Abstract: Provided herein are methods of using a compound provided herein (e.g., Compound 1, Compound 2, Compound 3, Compound 4, Compound 5, Compound 6, or Compound 7, or a stereoisomer or mixture of stereoisomers, pharmaceutically acceptable salt, tautomer, prodrug, solvate, hydrate, co-crystal, clathrate, or polymorph thereof), in combination with a second) active agent for treating cancer. The second active agent is one or more of a PLK1 inhibitor, a BRD4 inhibitor, a BET inhibitor, an NEK2 inhibitor, an AURKB inhibitor, an MEK inhibitor, a PHF19 inhibitor, a BTK inhibitor, an mTOR inhibitor, a PIM inhibitor, an IGF-1R inhibitor, an XPO1 inhibitor, a DOT1L inhibitor, an EZH2 inhibitor, a JAK2 inhibitor, a BIRCS inhibitor, or a DNA methyltransferase inhibitor.

Abstract: A method of predicting if a subject has an Activated B Cell-like (ABC) subtype or a non-ABC subtype of Diffuse Large B-Cell Lymphoma (DLBCL), comprising (a) obtaining a sample from the subject; (b) measuring the expression levels of CD10, MUM1, FOXP1, and optionally Bcl-6; (c) determining a composite score based on the expression levels of CD10, MUM1, and FOXP1, and optionally Bcl-6; and (d) predicting if the subject has an ABC subtype or a non-ABC subtype of DLBCL based on the composite score.

Abstract: A method for predicting the responsiveness of a patient having a hematological cancer to a treatment compound, comprising obtaining a biological sample from the patient having the hematological cancer; determining the expression level of one, two, three, four, five, or more genes; and comparing the expression level of the one, two, three, four, five, or more genes in the biological sample with a reference expression level of the same genes, wherein the treatment compound is 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione (lenalidomide), 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione (Compound A), or a stereoisomer, pharmaceutically acceptable salt, solvate, hydrate, co-crystal, clathrate, or a polymorph thereof.

Abstract: The present invention provides a process for characterizing a glatiramer acetate related drug substance or drug product comprising the steps of: a) obtaining a batch of the glatiramer acetate related drug substance or drug product; b) contacting mammalian cells with an amount of the glatiramer acetate related drug substance or drug product of step a); and c) i) determining the level of expression of at least one gene selected from the group consisting of ABCF2, ABI2, ACP6, AFG3L2, ALMS1, ARPC4, CALM3, CCDC64, CD84, CDC6, CHAF1A, CLU, COX11, DLGAP1, DTX4, FAM49B, FHL1, FNTB, GYPC, HFE, IL10, LPHN1, NACA, OLAH, PATZ1, PDK1, POLI, REEP5, RPL5, RPS6KA2, SEC31A, SETBP1, SNRPA1, SYNCRIP, TNFSF9, TOMM40, TPM1, TSHZ1, TSPAN13, UBAP2, VAV3, VDAC2, and ZFAND6; ii) determining the level of expression of at least one gene selected from the group consisting of BIRC3, CCL24, CCR1, CISH, CSF1R, CX3CR1, CXCL10, HSPD1, ICAM1, IL1B, IFNGR1, IL27, IL2RG, IL7R, IL1RN, MMP1, MMP9, MMP14, PGRMC1, PRDM1, CARD15, CCL2, CCL5, CD14,

Abstract: Provided herein are prognostic and diagnostic methods for predicting likelihood of clinical response of a subject having cancer to treatment with an immunotherapeutic agent. Also provided herein are methods for treating a subject having cancer with an immunotherapeutic agent after determining likelihood of clinical response of the subject to such treatment.

Abstract: The present invention provides a process for characterizing a glatiramer acetate related drug substance or drug product comprising the steps of: a) obtaining a batch of the glatiramer acetate related drug substance or drug product; b) immunizing a mammal with a predetermined amount of a glatiramer acetate related drug substance or drug product; c) preparing a culture of cells from the mammal of step b) at a predetermined time after immunization; d) incubating cells from the culture of step c) with a predetermined amount of the glatiramer acetate drug related substance or drug product of step a); and e) determining the level of expression of at least one gene disclosed herein or determining the level of biological activity of the cells of step c) as disclosed herein, thereby characterizing the glatiramer acetate related drug substance or drug product of step a).