02-5933. Prospective Grant of Exclusive License: Uses of Cyanovirin-N for HIV Vaccines

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

This is notice in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i) that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the inventions embodied in patents under “Supplementary Information” to OmniViral Therapeutics LLC, having a place of business in Gaithersburg, Maryland. The patent rights in these inventions have been assigned to the Government of the United States of America.

The field of use may be limited to four vaccine strategies based on:

1. Conjugate consisting of HIV virions inactivated with Cyanovirin-N or homolog thereof

2. Conjugate consisting of gp120, an HIV envelope protein, and Cyanovirin-N or homolog thereof

3. Native Cyanovirin-N or homolog thereof to stimulate a virus neutralizing response via endogenous anti-idiotypic antibodies

4. Identification of Cyanovirin-N-binding-site anti-idiotypic monoclonal antibodies, and use thereof as a primary antigen

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before May 13, 2002, will be considered.

ADDRESSES:

Requests for a copy of this patent application, inquiries, comments and other materials relating to the contemplated license should be directed to Cristina Thalhammer-Reyero, Ph.D., M.B.A., Technology Transfer Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852; Telephone: [phone] extension 263; Facsimile: [phone]; E-mail: [e-mail]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION:

The patents and patent applications to be licensed are:

Patent No 6,245,737, issued 06/12/2001, entitled “Conjugates of Antiviral Proteins or Peptides and Virus or Viral Envelope Glycoproteins”, (E-117-95/7);

PCT/US99/18975 (WO00/11036), filed Aug. 19, 1998, allowed, entitled “An Anti-Cyanovirin Antibody with an Internal Image of gp120, a Method of Use Thereof, and a Method of Using a Cyanovirin to Induce an Immune Response to gp120” (E-117-95/8);

PCT/US00/06247 (WO00/53213) filed March 10 2000, pending, entitled “Cyanovirin Conjugates, Matrix-Anchored Cyanovirin And Anti-Cyanovirin Antibody, And Related Compositions And Methods of Use” (E-074-99/2);

US Patent No. 6,015,876, issued 01/18/2000, entitled “Methods Of Using Cyanovirins” (E-074-99/3);

USSN 09/428,275 filed 10/27/1999, pending, entitled “Methods of Using Cyanovirins to Inhibit Viral Infection” (E-074-99/5);

USSN 09/714,884 filed 03/22/2001, pending, entitled “Conjugates of Antiviral Proteins or Peptides and Virus or Viral Envelope Glycoproteins” (E-074-99/8);

US Patent No. 5,843,882, issued Dec. 01, 1998, entitled “Antiviral Proteins and Peptides” (E-117-95/0);

US Patent No. 5,821,081, issued Oct. 13, 1998, entitled “Nucleic Acids Encoding Antiviral Proteins and Peptides, Vectors and Host Cells Comprising Same, and Methods of Producing the Antiviral Proteins and Peptides” (E-117-95/1);

US Patent No. 6,015,876, issued Jan. 18, 2000, entitled “Method of Using Cyanovirins (E-117-95/3);

US Patent No. 5,998,587, issued Dec. 7, 1999, entitled “Anti-Cyanovirin Antibody” (E-117-95/6);

And related U.S. and foreign cognates of the PCT patent applications.

The inventors have found that Cyanovirin-N, a naturally occurring anti-HIV protein originally isolated from Nostoc ellipipsosporum, a blue-green algae, has potent neutralizing activity against HIV 1 and 2 by blocking the fusion reaction between HIV and CD4 cells. Cyanovirin-N is now expressed in a DNA coding sequence in E. coli. New information on the nature of the interaction of the HIV envelope with the cell surface during the binding, entry and fusion process has led to new ideas about how to improve envelope immunogenicity. Among these ideas are the various ways of using Cyanovirin-N in preparing reagents for use in a potential HIV vaccine.

The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. This prospective exclusive license may be granted unless within 60 days from the date of this published notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Applications for a license filed in response to this notice will be treated as objections to the grant of the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Dated: March 5, 2002.

Jack Spiegel,

Director, Division of Technology Development and Transfer, Office of Technology Transfer.