Aveo Oncology has regained the full global rights to ficlatuzumab. Biodesix was co-developing the hepatocyte growth factor inhibitory antibody with Aveo but has chosen to exercise its opt-out right before the program moves into phase 3.
In 2014, two years after the drug failed a phase 2 lung cancer trial, Aveo and Biodesix agreed to evenly split the costs and profits associated with ficlatuzumab. The agreement provided Aveo with financial support from its companion diagnostic partner, but gave each party the option to opt out of the deal at any point up to the first commercial sale of the drug. With phase 3 on the horizon, Biodesix has exercised that option.
Biodesix’s action leaves Aveo fully responsible for taking ficlatuzumab through phase 3, but also frees it from the need to share profits in the event it gets the drug to market. The terms of the separation leave Biodesix responsible for costs related to a phase 2 trial and work on a companion diagnostic.
The investigator-sponsored phase 2 trial is assessing the use of ficlatuzumab in combination with Eli Lilly’s Erbitux in patients with head and neck squamous cell cancer (HNSCC). Aveo expects the investigator to complete enrollment in the fourth quarter and deliver results in the middle of 2021, but is already talking up the data and their implications for the program.
“The early data we have seen in the randomized, open-label HNSCC study with ficlatuzumab combined with cetuximab has led us to the decision to secure additional clinical manufacturing capacity ... in order to prepare for a potential HNSCC pivotal study,” Aveo CEO Michael Bailey said in a statement.
Having lost the financial support of Biodesix, Aveo plans to fund the production of ficlatuzumab for use in the planned phase 3 HNSCC trial and, potentially, midphase studies in pancreatic cancer and acute myeloid leukemia (AML). Aveo’s progress in AML was slowed by the pandemic.
If ficlatuzumab comes to market in any of the indications, Biodesix will receive low double digit royalties. Biodesix is also in line to pocket 25% of any future licensing revenue Aveo generates from the drug.