Abstract: The present invention provides methods for treating, reducing the severity, or inhibiting the growth of cancer (e.g., lung cancer). The methods of the present invention comprise administering a therapeutically effective amount of a programmed death 1 (PD-1) antagonist (e.g., an anti-PD-1 antibody), to a subject with lung cancer wherein the cancer tissue expresses PD-L1.

Abstract: B-cell maturation antigen (BCMA) is expressed on malignant plasma cells. The present invention provides methods for treating multiple myeloma using bispecific antibodies (bsAbs) that bind to both BCMA and CD3 and activate T cells via the CD3 complex in the presence of BCMA-expressing tumor cells. In certain embodiments, the bispecific antigen-binding molecules of the present invention are capable of inhibiting the growth of tumors expressing BCMA.

Abstract: The present disclosure provides methods for treating, reducing the severity, or inhibiting the growth of cancer (e.g., prostate cancer or metastatic castration-resistant prostate cancer). The methods of the present disclosure comprise administering to a subject in need thereof a therapeutically effective amount of a bispecific antibody or antigen-binding fragment thereof that specifically binds prostate-specific membrane antigen (PSMA) and CD28 in combination with an antibody or antigen-binding fragment thereof that specifically binds to programmed death receptor-1 (PD-1).

Abstract: The present disclosure provides methods for treating or inhibiting the growth of a tumor, including selecting a patient with cancer, wherein the patient has a tumor with threshold levels of both tumor mutation burden and expression of major histocompatibility complex, and administering to the patient a therapeutically effective amount of programmed death 1 (PD-1) inhibitor (e.g., an anti-PD-1 antibody or antigen-binding fragment thereof). In some embodiments, the cancer is skin cancer, such as basal cell carcinoma or cutaneous squamous cell carcinoma.

Abstract: The present invention provides methods for treating, reducing the severity, or inhibiting the growth of cancer (e.g., skin cancer). The methods of the present invention comprise administering to a subject in need thereof a therapeutically effective amount of a programmed death 1 (PD-1) antagonist (e.g., an anti-PD-1 antibody). In certain embodiments, the skin cancer is cutaneous squamous cell carcinoma or basal cell carcinoma.

Abstract: Administration regimens for therapeutic proteins (e.g., T cell-activating bispecific antibodies) that mitigate cytokine release syndrome and infusion-related reaction are disclosed. The methods employ initial fractional dosing with optional administration of additional agents such as steroids or cytokine antagonists that are discontinued with maximal weekly dosing over the course of the dosing regimen.

Abstract: Provided herein are methods of treating brain cancer in a subject, comprising evaluating one or more biological samples from a subject who has brain cancer for the presence of a miRNAs and administering interleukin-12 (IL-12); an immunogenic composition of human telomerase reverse transcriptase (hTERT), Wilms Tumor-1 (WT-1), and prostate specific membrane antigen (PSMA); and an anti-programmed cell death receptor 1 (PD-1) antibody to said subject if the subject has an increased expression level of the mIR-331-3p miRNA or isomiRs thereof and the miR-1537-3p miRNA or isomiRs thereof relative to a control population of subjects.

Abstract: Administration regimens for therapeutic proteins (e.g., T cell-activating bispecific antibodies) that mitigate cytokine release syndrome and infusion-related reaction are disclosed. The methods employ initial fractional dosing with optional administration of additional agents such as steroids or cytokine antagonists that are discontinued with maximal weekly dosing over the course of the dosing regimen.

Abstract: The present invention provides methods for treating, reducing the severity, or inhibiting the growth of cancer (e.g., skin cancer). The methods of the present invention comprise administering to a subject in need thereof a therapeutically effective amount of a programmed death 1 (PD-1) antagonist (e.g., an anti-PD-1 antibody). In certain embodiments, the skin cancer is cutaneous squamous cell carcinoma or basal cell carcinoma.

Abstract: The present invention provides methods for treating metastatic cancer comprising identifying subjects who will respond favorably to anti-VEGF therapy. According to certain aspects of the invention, subjects are identified based on their expression level of one or more predictive biomarkers. Favorable response to anti-VEGF therapy is indicated by high expression levels of certain biomarkers or by low expression levels of certain biomarkers. An exemplary predictive biomarker is VEGF-A. Also disclosed herein are prognostic biomarkers useful for identifying cancer-bearing subjects who are expected to have better relative survival outcomes.

Abstract: The present invention provides methods for treating, reducing the severity, or inhibiting the growth of cancer (e.g., lung cancer). The methods of the present invention comprise administering a therapeutically effective amount of a programmed death 1 (PD-1) antagonist (e.g., an anti-PD-1 antibody), to a subject with lung cancer wherein the cancer tissue expresses PD-L1.

Abstract: The disclosure relates to methods for treating or inhibiting the growth of a tumor in a patient with a skin cancer, including administering to the patient a therapeutically effective amount of a programmed death 1 (PD-1) inhibitor (e.g., an antibody or antigen-binding fragment thereof that specifically binds PD-1, PD-L1, and/or PD-L2). In certain embodiments, the method includes administering a PD-1 inhibitor as adjuvant treatment after the patient has completed surgery and optionally radiation therapy for skin cancer, such as CSCC, and is at high risk for disease recurrence. In certain embodiments, the method includes administering a PD-1 inhibitor as neoadjuvant treatment before planned surgery for skin cancer. In certain embodiments, the method includes administering a PD-1 inhibitor as neoadjuvant treatment before planned surgery for skin cancer and subsequently administering to the patient a PD-1 inhibitor as adjuvant therapy after such surgery.

Abstract: The present invention provides methods for treating, reducing the severity, or inhibiting the growth of cancer (e.g., lung cancer). The methods of the present invention comprise administering a therapeutically effective amount of a programmed death 1 (PD-1) antagonist (e.g., an anti-PD-1 antibody), to a subject with lung cancer wherein the cancer tissue expresses PD-L1.

Abstract: The present disclosure provides methods for treating, reducing the severity of, or inhibiting the growth of a tumor or improving overall survival in a cervical cancer patient, wherein the method includes selecting a patient with cervical cancer in need thereof and administering to the patient a therapeutically effective amount of a programmed death 1 (PD-1) inhibitor (e.g., an anti-PD-1 antibody or antigen-binding fragment thereof such as cemiplimab or a bioequivalent thereof). In certain embodiments, the patient has recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Abstract: The disclosure relates to methods for treating or inhibiting the growth of a tumor, wherein the methods include selecting a subject with a skin cancer and intralesionally administering to the tumor of the subject in need thereof a therapeutically effective amount of a programmed death 1 (PD-1) inhibitor (e.g., an antibody or antigen-binding fragment thereof that specifically binds PD-1, PD-L1, and/or PD-L2). In certain embodiments, the skin cancer is cutaneous squamous cell carcinoma. In certain embodiments, the PD-1 inhibitor is administered into multiple locations of the tumor lesion.

Abstract: Antibodies that specifically bind to toxins of C. difficile, antigen binding portions thereof, and methods of making and using the antibodies and antigen binding portions thereof are provided herein.

Abstract: The present invention provides methods for treating, reducing the severity, or inhibiting the growth of cancer (e.g., a B-cell cancer such as Hodgkin's lymphoma or acute lymphoblastic leukemia). The methods of the present invention comprise administering to a subject in need thereof a therapeutically effective amount of an antibody or antigen-binding fragment thereof that specifically binds to programmed death 1 (PD-1) receptor in combination with a therapeutically effective amount of a bispecific antibody that specifically binds to CD20 and CD3.

Abstract: B-cell maturation antigen (BCMA) is expressed on malignant plasma cells. The present invention provides methods for treating multiple myeloma using bispecific antibodies (bsAbs) that bind to both BCMA and CD3 and activate T cells via the CD3 complex in the presence of BCMA-expressing tumor cells. In certain embodiments, the bispecific antigen-binding molecules of the present invention are capable of inhibiting the growth of tumors expressing BCMA.

Abstract: Provided herein are nucleic acid molecules, proteins, compositions and methods for treating brain cancer in a subject. In some embodiments, the compositions comprise cancer antigens hTERT, WT-1, and PSMA. In some embodiments, the compositions also comprise an adjuvant. The methods comprise administering to a subject in need thereof the cancer antigens. According to certain embodiments, the methods further involve administering the adjuvant and an anti-PD-1 antibody. In certain embodiments, the methods further comprise administering radiation therapy and/or a chemotherapeutic agent. In certain embodiments, the methods are clinically proven safe, clinically proven effective, or both.

Abstract: The present invention relates to a method (dosage regimen) for administering a CD3×CD20 bispecific antibody to a human patient, comprising (a) administering a first dose of said antibody in a specific dosage; and consecutively (b) administering a second dose of said antibody after a period of time, wherein said second dose exceeds said first dose. The methods of the invention (and likewise the dosage regimen of the invention) are also suitable for treating B cell (CD20-positive) cancer in a human patient, or for ameliorating and/or preventing a medical condition mediated by the periodic or continued administration of a CD3×CD20 bispecific antibody to a human patient. The present invention also relates to the use of a CD3×CD20 bispecific antibody for the preparation of a pharmaceutical composition to be used in a method or treatment regime as defined in any one of the preceding claims.