Novel Cancer Immunotherapy Approaches For The Treatment And Prevention Of Cancer

The National Cancer Institute's Laboratory of Tumor Immunology and Biology is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize cancer immunotherapy using costimulation.  See below for specific details.

Technology:

Cancer immunotherapy is a recent approach to preventing and treating cancer that involves generating a tumor specific immune response using tumor associated antigens (TAAs), TAAs are primarily expressed in human tumor cells and not expressed in normal tissues. These antigens serve as targets for the host immune system and elicit responses that result in tumor destruction.  The initiation of an effective T-cell immune response to antigens requires two signals.  The first one is antigen specific via the peptide/major histocompatibility complex and the second or "costimulatory" signal is required for cytokine production, proliferation, and other aspects of T-cell activation.

The present technology describes recombinant poxvirus vectors encoding at least three or more costimulatory molecules and tumor associated antigens (TAAs).  The use of three costimulatory molecules such as B7.1, ICAM-1 and LFA-3 (TRICOM) has been shown to act in synergy with several tumor antigens to activate T cells.  The effects with TRICOM were significantly greater than with one or two costimulatory molecules.  Laboratory results support the greater effect of TRICOM to activate both CD4+ and CD8+ T cells.  Use of TRICOM alone or in conjunction with other costimulatory molecules can be a potential novel approach for the prevention or treatment of cancer.  The invention also describes the use of TRICOM in combination with target antigens as an immunogen or vaccine. 

R&D Status: The technology is beyond proof-of-concept, supported by laboratory results and publications.  Phase I and Phase II clinical data is available.

IP Status: 

1.    U.S. Patent No. 6,969,609 issued November 29, 2005 as well as issued and pending foreign counterparts;

2.    U.S. Patent Application No. 11/321,868 filed December 30, 2005;

3.    U.S. Patent No. 6,756,038 issued June 29, 2004 as well as issued and pending foreign counterparts;

4.    U.S. Patent No. 6,001,349 issued December 14, 1999 as well as issued and pending foreign counterparts;

5.    U.S. Patent No.6,165,460 issued December 26, 2000; as well as issued and pending foreign counterparts;

6.    U.S. Patent No. 7,118,738 issued October 10, 2006 as well as issued and pending foreign counterparts;

7.    PCT Application No. PCT/US97/12203 filed July 15, 1997;

8.    U.S. Patent Application Nos. 10/197,127.and 08/686,280 filed July 17, 2002 and July 25, 1996;

9.    U.S. Patent No. 6,946,133 issued September 20, 2005 as well as issued and pending foreign counterparts;

10.    U.S. Patent Application No. 11/606,929 filed December 1, 2006;

11.    U.S. Patent Nos. 6,893,869, 6,548,068 and 6,045,802 issued May 17, 2005, April 15, 2003 and April 4, 2000 respectively, as well as issued and pending foreign counterparts; and

12.    U.S. Patent. Application No. 11/090,686 filed March 8, 2005.

Value Proposition:

•          Novel approach to cancer treatment and prevention

•          Ability to generate a tumor specific immune response through activation of T-cells

•          Potential to use various combinations of costimulatory molecules and tumor associated antigens (TAAs) to develop cancer vaccines and therapies.

Cooperative Research and Development Agreement (CRADA) Opportunities:

A CRADA partner for the further co-development of this technology is currently being sought by the Laboratory of Tumor Immunology and Biology, Center for Cancer Research, NCI. The CRADA partner will (a) generate and characterize recombinant poxviruses expressing specific tumor-associated antigens, cytokines, and/or T-cell costimulatory factors, (b) analyze the recombinant poxviruses containing these genes with respect to appropriate expression of the encoded gene product(s), (c) supply adequate amounts of recombinant virus stocks for preclinical testing, (d) manufacture and test selected recombinant viruses for use in human clinical trials (with the exception of trials for prostatic diseases and melanoma), (e) submit Drug Master Files detailing the development, manufacture, and testing of live recombinant vaccines to support the NCI-sponsored IND and/or company-sponsored IND, (f) supply adequate amounts of clinical grade recombinant poxvirus vaccines for clinical trials conducted at the NCI Center for Cancer Research (CCR), and (g) provide adequate amounts of vaccines for extramural clinical trials, if agreed upon by the parties, and conduct clinical trials under company-sponsored or NCI-sponsored INDs. NCI will (a) provide genes of tumor-associated antigens, cytokines and other immunostimulatory molecules for incorporation into poxvirus vectors, (b) evaluate recombinant vectors in preclinical models alone and in combination therapies, and (c) conduct clinical trials (with the exception of trials for prostatic diseases and melanoma) of recombinant vaccines alone and in combination therapies.

 
Contact Information:

Kevin Brand
NCI Technology Transfer Center
Tel: 301-451-4566
Email:  kb229t@nih.gov