Royalty Report: Drugs, Cancer, Therapeutic – Collection: 26654

License Grant

We entered into an agreement giving us worldwide rights to use two proprietary hybridoma cell lines that are used in the production of BiovaxID with the University. These are the same cell lines that have been used by researchers at Stanford and the National Cancer Institute to perform their studies of the hybridoma idiotype vaccine in non-Hodgkins lymphoma. This agreement gives us exclusive rights to these cell lines through 2019 in the fields of B-cell and T-cell cancers, and it gives us non-exclusive rights in such fields of use at all times after 2019. The agreement also gives us the right to sublicense or transfer the licensed biological materials to collaborators in the licensed fields.

License Property

Biovaxid is a randomized phase III vaccine clinical research study being conducted at several cancer centers and clinics in the United States to compare two types of vaccine treatments for people with Stage III or IV follicular lymphoma — a type of cancer in the lymph nodes.

Field of Use

The rights granted apply to the medical field, primarily to cancer.

License Grant

University grants Licensee a license to the Biological Materials in the Licensed Field of Use to make, have made, use, import, offer to sell and sell Licensed Product in the Licensed Territory. The license is Exclusive, including the right to sublicense, in the Licensed Field of Use beginning on September 17, 2004, and ending on September 17, 2019.

License Property

Stanford has certain rights to biological material, specifically hybridoma cell lines known as K6H6/B5 and 1D12 .

Biological Materials means the K6H6/B5 and /or 1D12 cell lines.

Field of Use

Licensed Field of Use means the use of the Biological Materials to generate a series of personalized vaccines for the treatment of B and T cell neoplasms.

License Grant

Licensor grants exclusive rights to develop, commercialize and market Rituxan outside the United States and Canada.

License Property

Rituximabis a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases which are characterized by excessive numbers of B cells, overactive B cells, or dysfunctional B cells. This includes many lymphomas, leukemias, transplant rejection, and autoimmune disorders.

Field of Use

RITUXAN® (Rituximab) is indicated for the treatment of
Low-grade or follicular CD20-positive non-Hodgkin's lymphoma as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment
Follicular CD20-positive non-Hodgkin's lymphoma as an initial treatment with chemotherapy, and in patients whose initial treatment was successful, as a single-agent follow-up therapy
Low-grade or follicular CD20-positive non-Hodgkin's lymphoma as a single-agent follow-up therapy for patients who responded to initial treatment with CVP chemotherapy

License Grant

University hereby grants a worldwide exclusive license under the Licensed Technology, to develop, manufacture, have manufactured, use, market, import, have imported, offer for sale and sell Licensed Products.

License Property

“Licensed Products” shall mean all products derived from a combination of LYM-1 antibody or LYM-2 antibody plus the radioactive Iodine 131 combination.

United States Patent 4,724,213 issued February 9, 1988; Epstein, “Murine Hybridoma LYM-1 and Diagnostic Antibody Produced Thereby.”  United States Patent 4,724,212 issued February 9, 1988; Epstein, “Murine Hybridoma LYM-2 and Diagnostic Antibody Produced Thereby.”

“Hybridoma 173-9, Lym-1” (NU 8314-A)    A hybridoma clone, designated Lym-1, was produced from the fusion of primed mouse splenocytes and mouse myeloma NS-a cells. Hybridoma Lym-1 produced a murine IgG2a monoclonal antibody which recognizes a 31, 32, 33 and 35 kilodalton cell surface protein expressed in normal and malignant B lymphocytes.  Immunoperoxidase staining of a panel of normal human tissues shows that Lym-1 reacts with germinal center and mantle zone B lymphocytes and interdigitating histiocytes of the lymph node, medullary dendritic cells of the thymus, and weakly with surface epithlium of the colon. A subset of peripheral blood B cells are positive and no reactivity has been observed in human bone marrow by flow cytometric analysis. The antigen recognized by Lym-1 is not shed from the surface of lymphoma cells either in cell culture or in patients and is not modulated after Lym-1 binding. Lym-1 itself has been shown to have high avidity to human lymphoma cells IN VIVO as demonstrated by radionuclide binding studies in lymphoma patients using I-123 conjugates. Binding to normal tissues such as the bone marrow, spleen, lymph node, liver, kidney, lung or central nervous system has not been demonstrated in over 30 patients studied. Lym-1 has further been found to be highly stable to radionuclide conjugation methods and may be prepared as F(ab1)2 or F(ab) fragments without significant loss of antibody activity. Collectively, these data suggest that Lym-1 will be an appropriate reagent for IN VIVO diagnosis and therapy of the human B-cell lymphomas and leukemias.

'Hybridoma Clone 1010-9, Lym-2” (NU 8314-B) A hybridoma clone, designated Lym-2, was produced from the fusion of primed mouse splenocytes and mouse myeloma NS-1 cells. Hybridoma Lym-2 produced a murine IgG1 monoclonal antibody which recognizes a cell surface protein expressed in normal and malignant B lymphocytes. Immunoperoxidase staining of a panel of normal human tissues show that Pym-2 reacts with germinal center and mantle zone B lymphocytes and interdigitating histiocytes of the lymph node. A subset of peripheral blood B cells are positive and no reactivity has been observed in human bone marrow by flow cytometric analysis. Because of the remarkable specificity of Lym-2 for human B-cells and derived malignancies, these data suggest that Lym-2 will be appropriate for reagent for in vivo diagnostic and therapy of the human B-cell lymphomas and leukemias.

“Hybridoma Clone 818-18, BM-1” (NU 8216-C)  A hybridoma clone, designated 818-18, was produced from the fusion of primed mouse splenocytes and mouse myeloma NS-1 cells. Clone 818-18 produces a murine IgG1 monoclonal antibody which recognizes a nuclear antigen expressed in human granulocytes and myeloid precursors and acute and chronic myeloid leukemia. Immunoperoxidase staining with 818-18 on B5 fixed, paraffin embedded clot preparations of bone marrow aspirates shows positive nuclear staining of myeloid cells with normal non-specific background staining. The remarkable specificity of this reagent and its ability to stain B5 fixed, paraffin embedded tissues makes it a unique reagent for the diagnosis of myeloid derived leukemias.

Field of Use

Oncolym(R) was in a Phase II/III clinical trial for the treatment of non-Hodgkin's B-cell Lymphoma.

License Grant

The Licensee entered into an exclusive, worldwide License Agreement with a University for the AC Technology.

License Property

The AC Technology is based on the concept of haptenization.  

Our AC Technology utilizes the patient's tumor as the basis for a therapeutic vaccine.  By collecting and processing the cancer cells extracted from a patient's tumor most typically during the course of the first line of treatment, surgical tumor rescission, and then treating them with a hapten called dinitrophenol ('DNP'), a vaccine is prepared and then given back to the patient in an effort to elicit a systemic immune response to the unmodified, native cancer cells.

Field of Use

The Licensee is a development stage biotechnology company specializing primarily in the development and future commercialization of individualized cancer vaccines.  Our proposed vaccines consist of autologous (the patient's own) cancer cells that have been treated with a chemical ('haptenized') to make them more visible to the patient's immune system.  Our previous clinical trials for the AC Vaccine have concentrated on melanoma and ovarian carcinoma, which are our primary indications, and non-small cell lung cancer.

License Grant

The Swiss University hereby grants to Licensee, and Licensee hereby accepts, a license under Patent Rights to make and have made, use, sell, offer for sale, and import Licensed Products in the Field within the Territory and during the Term.

License Property

Patent Rights means any of the following  the PCT patent application entitled 'Treatment of B-cell lymphoma with microRNA', publication number WO 2012/041959.

MicroRNAs are naturally occurring, short ribonucleic acid, or RNA, molecules, or oligonucleotides, that play a critical role in regulating key biological pathways.

Field of Use

Field of use is for treatment of certain types of B-cell lymphoma with microRNA.
B-cell lymphoma is a type of cancer present in the lymph system.