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CPG oligodeoxynucleotides and their use to induce an immune response

Download the Abstract (PDF - 107KB)

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

Publications:
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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