75724 Federal Register / Vol. 65, No. 233 / Monday, December 4, 2000 / Notices

DNA sequence of NAG–1, 2)

compositions containing the NAG–1

sequence and 3) methods for treating

cancer patients using NAG–1.

Novel MHC Class II Restricted T Cell

Epitopes from the Cancer Antigen, NY–

ESO–1

DHHS Reference No. E–090–00/0 filed

28 Jan 2000 and

MHC Class II Restricted CD4+ T Cell

Epitopes From NY–ESO–1 Presented by

DP

DHHS Reference No. E–227–00/0 filed

29 Sep 2000

Wang et al. (NCI)

Licensing Contact: Elaine White: 301/

496–7056 ext. 282; e-mail:

gesee@od.nih.gov

NY–ESO–1 is a known tumor antigen

which is expressed on a broad range of

tumor types, including melanoma,

breast, bladder, ovarian, prostate, head

and neck cancers, neuroblastoma, and

small cell lung cancer. The abovereferenced inventions embody the

identification of a number of novel

immunogenic peptide epitopes, and

analogs thereof, which are derived from

the NY–ESO–1 tumor antigen.

DHHS Reference No. E–090–00/0

serves to identify novel MHC Class II

restricted epitopes of NY–ESO–1 which

are recognized by CD4+ T cells. DHHS

Reference No. E–227–00/0 embodies the

identification of two additional

immunogenic peptide epitopes of NY–

ESO–1. The latter two epitopes are

presented by HLA–DP4, a prevalent

MHC Class II allele present in 43–70%

of Caucasians. The inventors also

determined that the DP allele is highly

associated with the NY–ESO–1 antibody

production. In addition, one of these

epitopes has dual HLA A2 and DP4

specificity, thereby has the potential to

generate both CD4+ and CD8+ tumor

specific T cells. These epitopes may be

of great value as prophylactic and/or

therapeutic cancer vaccines for use

against a number of common cancers.

T-Cell Epitope of MAGE–12 and

Related Nucleic Acids, Vectors, Cells,

Compositions, and Methods of Inducing

an Immune Response to Cancer

Monica Panelli, Francesco Marincola,

Maria Bettinotti (NCI)

DHHS Reference No. E–056–00/0 filed

03 Mar 2000

Licensing Contact: Elaine White; 301/

496–7056 ext. 282; e-mail:

gesee@od.nih.gov

The current invention embodies the

identification of a T-cell epitope from

the cancer-specific antigen MAGE–12.

The MAGE family of genes encodes

human tumor specific antigens (TSA),

and various genes of this family are

expressed by tumors of different

histologies (melanoma, lung, colon,

breast, laryngeal cancer, sarcomas,

certain leukemias) and not by normal

cells (except testis and placenta). The

MAGE–12 peptide which is the subject

of the current invention is a specific

epitope within MAGE–12 (residues170–

178) which is recognized by tumor

infiltrating lymphocytes in the context

of HLA–Cw0702 (a common HLA type

in the Caucasian population). This Tcell epitope is advantageous in that it

represents a novel tumor rejection

antigen for use as a peptide vaccine

against melanoma or other cancer types

expressing MAGE–12 and may therefore

be of great value for use in cancer

immunotherapy.

Secreted Frizzled Related Protein,

sFRP, Fragments and Methods of Use

Thereof

JS Rubin, A Uren (both of NCI), and F

Reichsman, S Cumberledge

Serial No. 09/546,043 filed 10 April 00

Licensing Contact: Susan S. Rucker;

301/496–7056 ext 245; e-mail:

ruckers@od.nih.gov

This application relates to signal

transduction pathways and

mechanisms. More particularly, the

application describes various active

fragments of the secreted Wnt binding

protein sFRP–1 (secreted Frizzled

Related Protein-1). The sFRP–1

fragments described are capable of

binding to Wnt and therefore are able to

modulate Wnt activity. The fragments

may or may not contain the cysteine

rich domain (CRD) of sFRP–1 suggesting

that the CRD is not essential for Wnt

binding. In addition, in contrast to

earlier findings employing higher levels

of sFRP–1, the ability of sFRP–1 to

enhance Wnt signaling at low levels is

also described suggesting biphasic

regulation of Wnt signaling by sFRP–1.

The sFRP–1 fragments described herein

may be useful in the further study of

Wnt signaling as well as targets for the

development of small molecules which

can modulate Wnt signaling. PHS also

owns additional intellectual property

related to sFRP–1 which is described in

US Patent Application Serial Number

09/087,031 and which has been

published as WO 98/54325 (12/03/

1998).

This work has appeared, in part, in

Uren, A et al. JBC 275(6): 4374–4382

(Feb 11, 2000).

Dated: November 22, 2000.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 00–30714 Filed 12–1–00; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The invention listed below is

owned by an agency of the U.S.

Government and is available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of federally

funded research and development.

ADDRESSES: Licensing information and a

copy of the U.S. patent application

referenced below may be obtained by

contacting J. R. Dixon, Ph.D., at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804 (telephone 301/

496–7056 ext 206; fax 301/402–0220; email: jd212g@nih.gov). A signed

Confidential Disclosure Agreement is

required to receive a copy of any patent

application.

Entitled: ‘‘Discovery of Gene

Expressed in Many Cancers and Only

Normal Testis’’

Inventors: Drs. Ira H. Pastan (NCI),

Xiu F. Liu (NCI), Byungkook Lee (NCI)

and Lee J. Helman (NCI).

DHHS Ref. No. E–161–00/0 Filed:

September 1, 2000.

Large numbers of expressed sequence

tags (EST’s) have been cloned from

various normal and cancer tissues.

Cancer-testis antigens are a distinct

class of differentiation antigens that

have a restricted pattern of expression

in normal tissues. These genes are

primarily expressed in the primitive

germ cells, spermatogonia, in the

normal testis. Malignant transformation

is often associated with activation or

derepression of silent Cancer-testis

genes, and this results in the expression

of Cancer-testis antigen in a variable

proportion of a wide range of human

tumors. Three related genes, termed

XAGEs, were recently identified by

homology walking using the dbEST

database.

The XAGE–1 gene is a human Xlinked gene that is strongly expressed in

Federal Register / Vol. 65, No. 233 / Monday, December 4, 2000 / Notices 75725

normal testis, Ewing’s sarcoma, alveolar

rhabdomyosarcoma, as well as breast

cancer and other cancers (e.g., lung

carcinoma, prostate adenocarcinoma,

ovarian carcinoma, pancreatic

adenocarcinoma, glioblastoma, etc.).

The largest open reading frame of the

XAGE–1 transcript encodes a putative

protein of 16.3 kD (p16) with a potential

transmembrane domain at the amino

terminus. In addition, the XAGE–1

transcript contains a second ATG in the

reading frame corresponding to residue

66, which would encode a 9 kD protein

(p9). In vitro transfection experiments

using 293T cells have revealed a 9 kD

protein. However, the size of the protein

expressed endogenously is not yet

known. XAGE–1 shares homology with

GAGE/PAGE proteins in the C-terminal

end.

The invention relates to the fact that

the XAGE–1 gene is expressed in a

number of human cancers, specifically:

prostate, pancreatic, and ovarian

cancers, as well as a large percentage of

breast and lung tumors. The protein p9

and p16, immunogenic fragments

thereof, analogs of these proteins, and

nucleic acids encoding these proteins,

fragments, or analogs, can be

administered to persons with XAGE–1

expressing cancers to raise or augment

an immune response to the cancer. The

invention further provides nucleic acid

sequences encoding the protein, as well

as expression vectors, host cells, and

antibodies to the proteins. Further, the

invention provides immunoconjugates

that comprise an antibody to p16 or to

p9, and an effector molecule, such as a

label, a radioisotope, or a toxin. The

invention also provides methods of

inhibiting the growth of XAGE–1

expressing cells by contacting them

with immunoconjugates of an anti-p9 or

p16 antibody and a toxic moiety. The

invention also provides kits for the

detection of p9 or p16 proteins in a

sample. The XAGE–1 gene and encoded

protein could be of value in the

development of a cancer diagnostic and

cancer immunotherapy.

The above mentioned invention is

available for licensing on an exclusive

or non-exclusive basis.

Dated: November 22, 2000.

Jack Spiegel,

Director, Division of Technology Development

& Transfer, Office of Technology Transfer.

[FR Doc. 00–30716 Filed 12–1–00; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood

Institute; Notice of Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Heart, Lung,

and Blood Institute Special Emphasis Panel.

Date: December 1, 2000.

Time: 8 a.m. to 6 p.m.

Agenda: To review and evaluate grant

applications.

Place: Bethesda Holiday Inn, Bethesda, MD

20017.

Contact Person: Eric H Brown, Scientific

Review Administrator, Review Branch, Room

7204, Division of Extramural Affairs,

National Heart, Lung, and Blood Institute,

National Institutes of Health, Bethesda, MD

20892.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.233, National Center for

Sleep Disorders Research; 93.837, Heart and

Vascular Diseases Research; 93.838, Lung

Diseases Research; 93.839, Blood Diseases

and Resources Research, National Institutes

of Health, HHS)

Dated: November 22, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–30711 Filed 11–1–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney Diseases; Notice

of Closed Meetings

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meetings.

The meetings will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Diabetes and Digestive and Kidney Diseases

Special Emphasis, Panel, ZDK1 GRB–B(J3)M.

Date: December 4, 2000.

Time: 12:30 p.m. to 2:30 p.m.

Agenda: To review and evaluate grant

applications.

Place: 2 Democracy Plaza, 6707 Democracy

Blvd, Rm 645, Bethesda, MD 20892,

(Telephone Conference Call).

Contact Person: Ned Feder, Scientific

Review Administrator, Review Branch, DEA

NIDDK, Room 645, 6707 Democracy

Boulevard, National Institutes of Health,

Bethesda, MD 20892, (301) 594–8890.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

Name: of Committee: National Institute of

Diabetes and Digestive and Kidney Diseases

Special Emphasis Panel, ZDK1 GRB–B(J2)S.

Date: December 15, 2000.

Time: 3 p.m. to 5 p.m.

Agenda: To review and evaluate grant

applications.

Place: 2 Democracy Plaza, 6707 Democracy

Blvd, Rm 645, Bethesda, MD 20892,

(Telephone Conference Call).

Contact Person: Ned Feder, Scientific

Review Administrator, Review Branch, DEA,

NIDDK, Room 645, 6707 Democracy

Boulevard, National Institutes of Health,

Bethesda, MD 20892, (301) 594–8890.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.847, Diabetes,

Endocrinology and Metabolic Research;

93.848, Digestive Diseases and Nutrition

Research; 93.849, Kidney Diseases, Urology

and Hematology Research, National Institutes

of Health, HHS)

Dated: November 27, 2000.

Anna Snouffer,

Acting Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–30708 Filed 12–1–00; 8:45 am]

BILLING CODE 4410–01–M