Phase 1 Results of Amgen’s BiTE® Platform in Heavily Pre-Treated Patients With Multiple Myeloma and Acute Myeloid Leukemia

FDA Grants Fast Track Designation for AMG 420


THOUSAND OAKS, Calif., Dec. 3, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the first clinical results from studies evaluating investigational novel bispecific T cell engager (BiTE®) immunotherapies AMG 420 and AMG 330. In two separate Phase 1 dose escalation studies, AMG 420, which targets B-cell maturation antigen (BCMA), and AMG 330, which targets CD33, provided early evidence of tolerability and anti-tumor activity in patients with relapsed and/or refractory multiple myeloma and relapsed or refractory a…

Source: Amgen News ReleaseCategory: Pharmaceuticals Tags: Uncategorized Source Type: news

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Conclusions:We have demonstrated the feasibility and safety of multiple injections of CYAD-01 without preconditioning chemotherapy. We evidenced promising anti-leukemic activity with 42% ORR in r/r AML with 5/7 pts having clinical benefit. Rates of G3/4 CRS were low and manageable. Updated safety, activity and correlative science data of the complete dose-escalation segment will be presented.DisclosuresSallman: Celgene: Research Funding, Speakers Bureau. Kerre: Celyad: Consultancy; BMS: Consultancy; Celgene: Consultancy, Research Funding. Davila: Celyad: Consultancy, Membership on an entity’s Board of Directors or advisory…

Source: BloodCategory: Hematology Authors: Tags: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Immunotherapy Source Type: research

Understanding factors that shape the immune landscape across hematological malignancies is essential for immunotherapy development. How cancer-cell intrinsic genomic and epigenetic alterations influence immune signatures in hematological malignancies is not known. Here, we integrated over 8,000 transcriptomes of hematologic cancers and multilevel genomic datasets to investigate associations of immune states to cancer molecular subtypes, genetic and epigenetic alterations, and clinical outcomes.We utilized a resource of over 8,000 transcriptomes collected across 36 hematologic malignancies and normal hematopoietic cells (He…

Source: BloodCategory: Hematology Authors: Tags: 602. Disordered Gene Expression in Hematologic Malignancy, including Disordered Epigenetic Regulation: Poster II Source Type: research

First-in-Human Data Evaluating AMG 420 in Multiple Myeloma and AMG 330 in Acute Myeloid Leukemia Underscore Potential of BiTE® Immunotherapy Platform Across Hematologic Malignancies

BLINCYTO® (blinatumomab) Long-Term Data Demonstrate Benefits of Achieving Complete MRD Response in Adult Patients With Acute Lymphoblastic Leukemia and Reinforce BiTE® Proof-of-Concept

Data From Multiple Myeloma Research Foundation CoMMpass Trial of KYPROLIS® (carfilzomib) in Newly Diagnosed Multiple Myeloma Patients to be Presented at ASH


THOUSAND OAKS, Calif., Nov. 1, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today ann…

Source: Amgen News ReleaseCategory: Pharmaceuticals Tags: Uncategorized Source Type: news

Abstract
Currently, there is renewed interest in attempting to recruit the host immune system to eliminate cancers, and within this renewed activity, MUC1 continues to arouse interest. MUC1 has been considered a possible therapeutic target for the past 30 years as it is up-regulated, aberrantly glycosylated and its polarization is lost in many adenocarcinomas. Moreover, MUC1 is expressed by some haematopoietic cancers, including acute myeloid leukaemia and myeloma. Although multiple clinical trials have been initiated and immune responses have been documented, effective clinical benefit worthy of approval for gene…

Source: Biochemical Society TransactionsCategory: Biochemistry Authors: Tags: Biochem Soc Trans Source Type: research

There is a need to improve outcomes for patients with recurrent and/or refractory hematological malignancies. Immunotherapy holds the promise to meet this need, because it does not rely on the cytotoxic mechanism of conventional therapies. Among different forms of immunotherapy, redirecting T cells to hematological malignancies with bispecific antibodies (BsAbs) is an attractive strategy. BsAbs are an “off-the-shelf” product that is easily scalable in contrast to adoptive T-cell therapies. Among these, the bispecific T-cell engager blinatumomab has emerged as the most successful BsAb to date. It consists of 2 sin…

Source: BloodCategory: Hematology Authors: Tags: Immunobiology and Immunotherapy, Review Articles, Review Series Source Type: research

Monoclonal antibody (mAb)-based therapies have become an important modality for cancer treatment but have had limited success to date in acute myeloid leukemia (AML). Identification of new antigenic targets and antibody engineering techniques may overcome the modest anti-leukemic effects seen with most native antibodies studied previously in AML. Advances in bispecific immune-engaging antibody technology may improve the pharmacology of these agents, and the safety and efficacy of antibody-drug conjugates (ADCs) may be enhanced by better cytotoxic payloads and chemical linkers.

Publication date: Available online 10 November 2016 Source:Blood Cells, Molecules, and Diseases Author(s): Alessandro Allegra, Vanessa Innao, Demetrio Gerace, Doriana Vaddinelli, Caterina Musolino Hematological malignancies frequently express cancer-associated antigens that are shared with normal cells. Such tumor cells elude the host immune system because several T cells targeted against self-antigens are removed during thymic development, and those that persist are eliminated by a regulatory population of T cells. Chimeric antigen receptor-modified T cells (CAR-Ts) have emerged as a novel modality for tumor immunotherap…

Abstract
Hematological malignancies frequently express cancer-associated antigens that are shared with normal cells. Such tumor cells elude the host immune system because several T cells targeted against self-antigens are removed during thymic development, and those that persist are eliminated by a regulatory population of T cells. Chimeric antigen receptor-modified T cells (CAR-Ts) have emerged as a novel modality for tumor immunotherapy due to their powerful efficacy against tumor cells. These cells are created by transducing genes-coding fusion proteins of tumor antigen-recognition single-chain Fv connected to …

Source: Blood Cells, Molecules and DiseasesCategory: Hematology Authors: Tags: Blood Cells Mol Dis Source Type: research

Publication date: August 2016 Source:Clinical Lymphoma Myeloma and Leukemia, Volume 16, Supplement Author(s): Nicholas J. Short, Farhad Ravandi Dose intensification of chemotherapy and the combination of a third cytotoxic agent with standard cytarabine and anthracycline-based induction chemotherapy have led to improved outcomes in select groups of patients with acute myeloid leukemia (AML). However, despite some progress in this area, it appears that we might be reaching the limit of cytotoxic chemotherapy for the treatment of AML, especially in older patients and in those with poor-risk features whose disease tends to be…

Abstract
Dose intensification of chemotherapy and the combination of a third cytotoxic agent with standard cytarabine and anthracycline-based induction chemotherapy have led to improved outcomes in select groups of patients with acute myeloid leukemia (AML). However, despite some progress in this area, it appears that we might be reaching the limit of cytotoxic chemotherapy for the treatment of AML, especially in older patients and in those with poor-risk features whose disease tends to be relatively chemoresistant. Recent advances in the molecular classification of AML have identified pathogenic pathways that can…

Source: Clinical Lymphoma and MyelomaCategory: Cancer & Oncology Authors: Tags: Clin Lymphoma Myeloma Leuk Source Type: research



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