The invention relates, in part, to methods of scoring a sample containing tumor tissue from a cancer patient. The score is representative of a spatial proximity between at least one pair of cells, a first member of the at least one pair of cells expressing a first biomarker and a second member of the at least one pair of cells expressing a second biomarker that is different from the first biomarker. The score obtained from these methods can be indicative of a likelihood that a patient may respond positively to immunotherapy.

The disclosure provides methods of determining patient populations amenable or suitable for immunomodulatory treatment of disease such as cancer by measuring the relative or absolute levels of T-cell sub-populations correlated with disease such as cancer.

Provided are methods involving the assaying of a labeled cell suspension, e.g., to detect cancer-related cells, populations ON thereof and/or screen for metastatic cancer. Labeled cell suspensions may be assayed to detect whether a tumor infiltrating lymphocyte (TIL) population is present in a cellular suspension of a subject. Cancer-related cell populations of interest include, e.g., those expressing one or more markers, including where the markers are members of a marker panel. Markers assayed may vary depending on the context and may include protein markers, nucleic acid markers, cell cycle markers, DNA content markers, and the like. Useful markers include one or more immune checkpoint markers and/or one or more immune cell-type markers, including where the marker(s) assayed are part of one or more panels of markers. Also provided are methods of treating a subject for a neoplasia based on the outcome of an assay of a labeled cell suspension of sample from a subject. Kits for practicing the described methods are also provided.

This disclosure provides a novel method of controlling the glycosylation profile of a protein during production. The disclosure also provides a novel method of improving protein yield while controlling the glycosylation profile of a protein.

Provided herein is a method for predicting the probability of having or developing a non-fusion, wherein said method comprises determining the frequency of a subpopulation of CD8+ T cells selected from CD8+CD57+, CD8+CD28− and CD8+CD57+CD28− in a sample obtained from a patient. Also provided herein is a system for predicting the probability of having or developing a non-fusion.

The present application relates generally to methods for treating hematologic malignancy such as diffuse large B cell lymphoma (DLBCL), and in particular to methods involving detecting the expression of Programmed Death-Ligand 1 (PD-L1) in a biological sample of the subject and administering a T cell activation therapeutic with an inhibitor of PD-L1 or Programmed Death 1 (PD-1). It was surprisingly found that the level of PD-L1 expression correlates with the clinical responses with the T cell activation therapeutic together with an inhibitor of PD-L1 or PD-1 in the treatment of hematologic malignancies, thus, making PD-L1 an unexpected biomarker for the treatment of DLBCL.

The invention provides methods of treating cancer and methods for selecting treatment approaches for cancer.

A method for identifying a patient with malignant tumor which can be expected to benefit more from an immune checkpoint inhibitor, and agent for suppressing the progression of, suppressing the recurrence of, and/or treating malignant tumor, being prescribed based thereon, comprising use of a combination of two sets of evaluation items and specific condition defined by each of combination thereof.

The present invention relates to the field of tumor treatment and molecular immunology, and particularly, to an anti-CTLA4/anti-PD-1 bispecific antibody and use thereof. Specifically, the anti-CTLA4/anti-PD-1 bifunctional antibody comprises a first protein functional region targeting PD-1 and a second protein functional region targeting CTLA4, wherein, according to the EU numbering system, the heavy chain constant region of the immunoglobulin comprised in the bispecific antibody has mutations at any 2 or 3 of positions 234, 235 and 237, and the affinity constant of the bispecific antibody to FcγRIIIa and/or C1q is reduced after the mutation as compared to that before the mutation. The bifunctional antibody of the present invention can well and specifically bind to CTLA4 and PD-1, specifically relieve immunosuppression of CTLA4 and PD-1 in an organism, and activate T lymphocytes, thus having good application prospect.

The present invention belongs to the fields of tumor therapy and molecular immunology, and provides an anti-CTLA4 monoclonal antibody or antigen binding fragment thereof, a pharmaceutical composition thereof and use thereof. The monoclonal antibody of the present invention can block the binding of CLTA4 to B7, relieve the immunosuppression on the body by CTLA4, and activate T lymphocytes.