Royalty Report: Drugs, Cancer, Vaccine – Collection: 301043

License Grant

Licensor grants the exclusive license, with the right to grant sublicenses, under and to the Patent Rights during the term of this Agreement to conduct research in the Field of Use and to make, have made, use, import , offer for sale, sell and/or have sold Products in the Field of Use in the Territory.

License Property

The patent is titled Use of Toll-like receptor Ligands as adjuvants to vaccination therapy for brain tumors.

Field of Use

The Field of Use shall mean the therapeutic treatment thereof in patients suffering from cancer, including glioblastoma.

License Grant

The license granted by Licensor to Licensee shall be an exclusive license as to the agreed upon Field of Use, with a right to grant sublicenses, during the Term, to use, develop, make, have made, practice, import, carry out, manufacture, have manufactured, offer for sale, sell, offer for sale and/or have sold Products in the Field of Use in the Territory.

License Property

Products shall consist of any substance, device, apparatus or method covered in whole or in part by a Valid Claim useful to the diagnosis or treatment of disease or disorders utilizing a dendritic cell based vaccine for brain tumors and other cancers.

Field of Use

Field of Use is certain provisional patents and other proprietary intellectual property, relating to the work of Dr. John Yu with cellular therapies or diagnostics utilizing cellular therapies, including dendritic cell based vaccines for brain tumors and other cancers.  License is for a cancer vaccine therapy.

License Grant

For the Grant of Exclusive Rights, Licensor, nonprofit public benefit corporation, grants the exclusive, worldwide license, with the right to grant sublicenses, to conduct research in the Field of Use using the Patent Rights and 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 the Technical Information.

This agreement includes non-exclusive grants back from Licensee to Licensor.

License Property

The license is for certain technology for use as cellular therapies, including dendritic cell-based vaccines.

Field of Use

The Field of Use shall mean cellular therapies or diagnostics utilizing cellular therapies, including dendritic cell-based vaccines for neurological disorders including brain tumors and neurodegenerative disorders and other cancers.

License Grant

Licensor grants a worldwide, exclusive license to Licensor Patent Rights and Know-How to make, have made, use, import, offer to sell, and sell Product using Licensed Compound supplied by Licensor, or supplied by a third party, for use in the Field.

This agreement includes a non-exclusive grant back from Licensee to Licensor.

License Property

Licensor, through its Drug Delivery Systems Division, has expertise and technology, with know-how and patents owned by Licensor, relating to toll-like receptor TLR 7 and/or 8 immune response modifier (IRM) compounds, formulations, conjugation, delivery, and manufacturing including proprietary IRM compounds such as resiquimod and others, that are useful as vaccine adjuvants.

The Compound is designated by Licensor as Resiquimod (R-848), S36212, 1-(4-aminobutoxy) -2-butyl-lH-imidazo (4,5-cl quinolin-4-amine and conjugates thereof.

Product shall mean any combination of a Licensee Antigen Presenting Cell or APC Targeting Technology vaccine with a Licensed Compound to be utilized as a Vaccine Adjuvant.

Vaccine Adjuvant shall mean a Licensed Compound which is used to induce, augment, fine-tune, enhance, or desensitize an antigen-specific immune response to an antigen contained in a vaccine or generated by a DNA vaccine for the therapeutic treatment of an existing disease or prophylactic use as protection against future disease, including desensitization to allergens. The antigen and the vaccine adjuvant may be admixed, delivered simultaneously, conjugated, or delivered separately, provided however, that the separate administration of the antigen and vaccine adjuvant is limited to the topical, dermal or mucosal or intradermal routes of administration and must be administered within 48 hours at substantially the same site and labeled as such by the applicable regulatory authority.

TLR compounds, also called TLR7 and TLR8 agonists, are small organically synthesized molecules that offer flexibility in formulating and route of delivery, and ease in manufacturing, unlike most other TLR agonists, which are much larger and not as easy to manufacture.

Field of Use

Licensor’s patented TLR immune response modifier compounds, which may be useful as vaccine adjuvants, will be used by Licensee to develop new vaccine products.  This license agreement provides a great opportunity to combine synergistic technologies designed to treat various cancers and infectious diseases.

The Field shall mean human prophylactic or therapeutic vaccination against any and all cancer disease states and selected infectious diseases.

This agreement focus is Cancer and the Infectious Diseases
– human immunodeficiency virus (HIV);
– human papillomavirus (HPV); and,
– hepatitis B virus (HBV).

License Grant

For the Exclusive Licenses, Licensor grants
–  an exclusive license, including the right to sublicense, under the Licensor Patent Rights, to research, develop, make, have made, use, sell, offer for sale, supply, cause to be supplied and import Compounds and Licensed Products in the Territory;
–  an exclusive license, including the right to sublicense, to use Licensor Technology and Confidential information in connection with the research. development, making, having made, use, sale, oiler for sale, supply, causing to be supplied and importation of Compounds and Licensed Products in the Territory;
–  an exclusive license, including the right to sublicense, under the Licensor Patent Rights to research, develop, make, have made, use, sell, offer for sale, supply, cause to be supplied and import Diagnostic Assays in the Territory; and
–  an exclusive license, including the right to sublicense, to use Licensor Technology and Confidential information in connection with the research, development, making, having made, use, sale, offer for sale, supply, causing to be supplied and importation of Diagnostic Assays in the Territory.

For the Non-Exclusive Research License, Licensor grants a non-exclusive, irrevocable, perpetual license in the Territory, with the right to sublicense to Affiliates, to use for all research purposes the Licensor Technology and Confidential Information disclosed to Licensee during the Term, excluding any Patent Rights relating thereto.

License Property

Licensor owns or otherwise controls certain patents, patent applications, technology, know-how and scientific and technical information relating to an EGFRvIII mutant peptide comprising the amino acid sequence LYS-LYS-GLY-ASN-TYR.

CDX-110 means the EGFRvlll mutant peptide consisting of the amino acid sequence LEU-GLU-GLU-LYS-LYS-GLY-ASN-TYR-V AL-V AL-THR-ASP-HIS covalently linked to a Cysteine and conjugated to keyhole limpet hemocyanin (KLH).  CDX-110 is a therapeutic cancer vaccine candidate.

Compound means a peptide that comprises at least a portion of an EGFRvIII comprising the amino acid sequence LYS-LYS-GLY-ASN-TYR. as an antigen. alone or as a component of a larger peptide. protein or molecule.

EGFRvIII means EGFR variant III peptide, a variant of EGFR. previously referred to as a type II variation of EGFR, consisting of the amino acid sequence of EGFR as set forth in GenBank Accession No, CAA2524Q. except amino acids number 1 through 24 have been deleted and where amino acids number 30 through 297 have been replaced by a Glycine. and naturally occurring variants thereof.

Additional Component means a therapeutically active (alone or in combination) adjuvant. immunomodulator. immunoregulator or hapten.

APC Product means an antibody or fragment thereof. that is targeted to an antigen-presenting cell (APC) and that comprises or is connected to a Compound or Licensed Product.

Patents are for the EGFRvlll Patent Family 1, 2, and 3.

Field of Use

The field of use for CDX-110 includes the treatment of glioblastoma multiforme or GBM.

Glioblastoma, also known as glioblastoma multiforme (GBM), is the most aggressive type of cancer that begins within the brain.

Rindopepimut is an experimental therapeutic cancer vaccine that targets the tumor-specific molecule epidermal growth factor receptor variant III (EGFRvIII) in patients with Glioblastoma Multiforme (GBM)

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

Licensor hereby grants to Licensee an exclusive license under the Licensed Patents in the Territory to make, have made, develop, use, practice, import, export, distribute, market, promote, offer for sale, and sell Licensed Products in the Licensed Field.

Licensor hereby grants to Licensee a non-exclusive license in the Territory under Licensor’s rights in the Know-How to use and practice any method, process, or procedure within the Know-How and otherwise use and exploit the Know-How; all in the Licensed Field; provided however, that with respect to Project Information, such non-exclusive license shall be limited to the Project Information Licensed Field.

License Property

The technology relates to drugs used in the treatment of various cancers.

Licensed Patents means
Patent Applications 61/249,596; 61/423,842; 61/423,825; 61/392,296; 61/423,832; 61/254,395; 61/423,838

1.
REVERCOM

·
Drug summary Liposome-packaged combination of proprietary molecule, inhibitor of multidrug resistance transporter, and conventional chemotherapeutic agent.

·
Potential use adjuvant applied as part of chemotherapy of cancer patients.

2.
MOBILAN

·
Drug summary Adenovirus-based treatment inducing immune response. Ready for final stage of preclinical development.

·
Potential use Universal anti-cancer vaccine.

3.
ARKIL

·
Drug summary Androgen receptor inhibitor, prepared for Hit-2-Lead optimization studies.

·
Potential use Nanodrugs for treatment of prostate cancer (both hormone (androgen)-dependent and –independent/refractory forms).

4.
ANTIMYCON

·
Drug summary MYC inhibitor.

·
Potential use Drugs for treatment of a broad range of solid tumors (breast, prostate, colon, non-small cell lung carcinoma, etc.) and hematological malignancies.

Projects and Licensed Patents
1. Projects

Drug
Definition

Mobilan = Research, development and support of an immunotherapeutic drug candidate based on recombinant adenovirus vector, stimulating immune response in humans as a vaccine-like treatment for cancer or other indications.

Revercom = Research, development, formulation and support of a drug candidate based on proprietary Reversan compound as an adjuvant for chemotherapy.

Antimycon = Research, development, lead optimization, formulation and support of a drug candidate regulating cMyc transcription factor for cancer indications.

Arkil = Research, development, lead optimization, formulation and support of a drug candidate regulating androgen receptor for prostate cancer.

Xenomycin = Research, development, lead optimization, formulation and support of a drug candidates based on proprietary Curaxin family of compounds for anti-infective/anti-biotic/anti-fungal applications.

2. Licensed Patents

Product
Title
Inventors
Country
Application No.
Patent No.

MOBILAN = Use of Toll-Like Receptor and Agonist for Treating Cancer
Andrei Gudkov (RPCI, CBLI)
U.S.
61/249,596
n/a

MOBILAN = Toll-like receptor 5 agonist produced and secreted by mammalian cells
Andrei Gudkov (RPCI), Venkatesh Natarajan (RPCI)
U.S.
61/423,842
n/a

MOBILAN = Functional bacreriophage-based nanoparticles coated by Toll-like receptor 5 agonist
Andrei Gudkov (RPCI, CBLI), Venkatesh Natarajan (RPCI)
U.S.
61/423,825
n/a

ANTIMYCON = Small molecules inhibiting oncoprotein MYC
Andrei Gudkov (RPCI), Catherine Burkhart (CBLI), Mikhail Nikiforov (RPCI), Michelle Haber (CCIA), Murray Norris (CCIA)
U.S.
61/392,296
n/a

ANTIMYCON = Small Molecules Inhibiting Oncoprotein MYC
Andrei Gudkov (RPCI), Catherine Burkhart (CBLI), Mikhail Nikiforov (RPCI), Michelle Haber (CCIA), Murray Norris (CCIA)
U.S.
61/423,832
n/a

ARKIL = Method for treating androgen receptor positive cancers
Katerina Gurova (RPCI), Natalia Narizhneva (CBL)
U.S.
61/254,395
n/a

REVERCOM = Dual cargo nanoparticles combining MRP1 inhibitors with chemotherapeutic drugs
Andrei Gudkov (RPCI, CBLI), Aridam Sen (RPCI), Catherine Burkhart (CBLI), Padmaja Kunapuli (RPCI)
U.S.
61/423,838
n/a

Field of Use

“Application” means the intended use for a Licensed Product, including the diagnosing, treating, curing, mitigating, and/or preventing a disease or other condition in a human or other animal, such as small cell lung cancer, large cell lung cancer, or other specific disease state.