Tag: EHA

Company News: Merus Presents Preclinical Data on its Novel Bispecific Antibody MCLA-117 at EHA 2013

– Clinical Candidate Designed for the Treatment of Acute Myeloid Leukemia (AML) –

Merus B.V., a biopharmaceutical company focusing on innovative human antibody therapeutics, has presented preclinical data on its antibody MCLA-117 at the Annual 18th Congress of the EHA 2013 (European Hematology Association) in Stockholm. The compound is being developed for the treatment of acute myeloid leukemia (AML), a disease with very poor long-term prognosis.

MCLA-117 activates the patient’s own immune system by simultaneously binding to the CLEC12A molecule expressed by AML tumor cells and the CD3 molecule expressed by T cells. CLEC12A is a myeloid differentiation antigen that is expressed on 90-95% of de novo and relapsed AML cases and is selectively expressed on leukemic stem cells.

Co-incubation of patients´ resting T cells and AML tumor cells via MCLA-117 resulted in efficient tumor cell lysis, i.e. the potent killing of cancerous AML cells. By introducing mutations in the heavy chain constant region CH2 domain, Merus was able to develop an antibody that in peripheral blood mononuclear cell (PBMC) assays prevented the release of non-specific, pro-inflammatory cytokines, while retaining its full capacity to induce T cell-mediated elimination of AML tumor cells.

The MCLA-117 antibody is based on Merus’ proprietary Biclonics™ ENGAGE platform. Human bispecific antibodies from this platform can be manufactured and administered like conventional, full-length IgG molecules, thereby providing for high yield, good stability and a long serum half-life.

Company News: Study Demonstrates Micromet’s Blinatumomab Produces High Single-Agent Activity in Patients with Relapsed Acute Lymphoblastic Leukemia

– 75% of patients achieved a complete remission, with no evidence of remaining leukemic cells in blood or bone marrow –
– Data add to a growing body of clinical evidence demonstrating blinatumomab’s potential to be used across the course of the disease –

Data to be presented tomorrow at the 16th Annual Meeting of the European Hematology Association (EHA) in London, UK, show that Micromet’s blinatumomab produced a high complete remission rate in adult patients with acute lymphoblastic leukemia (ALL) who had relapsed following treatment with standard therapy. 1 Blinatumomab is the most advanced of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

Interim results from this phase 2 single-arm trial showed that 75% of patients (9 of 12) achieved a complete remission (CR) or CR with partial recovery of blood counts (CRh*) following treatment with blinatumomab.  All nine responding patients achieved a complete molecular response, or had no evidence of leukemic cells in their bone marrow, a key prognostic factor for patient survival.  Notably, four patients with genetic abnormalities typically associated with poorer outcomes all achieved a CR or CRh*.

Current treatment for Philadelphia negative relapsed/refractory ALL consists of combinations of toxic chemotherapy drugs that in the majority of cases fail to drive the disease into remission.  In more than 30 years, no new drug has been approved for use in this setting, leaving physicians with few options to improve long-term patient outcomes other than variations in the dose and schedule of old drugs with limited efficacy.  With current approaches, complete remission rates range from 17-45%. 2-6 Standard chemotherapy is associated with a mortality rate of up to 23%. 7 The average five-year survival rate for adult ALL patients after first relapse is 7%. 5

 

Click here to read the abstract

 

References:

  1. Topp, M.S. et. al. Haematologica. 2011; abstract no. 844
  2. Kantarjian H, et al. Cancer. 2010;116:5568–5574.
  3. Advani AS, et al. Br J Haematol. 2010;151(5):430.
  4. Oriol A, et al. Haematologica. 2010;98(4):589-596.
  5. Fielding  A, et al. Blood. 2007;109(3):944-950.
  6. O’Brien S, et al. Cancer. 2008;113:3186–3191.
  7. Bassan R, et al. J Clin Oncol. 2011;29(5):532-543.

Company News: Micromet Presents Updated Results From Phase 1 and Phase 2 Study of Blinatumomab

– Update Presented at the 15th Annual Congress of the European Hematology Association (EHA) –

Micromet, Inc. (NASDAQ: MITI) today announced updated clinical data from a Phase 1 and a Phase 2 trial, respectively, of its lead product blinatumomab (MT103). The data were presented at the 15th Annual Congress of the European Hematology Association (EHA) in Barcelona, Spain.

Results of the analysis from a Phase 2 trial in adult patients with minimal residual disease (MRD) positive acute lymphoblastic leukemia (ALL) demonstrate that a prolonged hematologic relapse-free survival was observed in patients treated with blinatumomab. A pivotal trial in adult MRD-positive ALL patients is scheduled to begin in Q3, 2010.

Updated results from a Phase 1 trial of blinatumomab in patients with relapsed non-Hodgkin’s lymphoma (NHL) demonstrated durable responses ranging up to 30 months. Blinatumomab is the first in a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

A conference call will be hosted tomorrow, June 15, 2010, at 08:30am ET / 02:30pm CET / 01:30pm UK time. Dial-in details and the complete announcements are available here.