59 results about "Pertuzumab" patented technology

The present application describes antibody formulations, including monoclonal antibodies formulated in histidine-acetate buffer, as well as a formulation comprising an antibody that binds to domain II of HER2 (for example, Pertuzumab), and a formulation comprising an antibody that binds to DR5 (for example, Apomab).

The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. α,α-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

The present application describes extending time to disease progression or survival in a cancer patient, where the patient's cancer displays HER activation, by treating the patient with a HER dimerization inhibitor, such as pertuzumab.

The present invention concerns fixed dosing of HER antibodies, such as Pertuzumab.

A method for selecting patients for therapy with a HER inhibitor, such as pertuzumab, based on gene expression analysis is described. A method for assessing HER phosphorylation or activation in a biological sample via gene expression analysis is also described.

This invention relates to the treatment of breast cancer in a subject, for example a female subject. Including methods of: treating metastatic breast cancer; refractory breast cancer; AR-positive breast cancer; AR-positive refractory breast cancer; AR-positive metastatic breast cancer; AR-positive and ER-positive breast cancer; triple negative breast cancer advanced breast cancer; breast cancer that has failed SERM (tamoxifen, toremifene), aromatase inhibitor, trastuzumab (Herceptin, ado-trastuzumab emtansine), pertuzumab (Perjeta), lapatinib, exemestane (Aromasin), bevacizumab (Avastin), and/or fulvestrant treatments; metastasis in a subject suffering from breast cancer; comprising administering to the subject a therapeutically effective amount of a selective androgen receptor modulator (SARM) compound.

Relating to the technical field of pharmaceutical preparations, the invention provides an antibody composition preparation composed of Trastuzumab and Pertuzumab. The antibody composition preparation has better tumor treatment activity. Compared with the independent treatment of Trastuzumab and Pertuzumab, the composition preparation shows a synergistic effect of the two antibodies, and can reach a tumor control rate of 92.43%. And the preparation provided in the invention has better stability, thus being in favor of long-term preservation of the antibody composition preparation. The antibody composition preparation provided in the invention is applicable to preparation of drugs treating diseases or symptoms suited to anti-HER2 antibody therapy. During application, the antibody composition preparation disclosed in the invention is used with a chemotherapeutic agent jointly or sequentially.

Methods of treating patients having HER2-positive, operable, locally advanced or inflammatory breast cancer with the antibody-drug conjugate Trastuzumab-MCC-DM1 and Pertuzumab are provided.

Methods of treating patients having HER2-positive cancer are provided. Certain methods involve treatment of HER2 positive breast cancer using a programmed cell death protein 1 (PD-1) binding antagonist or a programmed death ligand 1 (PD-L1) binding antagonist in combination with trastuzumab and pertuzumab or with trastuzumab emtansine. The treatment regimen may be used in various clinical settings, for example, for treatment in the neoadjuvant or metastatic setting.

The present invention relates to humanized bispecific anti-HER2 antibodies that comprise one antigen binding site containing variable regions of heavy and light chain of trastuzumab, and another antigen binding site containing variable regions of heavy and light chain of pertuzumab. The bispecific anti-HER2 antibodies is effective for treating cancer, such as breast cancer, gastric cancer, or ovarian cancer. Preferred bispecific anti-HER antibodies of the present invention are afucosylated antibodies. The present invention also relates to Chinese Hamster ovary (CHO) mutant cell line that has a dysfunctional Slc35C1 gene, which is the only dysfunctional gene in the mutant that affects glycan regulation.

Fixed dose HER2 antibody formulations for subcutaneous administration are provided along with their use in the treatment of cancer. The formulations include fixed dose subcutaneous formulations of pertuzumab and subcutaneous co-formulations of pertuzumab and trastuzumab, and their use in the treatment of cancer.

Provided are antibody-drug conjugate Pertuzumab-MCC-DM1 (that is, P-DM1) and a treating agent composition comprising the P-DM1 and an HER2 dimerisation inhibitor antibody. Also provided are uses of the P-DM1 and the treating agent composition in treating highly proliferative diseases.

The invention provides specific HER2 (human epidermal growth factor receptor 2) protein targeted polypeptide. The polypeptide is a mutant obtained with pertuzumab 46-65th amino acid as a template, can be specifically combined with HER2 high-expression positive breast cancer cells, and has the higher affinity than pertuzumab. The invention further provides a derivative of the polypeptide. The derivative is a bivalent or polyvalent formed from the polypeptide. The polypeptide has the character of targeting HER2 positive cancer cells, and is high in selectivity. The polypeptide can be prepared through a chemical synthesis method, is high in purity, small in molecular weight, strong in specificity, free of immunogenicity, safe and reliable, and can be used for cancer targeted therapy or cancer targeted molecular imaging and diagnosis.

Methods for the treatment of patients with HER2-positive, HER2-amplified and/or HER2-mutated advanced cancer by administration of pertuzumab plus trastuzumab are disclosed. In one aspect, the cancer is advanced HER2-positive, HER2-amplified and/or HER2-mutated colorectal, biliary, bladder, urothelial, salivary, lung, pancreatic, ovarian, prostate, or skin cancer. In another aspect, the cancer is HER2-positive, HER2-amplified and/or HER2-mutated colorectal, biliary, bladder, urothelial, salivary, lung, pancreatic, ovarian, prostate, or skin cancer that is refractory to one or more other treatment regimens.

The invention disclosed concerns a fixed dose combination (FDC) of pertuzumab, trastuzumab, and, optionally, recombinant human hyaluronidase (rHuPH20), which is administered subcutaneously to patients. The final efficacy and safety data for the FeDeriCa clinical trial, United States Prescribing Information (USPI) (including home-use) methods, and primary analysis of the PHranceSCa clinical trial are disclosed and claimed.