Oragenics said it has been informed by the Biomedical Advanced Research and Development Authority of BARDA's determination not to enter into negotiation with the company.
While BARDA noted the company's submission aligned with its mission, a combination of factors, including availability of funds, precluded the agency from entering into negotiations at this time.
BARDA noted that evaluation of vaccine development under the Operation Warp Speed program continues and can be an avenue for promising vaccine candidates, which the company believes Terra CoV-2 to be.
In addition, BARDA has suggested that if promising vaccine candidates are identified, there is also an opportunity for a potential partnership with the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).
BARDA is part of the US Department of Health and Human Services, OWS is a public-private partnership initiated by the White House in May 2020 and JPEO-CBRND is part of the US Department of Defense.
In March 2020, Oragenics acquired a non-exclusive license from the National Institutes of Health for its stabilized prefusion Terra CoV-2 spike protein.
Oragenics recently announced that its spike protein had been successfully inserted into Chinese Hamster Ovary cells and "mini-pool" production and analytical development are underway.
CHO cells are used to produce a number of FDA-approved recombinant proteins.
Oragenics, Inc. is focused on the creation of the Terra CoV-2 vaccine candidate to combat the novel coronavirus pandemic and the further development of effective treatments for novel antibiotics against infectious disease.
The company is dedicated to the development and commercialization of a vaccine candidate providing specific immunity from novel coronavirus. The Terra CoV-2 immunization leverages coronavirus spike protein research conducted by the National Institute of Health.
In addition, Oragenics has an exclusive worldwide channel collaboration with ILH Holdings, Inc. (n/k/a Eleszto Genetika, Inc.), relating to the development of novel lantibiotics.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA