Royalty Report: Drugs, Cancer, Biotechnology – Collection: 1455

License Grant

The Licensor, government public health organization, hereby grants and Licensee accepts, subject to the terms and conditions of this Agreement, a nonexclusive license to Licensee 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 import and have imported, and to offer for sale 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

Cancer Vaccines
Evaluation of Anthrax-Toxoid (AT) delivery system for efficiency in generating immune responses directed against tumor tissues in a mouse model system.
Application of the AT delivery system to two murine tumor models.

DNA Delivery Systems
Evaluation of the AT system for efficiency of DNA expression.
12/1/98
Testing of AT system for generating immune responses for Listeria monocytogenes.
12/1/98
Testing of a human pathogen as a DNA vaccine target.

Persistent Viral Infections
Application of the AT system to the (Latent Cytomegalovirus) LCMV model in mice.
12/1/98
Therapy of immunodeficiency virus (SHIV) infected Rhesus macaques and hepatitis B infected non-human primates using the AT system.

U.S. Patent Number 5,591,631 (USSN 08/021,601), entitled, “Anthrax Toxin Fusion Proteins And Related Methods”, Leppla et al., filed February 12, 1993, issued, January 7, 1997.

U.S. Patent Application Serial Number 08/082,849 (CIP of 08/021,601), entitled, “Anthrax Toxin Fusion Proteins And Related Methods”, Leppla et al., filed June 25, 1993.

Patent Application Serial Number 60/025,270, entitled, “Targeting Antigens To The MHC Class I Processing Pathway With An Anthrax Toxin Fusion Protein”, Klimpel et al., filed September 17, 1996.

Field of Use

Field of Use is for vaccines and immunotherapeutics for the prevention or treatment of human and animal diseases.

License Grant

The Licensor and Licensee entered into an exclusive, worldwide license agreement whereby we granted the Licensee the right to use our TranzFect technology in DNA-based vaccines targeted to four infectious diseases, one of which is HIV.

License Property

TranzFect is a delivery technology for DNA-based vaccines.

U.S. Patent
5,554,372 (subject to U.S. government regulations)
5,990,241
6,086,899

RE 36,665
5,567,859
5,696,298
5,824,322

Pending application 90/104,088

Foreign
W096/04932

6,086,899

Field of Use

The HIV Field shall mean the prevention and/or treatment of infection by Human immunodeficiency Virus.

License Grant

The Company obtains an exclusive worldwide license to the Licensed Patents, probasin gene (PG) and to practice, use or sell the Licensed Processes from Canadian University.

License Property

Licensed Patents shall mean all patent applications respecting PG (a) International PCT Application Serial No. PCT CA 9300319 filed August 9, 1993 entitled DNA Sequences of Rat Probasin Gene; and (b) all patent applications respecting PG which may be filed from time to time by University pursuant to this Agreement.

Field of Use

Field of Use shall mean human gene therapy involving the transfer of genetic material into target mammalian cells in vitro or in vivo for the purpose of intercellular drug delivery and/or treatment of a disease or medical condition.

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

The Company acquired the intellectual property rights relating to certain combination immunogene therapy technology from Licensor, an individual.

License Property

The technology allows for making a tumor cell more recognizable by the immune system and rendering it susceptible to the cell-killing component of the immune response.

A patent application has been filed for the technology entitled Combination Immunogene Therapy, United States Patent Application No. 09/826,025.  The standard approach in utilizing gene therapy to combat cancer has been to attempt to replace defective genes in cancer cells, which has proven to be impractical because of the number of genes involved. The combination gene therapy technology invented by Dr. Chang uses GM-CSF (a granulocyte macrophage colony stimulating factor) and B7-2 (a T-cell co-stimulating factor) to both build the body’s immune system and destroy cancer cells.  The treatment involves injecting the patient with two genes in one virus carrying a combination of B7-2 and GM-CSF.  Our technology, which shows potential for fighting cancer by enhancing one’s immune system and thereby increasing the number of cells that naturally destroy cancer, has proven effective in eradicating experimental human brain tumors implanted in mice and has undergone Phase 1 clinical trials in Canada.

Field of Use

The rights granted apply to the healthcare industry.

License Grant

Licensor, one of the nation’s leading research universities in topics such as health sciences, hereby grants to Licensee a limited, transferable (solely to Patriot Scientific or any purchaser of Licensee), exclusive license (referred to as Evaluation License) to evaluate the Materials for use in the Field of Use and to practice any method, process or procedure during the Evaluation Period solely for purposes of the Evaluation. The Evaluation License will terminate upon the expiration or termination of this Agreement, unless extended by mutual agreement. No other evaluation license will be granted in the Field of Use for the Evaluation Period.

Licensor hereby grants to Licensee the exclusive option to enter into a license agreement from Licensor for the commercial development, use, and sale of the Technology, products based on the Technology, patents, trade secrets, know-how, and other information related to the Technology;

License Property

Technology shall mean Materials or any intellectual property developed by Licensee from Materials including without limitation, all or any of the inventions and developments related thereto or arising out of any compositions, data, strains, patent applications, processes, techniques, contained therein and any physical embodiments thereof.

Materials shall mean the materials and/or intellectual property listed
– Licensor IDF Number 2013-2417 entitled “Non-Covalent Loading of Plant Picornavirus Particles” with US Patent Application US2015/0376578 A1 and EP Patent Application 14754692.3
– Licensor IDF Number 2015-2767 entitled “Cancer Immunotherapy using Virus Particles with US Patent Application US2018/0133304 A1 and associated foreign patent applications in Japan, China, Canada, Australia, and EP, US non-published patent application with patent serial number 16/612,214, and PCT Patent application with publication number WO 2018/208828 A1
– Licensor IDF Number 2017-3151 entitled “Melt Processed Viral Nanoparticle Constructs” with US Patent Application US2019/0350871 A1 and EP Patent Application 17868454.4

Patents shall mean any patent that issues or has issued to Licensor or patent application covering or consisting of the Technology and based on intellectual property in existence as of the Effective Date and any related patent or patent application that is a continuation, continuation-in-part, divisional, or reissue in the United States of America or any other country.

Field of Use

The technology is a novel platform technology using virus-like nanoparticles to treat and prevent cancer and infectious diseases in humans and for veterinary use.

The technology also has direct application as part of a vaccine platform, which has generated promising data in both cancer and infectious diseases, including COVID-19.
The researchers have collectively demonstrated that plant-derived, engineered VLP-based nanotechnologies stimulate a potent anti-tumor immune response in mouse models of metastatic melanoma, ovarian cancer, colon cancer, brain cancer and breast cancer, including companion dogs with metastatic melanoma. This data supports the potential to translate preclinical studies into veterinary applications, such as the treatment of cancer in companion animals, which has high relevance to human melanoma.
This immuno-oncology approach provides a personalized treatment approach by relieving the patient’s tumor-mediated immunosuppression and potentiating anti-tumor immunity against antigens expressed by their own tumor.

The vaccine platform is a natural extension of the immune-stimulating properties of the VLP, combined with directing the response to pre-defined targets. Instead of being a personal vaccine, the modular approach of linking disease specific targets to the VLP allows the potential to rapidly develop countermeasures for pandemics such as COVID-19.

Field of Use shall mean all therapeutic, diagnostic, vaccine and preventive uses of Technology for both veterinary and human applications. Final field of use, including specific indications, which may be narrower than the Field of Use, will be defined in any commercial use license. Said commercial use license will necessarily incorporate developmental, regulatory, and commercial distribution/sales milestones for each product that incorporates any Technology in the Field of Use. For clarification purposes, Technology and Materials shall not be used in or on humans during the Evaluation Period unless Licensee consults with Licensor regarding appropriate, and possibly expanded, indemnification and insurance requirements and receives Licensor’s written authorization to do so. Such authorization will be in Licensor’s sole discretion.