[Federal Register Volume 69, Number 177 (Tuesday, September 14, 2004)]
[Notices]
[Pages 55443-55445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-20656]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Licensing Opportunity and/or Cooperative Research and Development 
Agreement (``CRADA'') Opportunity: Live Attenuated Respiratory 
Syncytial Virus (RSV), Human Metapneumovirus (HMPV), and Parainfluenza 
Virus (PIV) Vaccines

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) is seeking Licensee(s) 
and/or a commercial collaborator(s) to further develop, test, and 
commercialize as live attenuated virus vaccines certain recombinant 
RSV, HMPV and/or PIV strains and associated intellectual property 
developed in the Laboratory of Infectious Diseases (LID), Division of 
Intramural Research, National Institute of Allergy and Infectious 
Diseases (NIAID).

DATES: Respondents interested in licensing the invention will be 
required to submit an ``Application for License to Public Health 
Service Inventions'' to NIH (attention Susan Ano, Ph.D. at the address 
mentioned below) on or before November 15, 2004, for priority 
consideration.
    Potential CRADA collaborators must submit a letter summarizing 
their interests and capabilities to the NIAID (attention Richard K. 
Williams, Ph.D. at the address mentioned below) on or before November 
15, 2004, for consideration. Guidelines for preparing full CRADA 
proposals will be communicated shortly thereafter to all respondents 
with whom initial confidential discussions will have established 
sufficient mutual interest.
    CRADA and PHS License Applications submitted thereafter may be 
considered if a suitable CRADA collaborator or Licensee(s) has not been 
selected.

FOR FURTHER INFORMATION CONTACT: Inquiries about these licensing 
opportunities should be addressed to Susan Ano, Ph.D., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: (301) 435-5515; facsimile: (301) 402-
0220; e-mail: [email protected]. Information about Patent Applications 
and pertinent information not yet publicly described can be obtained 
under the terms of a Confidential Disclosure Agreement. Respondents 
interested in licensing the inventions will be required to submit an 
``Application for License to Public Health Service Inventions''.
    Depending upon the mutual interests of the Licensee(s) and the 
NIAID, a CRADA to collaborate to develop RSV, HMPV, and/or PIV vaccines 
in humans may also be negotiated. Proposals and questions about this 
CRADA opportunity should be addressed to Richard K. Williams, Ph.D., 
Technology Development Associate, Office of Technology Development, 
NIAID, 6610 Rockledge Drive, Room 4071, Bethesda, MD 20892-6606; 
telephone: (301) 402-0960; e-mail: [email protected]. Respondents 
interested in submitting a CRADA Proposal should be aware that it may 
be necessary to secure a license to the above-mentioned patent rights 
in order to commercialize products arising from a CRADA.

SUPPLEMENTARY INFORMATION: The portfolios listed below describe 
approaches to the development of live, attenuated vaccines for 
intranasal delivery against respiratory syncytial virus (RSV) subgroups 
A and B, human

[[Page 55444]]

metapneumovirus (HMPV), and three parainfluenza viruses (PIV1, -2, and 
-3), which account for up to 55-60% of serious respiratory tract 
infection in children and infants less than one year of age. Live 
attenuated viruses are the most promising candidate vaccines because 
they induce both local and systemic immunity and are efficacious even 
in the presence of passively transferred serum antibodies, the very 
situation found in the target population of infants with maternally 
derived antibodies.
    These patents and patent applications describe broadly the 
generation of live attenuated vaccine viruses from recombinant cDNA 
clones for RSV, HMPV and PIV1, 2 and 3. For RSV and the PIVs, 
attenuation is achieved by missense mutations optimized for genetic 
stability, by gene deletion (e.g. E-089-1997; E-194-1999), by deletion 
of codons, by host range sequences (e.g. E-178-1999; E-201-2000; E-202-
1999; E-187-1995), or by a combination of these (e.g. E-142-1996). HMPV 
has been attenuated by gene deletion (E-093-2003) and should be 
amenable to the other methods as well. Chimeras are described that 
contain the protective antigens of RSV subgroup B on an attenuated 
subgroup A background (e.g. E-178-1999), using a single attenuated 
backbone to make vaccines against both subgroups. Importantly, each of 
PIV viruses can be used as stable, efficient vectors for expressing the 
protective antigens of RSV, HMPV, or other viral pathogens in a 
schedule that permits boosting of immune responses (e.g. E-099-1999; E-
089-1997; E-280-2001; E-092-2002). In this strategy, the PIV vector is 
a needed vaccine in addition to the expressed RSV/HMPV antigens, 
resulting in a bi- or multi-valent vaccine virus.
    Augmentation of the immune response to the protective antigens can 
be achieved by positioning them in a more promoter proximal position 
(e.g. E-225-2000), by altering the regulation of viral transcription 
and replication by gene deletion, by deleting proteins that interfere 
with the host immune response, or by introducing an immunopotentiating 
molecule such as GM-CSF into the coding sequence of the vaccine virus 
(e.g. E-041-1999). Each of the viruses replicates efficiently in vitro, 
and stability of the attenuation phenotype can be achieved for each of 
the viruses described.
    There are multiple approaches to the development of these live 
attenuated intranasal vaccines for RSV and PIV, making it possible for 
different parties to pursue unique approaches to vaccine development. 
The following patents and patent applications are available for 
licensing; certain virus vaccine strains are also available for 
licensing.

RSV Portfolio

1. E-123-1992/0,1,2

Attenuated Respiratory Syncytial Virus Vaccine Compositions

    U.S. Patent 5,922,326 (issued July 13, 1999); U.S. Patent 
6,284,254 (issued September 4, 2001); U.S. Patent 5,882,651 (issued 
March 16, 1999); PCT/US93/03670 (publication WO 93/21310) and all 
corresponding foreign rights.

2. E-187-1995/0,1,2

Production of Infectious Respiratory Syncytial Virus From Cloned 
Nucleotide Sequences

    U.S. Patent 6,264,957 (issued July 24, 2001); PCT/US96/15524 
(publication WO 97/12032) and all corresponding foreign rights.

3. E-142-1996/0-4

Production of Attenuated Respiratory Syncytial Virus Vaccines From 
Cloned Nucleotide Sequences

    U.S. Patent 5,993,824 (issued November 30, 1999); U.S. Patent 
6,689,367 (issued February 10, 2004); USSN 09/444,067 (filed 
November 19, 1999); USSN 09/444,221 (filed November 19, 1999); PCT/
US97/12269 (publication WO 98/02530) and all corresponding foreign 
rights.

4. E-040-1999/0

Production of Attenuated Negative Stranded RNA Virus Vaccines From 
Cloned Nucleotide Sequences

    USSN 09/958,292 (filed January 1, 2002); PCT/US00/09695 
(publication WO 00/61737) and all corresponding foreign rights.

5. E-041-1999/0

Production of Recombinant Respiratory Syncytial Viruses Expressing 
Immune Modulatory Molecules

    U.S. Patent 6,699,476 (issued March 2, 2004); USSN 10/031,095 
(filed January 9, 2002); USSN 10/754,895 (filed January 8, 2004); 
PCT/US00/19042 (publication WO 01/04271) and all corresponding 
foreign rights.

6. E-194-1999/0

Production of Attenuated Respiratory Syncytial Virus Vaccines Involving 
Modification of M2 ORF2

    U.S. Patent 6,713,066 (issued March 30, 2004).
    7. E-178-1999/0,1,2

Production of Attenuated, Human-Bovine Chimeric Respiratory Syncytial 
Virus Vaccines (E-178-1999/0,1,2)

    USSN 09/602,212 (filed June 23, 2000); USSN 10/030,951 (filed 
January 8, 2002); USSN 10/704,116 (filed November 7, 2003); PCT/
US00/17755 (publication WO 01/04335) and all corresponding foreign 
rights.
    8. E-225-2000/0
    Respiratory Syncytial Virus Vaccines Expressing Protective 
Antigens From Promotor-Proximal Genes
    USSN 09/887,469 (filed June 22, 2001); USSN 10/312,191 (filed 
December 20, 2002); PCT/US01/20107 (publication WO 02/00693) and all 
corresponding foreign rights.

PIV Portfolio

1. E-089-1997/2,3,4,5,6

Production of Parainfluenza Virus From Cloned Nucleotide Sequences

    USSN 09/424,628 (filed April 5, 2000), USSN 09/083,793 (filed 
May 22, 1998), USSN 09/586,479 (filed June 1, 2000), USSN 09/459,062 
(filed December 10, 1999); USSN 09/350,831 (filed November 9, 1999); 
U.S. Patent 6,410,023 (issued June 4, 2002); U.S. Patent 6,410,023 
(issued June 25, 2002); PCT/US98/10551 (publication 98/53078), PCT/
US00/18523 (publication WO 01/03744) and all corresponding foreign 
rights.

2. E-099-1999/0,1

Use of Recombinant Parainfluenza Viruses (PIVs) as Vectors To Protect 
Against Infection and Disease Caused by PIV and Other Human Pathogens

    USSN 09/733,692 (filed December 8, 2000), PCT/US00/33293 
(publication WO 01/42445) and all corresponding foreign rights.

3. E-202-1999/0

Attenuated Human-Bovine Chimeric Parainfluenza Virus (PIV) Vaccines

    USSN 10/030,544 (filed January 8, 2002); PCT/US00/17066 
(publication WO 01/04320) and all corresponding foreign rights.

4. E-201-2000/0

Attenuated Human-Bovine Chimeric Parainfluenza Virus (PIV) Vaccines

    USSN 09/900,112 (filed July 5, 2001).
    5. E-280-2001/0

Recovery of Recombinant Human Parainfluenza Virus Type 1 (HPIV1) from 
cDNA and Use of Recombinant HPIV1 as Vaccines and Vectors to Protect 
Against Infection and Disease Caused by PIV and Other Human Pathogens

    USSN 10/302,547 (filed November 21, 2002); PCT/US02/37688 
(publication WO 03/043587) and all corresponding foreign rights.

6. E-092-2002/0

Recovery of Recombinant Human Parainfluenza Virus Type 2 (HPIV) From 
cDNA and Use of Recombinant HPIV2 in Immunogenic Compositions and as 
Vectors To Elicit Immune Responses Against PIV and Other Human 
Pathogens

    USSN 10/667,141 (filed September 18, 2003); PCT/US03/29685 
(publication WO 2004/027037).

HMPV Portfolio

1. E-093-2003/0-2

Recovery of Recombinant Human Metapneumovirus (HMPV) From cDNA and Use 
of Recombinant HMPV in Immunogenic Compositions and as Vectors To 
Elicit Immune Responses Against HMPV and Other Human Pathogens

    USSN 60/451,119 (filed February 28, 2003); USSN 60/478,667 
(filed June 13, 2003); PCT/US04/05881 (filed February 27, 2004); and 
USSN 10/789,400 (filed February 27, 2004).


[[Page 55445]]


    Dated: September 7, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-20656 Filed 9-13-04; 8:45 am]
BILLING CODE 4140-01-P