Batiraxcept (formerly AVB-500), is an ultra-high affinity decoy protein that binds to GAS6 and thereby prevents AXL signaling to inhibit metastasis and tumor growth and restore sensitivity to anti-cancer agents. Batiraxcept is currently being evaluated in multiple clinical trials.
Batiraxcept has been granted Fast Track Designation by the U.S. FDA for both clear cell renal cell carcinoma and platinum-resistant ovarian cancer and Orphan Drug Designation for pancreatic ductal adenocarcinoma. Batiraxcept has been granted Orphan Drug Designation by the European Commission for platinum resistant recurrent ovarian cancer.
Analysis of all safety data to date showed that batiraxcept has been generally well tolerated with no dose-limiting toxicities or unexpected safety signals. A P1B platinum-resistant ovarian cancer trial (N = 53) demonstrated more than a doubling of progression-free survival in a patient subgroup that represents the P3 population.