AVEO Pharmaceuticals, Inc. (Nasdaq: AVEO) 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."
About Ficlatuzumab and the HGF/c-MET Pathway
The HGF/c-MET pathway is believed to play an important role in regulating tumor growth, invasion and metastasis, making it an exciting novel target in oncology. 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 HGF/c-MET pathway has only one known ligand (HGF) that binds to one known receptor (c-MET) to initiate signaling. 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 TM (HRP), is a potent HGF inhibitory antibody with high affinity for the HGF ligand.
In AVEO's proprietary tumor models with elevated HGF/c-MET signaling, ficlatuzumab exhibited strong additive anti-tumor 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 tumor 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 1b/2 clinical trial evaluating ficlatuzumab in combination with gefitinib (Iressa TM) versus gefitinib monotherapy as first-line therapy in patients with NSCLC. Top-line data from the ongoing Phase 2 portion of the trial are expected in 2012.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates in 50 countries and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed for 125 years to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
Today, Boehringer Ingelheim is one of the world's leading companies for contract development and manufacture of biopharmaceuticals. All types of services from mammalian cell line or microbial strain development to final drug production can be delivered within a one-stop-shop concept. Boehringer Ingelheim delivers services for pre-clinical development up to global market supply with a strong commitment to its customers at its global manufacturing facilities for mammalian cell culture and microbial fermentation. Boehringer Ingelheim has brought 19 molecules to market and has many years of experience in multiple molecule classes such as monoclonal antibodies, recombinant proteins, interferons, enzymes, fusion molecules and plasmid DNA. Furthermore, high-titer platform technologies for new antibody mimetic formats such as scaffold proteins and antibody fragments are available for the manufacture of customer products.
About AVEO
AVEO Pharmaceuticals (NASDAQ: AVEO) is a cancer therapeutics company committed to discovering, developing and commercializing targeted therapies to impact patients' lives. The company's lead product candidate, tivozanib, is currently being investigated in a global, randomized Phase 3 clinical trial called TIVO-1 comparing tivozanib to sorafenib in patients with advanced renal cell carcinoma, as well as additional clinical studies in other solid tumor types. AVEO's second most advanced product candidate, ficlatuzumab (AV-299), is a potent, functional HGF inhibitory antibody that is currently in Phase 2 clinical development. AVEO's proprietary Human Response Platform™ is designed to offer the company a unique advantage in cancer drug development and has provided a discovery engine for multiple therapeutic targets. This approach has resulted in a promising pipeline of monoclonal antibodies against novel targets including HGF, ErbB3, RON, Notch and FGFR.