Molecular vaccine linking intercellular spreading protein to...

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Recombinant virus encoding one or more heterologous proteins...

Reexamination Certificate

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C424S204100, C424S229100

Reexamination Certificate

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10343719

ABSTRACT:
Superior molecular vaccines comprise nucleic acids, including naked DNA and replicon RNA, that encode a fusion polypeptide that includes an antigenic peptide or polypeptide against which an immune response is desired. Fused to the antigenic peptide is an intercellular spreading protein, in particular a herpes virus protein VP22 or a homologue or functional derivative thereof. Preferred spreading proteins are VP22 from HSV-1 and Marek's disease virus. The nucleic acid can encode any antigenic epitope of interest, preferably an epitope that is processed and presented by MHC class I proteins. Antigens of pathogenic organisms and cells such as tumor cells are preferred. Vaccines comprising HPV-16 E7 oncoprotein are exemplified. Also disclosed are methods of using the vaccines to induce heightened T cell mediated immunity, in particular by cytotoxic T lymphocytes, leading to protection from or treatment of a tumor.

REFERENCES:
patent: 6017735 (2000-01-01), O'Hare et al.
patent: WO 98 32866 (1998-07-01), None
Michel Nico et al. “Improved Immunogenicity of Human Papillomavirus Type 16 E7 DNA After Fusion to the Herpes Simplex Virus 1 VP22 Gene” Barcelona, Spain, Jul. 23-28, 2000, Abstract 458, XP002201712.
Michel Nico et al. “Enhanced Immunogenicity of HPV 16 E7 Fusion Proteins in DNA Vaccination” Virology vol. 294, pp. 47-59, 2002, XP002201708.
Wolfgang W. Leitner, et al. “DNA and RNA-Based Vaccines: Principles, Progress and Prospects” Vaccine, vol. 18, pp. 765-777, Dec. 10, 1999, XP002201709.
G.J.P. Fernando et al. “Expression, Purification and Immunological Characterization of the Transforming Protein E7, From Cervical Cancer-Associated Human Papillomavirus Type 16” Clin. Exp. Immunol, vol. 115, pp. 397-403, 1999, XP002201710.
Wen-Fang Cheng et al. “Enhancement of Sindbis Virus Self-Replicating RNA Vaccine Potency by Linkage of Herpes Simplex Virus Type 1 VP22 Protein to Antigen” Journal of Virology, vol. 75, No. 5, pp. 2368-2376, Mar. 2001-03, XP002201711.
Gillian Elliott, et al., “Intercellular Trafficking and Protein Delivery by a Herpesvirus Structural Protein”, http://www.cell.com/cgi/content/full88/2/223/, Cell, vol. 88, 223-233, Jan. 1997, 12 pages.

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