-CoV-2, incorporating CoV-2 S-2P, a stabilized pre-fusion spike protein gene created by the NIIH, which has issued a worldwide, nonexclusive intellectual property license to Oragenics wholly-owned subsidiary Noachis Terra.
2021 Status: Hamster Challenge Study Launched—Oragenics said September 15 that it launched a hamster challenge study designed to evaluate the immunogenicity and viral load reduction impact of Terra CoV-2. The study is intended to provide data for several vaccine formulations, using adjuvants specific for both intranasal and intramuscular routes of administration.
An assessment of cross-neutralization titers against the Wuhan, Beta and Delta variants of COVID-19 and reduction in the viral load of the Wuhan challenge virus will be used to establish the most promising formulations to advance to human clinical studies, Oragenics said. The study is being conducted by the Company’s Canadian collaborator with results expected in November.
2020 Status: Oragenics said August 20 that it entered into a process development and drug substance manufacturing agreement of undisclosed value with Avid Bioservices, through which Avid agreed to provide Oragenics with analytical method development, process development, and drug substance manufacturing services to support development of Terra CoV-2.
The companies said they will immediately begin the initial phase of the project, which includes analytical method feasibility and qualification activities, followed by upstream and downstream process development and CGMP drug substance manufacturing of Terra CoV-2 within Avid’s Myford facility in Irvine, CA, where the company is based. These activities are designed to support Oragenics’ goal of advancing Terra CoV-2 into human clinical trials by early 2021, the companies said.
Oragenics President and CEO Alan Joslyn, PhD, said in a statement that Avid’s manufacturing infrastructure includes three 2000L single-use bioreactors and “considerable” space for expansion.
On July 22, Oragenics said its NIH-created, company-licensed stabilized pre-fusion spike protein gene CoV-2 S-2P generated neutralizing antibodies in mice during immunization against SARS-CoV-2 in an NIH preclinical study. The study showed that the spike protein, adjuvanted with the TLR-4-agonist Sigma Adjuvant System designed to induce T cell activation, generated neutralizing antibody titers in both a pseudovirus neutralization assay and a plaque reduction neutralization titer (PRNT) assay.
The immunization also produced a balanced Th1/Th2 response, Oragenics said, with President and CEO Alan Joslyn, PhD, stating that the company anticipated conducting Phase I human clinical studies in early 2021.
On July 10, Oragenics said its NIH-created stabilized pre-fusion spike protein gene was successfully inserted into Chinese Hamster Cells, as part of work being conducted with contract research organization Aragen Bioscience, with mini-pool production and analytical development now underway. A transfer to full-scale manufacture is expected to commence later this summer.
“As we await Biomedical Advanced Research and Development Authority (BARDA) and other federal and state non-dilutive grant decisions, we expect to use our available cash to continue development of TerraCoV2, with the goal of bringing this COVID-19 vaccine candidate into human clinical trials by early 2021,” said Oragenics President and CEO Alan Joslyn, PhD.
In May, Oragenics said that through its newly-acquired subsidiary Noachis Terra, it entered into an agreement with Aragen to advance TerraCov2. Aragen, a wholly owned subsidiary of GVK BIO, agreed to provide cell line development services to Oragenics to aid in the development of the vaccine candidate. Oragenics that month acquired Noachis Terra through a stock purchase agreement under which it paid $1.925 million, part of which retired outstanding obligations of Noachis Terra with the rest being paid to founder and former sole shareholder Joseph Hernandez. Oragenics issued 9.2 million shares of its common stock, plus warrants to purchase another 9.2 million shares of common stock, at an exercise price of $1.25 per share and a five-year term.
Oragenics disclosed that it may be obligated to pay Hernandez contingent cash consideration in the future in accordance with the agreement, in exchange for all issued and outstanding common stock of Noachis Terra, which became a wholly-owned subsidiary of the Company.
TerraCoV2 is based on coronavirus spike protein research conducted by the NIH, which has issued a worldwide, nonexclusive intellectual property license to Noachis Terra in March.
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: