Royalty Report: Drugs, Cancer, Disease – Collection: 7111

License Grant

The Licensor, non-profit hospital, grants to Licensee the exclusive, worldwide License, with the right to grant subLicenses, to conduct research, develop Products, modify existing and/or future Products, and market such Products in the Field of Use using the Patent Rights and/or the Technical Information and to develop, use, make, have made, practice, import, carry out, manufacture, have manufactured, offer for sale, sell and/or have sold Products in the Field of Use in the territory using the Patent Rights and/or the Technical Information.

License Property

The Licensor owns and is entitled to grant License rights with respect to certain Patent Rights and Technical Information invented or developed in the course of the Licensor’s Molecular Oncology Research Program in the field of human therapeutic products, including new pharmaceutical products and/or non-prescriptive products based on, or utilizing the Patent Rights and/or Technical Information developed in the course of the Program.

Product or Products shall mean any human therapeutics, diagnostics (including algorithms or any components thereof), bioinformatics and any other human health care products and/or services in the Field of Use utilizing or derived in any manner whatsoever from any of the Patent Rights, Technical Information or Licensee Improvements, which Product(s), except for the license granted hereunder, would infringe a Valid Claim, the Patent Rights or those Future Patent Rights licensed to Licensee.

Licensee has developed a new anti-cancer agent as well as a new methodology specific for the treatment of invasive tumors such as glioblastoma multiforme, the most aggressive form of brain cancer, as well as both Her2-positive and Her2-negative breast cancers.

Licensee believes this approach is effective against brain and breast cancer in rodents, significantly extending their longevity and decrease the tumor size. Licensee proposes to expand this proprietary technology to other forms of cancer treatments together with common eye diseases such as age-related macular degeneration and diabetic retinopathy.

The technology is a family of related nano-biopolymers collectively referred to as Polycefin™ that are capable of acting as a drug delivery and targeting platform for cancer therapy and diagnostics. The new nanoscale drug, Polycefin, based on Licensee’s delivery system, was developed and patented by Licensee’s scientists. It is non-toxic, non-immunogenic, and biodegradable. It is based on a naturally derived polymer, i.e., polymalic acid. A significant feature of this novel agent is its ability to target multimeric tumor-associated proteins with one drug, a capability that other existing agents do not have. Licensee has proven that the significant anti-tumor and anti­angiogenic activity of this new drug is effective against both brain and breast cancers.

Polycefin are designed to target cancer cells and deliver a variety of bound therapeutics to them. In vivo pre-clinical studies have shown evidence that existing cancer drugs could have increased efficacy and reduced side effects when attached to the Polycefin  platform. Polycefin’s have the ability to harbor various drugs at the same time making it a master delivery vehicle that can be customized for a particular tumor and potentially for an individual patient.  Additionally, in vivo testing has shown efficacy against more than one type of cancer (breast and  brain) suggesting that Polycefin may have application to a wide range of cancer types, therapeutics and diagnostics.

Patent Rights
Title
Antisense Inhibition of Laminin-8 expression to Inhibit Human Gliomas
U.S. Patent & Trademark Office
Application No.
10/570,747
Filing Date
January 30, 2007
Patent No.
7,547,511
Issue Date
June 16, 2009

U.S. Patent & Trademark Office
Application No.
12/473,992
Filing Date
May 28, 2009

Japanese Patent Office
Application No.
2006-526391
Filing Date
September 13, 2004

Title
Polymalic Acid-Based Multifunctional Drug
Delivery System
U.S. Patent & Trademark Office
Application No.
10/580,999
Filing Date
March 12, 2007

European Patent Office
Application No.
04813049.6
Filing Date
December 3, 2004

Japanese Patent Office
Application No.
2006-542822
Filing Date
December 3, 2004

Title
Poly(Beta Malic Acid) with Pendant Leu-Leu-Leu
Tripeptide for effective Cytoplasmic Drug deliver

U.S. Patent & Trademark Office
Application No.
PCT/US2009/40252
Filing Date
April 10, 2009

Title
Drug delivery of Temozolomide for Systemic based treatment of Cancer
U.S. Patent & Trademark Office
Application No.
61/285,495
Filing Date
December 10, 2009

Field of Use

Field of Use shall mean human therapeutic products, including new pharmaceutical products and/or non-prescriptive products based on, or utilizing the Patent Rights and/or Technical Information developed in the course of the Program.

License Grant

Licensor out-licensed our secondary LiPlaCis® and 2X-111 programs to Licensee of Norway for Phase 2 clinical development of each program together with its DRP® companion diagnostic. Licensor will support Licensee in these studies by providing DRP® companion diagnostic analysis for screened patients in each trial.

License Property

LiPlaCis® is an advanced, targeted liposomal formulation of Cisplatin, one of the world’s most widely used chemotherapies. The specific LiPlaCis® formulation utilizes a proprietary phospholipase A (sPLA2-IIA) cleavage substrate for controlled, selective hydrolyzation, disruption and release of drug payload in the presence of tumor cells. This delivery vehicle may result in drug accumulation directly at tumor site, thereby potentially increasing drug targeting at the tumor and reducing negative, off target drug effects and toxicity that is well known for cisplatin.

X-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, it 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.

DRP® is a predictive biomarker platform to generate drug-specific companion diagnostics.  it is used as a companion diagnostics platform to advance therapeutic candidates by targeting and evaluating patient sub-populations having gene signatures, determined by the DRP® companion diagnostics platform, that will potentially correlate with drug efficacy and patient response to treatment.

Field of Use

Field of use is for the treatment of metastatic breast cancer (mBC) and advance 2X-111 for the treatment of glioblastoma multiforme (GBM) such as brain 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.