Oragenics, Inc. (NYSE MKT: OGEN), a leader in the development of novel, effective antibiotics and oral care probiotics, and Intrexon Corporation (NYSE: XON), a leader in synthetic biology, today announced the establishment of an Exclusive Channel Collaboration (ECC) to develop and commercialize genetically modified probiotics for the treatment of diseases of the oral cavity, throat, sinus and esophagus. The team is expected to initially focus on therapies for Behçet’s disease and aphthous stomatitis.
The collaborators will utilize their technical and clinical expertise with genetically modified oral microbes to pursue a novel, short-term therapeutic agent. The ECC plans to design genetically modified probiotics that will work orally, administered in, for example, lozenge form rather than through the digestive system – thereby increasing the probability of effective treatment outcomes.
It is anticipated that the therapeutic will treat oral lesions associated with Behçet’s, targeting pain management and functional impairment by suppressing the inflammatory response, reducing frequency of occurrence and avoiding the onset of new lesions. The same treatment may also be applicable in the more commonly experienced recurrent aphthuous stomatitis, better known as canker sores. Both disease states are currently only treated symptomatically and with limited success.
John N. Bonfiglio, Ph.D., President and Chief of Executive Officer of Oragenics, was motivated by the continued success of Oragenics’ existing ECC with Intrexon, coupled with the potential market opportunity for a modified probiotic, to establish an additional collaboration with Intrexon.
“Intrexon’s cutting edge technology in gene manipulation enables us to expand our current expertise in the field of oral probiotics. Working together with Intrexon, we will capitalize upon the experience gained from our first GM microbial offering to establish a new modified probiotic that will improve the lives of currently underserved patients,” Bonfiglio said.
Samuel Broder, M.D., Senior Vice President of Intrexon’s Health Sector and former Director of the National Cancer Institute was intrigued by the possibility of expanding Oragenics’ oral probiotics capabilities to encompass new applications through the collaboration of Intrexon’s synthetic biology expertise.
“Oragenics has an expertise in oral probiotics that lays the foundation for the development of a genetically modified product, including clinical and regulatory experience,” Dr. Broder said. “Their patented oral probiotic technology makes the company an ideal collaborator for the treatment of these unmet clinical needs. We look forward to deepening our already fruitful collaborative relationship to include this new therapeutic opportunity.”
In June 2012, Oragenics and Intrexon entered into an ECC to develop and commercialize lantibiotics, a novel class of broad-spectrum antibiotics, for the treatment of infectious diseases. The collaboration recently demonstrated initial success in producing improved titers of Oragenic’s lead compound MU1140 through a genetically engineered host, progressing toward the goal of commercial production of lantibiotics.
Through the new ECC, Intrexon will be responsible for technology discovery efforts, cell-engineering development, and certain aspects of the manufacturing process. Oragenics will be responsible for conducting preclinical and clinical development of candidate probiotics, as well as for other aspects of manufacturing and the commercialization of the product(s).
Under terms of the ECC agreement:
Oragenics paid Intrexon a technology access fee of $6.0 Million at closing, payable in
1,348,000 shares of Oragenics’ common stock at a value per share of $3.00 and a promissory note in the principal amount of $1,956,000. In addition, Oragenics will pay to Intrexon program costs, developmental milestone fees and commercial royalties.
- Intrexon will provide access to its platform technologies and capabilities including the UltraVector® platform, DNA and RNA MOD engineering, cell system engineering, genome engineering, and protein engineering.
Concurrently with the ECC agreement, Intrexon also purchased 1.3 Million shares of Oragenics’ common stock in a private placement at a price per share of $3.00 for an aggregate purchase price of $3.9 Million. The net proceeds will be used for development of key initiatives relating to Organics’ probiotics program that is part of its new exclusive channel collaboration with Intrexon, and general corporate purposes.
The Oragenics common stock sold to Intrexon in the private placement transaction has not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws and was issued and sold in reliance upon the exemption from registration contained in Section 4(2) of the Securities Act and Regulation D promulgated thereunder. Accordingly, the securities issued to Intrexon may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
This press release does not constitute an offer to sell or the solicitation of an offer to buy Oragenics’ securities, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.
___________________________________________________________________________________________________________
Related articles on DentistryIQ.com
___________________________________________________________________________________________________________
