Agennix Inc. has been granted fast track designation by the U.S. Food and Drug Administration (FDA) for their investigative agent talactoferrin alfa (talactoferrin) for first-line therapy of renal cell carcinoma (RCC) in combination with Sutent® (sunitinib).
Talactoferrin aids in the recruitment of immature dendritic cells that have captured tumor antigens to the gut-associated lymphoid tissue (GALT). Once residing in GALT, talactoferrin promotes dendritic cell maturation away from the tumor, reducing tumor effects against the immune system.
The submission to the FDA is based on results from a Phase I trial as well as a single-arm Phase II trial in which patients with clear-cell RCC who had failed standard therapy received talactoferrin and achieved a 77% survival rate at one year.
Cancer & COVID-19 - What You Need to Know During the "COVID" Era
What you need to know to reduce risks and receive optimal diagnosis and treatment during the COVID-19 pandemic.
COVID-19 Vaccination in Patients with Blood Cancers
Studies of COVID-19 vaccine effectiveness in myeloma and lymphoma available - vaccine relatively ineffective.
Blood Cancers and COVID-19 - What You Need to Know
COCID-19 puts individuals with leukemia, lymphoma, myeloma and MPN's at risk - learn how to optimize your care.