AVEO enters into worldwide agreement with Biodesix

CAMBRIDGE, Mass. & BOULDER, Colo.—AVEO Oncology and Biodesix, Inc. have struck a worldwide agreement for the development and commercialization of ficlatuzumab, AVEO’s hepatocyte growth factor (HGF) inhibitory antibody, with a Biodesix companion diagnostic test. The agreement and clinical development program will make use of VeriStrat, a serum protein test that aids physicians in making treatment decisions for patients with advanced non-small cell lung cancer (NSCLC), as a selection assay to identify the NSCLC patients most likely to respond positively to ficlatuzumab. VeriStrat is a multivariate, blood-based protein test that determines whether patients will have good or bad outcomes after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor therapy, such as erlotinib or chemotherapy, and is based on Biodesix’ proprietary proteomics platform.

“We are pleased to initiate this collaboration with AVEO,” David Brunel, CEO of Biodesix, commented in a statement. “Ficlatuzumab is targeting an oncogenic pathway that we believe may be important in certain patient subsets. By leveraging our multiplexed platform and advanced analytics, we hope to identify those patients who gain substantial benefit from ficlatuzumab. We believe our initial work with AVEO is very encouraging.”

Per the terms of the agreement, AVEO will be responsible for conducting a proof-of-concept study of ficlatuzumab in combination with erlotinib in patients with advanced NSCLC that have been selected using the VeriStrat test. For its part, Biodesix will fund up to $15 million of the cost of the study, which the partners expect to begin later this year. After the proof-of-concept study, any additional development, regulatory and commercial costs for the compound will be shared equally, as will any profits. Should the compound secure regulatory approval, AVEO will lead worldwide commercialization of ficlatuzumab, while Biodesix will handle all development, including U.S. Food and Drug Administration engagement activities and sales and marketing costs for VeriStrat, for which it will retain total revenues for sales.

“This agreement accomplishes a key strategic objective of advancing our pipeline assets through external collaborations and funding,” Tuan Ha-Ngoc, president and CEO of AVEO, said in a press release. “The exploratory analysis suggests that Biodesix’ novel diagnostic test may help define patient populations that can benefit from treatment with ficlatuzumab. We believe this type of innovative partnership between a therapeutic and a molecular diagnostic company is important to advancing personalized medicine.”

Ficlatuzumab is a humanized IgG1_K antibody that binds to the HGF ligand with high affinity and specificity to inhibit biological activities of the HGF/c-Met pathway. Activation of that pathway is thought to play a role in normal processes of embryonic development and wound healing, but when dysregulated, it is thought to play a role in cancer development, metastasis and drug resistance. AVEO’s Human Response Platform has also shown it to be one of the most potent drivers of tumor growth. Over-expression of HGF/c-Met is seen in a wide range of solid tumors, including breast, colorectal, lung, prostate and head and neck, in addition to hematologic malignancies. Up-regulation of the HGF/c-Met pathway can cause resistance to EGFR-targeted therapies, and HGF has been demonstrated to be one of the most potent growth factors capable of driving resistance to a number of anti-cancer therapies.