Royalty Report: Drugs, Cancer, Disease – Collection: 6343

License Grant

Initiated on March 22, 2006 as part of Cooperative Research and Development Agreement (CRADA), the Licensor has granted an exclusive, worldwide License to the Licensee.

The Licensor, government public health organization, desires to transfer certain inventions to the private sector through commercialization Licenses to facilitate the commercial development of products and processes for public use and benefit for the Treatment of Glioblastomas and other Central Nervous System (CNS) tumors.  Glioblastoma Multiforme is the most common and most aggressive type of primary human brain cancer. The name derives from the fact that the brain cell that loses growth control and becomes a brain cancer cell is a glial cell (glioblastoma); as the altered glial cells grow without restraint, they take on many different shapes (multiforme).

License Property

U.S. Provisional Patent Application No. 60/771,163, filed February 6, 2006, entitled Use of Phosphatases To Treat Glioblastomas (HHS Ref. No. E-123-2006/0-US-01);
    
U.S. Provisional Patent Application No. 60/797,201, filed May 2, 2006, entitled Use of Phosphatases To Treat Glioblastomas (HHS Ref. No. E-123-2006/1-US-01)          
  
U.S. Patent Application Serial No. 11/703,401, filed February 6, 2007, entitled Use of Phosphatases To Treat Glioblastomas (HHS Ref. No. E-123-2006/0-US-03)

Field of Use

Licensed Fields of Use Treatment of Glioblastomas and other Central Nervous System (CNS)tumors.

License Grant

The Licensor, government public health organization, hereby grants and Licensee accepts a nonexclusive license under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import or have imported any Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.

License Property

Pursuant to the License Agreement, licensor granted to the Company a non-exclusive worldwide right and license to develop and manufacture certain proprietary autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma, ovarian cancer, breast cancer, and colorectal cancer.

The intellectual property subject to the License Agreement is covered by 43 patents and patent applications, consisting of nine issued United States patents, 13 pending patent applications in the United States, and 21 foreign patents and patent applications as counterparts of U.S. patents/patent applications. The Company also has limited rights to sublicense the intellectual property subject to the License Agreement. The License Agreement will expire on a product-by-product basis upon the expiration of the subject patent rights.

Tumor infiltrating lymphocytes (TIL) are a subset of T lymphocytes (T cells) that migrate and are located within a tumor site. TIL isolated from these tumor sites exhibit natural anti-tumor activity without genetic modifications. For the avoidance of doubt, cell therapy products involving genetically modified tumor infiltrating lymphocytes are excluded from Licensed Fields of Use.

Patent(s) or Patent Application(s)
1.
United States Patent No. 5,399,346 issued March 21, 1995 [HHS Ref. No. E-189-1989/3-US-02]

2.
United States Patent No. RE39788 issued August 21, 2007 [HHS Ref. No. E-189-1989/3-US-04]

3.
United States Patent No. 5,830,755 issued November 3, 1998 [HHS Ref. No. E-093-1995/0-US-01]

4.
Australian Patent No. 709122 issued December 2, 1999 [HHS Ref. No. E-093-1995/0-AU-03]

5.
United States Patent No. 6,734,014 issued May 11, 2004 [HHS Ref. No. E-040-1996/0-US-07]

6.
United States Patent No. 7,378,277 issued May 27, 2008 [HHS Ref. No. E-040-1996/0-US-08]

7.
United States Patent No. 7,723,111 issued May 25, 2010 [HHS Ref. No. E-323-2000/0-US-01]

8.
European Patent No. 1379670 issued August 6, 2008 [HHS Ref. No. E-323-2000/0-EP-03]

9.
United States Patent Application No. 12/715,829 filed March 2, 2010 [HHS Ref. No. E-323-2000/0-US-09]

10.
United States Patent Application No. 10/526,697 filed May 5, 2005 [HHS Ref. No. E-275-2002/1-US-02]

11.
European Patent Application No. 3794636.5 filed April 4, 2005 [HHS Ref. No. E-275-2002/1-EP-03]

12.
Canadian Patent Application No. 2,497,552 filed March 2, 2005 [HHS Ref. No. E-275-2002/1-CA-04]

13.
Australian Patent Application No. 2003265948 filed September 5, 2003 [HHS Ref. No. E-275-2002/1-AU-05]

14.
United States Patent Application No. 13/178,644 filed July 8, 2011 [HHS Ref. No. E-275-2002/1-US-06]

15.
United States Patent No. 7,381,405 issued June 3, 2008 [HHS Ref. No. E-297-2002/0-US-02]

16.
Canadian Patent Application No. 2,501,087 filed April 1, 2005 [HHS Ref. No. E-297-2002/0-CA-03]

17.
Australian Patent No. 2002353822 issued February 23, 2009 [HHS Ref. No. E-297-2002/0-AU-04]

18.
United States Patent No. 7,915,036 issued March 29, 2011 [HHS Ref. No. E-106-2004/0-US-02]

19.
United States Patent Application No. 11/576,621 filed April 4, 2007 [HHS Ref. No. E-340-2004/2-US-02]

20.
Canadian Patent Application No. 2,590,401 filed April 4, 2007 [HHS Ref. No. E-340-2004/2-CA-03]

21.
Australian Patent No. 2005336093 issued June 9, 2011 [HHS Ref. No. E-340-2004/2-AU-04]

22.
European Patent Application No. 05858553.0 filed April 5, 2007 [HHS Ref. No. E-340-2004/2-EP-05]

23.
Australian Patent Application No. 2007248019 filed May 3, 2007 [HHS Ref. No. E-086-2006/0-AU-03]

24.
Canadian Patent Application No. 2,651,174 filed November 3, 2008 [HHS Ref. No. E-086-2006/0-CA-04]

25.
European Patent Application No. 07797329 filed May 3, 2007 [HHS Ref. No. E-086-2006/0-EP-05]

26.
United States Patent Application No. 12/298,927 filed May 3, 2007 [HHS Ref. No. E-086-2006/0-US-06]

27.
United States Patent No. 7,820,174 issued October 26, 2010 [HHS Ref. No. E-106-2006/3-US-01]

28.
United States Patent Application No. 12/870,941 filed August 30, 2010 [HHS Ref. No. E-106-2006/3-US-03]

29.
Australian Patent Application No. 2009282886 filed August 20, 2009 [HHS Ref. No. E-106-2006/3-AU-04]

30.
Canadian Patent Application No. 2,734,838 filed August 20, 2009 [HHS Ref. No. E-106-2006/3-CA-05]

31.
European Patent Application No. 09791694.4 filed August 20, 2009 [HHS Ref. No. E-106-2006/3-EP-06]

32.
Australian Patent Application No. 2008206442 filed January 11, 2008 [HHS Ref. No. E-059-2007/2-AU-02]

33.
Canadian Patent Application No. 2,674,445 filed July 3, 2009 [HHS Ref. No. E-059-2007/2-CA-03]

34.
European Patent Application No. 08727582.2 filed January 11, 2008 [HHS Ref. No. E-059-2007/2-EP-04]

35.
United States Patent Application No. 12/522,321 filed July 7, 2009 [HHS Ref. No. E-059-2007/2-US-05]

36.
PCT Patent Application No. PCT/US2010/021909 filed January 25, 2010 [HHS Ref. No. E-043-2009/0-PCT-02]

37.
PCT Patent Application No. PCT/US2010/031988 filed April 22, 2010 [HHS Ref. No. E-170-2009/0-PCT-02]

38.
PCT Patent Application No. PCT/US2010/048701 filed September 14, 2010 [HHS Ref. No. E-205-2009/0-PCT-02]

39.
United States Patent Application No. 12/869,390 filed August 26, 2010 [HHS Ref. No. E-273-2009/0-US-02]

40.
United States Provisional Patent Application No. 61/405,668 filed October 22, 2010 [HHS Ref. No. E-236-2010/0-US-01]

41.
United States Provisional Patent Application No. 61/384,931 filed September 21, 2010 [HHS Ref. No. E-269-2010/0-US-01]

42.
United States Provisional Patent Application No. 61/466,200 filed March 22, 2011 [HHS Ref. No. E-114-2011/0-US-01]

43.
United States Provisional Patent Application No. 61/473,409 filed April 8, 2011 [HHS Ref. No. E-148-2011/0-US-01]

Field of Use

Licensed Fields of Use

(a) The use of the Licensed Patent Rights to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma.

(b) The use of the Licensed Patent Rights to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of ovarian cancer.

(c) The use of the Licensed Patent Rights to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of breast cancer.

(d) The use of the Licensed Patent Rights to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of colorectal cancer.

License Grant

Licensor licensed to Licensee patents and materials for the development and commercialization of novel cancer immunotherapy agent derived from the VAC platform utilizing an antigen provided by Licensee.

License Property

VAC platform is an allogeneic, or “off-the-shelf,” cancer immunotherapy derived from pluripotent stem cells for which a clinical trial in non-small cell lung cancer.

Field of Use

The collaboration will generate a novel product candidate derived from Licensor’s investigational allogeneic VAC cancer immunotherapy platform and targeting a proprietary Tumor Associated Antigen (TAA) construct provided by Licensee, for the treatment of glioblastoma multiforme (GBM).

Glioblastoma, also known as glioblastoma multiforme (GBM), is the most aggressive type of cancer that begins within the brain. Initially, signs and symptoms of glioblastoma are nonspecific. They may include headaches, personality changes, nausea, and symptoms similar to those of a stroke.

License Grant

Licensor in-licensed to Licensee the exclusive worldwide rights to the central nervous system (“CNS”) and/or cerebrocardiovascular drug application, including the (preventive) treatment of peripheral effects of agents causing CNS disease or symptoms, including cancer, for 2X-111.

License Property

2X-111 is an advanced, targeted liposomal formulation of Doxorubicin, one of the world’s most widely used chemotherapies. The specific 2X-111 formulation, which exploits a glutathione enhanced PEG-liposomal delivery system, may allow 2X-111 to cross the blood-brain barrier (BBB), thereby potentially enabling the treatment of primary brain tumors, such as glioblastoma multiforme (GBM), and secondary brain tumors that originated from cancers outside the brain, such as metastatic breast cancer.

Doxorubicin is a type of chemotherapy drug called an anthracycline. It slows or stops the growth of cancer cells by blocking an enzyme called topo isomerase 2, which is necessary for DNA replication. Topo isomerase 2 is an enzyme that cuts both strands of the DNA helix simultaneously in order to manage DNA tangles and supercoils.

Preclinical studies have been performed in order to determine the anti-cancer activity and toleration of 2X-111 both systemically and in the CNS prior to the start of the human clinical trials.

Field of Use

Field of use is for treatment of peripheral effects of agents causing CNS (central nervous system) disease or symptoms, including Cancer.

The right is  to the central nervous system (“CNS”) and/or cerebrocardiovascular drug application, including the (preventive) treatment of peripheral effects of agents causing CNS disease or symptoms, including cancer, for 2X-111

The central nervous system (CNS) is the part of the nervous system consisting primarily of the brain and spinal cord.

Cerebrovascular disease refers to a group of conditions, diseases, and disorders that affect the blood vessels and blood supply to the brain. If a blockage, malformation, or hemorrhage prevents the brain cells from getting enough oxygen, brain damage can result.

Licensee believes may allow 2X-111 to cross the blood-brain barrier (BBB), thereby potentially enabling the treatment of primary brain tumors, such as glioblastoma multiforme (GBM), and secondary brain tumors that originated from cancers outside the brain, such as metastatic breast cancer.

License Grant

The Licensor, government organization, hereby grants and Licensee accepts, a nonexclusive, worldwide License under the Patent Rights any of the Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.

License Property

The use of the Licensed Patent Rights to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of ovarian cancer, breast cancer and colorectal cancer.

Tumor infiltrating lymphocytes (TIL) are a subset of T lymphocytes (T cells) that migrate and are located within a tumor site. TIL isolated from these tumor sites exhibit natural anti-tumor activity without genetic modifications.

For the avoidance of doubt, cell therapy products involving genetically modified tumor infiltrating lymphocytes are excluded from Licensed Fields of Use.

Upon written approval, which shall include prior review of any subLicense Agreement by PHS and which shall not be unreasonably withheld, Licensee may enter into sublicensing Agreements.

United States Patent No. 5,399,346 issued March 21, 1995 [HHS Ref. No. E-189-1989/3-US-02]

United States Patent No. RE39788 issued August 21, 2007 [HHS Ref. No. E-189-1989/3-US-04]

United States Patent No. 5,830,755 issued November 3, 1998 [HHS Ref. No. E-093-1995/0-US-01]

Australian Patent No. 709122 issued December 2, 1999 [HHS Ref. No. E-093-1995/0-AU-03]

United States Patent No. 6,734,014 issued May 11, 2004 [HHS Ref. No. E-040-1996/0-US-07]

United States Patent No. 7,378,277 issued May 27, 2008 [HHS Ref. No. E-040-1996/0-US-08]

United States Patent No. 7,723,111 issued May 25, 2010 [HHS Ref. No. E-323-2000/0-US-01]

European Patent No. 1379670 issued August 6, 2008 [HHS Ref. No. E-323-2000/0-EP-03]

United States Patent Application No. 12/715,829 filed March 2, 2010 [HHS Ref. No. E-323-2000/0-US-09]

United States Patent Application No. 10/526,697 filed May 5, 2005 [HHS Ref. No. E-275-2002/1-US-02]

European Patent Application No. 3794636.5 filed April 4, 2005 [HHS Ref. No. E-275-2002/1-EP-03]

Canadian Patent Application No. 2,497,552 filed March 2, 2005 [HHS Ref. No. E-275-2002/1-CA-04]

Australian Patent Application No. 2003265948 filed September 5, 2003 [HHS Ref. No. E-275-2002/1-AU-05]

United States Patent Application No. 13/178,644 filed July 8, 2011 [HHS Ref. No. E-275-2002/1-US-06]

United States Patent No. 7,381,405 issued June 3, 2008 [HHS Ref. No. E-297-2002/0-US-02]

Canadian Patent Application No. 2,501,087 filed April 1, 2005 [HHS Ref. No. E-297-2002/0-CA-03]

Australian Patent No. 2002353822 issued February 23, 2009 [HHS Ref. No. E-297-2002/0-AU-04]

United States Patent No. 7,915,036 issued March 29, 2011 [HHS Ref. No. E-106-2004/0-US-02]

United States Patent Application No. 11/576,621 filed April 4, 2007 [HHS Ref. No. E-340-2004/2-US-02]

Canadian Patent Application No. 2,590,401 filed April 4, 2007 [HHS Ref. No. E-340-2004/2-CA-03]

Australian Patent No. 2005336093 issued June 9, 2011 [HHS Ref. No. E-340-2004/2-AU-04]

European Patent Application No. 05858553.0 filed April 5, 2007 [HHS Ref. No. E-340-2004/2-EP-05]

Australian Patent Application No. 2007248019 filed May 3, 2007 [HHS Ref. No. E-086-2006/0-AU-03]

Canadian Patent Application No. 2,651,174 filed November 3, 2008 [HHS Ref. No. E-086-2006/0-CA-04]

European Patent Application No. 07797329 filed May 3, 2007 [HHS Ref. No. E-086-2006/0-EP-05]

United States Patent Application No. 12/298,927 filed May 3, 2007 [HHS Ref. No. E-086-2006/0-US-06]

United States Patent No. 7,820,174 issued October 26, 2010 [HHS Ref. No. E-106-2006/3-US-01]

United States Patent Application No. 12/870,941 filed August 30, 2010 [HHS Ref. No. E-106-2006/3-US-03]

Australian Patent Application No. 2009282886 filed August 20, 2009 [HHS Ref. No. E-106-2006/3-AU-04]

Canadian Patent Application No. 2,734,838 filed August 20, 2009 [HHS Ref. No. E-106-2006/3-CA-05]

European Patent Application No. 09791694.4 filed August 20, 2009 [HHS Ref. No. E-106-2006/3-EP-06]

Australian Patent Application No. 2008206442 filed January 11, 2008 [HHS Ref. No. E-059-2007/2-AU-02]

Canadian Patent Application No. 2,674,445 filed July 3, 2009 [HHS Ref. No. E-059-2007/2-CA-03]

European Patent Application No. 08727582.2 filed January 11, 2008 [HHS Ref. No. E-059-2007/2-EP-04]

United States Patent Application No. 12/522,321 filed July 7, 2009 [HHS Ref. No. E-059-2007/2-US-05]

PCT Patent Application No. PCT/US2010/021909 filed January 25, 2010 [HHS Ref. No. E-043-2009/0-PCT-02]

PCT Patent Application No. PCT/US2010/031988 filed April 22, 2010 [HHS Ref. No. E-170-2009/0-PCT-02]

PCT Patent Application No. PCT/US2010/048701 filed September 14, 2010 [HHS Ref. No. E-205-2009/0-PCT-02]

United States Patent Application No. 12/869,390 filed August 26, 2010 [HHS Ref. No. E-273-2009/0-US-02]

United States Provisional Patent Application No. 61/405,668 filed October 22, 2010 [HHS Ref. No. E-236-2010/0-US-01]

United States Provisional Patent Application No. 61/384,931 filed September 21, 2010 [HHS Ref. No. E-269-2010/0-US-01]

United States Provisional Patent Application No. 61/466,200 filed March 22, 2011 [HHS Ref. No. E-114-2011/0-US-01]

United States Provisional Patent Application No. 61/473,409 filed April 8, 2011 [HHS Ref. No. E-148-2011/0-US-01]

Field of Use

The use of the Licensed Patent Rights to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma.

License Grant

Licensor hereby grants to Licensee an exclusive license, even as to Licensor, under the Patent Rights, to research, develop, make, have made, use, offer to sell, sell, export and/or import and commercialize Licensed Products within the Licensed Territory for use within the Licensed Field. For purposes of clarity Licensee shall have the right, but not the obligation, to conduct research regarding the Patent Rights. For the avoidance of doubt and except as to the Patent Rights and rights to Technology granted, nothing in this Agreement shall serve to grant Licensee any right, title or interest to any other intellectual property right owned or controlled by Licensor. Moreover, Licensee agrees and acknowledges that nothing in this Agreement shall preclude Licensor from engaging in future research, development, production, distribution, sale or commercialization of any product or service in the Licensed Field, or which may compete with a Licensed Product, provided such product or service are not covered by the Patent Right licensed herein.

License Property

The technology and patents are for the chemical compound commonly known as Berubicin.  Berubicin is an anthracycline, which is a class of drugs that are among the most powerful chemotherapy drugs known and as a class are effective against more types of cancer than any other class of chemotherapeutic agents.

Berubicin is a novel therapy for the treatment of glioblastoma. Berubicin is one of the first anthracyclines (the most potent class of cancer drugs) to cross over the blood brain barrier and kill tumor cells in humans.

Glioblastoma is a type of astrocytoma, a cancer that forms from star-shaped cells in the brain called astrocytes. In adults, this cancer usually starts in the cerebrum, the largest part of your brain. Glioblastoma tumors make their own blood supply, which helps them grow

Field of Use

Licensed Field means the use of Licensed Product for the treatment of cancer through any type of administration, whether now known or yet to be developed.