Royalty Report: Drugs, Cancer, Therapeutic – Collection: 260705

License Grant

The Licensee entered into a second agreement with the Licensor for a non-exclusive license to certain recombinant monoclonal antibody reactive with human programmed death protein, PD-1 antibody. The Licensee expects to use this protein in certain oncology drug candidates.

License Property

Certain recombinant monoclonal antibody reactive with human programmed death protein, PD-1 antibody.

Field of Use

The Licensee is a clinical-stage biopharmaceutical company and expects to use this protein in certain oncology drug candidates.

License Grant

The Company received exclusive development and commercialization rights worldwide to MGA012, an investigational monoclonal antibody that inhibits programmed cell death protein 1 (PD-1). MGA012 is currently in clinical development by Licensor.

License Property

MGA012 is an investigational monoclonal antibody that inhibits programmed cell death protein 1 (PD-1). MGA012 is currently in clinical development by Licensor.

Field of Use

This agreement pertains to the drug industry.
Antibodies targeting PD-1 have shown clinical efficacy in the treatment of various tumors. These antibodies act as checkpoint inhibitors, releasing the “brakes” on the immune system that are often imposed by tumors as a means to evade immune detection.

License Grant

The Parties entered into an agreement to obtain a license under certain patents owned and/or exclusively licensed by one or more of those parties that includes the right to develop and sell Libtayo.

License Property

Libtayo® (cemiplimab), an antibody targeting the receptor known as programmed cell death protein 1 (PD-1).

LIBTAYO® is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

Cutaneous squamous cell carcinoma (cSCC) is a type of skin cancer.

Field of Use

This agreement pertains to the drug industry relating to antibody-based cancer treatments in the field of immuno-oncology.

License Grant

Licensor hereby grants to Licensee a right and license or, in the case of Patents licensed to Licensor under the Licensor In-Licenses, a sublicense, under the Licensed Technology, to make, have made, use, offer to sell, sell and have sold Products except as set forth in this agreement in the relevant Field, and in the Territory.

License Property

Table 1 BR96sFv-PE40 Program

The following patents and patent applications, together with the know-how related thereto, constitute the BR96 sFV-PE40 Program

Patent
  
Description
License Type

Number
Number

57,444
5,491,088
  
Murine monoclonal antibody BR96, chimeric BR96 and antigen binding fragments of BR96.
Exclusive

459,354

  
Recombinant BR96 molecules having the antigen binding region of murine BR96.
Exclusive

Table 2 BR96/Drug Conjugate Program

Application
Patent
  
Description
License Type

Number
Number

353,729
5,122,368
  
Linker chemistry having an acylhydrazone linkage through C13 keto group of anthracycline to nonimmunoglobulin ligand. Linker arm also includes thioether or disulfide bond.
Partially-Exclusive for Linkers

96,628

  
Acylhydrazone linkage through C13 keto group of anthracycline to immunoglobulin. Linker arm also includes thioether or disulfide bond.
Partially-Exclusive for Linkers

824,951
5,622,929
  
Anthrecycline ligand conjugates where linkage is an acylhydrazone through C13 keto position of anthracycline. Linker also contains succinimido moiety. Chemistry is used to make first generation chiBR96-Dox.
Partially-Exclusive for Linkers

08/468,162
5,606,017
  
Anthracycline intermediate having acylhydrazone linkage through C13 keto position of anthracycline and a Michael Addition Receptor. Intermediate in conjugation used to make first generation chiBR96-Dox.
Partially-Exclusive for Linkers

08/469,840

  
Process for conjugation using intermediate above with reduced immunoglobulin to increase total drug to antibody yield. Process is used to make first generation chiBR96-Dox.
Partially-Exclusive for Linkers

62,366

  
Enzyme cleavable peptide linker for making cytotoxic drug ligand conjugates. Linkers are used to make second generation BR96-Dox.
Partially-Exclusive for Linkers

57,444
5,491,088
  
Murine monoclonal antibody BR96, chimeric BR96 and antigen binding fragments of BR96.
Exclusive

77,253

  
Immunoconjugates of murine monoclonal antibody BR96, chimeric BR96 and other recombinant antigen binding fragments. Includes single chain and bispecific recombinant constructs.
Exclusive

333,840

  
Methods of treating human carcinoma by administering murine BR96, chimeric BR96 or any recombinant antigen binding construct either by itself or conjugates with various agents. Also includes diagnostic kits.
Exclusive

459,354

  
Recombinant BR96 molecules having the antigen binding region of murine BR96.
Exclusive

08/285,936

  
Mutants of BR96 which have increased binding affinity/avidity to antigen.
Exclusive

08/487,860

  
Mutants of BR96 which have increased binding affinity/avidity to antigen.
Exclusive

60/030/367

  
Branched peptide linker for linking thiol group on targeting ligand to two or more drug moieties.
Partially-Exclusive for Linkers

5,204,244
  
Production of chimeric antibodies by homologous recombination.
Non-Exclusive

5,202,238
  
Production of chimeric antibodies by homologous recombination.
Non-Exclusive

5,482,856
  
Production of chimeric antibodies by homologous recombination.
Non-Exclusive

Table 3 G28-5 SfV/Immunotixin Program

The patents and patent applications (the “Washington Patents”), together with the know-how related thereto, sublicensed under the Washington Agreement constitute the G28-5 sFv/Immunotoxin Program. [Exclusive]

Table 4 BD1 Program

The following patents and patent applications, together with the know-how related thereto, constitute the BD1 Program

Application
Patent
Description
License Type

Number
Number

08/245,754
5,541,110
Isolated oligonucleotide sequence encoding Bryodin 1, recombinant vectors and plasmids, and transfected host cells.
Exclusive

08/597,731

Methods for the recombinant production of Bryodin 1 and Bryodin 1-ligand fusion proteins.
Exclusive

08/324,301
5,597,569
Ribosome-inactivating protein Bryodin 2 in an isolated form, linked to a ligand as a conjugate or a fusion protein, pharmaceutical compositions, nucleotide sequence, transfected host cells and recombinant production.
Exclusive

Table 5 ADEPT Program

The following patents and patent applications, together with the know-how related thereto, constitute the ADEPT Program

Application

Number
Patent
Description
License Type

(filed 5/7/96)
Number

Recombinant L49sFv-¨ lactamase fusion proteins which recognize p97 melanoma antigen and activate-cephalosporin derivatized prodrug molecules.
Exclusive

211,301
4,975,278
Methods for delivering cytotoxic agents to tumor cells by administering an effective amount of at least one antibody-enzyme conjugate, wherein the antibody is specific for a tumor associated antigen and the enzyme converts at least one weakly cytotoxic prodrug to its corresponding cytotoxic parental form; and the administration of an effective amount of the prodrug.
Non-Exclusive

Table 6 Residual Program

The following patents and patent applications, together with the know-how related thereto, constitute the Residual Program

Application
Patent
Description
License Type

Number
Number

684,759
4,935,495
Monoclonal antibodies, Fab, F(ab1)2 or Fv fragments thereof which compete for binding with L6 to its antigen.
Partially-Exclusive for Cancer

776,321
4,906,562
Methods for detecting malignancy using L6 or other monoclonal antibodies or fragments thereof which compete with L6 for binding to its antigen.
Exclusive

523,309
5,091,177
Method for reducing population of tumor cells using L6 or monoclonal antibodies which compete for binding with L6 to its antigen.
Exclusive

443,696
5,242,824
Monoclonal antibody BR64 and antigen binding fragments thereof.
Exclusive

08/726,528

Monoclonal antibodies and recombinant antigen binding molecules which recognize the G733-1 but not G733-2 antigen. Specifically BR110.
Partially-Exclusive for Cancer

527,227
5,165,922
Method of treating breast carcinoma in an unresponsive patient by first administering monoclonal antibody L6 followed by administration of a chemotherapeutic agent.
Exclusive

5,663,158
Method for treating vascular leak syndrome.
Non-Exclusive

The Residual Program also includes antibodies L6, L49, BR64, BR110, OV578.1 and OV569.1 [Exclusive]

Field of Use

Field shall be the treatment and diagnosis of cancer in humans.

The Field with respect to Licensed Technology for which Licensee is granted a right and license that is partially exclusive shall be

(i) if this Agreement indicates that such license is partially exclusive for linkers, all monoclonal antibody targeting applications; or (ii) if the agreement indicates that such license is partially exclusive for cancer, the treatment and diagnosis of cancer in humans. The Field with respect to Licensed Technology for which Licensee is granted a right and license that is non-exclusive shall be the treatment and diagnosis of cancer in humans. Notwithstanding the foregoing, the Field with respect to the G28-5 Licensed Technology shall be for the use of the antibody G28-5 fused with a toxin for the treatment of cancer in humans.

License Grant

This agreement is for Collaborative Research. The goal of the Program is to humanize and optimize Candidate Molecules.  The plan includes antibody cloning, assay development and validation, design and synthesis of Humanization/Optimization Libraries, Screening, Characterization, Affinity Maturation, Iterative Affinity Maturation and Deliverables.

Licensor shall optimize and humanize the Candidate Molecules as set forth in the Research Plan. Licensor shall use its commercially reasonable efforts to perform its obligations under the Program in accordance with the Research Plan. Licensor shall provide the personnel, materials, equipment and other resources required to conduct its obligations under the Program. Licensor shall perform its obligations under the Program in accordance with high scientific and professional standards, and in compliance in all material respects with the requirements of applicable laws and regulations.

Licensee shall use its best efforts to actively research, develop and obtain regulatory approvals to market in major markets throughout the world at least one Product.

License Property

Product shall mean any product for use in the Field, which is a composition that incorporates one or more Program Antibodies or is derived from one or more Program Antibodies.

The Candidate Molecules shall mean, collectively, monoclonal antibody (mAb) HUIV26 and mAb HUI77 as provided by Licensee to Licensor.

Materials shall mean the Candidate Molecules, DNA sequence information and the cDNA to encode Candidate Molecules and the hybridoma cell lines expressing the Candidate Molecules.

Program Antibody shall mean the optimized and humanized compositions of matter developed under the Program, and the cDNA encoding such compositions of matter, delivered to Licensee.

Licensor utilizes its technology to humanize a murine monoclonal antibody, which is now referred to as D93, and another of our anti-angiogenic monoclonal antibodies.

Field of Use

The Field shall mean human and veterinary therapeutic and diagnostic applications.

D93 is humanized, anti-angiogenic monoclonal antibody, in patients with solid tumors.

License Grant

In consideration of the mutual covenants contained in this Amendment and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree to amend several sections including but not limited to Royalties and Licensee shall have the right, at its sole discretion, either itself or through counsel  of its choice, to control the preparation, filing, prosecution, maintenance and enforcement of all Patents which claim Program Antibodies.

License Property

This agreement is for Collaborative Research. The goal of the Program is to humanize and optimize Candidate Molecules. The plan includes antibody cloning, assay development and validation, design and synthesis of Humanization/Optimization Libraries, Screening, Characterization, Affinity Maturation, Iterative Affinity Maturation and Deliverables. Licensor shall optimize and humanize the Candidate Molecules as set forth in the Research Plan. Licensor shall use its commercially reasonable efforts to perform its obligations under the Program in accordance with the Research Plan. Licensor shall provide the personnel, materials, equipment and other resources required to conduct its obligations under the Program. Licensor shall perform its obligations under the Program in accordance with high scientific and professional standards, and in compliance in all material respects with the requirements of applicable laws and regulations. Licensee shall use its best efforts to actively research, develop and obtain regulatory approvals to market in major markets throughout the world at least one Product.

Product shall mean any product for use in the Field, which is a composition that incorporates one or more Program Antibodies or is derived from one or more Program Antibodies. The Candidate Molecules shall mean, collectively, monoclonal antibody (mAb) HUIV26 and mAb HUI77 as provided by Licensee to Licensor. Materials shall mean the Candidate Molecules, DNA sequence information and the cDNA to encode Candidate Molecules and the hybridoma cell lines expressing the Candidate Molecules. Program Antibody shall mean the optimized and humanized compositions of matter developed under the Program, and the cDNA encoding such compositions of matter, delivered to Licensee.

Field of Use

HUI77 and HUIV26 are anti-angiogenic mouse antibodies discovered using subtractive immunization, which could enable Licensee to pursue the commercialization of these antibodies.

Licensee is developing a family of antibodies that is selective for angiogenesis.  Anti-angiogenesis as a treatment for cancer.

License Grant

Assignor (from France) hereby irrevocably sells, conveys, assigns and will assign, transfers and relinquishes solely and exclusively to Assignee (from Israel), Assignor’s entire right, title and interest in and to the Patent Rights, Technology and Deliverables. Assignee shall pay Assignor royalties based on Net Sales of Products.

License Property

The Licensee obtained all rights, titles and interests in and to the patent rights, technology and deliverables related to the anti-Ferritin mAb, AMB8LK, including its nucleotide and protein sequences, its ability to recognize human acid and basic ferritins,  or a part of its ability to recognize human acid and basic ferritins.

Technology means the data including electronic data, documents, information (including electronic information), records discoveries, improvements, know-how, trade secrets, methods, materials and compositions, and processes including synthesis, developed by or otherwise acquired by Assignor as of the Effective Date and relating to (i) Use of anti-ferritin monoclonal antibodies in the treatment of some cancers or (ii) Nucleotide and protein sequences of an antibody directed against an epitope common to human acidic and basic ferritins, monoclonal antibodies or antibody-like molecules comprising these sequences or the Deliverables or the uses thereof as described in the Patent Rights.

Products or Product means a product containing AMB8LK or the manufacture, use, sale, offering for sale, or importation of which would infringe a Valid Claim of the Patent Rights.

AMB8LK means a monoclonal antibody, as described in applications WO2009/037525 and US20090074657, including its nucleotide and protein sequences, recognizing human acid and basic ferritins, or a part of this antibody able to recognize human acid and basic ferritins. AMB8LK includes the variable heavy chain of this monoclonal antibody, the variable light chain of this monoclonal antibody as well as variants of these chains, a chimeric or humanized anti-ferritin monoclonal antibody comprising the variable heavy chain, the variable light chain and/or their variants and functional fragment of these antibodies (Fv, Fab, scFv, bis-scFv or diabody).

Field of Use

The Licensee is a clinical stage biopharmaceutical company specializing in the development and commercialization of targeted therapeutics, including mAbs, nanotherapeutics and antibody drug conjugates, for the treatment of inflammatory diseases and cancer. AMB8LK is a monoclonal antibody.