Oragenics has entered into an agreement with KBI Biopharma for the process transfer, process optimization and cGMP manufacturing of the company’s intranasal vaccine candidate NT-CoV2-1, which is expressed in a proprietary CHO cell line. The agreement covers, among other things, both a 200L demonstration run and a 500L cGMP run.

“We are delighted to enter into a development collaboration for our SARS-CoV-2 intranasal vaccine candidate with an outstanding commercial partner,” said Frederick Telling, chairman of Oragenics. “Successful completion of work under this agreement will enable Oragenics to secure material for a future expected Phase 2 clinical trial. Intranasally delivered SARS-CoV-2 vaccines could provide increased protection in the nose and throat where viral entry occurs. This could lead to lower transmission of the virus compared to the currently available intramuscularly delivered vaccines as well as offering a needle-free delivery option.”

Brandon Vail, senior vice president, KBI Business Development, said, “As a contract manufacturer accelerating the development of innovative discoveries into life-changing biological products, KBI is perfectly positioned for first manufacturing for Oragenics. KBI is proud of the important role in the continued fight against SARS-CoV-2 through our partnership with Oragenics.”

Oragenics previously demonstrated robust immune response and reduction of SARS-CoV-2 viral loads to undetectable levels in the nasal passages and lungs five days following a viral challenge in preclinical models. The company intends to file an IND in 2022 to conduct a first-in-human clinical study with NT-CoV2-1.