As a late clinical-stage biopharmaceutical company focused on oncology, our business model is to in-license novel compounds, develop them through clinical stages, and then seek to commercialize them through out-licensing arrangements with biotechnology and pharmaceutical companies or evaluating, on a case-by-case basis, the commercialization of our therapeutic candidates independently.
Our lead program, motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem-cell mobilization for autologous bone-marrow transplantation and has reported positive results from pharmacoeconomic studies. These outstanding results support the goal of motixafortide becoming the standard of care mobilization agent in autologous bone-marrow transplantation, and in this regard, after a successful pre-NDA meeting with the FDA, we are currently preparing an NDA submission in mid-2022.
Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a collaboration agreement with MSD. Substantial improvement was observed across all study endpoints, including overall survival, progression free survival, and overall response rate, in the most challenging PDAC patients. The asset was also successfully evaluated in a Phase 2 study in r/r AML.
Motixafortide is currently being studied in two notable investigator-initiated trials: in a Phase 2 study for the treatment of pancreatic cancer in combination with LIBTAYO® and chemotherapy, and in a Phase 1b study for patients with Acute Respiratory Distress Syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections.
We are also developing a second oncology program, AGI-134, a novel immunotherapy treatment for multiple solid tumors, that is currently being investigated in a Phase 1/2a study.