Clinic business

AVEO Oncology Announces Clinic –

– This Agreement Follows AVEO’s Entering into a Similar Agreement with Merck KGaA, Darmstadt, Germany to Provide Cetuximab Clinical Drug Supply Outside of the United States and Canada –

– AVEO currently manufactures the clinical supply of ficlatuzumab; Potential Phase 3 registration clinical trial in R/M negative HPV HNSCC expected in 1H 2023 –

BOSTON, June 22, 2022 (GLOBE NEWSWIRE) — AVEO Oncology (AVEO), a commercial-stage biopharmaceutical company focused on oncology, today announced that it has entered into a clinical trial collaboration and supply agreement in America du Nord with Eli Lilly and Company (Lilly) to evaluate ficlatuzumab in combination with ERBITUX® (cetuximab), an anti-EGFR antibody, in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Fillatuzumab is AVEO’s potent investigational humanized immunoglobulin G1 monoclonal antibody that targets hepatocyte growth factor.

“This clinical trial collaboration and supply agreement with Lilly follows a similar engagement we entered into with Merck KGaA, Darmstadt, Germany earlier this year, both of which we believe serve as validation for our development plan. clinical development of filatuzumab. We expect these collaborations to play an important role in advancing the combination of ficlatuzumab and cetuximab,” said Michael Bailey, President and CEO of AVEO. “We reported positive Phase 2 clinical data last year that show that ficlatuzumab in combination with cetuximab has the potential to play a significant role in the treatment of patients with HPV-negative R/M HNSCC. (HPV), which is associated with particularly poor outcomes. We continue to be in discussions with regulators on the final design of a potential pivotal study for this combination therapy, which we expect to begin in the first half of 2023.”

Under terms of the agreement, Lilly will provide clinical drug supply cetuximab in the United States and Canada for AVEO’s potential registration study, which will evaluate ficlatuzumab with cetuximab in the HNSCC R/M HPV negative. AVEO will serve as the study sponsor and will be responsible for the execution of the trial.

In June 2021, AVEO announced positive results from a randomized 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 combination filatuzumab and cetuximab demonstrated both a higher overall response rate, including two patients with complete responses, and a median progression-free survival greater than historical data for current patients. standards of care. In September 2021, the FDA granted Fast Track designation for the combination of ficlatuzumab and cetuximab in relapsed/recurrent HPV negative HNSCC. A copy of the presentation is available at

AVEO recently commenced clinical supply manufacturing of ficlatuzumab in the second quarter of 2022, with the potential registration study expected to be initiated in the first half of 2023. AVEO plans to continue discussing potential pivotal study designs on the ficlatuzumab with the FDA and to continue its ongoing partnership dialogues.

About filatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) immunoglobulin G1 (IgG1) inhibitor antibody that binds to HGF ligand with high affinity and specificity. HGF is the natural ligand for c-Met and blocking HGF inhibits signaling through the HGF/c-Met signaling pathway. Fillatuzumab is currently being evaluated in head and neck squamous cell carcinoma (HNSCC) and pancreatic cancer. The United States Food and Drug Administration has designated the study of ficlatuzumab and ERBITUX as a Fast Track Development Program® (cetuximab) for relapsed/relapsed HNSCC in September 2021.

About AVEO Pharmaceuticals, Inc.

AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to providing medicines that improve the lives of cancer patients. AVEO currently markets FOTIVDA® (tivozanib) in the United States for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) after at least two prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has other experimental programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion in order to diversify representation within the company.

ERBITUX® is a trademark owned or licensed to Eli Lilly and Company, its subsidiaries or affiliates.

Caution 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”, “conceive”, “expect”, “hope”, “intend”, “may”, “plan”, “potential”, “could”, ” should”, “should”, “seek”, “expect”, “move forward”, “objective”, “strategy” or the negative form 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 other things, statements about: the potential of 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 HNSCC R/M and other indications; the availability of filatuzumab clinical supplies; the expected date of patient enrollment for AVEO’s registration study in the HPV negative HNSCC R/M; potential results of a registration study of ficlatuzumab with cetuximab to provide opportunities for AVEO to pursue regulatory strategies; the potential clinical utility of filatuzumab in areas of unmet need; and AVEO’s strategy, outlook, 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 AVEO’s forward-looking statements due to a number of important factors, including risks relating to: AVEO’s ability, and the ability to its collaborators and licensees, to demonstrate to the satisfaction of applicable regulatory bodies such as the FDA the safety, efficacy and clinically meaningful benefits of ficlatuzumab, as well as the risks associated with the timing and costs of research and procurement regulatory approvals; AVEO’s ability to enter into and maintain its collaboration and licensing agreements with third parties, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under such agreements; AVEO’s reliance on third-party vendors for the development, manufacturing, supply, storage and distribution of ficlatuzumab; AVEO’s ability to obtain sufficient clinical supplies of its product candidates; potential adverse effects of the COVID-19 pandemic on the drug supply of ficlatuzumab, the ability to successfully enroll a registration study in the HNSCC R/M, AVEO’s business continuity, financial condition, results of operations, liquidity and the ability to commercialize FOTIVDA, to manufacture clinical products and commercial product and to timely initiate new trials or complete its ongoing clinical trials; competitive factors; and risks discussed in the sections titled “Summary of Risk Factors”, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources” included in the reports. AVEO’s quarterly and annual filings with the Securities and Exchange Commission (SEC) and in other documents filed by AVEO with the SEC. The forward-looking statements contained 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. Although AVEO may choose to update these forward-looking statements at some point in the future, it expressly disclaims any obligation to do so. You should therefore not rely on these forward-looking statements as representing the views of AVEO as of any date other than the date of this press release.

Any reference to AVEO’s website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.

AVEO Investor Relations Contact:
Hans Vitzthum, LifeSci Advisors
(617) 430-7578
[email protected]