Royalty Report: Drugs, Vaccine, Cancer – Collection: 113052

License Grant

The company executed a worldwide exclusive license agreement with the the University for ThermoVax®, which is the subject of U.S. patent number 8,444,991 issued on May 21, 2013 titled “Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition.”

License Property

This patent and its corresponding foreign filings are licensed to us by the University and they address the use of adjuvants in conjunction with vaccines that are formulated to resist thermal inactivation. U.S. Patent 8,444,991 is expected to expire in December 2031. The license agreement also covers thermostable vaccines for biodefense as well as other potential vaccine indications.

Field of Use

This agreement pertains to the drug industry relating to vaccines.

The company is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.  The Company maintains two active business segments BioTherapeutics and Vaccines/BioDefense.

The Company’s BioTherapeutics business segment is developing a first-in-class photodynamic therapy (SGX301) utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”), proprietary formulations of oral beclomethasone 17, 21-dipropionate (“BDP”) for the prevention/treatment of gastrointestinal (“GI”) disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201), and it’s novel innate defense regulator (“IDR”) technology dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer.

The Company’s Vaccines/BioDefense business segment includes active development programs for RiVax™, its ricin toxin vaccine candidate, VeloThrax™, an anthrax vaccine candidate, OrbeShield®, a GI acute radiation syndrome (“GI ARS”) therapeutic candidate and SGX943, a melioidosis therapeutic candidate. The development of the vaccine programs currently supported by the heat stabilization technology, known as ThermoVax®, under existing and on-going government contract funding. With the government contract from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Company will attempt to advance the development of RiVax™ to protect against exposure to ricin toxin. The Company plans to use the funds received under the government contracts with the Biomedical Advanced Research and Development Authority (“BARDA”) and NIAID to advance the development of OrbeShield® for the treatment of GI ARS.

License Grant

The Parties executed a worldwide exclusive sublicense agreement for the heat stabilization technology.

License Property

The heat stabilization technology, known as ThermoVax®. ThermoVax®  The indication – Thermostability of aluminum adjuvanted vaccine for ricin (Vaccine Thermostability Platform)

ThermoVax® is a novel method of rendering aluminum salt, (known colloquially as Alum), adjuvanted vaccines stable at elevated temperatures. Alum is the most widely employed adjuvant technology in the vaccine industry. The value of ThermoVax® lies in its potential ability to eliminate the need for cold chain production, transportation, and storage for Alum adjuvanted vaccines. This would relieve the high costs of producing and maintaining vaccines under refrigerated conditions. Based on historical reports from the World Health Organization and other scientific reports, we believe that a meaningful proportion of vaccine doses globally are wasted due to excursions from required cold chain temperature ranges. This is due to the fact that most Alum adjuvanted vaccines need to be maintained at between 2 and 8 degrees Celsius (“C”) and even brief excursions from this temperature range (especially below freezing) usually necessitates the destruction of the product or the initiation of costly stability programs specific for the vaccine lots in question. ThermoVax® has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines for ricin exposure in emergency settings.

The development of the vaccine programs currently is supported by our heat stabilization technology.  The focus is on developing and commercializing products to treat rare diseases where there is an unmet medical need.

Proof-of-concept preclinical studies with ThermoVax® indicate that it is able to produce stable vaccine formulations using adjuvants, protein immunogens, and other components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage conditions. These studies were conducted with our aluminum-adjuvanted ricin toxin vaccine, RiVax® and our aluminum-adjuvanted anthrax vaccine, VeloThrax®.

Field of Use

This agreement pertains to the drug industry for use in the fields of ricin and Ebola vaccines.

License Grant

This worldwide exclusive license agreement with the Israeli Licensor, the technology transfer company of the University, for the rights to a novel, first-in-class, photodynamic therapy that utilizes safe visible light for activation, referred to as SGX301.

License Property

SGX301 is a novel, first-in-class photodynamic therapy using a potent photosensitizer, synthetic hypericin, that is topically applied and activated by safe visible fluorescent light. This treatment avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet A (UVA) light exposure. Topical, synthetic hypericin has demonstrated safety in a Phase 1 clinical study in healthy volunteers.  In a Phase 2, placebo-controlled, clinical study in patients with cutaneous T-cell lymphoma (CTCL), the drug was safe, well tolerated, and effective in ameliorating the skin lesions.

Cutaneous T-cell lymphoma (CTCL) is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system.

In addition to issued and pending patents, we also have “Orphan Drug” designations for SGX301 in the U.S.

The exclusive license includes rights to several issued US patents, including U.S. patent numbers 6,867,235 and 7,122,518, among other domestic and foreign patent applications.

Field of Use

Licensee is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.

License Grant

The Licensor entered into an Exclusive License Agreement with the Licensee, for the rights to intellectual property, including know-how, and granting the right to commercially exploit the covered products worldwide.

License Property

The Intellectual Property relates to orBec/oral BDP and the development of proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation, including pediatric Crohns disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec).

License Grant

The Licensor, government organization of England, grants the Licensee of England a nonexclusive worldwide license to use the Intellectual Property to develop, make, or have made, use, keep, sell, offer to sell, import and export Licensed Products, and to develop, make, have made, and use Anthrax Vaccine for the purpose of Licensor exercising the rights and licenses granted to Licensor with respect to Licensed Product.

License Property

Anthrax Vaccine shall mean protective antigen from Bacillus anthracis (anthrax) which is produced using recombinant technology.

Anthrax Vaccine Dose shall mean the quantity of a formulation containing Anthrax Vaccine given to an individual in a single immunization.

Licensed Product shall mean an Anthrax Vaccine Dose the manufacture, use, sale, keeping, importing or exporting of which would, in the absence of the license granted under this Agreement, constitute an infringement of the Patents or that uses other Intellectual Property.

The patent is for Expression System (Anthrax Immuuogenic Polypeptide), a UK Priority Patent Application.

Recombinant Bacillus Anthracis (Anthrax) Protective Antigen Vaccine containing Alum

The patent covers MOD Case P1454 Expression System.

Field of Use

These agreements allow for the licensing of certain patents and technology necessary to perform development of the rPA and rYP programs as required under the Company’s government contracts with the NIAID.

PharmAthene is a biodefense company engaged in the development and commercialization of medical countermeasures against biological and chemical weapons.

License Grant

The Licensee entered into a worldwide nonexclusive License Agreement with the Licensor, the primary agency of the United States government responsible for biomedical and public health research, for the use of certain patents and tangible materials to be used in the development and commercialization of a vaccine for the SARS-CoV-2 virus.

License Property

The focus is on the development of a vaccine for the SARS-CoV-2 virus and other strains of coronavirus using patented and patent-pending technology.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 is the strain of coronavirus that causes coronavirus disease 2019 (COVID-19), the respiratory illness responsible for the COVID-19 pandemic.

Field of Use

Licensee focus is on developing novel antibiotics against infectious diseases; especially a vaccine for the SARS-CoV-2 virus and other strains of coronavirus using patented and patent-pending technology. The goal is accelerating the development of much needed new antibiotics that can work against resistant strains of bacteria and the development of biotherapeutics for oral mucositis and other diseases and conditions of the oral cavity, throat, and esophagus.

License Grant

Pursuant to the Agreement, Licensee obtained an exclusive license under Licensor patent rights and know-how to develop, make, have made, use and sell Licensed Products in the Territory.

With this amendment the parties wish to amend the Agreement to provide for the reversion of rights to Licensor under the Licensor patent rights and know-how for Influenza vaccine, HPV vaccine and HSV vaccine.

As of the Amendment Effective Date, the license granted to Licensee, and the rights and obligations of Licensee and Licensor arising therefrom, shall no longer apply to Influenza vaccine, HPV Vaccine and HSV Vaccine, and these vaccines shall no longer be deemed to be Licensed Products under the Agreement.

Hereby amended Licensor grants to Licensee an exclusive license, even as to Licensor, under Licensor know-how and patent rights to develop, make, have made, use and sell Licensed products in the Territory with the right to grant sub licenses to Affiliates of Licensee and those persons or entities through whom Licensee, in the normal course of its business collaborates in the manufacture and sale of its products; provided however, that nothing in this Agreement shall prohibit Licensor from utilizing the Licensor know-how and/or patent rights, exclusive of Licensee know-how, to develop, make, have made, use and sell, either by itself or with one or more third parties, products for the treatment of infectious diseases provided, further, notwithstanding the preceding proviso, that Licensor shall not have any right to develop, make, have made, use, or sell, either by itself or with one or more third parties, Treatment Vaccines.

Licensor grants an option to obtain a license under theLicensor patent rights and know-how to make, have made, use, sell, offer to sell and import Cancer Vaccines in the Territory for up to three (3) Cancer targets. Such Cancer target license shall be exclusive, even as to Licensor, for each Cancer Target so licensed, and shall be sublicenseable by Licensee pursuant to the terms applicable to Licensed Products.

License Property

This amendment includes Amended Definitions Relating to Cancer targets, and, Licensed Product means a bulk or finished AIDS Vaccine, or other vaccine for the prevention of human infectious disease if licensed hereunder, which utilizes the Technology or technology which is developed by Licensor during and as a result of the research collaboration program; and upon the exercise of an Option for a Cancer vaccine, such bulk or finished Cancer vaccine for the prevention of Cancer Indications, provided, however, that if any vaccine is also capable of being used for treatment of the same human infectious disease or Cancer indication, then such therapeutic use of such vaccine shall also be considered a Licensed Product for purposes of the license being granted by Licensor to Licensee under this Agreement; and Treatment vaccines.

Treatment vaccines means a bulk or finished vaccine.

Field of Use

The field of use is for the treatment of Human Immunodeficiency Virus (HIV-1) and/or diseases caused by infection with HIV-1 in humans;  Hepatitis Virus (HBV) and or diseases caused by infection with HBV in humans; and Cancer vaccines for the treatment, but not prevention or prevention and treatment, of Cancer Indications.