Tag: solid tumors

Company News: Merus starts Phase I/II clinical trial for MCLA-128, an ADCC-enhanced bispecific antibody for solid tumors

– First patient dosed in trial with potent bispecific antibody overcoming resistance to HER2-targeted therapies –

Merus B.V., a leader in developing best-in-class bispecific antibody therapeutics to treat cancer patients, today announced the initiation of a phase I/II clinical study of MCLA-128 for the treatment of solid tumors. MCLA-128 is an ADCC-enhanced, full-length IgG bispecific antibody that simultaneously targets the growth factor receptors HER2 and HER3.

The trial is an open-label, European multi-center dose escalation study to assess the safety, tolerability and anti-tumor activity of MCLA-128. The first part of the study is designed as a dose escalation study, followed by a second part to further characterize the safety, tolerability and clinical efficacy of MCLA-128. Initially, the study will enroll 52 patients with advanced epithelial tumors. Primary endpoint is safety; secondary endpoints include, among others, the immunogenicity of MCLA-128 as well as anti-tumor response and clinical benefit.

 

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.