Policy & Regulation
Oragenics Provides Update on SARS-CoV-2 (COVID-19) Vaccine Programme
10 July 2020 - - US-based biotechnology company Oragenics, Inc. (NYSE American: OGEN) has provided an update on progress with its SARS-CoV-2 (COVID-19) vaccine candidate and announced the termination of its clinical development programme with AG013 for the treatment of severe oral mucositis in cancer patients.

While working with contract research organization Aragen Bioscience to advance the company's recently acquired COVID-19 vaccine candidate, TerraCoV2, the National Institutes of Health-created stabilized pre-fusion spike protein gene has been successfully inserted into Chinese Hamster Cells and "mini-pool" production and analytical development are underway.

The transfer to full-scale manufacture is expected to commence later this summer.

Separately, following a further review of new data and other factors related to the company's international multicenter Phase 2 clinical trial of AG013 in oral mucositis, Oragenics has determined to cease further development of AG013 in this indication by discontinuing the trial and withdrawing the applicable Investigational New Drug application.

As a result, on July 9, 2020, the company, Precigen, Inc. and Precigen's wholly owned subsidiary mutually agreed to terminate the Exclusive Channel Collaboration agreement for AG013 as a treatment of severe oral mucositis in cancer patients. The company expects to continue to comply with any applicable regulatory requirements with respect to discontinuing the clinical trial.

Oragenics, Inc. is focused on developing the TerraCoV2 immunization product candidate to combat the novel coronavirus pandemic and the further development of effective treatments for novel antibiotics against infectious disease.

Through its wholly owned subsidiary Noachis Terra, the company is dedicated to the development and commercialisation of a vaccine candidate providing specific immunity from the novel coronavirus, SARS-CoV-2, which causes COVID-19.

The TerraCoV2 immunization leverages coronavirus spike protein research conducted by the National Institutes of Health, which issued a worldwide, nonexclusive intellectual property license to Noachis Terra.

In addition, Oragenics has an exclusive worldwide channel collaboration with ILH Holdings, Inc. relating to the development of novel antibiotics.
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