KBI TO PRODUCE MATERIAL FOR USE IN FUTURE EXPECTED PHASE 2 CLINICAL TRIAL OF ORAGENICS’ INTRANASAL VACCINE CANDIDATE
TAMPA, Fla. (March 10, 2022) – Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced it has entered into an agreement with KBI Biopharma, Inc. (“KBI”) 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. 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," stated Frederick W. Telling, Ph.D., Executive Chairman of Oragenics. "As a contract manufacturer accelerating the development of innovative discoveries into life-changing biological products, KBI is perfectly positioned for first manufacturing for Oragenics," said Brandon Vail, Senior Vice President, KBI Business Development. "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. About KBI Biopharma, Inc. KBI Biopharma, a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. With each of its 500+ client partners, KBI works closely to personalize and rapidly accelerate drug development programs. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, KBI delivers robust process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. Recognized for quality manufacturing, KBI helps partners advance drug candidates into the clinic and beyond. KBI serves its global partners with multiple locations in Europe and the USA.
About Oragenics, Inc. Oragenics, Inc. is a development-stage company dedicated to fighting infectious diseases including coronaviruses and multidrug-resistant organisms. Its lead product is NT-CoV2-1, an intranasal vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus. The NT-CoV2-1 program leverages coronavirus spike protein research licensed from the NIH and the NRC with a focus on reducing viral transmission and offering a more patient-friendly intranasal administration. Its lantibiotics program features a novel class of antibiotics against bacteria that have developed resistance to commercial antibiotics.
