Royalty Report: Drugs, Cancer, Antibody – Collection: 340451

License Grant

Licensor grants to Licensee a non-exclusive, royalty-bearing license under Patent Rights, with the right to grant Sublicenses in accordance with agreement, to use, make, have made, develop, market, import, distribute, sell and have sold Licensed Products and Licensed Processes in the Territory for the Field of Use during the Term.

License Property

Patent #10,526,660 – Methods for evaluating and treating Waldenstroms macroglobulinemia

CXCR4, or C-X-C receptor type 4, is a G-coupled protein receptor, or GCPR, and its sole ligand is the chemokine CXCL12. Chemokines are signaling proteins that guide the migration of immune cells within the body by binding to receptors on the surface of target cells.

Field of Use

Field of Use means the therapeutic use of Licensee’s CXCR4 antagonist for treatment of Waldenstrom’s Macroglobulinemia in combination with BTK inhibitors, including ibrutinib.

Waldenström’s is a rare form of non-Hodgkin’s lymphoma and B-cell lymphoproliferative disorder most often caused by mutations in a gene for MYD88.  It is a blood cancer.

License Grant

Licensor grants to the Licensee of the British Virgin Islands, an exclusive, even as to Licensor, license to develop, manufacture, make, have made, use, sell, offer to sell and import the Licensed Products under the Patent Rights, within the Field, and restricted to the Territory during the term of this Agreement.

License Property

Licensed Compound shall mean the IgGl form of the fully human antibody called STI-A1014 listed as SH1E2 clones 18-Dl O and 1 l 7-A7 that binds to human PD-Ll and is described in published PCT application WO 2013/181634 where the antibody is called SH1E2, which is covered by the Patent Rights.

The patent is titled Antigen binding proteins that bind PD-Ll.

Licensed Products shall mean any pharmaceutical product containing the Licensed Compound as an active ingredient, alone or in combination with other active ingredients and commercialized for an indication within the field.

Antibodies targeting PD-1 and PD-L1, thus, harnessing the cancer patient's own immune system for treatment of various solid and hematological malignancies have demonstrated tremendous therapeutic potential rarely seen with conventional oncolytic drugs.

Field of Use

Field shall mean treatment and management of human diseases and disorders.

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.