Date: 2014-08-06
Type of information: Initiation of the trial
phase: 2b
Announcement: initiation of the trial
Company: Merck Serono, a Merck KGaA company (Germany) Symphogen (Denmark)
Product: Sym004
Action
mechanism: Sym004 is composed of two anti-EGFR mAbs targeting different non-overlapping epitopes. Sym004 not only blocks ligand binding, receptor activation/phosphorylation and downstream signaling but also elicit removal of the EGFR receptors from the cancer cell surface by inducing EGFR internalization and degradation.
Disease: metastatic colorectal cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On August 6, 2014, Symphogen, a private biopharmaceutical company developing recombinant antibody mixtures, announced that its collaborative partner, Merck KGaA, Darmstadt, Germany, through its biopharmaceutical division, Merck Serono has initiated two new clinical studies evaluating Sym004, an investigational antibody mixture targeting the epidermal growth factor receptor (EGFR). The trials are a Phase 2b study in patients with metastatic colorectal cancer (mCRC) and a Phase 1b study in patients with Non-Small Cell Lung Cancer (NSCLC). Symphogen also reports that it is eligible to receive two milestone payments from Merck for achieving certain agreed goals in the collaboration, related to the bi-weekly dosing study and the mCRC study. Sym004 was out-licensed to Merck KGaA in September 2012 following phase 2 clinical data in late stage cancer patients. Sym004 was the subject of data presentations at the 2013 and 2014 ASCO Annual Meetings in Chicago, IL. At these meetings, Sym004 reported Phase 2 proof-of-concept data in squamous cell carcinoma of the head & neck (SCCHN) and in metastatic colorectal cancer that signaled clinical activity and were supportive of the proposed mechanism of action, respectively.
