AVEO Pharmaceuticals, Inc. and Boehringer Ingelheim have entered into an agreement for large-scale process development and clinical manufacturing of ficlatuzumab, AVEO’s novel HGF inhibitory antibody that is currently in phase II clinical development in patients with non-small cell lung cancer (NSCLC).

Boehringer Ingelheim will produce ficlatuzumab for clinical trials at its biopharmaceutical site in Fremont, USA. AVEO retains all rights to the development and commercialization of ficlatuzumab. Financial terms of the agreement were not disclosed.

“We believe Boehringer Ingelheim is an ideal manufacturing partner based on its expertise in monoclonal antibodies,” said Elan Ezickson, executive vice president and chief business officer at AVEO. “This agreement is further evidence of the progress we are making in the clinical development of ficlatuzumab, and we look forward to working with Boehringer Ingelheim to prepare for the manufacturing activities for ficlatuzumab that would support phase III and beyond.”

Frank Ternes, senior vice president of the Contract Manufacturing Business Biopharmaceuticals at Boehringer Ingelheim, commented, “We are delighted to be chosen by AVEO as a manufacturing partner for ficlatuzumab and we look forward to leveraging our more than 25 years expertise in this area to support AVEO in further executing 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.”

The HGF/c-MET pathway is believed to play an important role in regulating tumour growth, invasion and metastasis, making it an exciting novel target in oncology. HGF/c-MET over-expression is observed in many tumours including bladder, lung, breast, gastric, ovarian, prostate, colorectal, head and neck, certain sarcomas and several other solid tumours as well as haematologic malignancies. The HGF/c-MET pathway has only one known ligand (HGF) that binds to one known receptor (c-MET) to initiate signalling. In addition, translational research suggests that increased HGF and/or c-MET receptor amplification may confer resistance to EGFR inhibitors. Ficlatuzumab (AV-299), an antibody discovered by AVEO through its Human Response Platform (HRP), is a potent HGF inhibitory antibody with high affinity for the HGF ligand.

In AVEO’s proprietary tumour models with elevated HGF/c-MET signalling, ficlatuzumab exhibited strong additive anti-tumour effect when given in combination with other approved anti-cancer agents such as erlotinib (Tarceva), cetuximab (Erbitux) and temozolomide (Temodar). In additional preclinical studies, ficlatuzumab was more effective at inhibiting tumour growth (at the dose tested) than other anti-HGF antibodies currently in clinical development.

Following successful completion of earlier clinical trials, AVEO initiated a phase I b/II clinical trial evaluating ficlatuzumab in combination with gefitinib (Iressa) versus gefitinib monotherapy as first-line therapy in patients with NSCLC. Top-line data from the ongoing phase II portion of the trial are expected in 2012.

AVEO Pharmaceuticals is a cancer therapeutics company committed to discovering, developing and commercializing targeted therapies to impact patients’ lives.

The Boehringer Ingelheim is committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.