Aveo Pharmaceuticals has signed a manufacturing agreement with Boehringer Ingelheim for large-scale process development and clinical manufacturing of ficlatuzumab (AV-299), used to treat patients with non-small cell lung cancer.
Developed by Aveo using its Human Response Platform, ficlatuzumab is a HGF inhibitory antibody that is currently in Phase II clinical development.
Boehringer Ingelheim will produce ficlatuzumab for clinical trials at its biopharmaceutical site in Fremont, US.
Aveo retains all rights to develop and commercialise the drug.
In proprietary tumour models with elevated HGF/c-MET signalling, ficlatuzumab has demonstrated improved anti-tumour effect when given in combination with other approved anti-cancer agents such as erlotinib, cetuximab and temozolomide.
In earlier pre-clinical studies, ficlatuzumab was found effective at inhibiting tumour growth compared to other anti-HGF antibodies, which are currently in clinical development.
Following successful completion of earlier clinical trials, Aveo has commenced a Phase Ib/II clinical trial assessing diclatuzumab in combination with gefitinib versus gefitinib monotherapy as first-line therapy in patients with NSCLC.
The findings from the ongoing Phase II portion of the trial are likely to be reported in 2012.
Aveo executive vice-president and chief business officer Elan Ezickson said the agreement will help the companies to advance the clinical development of ficlatuzumab.
”We look forward to working with Boehringer Ingelheim to prepare for the manufacturing activities for ficlatuzumab that would support Phase III and beyond," Ezickson said.
Boehringer Ingelheim Contract Manufacturing Business Biopharmaceuticals senior vice-president Frank Ternes said he was pleased that the company had been selected by Aveo to further execute its clinical development strategies for ficlatuzumab.
”This customer project is an important milestone for our Fremont site and a further confirmation that our expansion into the US is of added value for our customers," Ternes added.
Financial terms of the agreement have not been disclosed.