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Manufacturing of Ficlatuzumab Clinical Supply to Commence in 2Q 2022; Initiation of Registrational Study in HPV Negative R/M HNSCC Expected in 1H 2023
BOSTON, Jan. 04, 2022 (GLOBE NEWSWIRE) -- AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, today 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.
“This collaboration with Merck KGaA, Darmstadt, Germany will play an important role in the advancement of both the ficlatuzumab and cetuximab programs,” said Michael Bailey, president and chief executive officer of AVEO. “The ficlatuzumab and cetuximab combination has demonstrated the potential to play a meaningful part in the treatment of patients with human papillomavirus (HPV) negative R/M HNSCC, which is associated with particularly poor outcomes. We look forward to continuing our dialogue with regulators to finalize the design of a pivotal study, which we now expect to commence in the first half of 2023.”
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.
In June 2021, the Company announced positive results from a randomized confirmatory Phase 2 study of ficlatuzumab alone or in combination with cetuximab in patients with pan-refractory metastatic HNSCC. Of note, patients with HPV negative disease, a subgroup normally associated with poorer outcomes, who received the ficlatuzumab and cetuximab combination demonstrated both a superior overall response rate and median progression free survival over single agent ficlatuzumab. A copy of the presentation is available at www.aveooncology.com.
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.
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 metastatic pancreatic ductal cancer (PDAC). Ficlatuzumab was granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of patients with recurrent or metastatic HNSCC.
About AVEO Pharmaceuticals, Inc.
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 U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
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 Securities and Exchange Commission (SEC) and in other filings that AVEO makes with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release, and subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO's views as of any date other than the date of this press release.
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AVEO Public Relations Contact:
David Pitts, Argot Partners
AVEO Investor Relations Contact:
Hans Vitzthum, LifeSci Advisors