Archive: Company News

Company News: Micromet Announces Solid Tumor BiTE Antibody Collaboration with Amgen

– Collaboration on up to three targets and two programs

– Upfront payment of €10 million upon deal execution

– Maximum deal value of €695 million plus royalties and development cost reimbursement

 

Micromet, Inc. (NASDAQ: MITI) announced today that it has entered into a collaboration agreement with Amgen Inc. for the research of BiTE antibodies against three undisclosed solid tumor targets. Amgen will have the right to pursue development and commercialization of BiTE antibodies against up to two of these targets, to be selected by Amgen.

Under the terms of the agreement, Amgen is expected to pay €10 million upon deal execution.  If milestones in multiple indications and tumor types are achieved, Micromet is eligible to receive up to €342 million in clinical and commercial milestone payments.  Micromet is also eligible to receive up to double-digit royalties on worldwide net sales.

For the second BiTE program, Micromet is eligible to receive an additional cash payment upon initiation of the program, milestones, royalties and development funding comparable to the first program. The combined potential payments to Micromet from both programs, excluding reimbursement of research and development costs, are approximately €695 million.  The initial development plan contemplates €25 million in funding of Micromet R&D activities if two BiTE antibodies are advanced to IND.  All expected costs associated with the research, development and commercialization of the BiTE antibodies will be borne by Amgen.

Micromet will be primarily responsible for the discovery and pre-clinical development of the BiTE antibodies. Amgen will lead the clinical development, manufacturing, and commercialization of any products resulting from the collaboration.

Company News: SuppreMol Initiates Phase IIa Clinical Trial in Systemic Lupus Erythematosus (SLE) With Its Lead Candidate SM101

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases and allergies, today announced the initiation of a Phase IIa clinical trial with its lead product SM101 in Systemic Lupus Erythematosus (SLE).

The multi-centric, randomized, double-blind, placebo-controlled, parallel group Phase IIa study will enroll 50 SLE patients with or without a history of Lupus Nephritis and a SELENA-SLEDAI score of ≥ 6 and active serological status. Over four weeks, two groups of twenty patients each will intravenously receive 6 or 12 mg/kg/week of SM101, while 10 patients will receive placebo. 30 clinical sites in Australia, Belgium, the Czech Republic, France, Germany, Italy, Poland, Spain, and the UK will participate.

The primary endpoint of the proof-of-concept trial is safety based on the incidence of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE). Further safety endpoints comprise, among others, vital signs, body temperature, body weight, electrocardiogram, safety laboratory assessments, and the occurrence of anti-drug antibodies (ADAs). Efficacy is determined by overall and renal disease score assessments, proteinuria, urine sediment, a number of biochemical, biological and molecular markers, and use of rescue medication. Results of the trial are expected for 2013.

SM101 already has been shown to have an excellent safety and tolerability profile as well as favorable pharmacokinetics in a Phase Ia trial in 48 healthy volunteers completed in 2009. Subsequently, a Phase Ib/IIa multi-center clinical trial for the treatment of Primary Immune Thrombocytopenia (ITP) was started in early 2010.

Company News: Scil Technology Receives Public Research Grant for Novel Rheumatoid Arthritis Treatments

Scil Technology GmbH, a biopharmaceutical company with core expertise in protein drug development, formulation and analytics, today announced that it has been awarded research funding by the German Federal Ministry of Education and Research (BMBF) under BMBF’s KMU-innovativ scheme. The EUR 0.9 million grant supports Scil Technology’s research program to explore the therapeutic potential of repellent proteins for the treatment of rheumatoid arthritis (RA).

The course of RA is affected by the destruction of cartilage tissue and inflammation of the joints. Recently, it has been published that so-called repellent proteins inhibit fundamental processes relevant for the development of the disease. Repellent proteins therefore bear the potential to provide the first causative treatment of RA.

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.

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