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CPG oligodeoxynucleotides and their use to induce an immune response

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Technology Summary

While oligonucleotides comprising 5'—C—phosphate—G—3 ' (CpG) sequences can effectively induce an immune response in human immune system cells, individuals respond with considerable heterogeneity depending on the specific CpG sequence. Unpredictable immune responses to CpGs present a challenge for inducing a consistent therapeutic immune response in all members of a diverse population using a single CpG sequence, even when that sequence is replicated in a CpG oligonucleotide.

FDA inventors discovered that using a mixture of multiple immune-activating oligonucleotides with different CpG motifs can induce a broad-based immunomodulatory response in a wide cross-section of subjects. These oligodeoxynucleotide mixtures comprise either different oligodeoxynucleotides expressing different CpG motifs or a single oligodeoxynucleotide containing multiple different motifs. These oligodeoxynucleotides also have the capacity to stimulate humoral, cell-mediated immune responses or both humoral and cell-mediated immune responses, depending on the motifs utilized.

Potential Commercial Applications Competitive Advantages
  • Treating allergies, infectious diseases, cancer, and autoimmune disorders;
  • Vaccine adjuvants for conventional and DNA vaccines
  • Anti-sense therapeutics.
  • Multiple different ODN can be administered to induce an immune response

Inventors: Dennis Klinman, Daniela Verthelyi, Ken Ishii

Klinman et al., "CpG Motifs Present in Bacterial DNA Rapidly Induce Lymphocytes to Secrete Interleukin 6, Interleukin 12 and Interferony.” Proc. Natl. Acad. Sci. USA 93: 2879-2883 (1996). PMID: 8610135

Intellectual Property:
United States Patent No. 7,919,477 issued 04.05.2011
United States Patent No. 7,521,063 issued 04.21.2009
United States Patent No. 8,232,259 issued 12.01.2015
International Patents

Product Area: Vaccine, adjuvant, therapeutic, allergy

FDA Reference No: E-2000-011

Licensing Contact:
Ken Millburne, J.D.
FDA Technology Transfer Program
Email: FDAInventionlicensing@fda.hhs.gov
Phone: 301-346-3964

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