Announces Decision to Fund Clinical Manufacture of Ficlatuzumab for Potential Phase 3 Study and Update to Biodesix Partnership
No Change to AVEO Cash Runway Guidance
BOSTON, MA, USA I September 08, 2020 I AVEO Oncology (Nasdaq: AVEO) today announced that it has regained full global rights to ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody which binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO also announced today that it plans to fund the clinical manufacture of ficlatuzumab to enable a potential registrational Phase 3 clinical trial in head and neck squamous cell cancer (HNSCC), as well as additional potential development in Phase 2 studies in pancreatic cancer and acute myeloid leukemia (AML). Following the decision, Biodesix, a leading diagnostic company, has exercised its contractual right to reduce its future financial obligations in exchange for reduced partnership economics. Under the terms of the agreement between AVEO and Biodesix, Biodesix will continue to fund 50% of the ongoing HNSCC Phase 2 trial, and will be entitled to a low double digit royalty on any future product sales as well as 25% of future licensing revenue, subject to certain limitations.
“We are very pleased to regain full rights to another late-stage asset. This comes at a strategic point in our Company’s history, as we continue to build a commercial biopharmaceutical company with a broad oncology portfolio that has the potential to enable a long-term, sustainable growth model,” said Michael Bailey, president and chief executive officer of AVEO. “The early data we have seen in the randomized, open-label HNSCC study with ficlatuzumab combined with cetuximab (ERBITUX®) has led us to the decision to secure additional clinical manufacturing capacity, which we expect to fund within our previously announced cash runway guidance, in order to prepare for a potential HNSCC pivotal study. We look forward to presenting final results from the Phase 2 study in the middle of 2021, and to providing an update on our potential pivotal program within that timeframe.”
Ficlatuzumab is being studied in an ongoing randomized, open-label confirmatory Phase 2 study in combination with cetuximab, an EGFR-targeted antibody, in cetuximab-resistant, recurrent metastatic HNSCC. The study was designed to confirm findings from a Phase 1 study of ficlatuzumab and cetuximab where the combination was well tolerated and resulted in a disease control rate of 67%, as well as prolonged progression free and overall survival compared to historical controls. The Phase 2 multi-center study is being conducted under the direction of Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center. Enrollment is expected to conclude in the fourth quarter of 2020, and results from the study are expected to be presented at a scientific meeting in 2021.
For more information, please refer to the Current Report on Form 8-K which will be filed by AVEO with the U.S. Securities & Exchange Commission on September 8, 2020.
About AVEO Pharmaceuticals, Inc.
AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. AVEO’s strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO’s lead candidate, tivozanib (FOTIVDA®) is approved in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and potentially commercialize tivozanib in North America as a treatment for renal cell carcinoma and hepatocellular carcinoma. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO’s earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.
SOURCE: AVEO Oncology
Post Views: 23
Announces Decision to Fund Clinical Manufacture of Ficlatuzumab for Potential Phase 3 Study and Update to Biodesix Partnership
No Change to AVEO Cash Runway Guidance
BOSTON, MA, USA I September 08, 2020 I AVEO Oncology (Nasdaq: AVEO) today announced that it has regained full global rights to ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody which binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO also announced today that it plans to fund the clinical manufacture of ficlatuzumab to enable a potential registrational Phase 3 clinical trial in head and neck squamous cell cancer (HNSCC), as well as additional potential development in Phase 2 studies in pancreatic cancer and acute myeloid leukemia (AML). Following the decision, Biodesix, a leading diagnostic company, has exercised its contractual right to reduce its future financial obligations in exchange for reduced partnership economics. Under the terms of the agreement between AVEO and Biodesix, Biodesix will continue to fund 50% of the ongoing HNSCC Phase 2 trial, and will be entitled to a low double digit royalty on any future product sales as well as 25% of future licensing revenue, subject to certain limitations.
“We are very pleased to regain full rights to another late-stage asset. This comes at a strategic point in our Company’s history, as we continue to build a commercial biopharmaceutical company with a broad oncology portfolio that has the potential to enable a long-term, sustainable growth model,” said Michael Bailey, president and chief executive officer of AVEO. “The early data we have seen in the randomized, open-label HNSCC study with ficlatuzumab combined with cetuximab (ERBITUX®) has led us to the decision to secure additional clinical manufacturing capacity, which we expect to fund within our previously announced cash runway guidance, in order to prepare for a potential HNSCC pivotal study. We look forward to presenting final results from the Phase 2 study in the middle of 2021, and to providing an update on our potential pivotal program within that timeframe.”
Ficlatuzumab is being studied in an ongoing randomized, open-label confirmatory Phase 2 study in combination with cetuximab, an EGFR-targeted antibody, in cetuximab-resistant, recurrent metastatic HNSCC. The study was designed to confirm findings from a Phase 1 study of ficlatuzumab and cetuximab where the combination was well tolerated and resulted in a disease control rate of 67%, as well as prolonged progression free and overall survival compared to historical controls. The Phase 2 multi-center study is being conducted under the direction of Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center. Enrollment is expected to conclude in the fourth quarter of 2020, and results from the study are expected to be presented at a scientific meeting in 2021.
For more information, please refer to the Current Report on Form 8-K which will be filed by AVEO with the U.S. Securities & Exchange Commission on September 8, 2020.
About AVEO Pharmaceuticals, Inc.
AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. AVEO’s strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO’s lead candidate, tivozanib (FOTIVDA®) is approved in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and potentially commercialize tivozanib in North America as a treatment for renal cell carcinoma and hepatocellular carcinoma. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO’s earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.
SOURCE: AVEO Oncology
Post Views: 23
