Boehringer will take care of process development and clinical manufacturing of ficlatuzumab.
Aveo Pharmaceuticals and Boehringer Ingelheim entered into a manufacturing agreement for the former’s clinical-stage mAb therapeutic, ficlatuzumab. The deal covers large-scale process development and clinical manufacturing.
This HGF inhibitory antibody is currently in Phase II development as a treatment for non-small-cell lung cancer (NSCLC) and in Phase I solid tumor trials. Boehringer Ingelheim will produce ficlatuzumab for clinical trials at its biopharmaceutical site in Fremont, CA.
The HGF/c-MET pathway is believed to play an important role in regulating tumor growth, invasion, and metastasis, according to Aveo. HGF/c-MET over-expression is observed in many tumors including bladder, lung, breast, gastric, ovarian, prostate, colorectal, head and neck, certain sarcomas and several other solid tumors, as well as hematologic malignancies, the firm ads.
The HGF/c-MET pathway has only one known ligand (HGF) that binds to one known receptor (c-MET) to initiate signaling. In addition, research suggests that increased HGF and/or c-MET receptor amplification may confer resistance to EGFR inhibitors.
Aveo’s Phase II NSCLC trial is evaluating ficlatuzumab in combination with Iressa versus gefitinib monotherapy as first-line therapy. The Phase I study is looking at the molecule in combination with Tarceva as a treatment for solid tumors.