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46878 Federal Register / Vol. 70, No. 154 / Thursday, August 11, 2005 / Notices
Chimeric Lentiviral Vectors invention also provides for methods of Licensing Contact: Robert M. Joynes;
Suresh K. Arya (NCI). use to inhibit viral infections 301/594–6565; joynesr@mail.nih.gov.
HHS Reference No. E–191–2005/0— therapeutically and prophylactically as The subject invention is related to a
Research Tool. well as methods of inhibiting virus in potential vaccine against malaria, and in
Licensing Contact: Susan Ano; 301/435– biological samples or inanimate objects. particular to a vaccine that can prevent
5515; anos@mail.nih.gov. Thus, further development of the malaria infection in pregnant women.
Lentiviral vectors have extensive invention may yield novel therapies and The invention relates to the
application in the areas of gene therapy, methods in the prevention of HIV and identification of chondroitin sulphate A
functional genomics, and target other retroviruses, and treatment of (CSA) binding domains in var2CSA
validation, among others. Available for chronic infection in patients with homologs from different parasite strains.
licensing as biological materials are resistance to current therapies. Malaria in pregnancy is a serious
chimeric HIV–1 and HIV–2 lentiviral In addition to licensing, the complication associated with the
transfer and packaging vectors. When technology is available for further parasitized erythrocyte (PE)
using lentiviral vectors, it is important development through collaborative sequestration in the placenta. With
that the vectors incorporate as many research opportunities with the successive pregnancies, pregnant
safety features as possible to avoid the inventors. women develop antibodies that
generation of recombinants or Recombinant MVA Viruses Expressing recognize placental variants worldwide
replication competent viruses. In other Clade A/G and Clade B Modified HIV suggesting these isolates express
available vector systems derived from Env, Gag and Pol Genes Useful for HIV conserved determinants. Plasmodium
HIV–1 or HIV–2, viral genetic elements Vaccine Development falciparum encodes multiple copies of
needed for vector production have been an erythrocyte surface adhesion ligands
split into three parts to address safety Bernard Moss and Linda S. Wyatt called var genes. Recent work suggests
concerns. In the chimeric vectors (NIAID) that two different var genes (var1CSA
available herein, the safety is further U.S. Provisional Application No. 60/ and var2CSA) could have an important
enhanced by taking advantage of the 604,918 filed 27 Aug 2004 (HHS role in PE binding to chondroitin
sequence divergence of HIV–1 and HIV– Reference No. E–337–2004/0–US–01). sulphate A (CSA), a primary placental
2 coupled with functionally Licensing Contact: Susan Ano; 301/435– adherence receptor. It has now been
complementary nature of the genetic 5515; anos@mail.nih.gov. shown that var2CSA is transcribed in
elements. The chimeric packaging The current technology relates to the CSA-binding parasites and that the
vectors primarily involve swapping of construction, characterization and disruption of var2CSA results in the
the gag-pol or tat-rev genes, while the immunogenicity of modified vaccinia inability of the parasites to recover the
transfer vectors involve swapping of the Ankara (MVA) recombinant viruses. The CSA-binding phenotype. Furthermore,
leader-gag sequences. These vectors are MVA double recombinant viruses when expressed in Chinese hamster
potential candidates for use in gene express modified/truncated HIV–1 Env ovary (CHO) cells, three Duffy binding-
therapy, for cell therapy with and mutated HIV Gag Pol under the like domains (DBL2–X, DBL3–X and
genetically modifying stem cells ex control of vaccinia virus early/late DBL6-e) from var2CSA revealed strong
vivo, for use of siRNA or RNA promoters. This technology describes and specific binding to CSA. The
interference for therapeutics, for the MVA double recombinant viruses identification of multiple binding
creation of transgenic animals, and for made by homologous recombination of domains in var2CSA is envisioned as
pathway analysis and target validation single MVA recombinants, one forming the basis of a vaccine against
by introducing novel genes. expressing Env and one expressing Gag malaria, especially in pregnancy.
In addition to licensing, the Pol. These single MVA recombinants are In addition to licensing, the
technology is available for further made using a transiently expressed GFP technology is available for further
development through collaborative marker that is deleted in the final development through collaborative
research opportunities with the viruses. Two recombinant MVA viruses research opportunities with the
inventors. (MVA 65A/G and MVA 62B) made by inventors.
this technology have been shown to Vaccines and Methods of Treating
Scytovirin Domain 1 (SD1) Related produce HIV virus-like-particles that are
Polypeptide Drug-Resistant HIV–1 and Hepatitis B
immunogenic in mice. In addition, these Viruses
Barry R. O’Keefe et al. (NCI) two recombinant MVA viruses
U.S. Provisional Application No. 60/ demonstrate stability through repeated Andrew Catanzaro (NCI), Jay A.
684,353 filed 25 May 2005 (HHS passage of the LVD Seed Stock. This Berzofsky (NCI), Robert Yarchoan
Reference No. E–180–2005/0–US–01). invention provides safe and stable (NCI), Takahiro Okazaki (NCI), James
Licensing Contact: Sally Hu; 301/435– immunogenic clade A/G and clade B T. Snyder II (NCI), Samuel Broder.
5606; e-mail: hus@mail.nih.gov. vectors that may be tested as an AIDS U.S. Provisional Application No. 60/
The invention provides composition vaccine candidate. Therefore, it is a 655,984 filed 22 Feb 2005 (DHHS
claims for a scytovirin domain 1 (SD1) promising technology to develop Reference No. E–137–2003/1–US–01).
antiviral polypeptide, nucleic acids prophylactic and therapeutic AIDS Licensing Contact: Robert M. Joynes;
encoding the polypeptide, related fusion vaccines for U.S. and for West Africa, 301/594–6565; joynesr@mail.nih.gov.
proteins and conjugates, isolated cells, particularly when used in combination This technology relates to methods for
vectors, and antibodies that bind to the with a DNA vaccine. lowering a viral load of a virus where
polypeptide. The polypeptide of this the virus causes a chronic viral infection
Chondroitin Sulphate A Binding and is resistant to an antiviral drug. The
invention has the ability to bind to viral
Domains: Potential Vaccine for Malaria method comprises administering to a
proteins, such as gp41 and gp120 of
HIV, and exhibit anti-viral activity Louis H. Miller (NIAID), et al. host a medicament comprising an
against type C and D retroviruses such U.S. Provisional Application No. 60/ antiviral drug to restrict the intracellular
as HIV–1 and HIV–2, Ebola, SARS, 615,300 filed 30 Sep 2004 (DHHS multiplication of the virus and that is
Influenza viruses and others. The Reference No. E–221–2004/0–US–01). capable of selecting for a predetermined
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Federal Register / Vol. 70, No. 154 / Thursday, August 11, 2005 / Notices 46879
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