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DPOLT™ Synthetic Chemistry Platform
Background. Differentially Protected Orthogonal Lantionine Technology (DPOLT) is a solid/liquid phase peptide synthesis platform technology that has broad application for the cost-effective manufacture of a number of commercially important bioactive peptides, including lantibiotics. Lantibiotics, which include the Company’s lead antibiotic drug candidate, MU1140™, constitute a potentially important class of antibiotics. The commercial need for new antibiotics has been emphasized recently by the well-publicized fact that many strains of medically important bacteria have become increasingly resistant to currently marketed antibiotics.
In May 2006, Oragenics announced that it had received a competitive Small Business Innovative Research (SBIR) Phase 1 grant from the National Science Foundation (NSF). The funded research, which began in the third quarter of 2006, has been focused on the production of specific lantibiotics of commercial interest. In February of 2008, the Company was awarded an SBIR Phase II grant from NSF to help support continued development and commercialization of this platform technology as it relates to the analog synthesis by DPOLT of representative antibiotic candidates with potentially improved peptide stability or bioavailability. Oragenics filed a US and international patent application in August of 2006 covering the intellectual property surrounding the DPOLT solid/liquid phase peptide synthesis platform technology.
Technical Background. Lantibiotics constitute a family of polycyclic peptides that are produced by bacteria, and are highly modified structurally. Until now, attempts to study any of the more than fifty known lantibiotics for its potential usefulness as a therapeutic agent has been hindered by difficulties in producing sufficiently pure material, in amounts adequate for preclinical and clinical testing. In October of 2008, Oragenics announced that its research team, lead by Dr. Jeffrey Hillman, successfully synthesized the first complete and bioactive analog of a lantibiotic, its own MU1140. The Company also announced at that time that it had retained the services of Almac Sciences of the UK, a leading contract manufacturer, to refine and scale-up GMP production of the synthetic MU1140 analog to achieve sufficient quantities for it to be fully tested for regulatory approval.
Regulatory Status. DPOLT has already demonstrated proof-of concept, with the successful synthesis of an active analog of MU1140. Once Almac Sciences successfully scales-up the manufacturing process and provides Oragenics with sufficient GMP material, the Company plans to complete the necessary remaining preclinical testing and then file an Investigational New Drug (IND) application with the FDA to begin clinical testing of this new antibiotic drug candidate for safety and efficacy. The Company anticipates that it could enter clinical trials near the end of 2009 or early in 2010.
