AgilVax Triggers $2 Million Phase II Fast Track SBIR Grant and Initiates GMP Manufacturing

AgilVax, Inc., a biotechnology company developing targeted antibody-based therapies for the treatment of various cancers, including metastatic breast cancer (MBC), announced that the company has triggered Phase II funding of $2 million from its Fast Track Small Business Innovation Research (SBIR) grant awarded by the National Cancer Institute (NCI). AgilVax accomplished its Phase I goals ahead of schedule, which enabled the early initiation of the Phase II portion of the grant. Phase II is focused on studies that support an Investigational New Drug (IND) application for AgilVax’s lead product, AX09. As a result of the grant award, AgilVax selected a prominent Contract Manufacturing Organization (CMO) and initiated cGMP manufacturing of AX09.

AX09 is being developed as an antibody-based therapy for the treatment of MBC by inhibiting the function of xCT, which is associated with tumor growth and metastatic progression. xCT overexpression occurs in several cancers leading to overarching metabolic changes that reprogram cells for tumor growth and survival. AgilVax’s AX09 shows significant anti-xCT immune response in preclinical breast cancer models, where tumor impairment and reduced metastatic progression have been demonstrated. Several peer reviewed publications elucidate the preclinical evidence of AX09 and the importance of xCT in cancer metastasis.

Dr. Federica Pericle, President and CEO of AgilVax and Principal Investigator, stated, “Initiating the GMP manufacturing program for AX09 is an important milestone for the company. We are now one-step closer to the clinic, where we can provide patients suffering from metastatic breast cancer and other cancers a novel therapeutic option. We are also grateful to NCI for the continued support, which is instrumental in supporting the development of AX09.”