On September 20, 2021 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma (R/R HNSCC) (Press release, AVEO, SEP 20, 2021, View Source [SID1234587956]). Ficlatuzumab is AVEO’s investigational potent humanized immunoglobulin G1 monoclonal antibody that targets hepatocyte growth factor.

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"The FDA’s decision to grant FTD underscores the potential for ficlatuzumab to address a serious unmet need and serve as a meaningful therapeutic option for patients with metastatic HNSCC," said Michael Bailey, president and chief executive officer of AVEO. "We are committed to unlocking the full potential of ficlatuzumab in patients with HNSCC and look forward to working closely with the FDA to determine next steps for the program."

In June 2021, the Company announced positive results from a randomized confirmatory Phase 2 study of ficlatuzumab, AVEO’s hepatocyte growth factor (HGF) targeted antibody, alone or in combination with cetuximab, an EGFR-targeted antibody, in patients with metastatic HNSCC who relapsed or were refractory to prior immunotherapy, chemotherapy, and cetuximab (pan-refractory). 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. A copy of the presentation is available at www.aveooncology.com.

As previously disclosed, a shortage of required key raw materials and manufacturing supplies also used in COVID-19 vaccine manufacturing has delayed the delivery of the clinical supply of ficlatuzumab. The Company anticipates the potential start date for a registrational study in HPV negative HNSCC will be in 2023. The Company expects to continue to discuss potential ficlatuzumab pivotal study designs with the FDA and to continue ongoing partnership dialogues.

About Fast Track Designation

Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, enabling drugs to reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is an investigational 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).