TerraCoV2 / Oragenics, National Institute of Allergy and Infectious Diseases - LARVOL DELTA

Oragenics Enters into Material Transfer Agreement with Biodextris for Mucosal Adjuvant for Intranasal COVID-19 Vaccine (Businesswire) - "Oragenics, Inc....announced it has entered into a material transfer agreement with Biodextris Inc. for the use of three intranasal mucosal adjuvants in the Company’s Terra CoV-2 vaccine against COVID-19....BDX100, BDX300 and BDX301 are proteosome-based adjuvants...The initial agreement calls for the three intranasal adjuvants to be used in combination...as part of the preclinical immunological evaluation...The information generated from the studies employing the new intranasal vaccine candidate would potentially support the U.S. Food and Drug Administration ('FDA') Investigational New Drug ('IND') application and an application to Health Canada to initiate clinical trials."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

FDA Broadly Supports Oragenics’ Pre-IND Development Program for its SARS-CoV-2 Vaccine (Businesswire) - "Oragenics, Inc....announced receipt of feedback to its Type B Pre-IND Meeting Request from the U.S. Food and Drug Administration ('FDA') that it is in broad agreement with the Company’s planned approach to clinical development of its SARS-CoV-2 vaccine....Oragenics expects to file the IND by the end of the first quarter of 2021 and commence patient enrollment in the Phase 1 clinical study early in the second quarter of 2021....The FDA has requested additional preclinical animal data for inclusion in the IND filing..."

FDA event • IND • New P1 trial • Infectious Disease • Novel Coronavirus Disease

Oragenics Provides Update on SARS-CoV-2 (COVID-19) Program (Businesswire) - "Oragenics, Inc....today provided an update on progress with its SARS-CoV-2 (COVID-19) vaccine candidate....While working with 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 ('CHO') and 'mini-pool' production and analytical development are underway....'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...'"

Financing • Infectious Disease • Novel Coronavirus Disease

Oragenics acquires Noachis Terra Inc., to develop its TerraCoV2 NIH-generated SARS-CoV-2 (Covid19) vaccine candidate utilizing “Spike Protein” (Businesswire) - "Oragenics, Inc....today announced its acquisition of Noachis Terra Inc., following its entry into a stock purchase agreement...to develop and commercialize TerraCoV2, a vaccine candidate which could provide specific immunity from the novel coronavirus....Noachis Terra Inc., holds a worldwide, nonexclusive license to the TerraCoV2 vaccine candidate from the National Institute of Allergy and Infectious Diseases (NIAID)..."

Commercial • M&A • Infectious Disease • Novel Coronavirus Disease