Royalty Report: Drugs, HIV / AIDs, Cancer – Collection: 118355

License Grant

The Licensors, including a University, granted a worldwide, exclusive license to commercialize and exploit natural hypericin and synthetic hypericin compounds to inactivate viruses and retroviruses as a therapeutic or preventive treatment for viral or retroviral diseases, and for anti-glioma, meaning brain tumor, indications.

License Property

Hypericin is a chemically synthesized analog of St. Johns wort.

VIMRxyn(R) is comprised of chemically synthesized hypericin and, in laboratory tests, has inhibited the infection of normal cells by targeted viruses. Hypericin is an aromatic polycyclic dione found in the stem and petals of the common Saint John's wort, a plant which has been used as a folk remedy since the Middle Ages. Hypericin plant extracts continue to be used as lay treatments for various disorders. The Company is investigating utilizing VIMRxyn as a treatment for viral and retroviral diseases, including the human immune deficiency virus ('HIV'), which is the retrovirus responsible for Acquired Immune Deficiency Syndrome ('AIDS'), and also is investigating utilizing VIMRxyn as a treatment for hepatitis C, as a therapeutic for brain cancer (glioma), and as a means of inactivating HIV and other lipid-enveloped viruses in blood collected for transfusions.

Field of Use

The field of use is for treatment of glioblastoma multiforme, a serious form of brain cancer, among other diseases.

License Grant

Licensor sold Leronlimab to Licensee where Licensee is responsible for all development, manufacturing and commercialization efforts.

License Property

Leronlimab (PRO 140) is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases including certain liver diseases.

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control.  Blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer.

Field of Use

The field of use is for the treatment in HIV infection, tumor metastases, and other diseases including certain liver diseases.

HIV (human immunodeficiency virus) is a virus that attacks cells that help the body fight infection.
Metastasis means that cancer spreads to a different body part from where it started.
Liver cancer is the growth and spread of unhealthy cells in the liver.

Licensee is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor.

License Grant

Pursuant to the terms of a certain License Agreement, by and between a University, the Licensors Designee in this agreement, and Licensor, the University and Licensor have agreed to grant Licensee a sublicense in certain inventions relating to ß-L-FD4C.

Licensor hereby grants to Licensee a non-transferable, worldwide, exclusive license under the Licensed Technology to make, have made, import, export, use, sell and have sold Licensed Products and practice the Inventions.

License Property

The University has licensed to Licensor certain inventions relating to, among other things, potential anti-viral compounds, including ß-L-FD4C.

The patents include
Novel L-23-Dideoxy Nucleoside Analogs as Anti-Hepatitis (HBV) Agents;
Reduced Toxicity Compositions and Methods for Treating HIV Infections; and,
Process for High Yield Diastereoselective Syntheses of Dideoxvnucleotides.

Field of Use

The field of use includes HIV treatments.

License Grant

Licensor grants an exclusive (even as to  Licensor), license under the Patent Assets and Know-How, including the right to grant sublicenses, to develop, make, have made, use, import, offer for sale, market and sell and otherwise dispose of Compound and Product, including any Improvements thereto, in the Territory.

License Property

The Licensed products contain the compound.  The Compound shall mean a condensation polymer of an aromatic sulfonic acid and an aldehyde or a pharmaceutically acceptable salt or prodrug thereof or a derivative, homolog, or analog thereof.

Field of Use

The Compound is for a candidate topical microbicide used to prevent infection by the human immunodeficiency virus (HIV) and other sexually transmitted pathogens.

License Grant

Licensor assigned to Licensee in the Progenics Purchase Agreement, pursuant to which we have an exclusive worldwide license to develop, make, have made, import, use, sell, offer to sell or have sold products that incorporate the humanized form of the leronlimab antibody developed under the agreement.

License Property

Leronlimab, a monoclonal antibody C—C chemokine receptor type 5 (“CCR5”) receptor antagonist, to be used as a platform drug for various indications. The target of leronlimab is the immunologic receptor CCR5. The CCR5 receptor is a protein located on the surface of various cells including white blood cells and cancer cells. On white blood cells, it serves as a receptor for chemical attractants called chemokines. The CCR5 receptor is also the co-receptor needed for certain strains of HIV to infect healthy T-cells. Recent research has identified the CCR5 receptor as an important target for many disease processes, including cancer metastasis and certain immunological conditions. Leronlimab is a unique humanized monoclonal antibody.

Leronlimab binds to the second extracellular loop and N-terminus of the CCR5 receptor, and due to its selectivity and target-specific mechanism of action, leronlimab does not appear to activate the immune function of the CCR5 receptor through agonist activity. This apparent target specificity differentiates leronlimab from other CCR5 antagonists. Leronlimab is a competitive rather than allosteric inhibitor of the CCR5 receptor.

Field of Use

Leronlimab (PRO 140) is a CCR5 antagonist with the potential for multiple therapeutic indications, today provided an update on leronlimab (PRO140) as a single agent for maintenance of HIV viral load suppression (HIV-1 RNA < 50 copies/mL).

The latest investigative monotherapy trial has revealed sufficient data to more precisely design the pivotal Phase 3 monotherapy trial that Licensee plans to use as the basis for label expansion after the potential approval of leronlimab (PRO140) for HIV patients as a combination therapy with HAART.  The longer half-life of leronlimab may help to reduce the number of non-responders in the first ten weeks of monotherapy, if the treatment overlaps with existing regimen of leronlimab for four weeks before initiating monotherapy.  Under the current trial protocol, patients have 7 days of overlap with their HAART regimen and leronlimab before initiating monotherapy.

The U.S. Food and Drug Administration (FDA) has granted a “Fast Track” designation to leronlimab (PRO 140) as a combination therapy with HAART for HIV-infected patients.  Leronlimab (PRO 140) is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling.  Leronlimab (PRO 140) has successfully completed nine Phase 1/2/3 clinical trials in over 700 people, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.

Field of use is to treat human immunodeficiency virus (“HIV”) patients with multiple resistance to current standard of care, COVID-19 patients, and metastatic Triple Negative Breast Cancer (“mTNBC”), among other indications.