“We’re looking to license potent new molecules from academic institutions for these indications,” says Qiang Xu, Ph.D., director of the MucoCept research program at Osel.
Gastrointestinal microbes, designed to deliver antibodies against inflammatory agents, could treat inflammatory bowel disorders. Colleagues in Europe completed a Phase I study of Crohn’s patients treated with a Lactococcus that delivers interleukin-10. “It’s a revolutionary way to think about the delivery of biologics,” says Dr. Lee.
The technology may also raise perception and safety issues. Will consumers who protest genetically engineered corn want a modified bacterium inserted into their bodies? “It’s a pioneering program, and the FDA will probably raise safety concerns,” says Dr. Xu.
Osel plans to address potential safety and environmental issues before seeking FDA approval. For instance, the European group designed a unique biological containment system to prevent their bacterium from entering the environment.
Osel researchers have demonstrated that their human Lactobacillus strain replicates poorly outside the body. The success of the MucoCept platform lies in proving that “the genetic modifications we make do not alter the bacterium’s pathogenic potential or growth properties,” Dr. Lee says.
A now defunct biotechnology company tried previously to develop an HIV microbicide for women by expressing CV-N in E. coli bioreactors, purifying it, and formulating a gel. This approach, however, proved difficult, costly, and impractical. Osel’s bacterial product that colonizes the vaginal mucosa and expresses the microbicide locally will be self-renewing, inexpensive to manufacture, and able to treat women globally.
Dr. Lee foresees a tablet form of the microbicide to preserve its activity during shipping. Once inserted into the vagina, the body’s fluids will trigger bacterial growth and CV-N production.