AVEO Oncology announced that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany to evaluate ficlatuzumab in combination with ERBITUX® (cetuximab), an EGFR-targeted antibody, in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Ficlatuzumab is AVEO's investigational potent humanized immunoglobulin G1 monoclonal antibody that targets hepatocyte growth factor. Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will provide cetuximab clinical drug supply in all countries outside of the U.S. and Canada for AVEO's future registrational study, which will assess ficlatuzumab with cetuximab in HPV negative R/M HNSCC.

AVEO will serve as the study sponsor and will be responsible for costs associated with the trial execution. The Company expects to commence manufacturing of ficlatuzumab clinical supply in the second quarter of 2022, subject to availability of key raw materials and manufacturing supplies also used in COVID-19 vaccine manufacturing, with the initiation of a registrational study now anticipated in the first half of 2023. The Company expects to continue to discuss potential ficlatuzumab pivotal study designs with the FDA and to continue ongoing partnership dialogues.