AVEO Oncology Announces Clinical Trial Collaboration and Supply Agreement with Eli Lilly and Company for ERBITUX® (cetuximab) in North America to Evaluate Ficlatuzumab and Cetuximab in Patients with Recurrent or Metastatic HNSCC
- This agreement follows AVEO’s entry into a similar agreement with Merck KGaA, Darmstadt,
- AVEO Currently Manufacturing Ficlatuzumab Clinical Supply; Potential Phase 3 Registrational Clinical Trial in HPV Negative R/M HNSCC Expected in 1H 2023 -
“This clinical trial collaboration and supply agreement with Lilly follows a similar engagement we entered into with Merck KGaA, Darmstadt,
Under the terms of the agreement, Lilly will provide cetuximab clinical drug supply in the
AVEO recently commenced manufacturing of ficlatuzumab clinical supply in the second quarter of 2022, with the potential registrational study expected to be initiated in the first half of 2023. AVEO expects to continue to discuss potential ficlatuzumab pivotal study designs with the FDA and to continue ongoing partnership dialogues.
Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) immunoglobulin G1 (IgG1) inhibitory antibody that binds to the HGF ligand with high affinity and specificity. HGF is the natural ligand of c-Met and blocking HGF inhibits signaling through the HGF/c-Met signaling pathway. Ficlatuzumab is currently being evaluated in squamous cell carcinoma of the head and neck (HNSCC) and pancreatic cancer. The
AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the
ERBITUX® is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “design,” “expect,” “hope,” “intend,” “may,” “plan,” “potential,” “could,” “should,” “would,” “seek,” “look forward,” “advance,” “goal,” “strategy,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the potential for ficlatuzumab as a treatment option for patients with R/M HNSCC; the potential efficacy, safety and tolerability of ficlatuzumab, both as a stand-alone drug candidate and in combination with other therapies in R/M HNSCC and other indications; the availability of clinical supplies of ficlatuzumab; the anticipated patient enrollment date for AVEO’s registrational study in HPV negative R/M HNSCC; the potential outcomes from a registrational study in ficlatuzumab with cetuximab to provide AVEO with opportunities to pursue regulatory strategies; the potential clinical utility of ficlatuzumab in areas of unmet need; and AVEO’s strategy, prospects, plans and objectives for FOTIVDA, ficlatuzumab and its other product candidates and for AVEO generally. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO’s ability, and the ability of its collaborators and licensees, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA the safety, efficacy, and clinically meaningful benefit of ficlatuzumab, and risks relating to the timing and costs of seeking and obtaining regulatory approvals; AVEO’s ability to enter into and maintain its third party collaboration and license agreements, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under these arrangements; AVEO’s dependence on third-party vendors for the development, manufacture, supply, storage and distribution of ficlatuzumab; AVEO’s ability to obtain sufficient clinical supplies of its product candidates; the potential adverse effects of the COVID-19 pandemic on drug supply of ficlatuzumab, ability to successfully enroll a registrational study in R/M HNSCC, AVEO’s business continuity, financial condition, results of operations, liquidity and ability to commercialize FOTIVDA, manufacture clinical and commercial product and timely initiate new trials or complete its ongoing clinical trials; competitive factors; and those risks discussed in the sections titled “Risk Factor Summary,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s quarterly and annual reports on file with the
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Source: AVEO Pharmaceuticals, Inc.