Agilvax, Inc. announced on 8/7/18 the receipt of a Fast Track Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI). The grant will provide up to $2.3 million in funding for preclinical studies, cGMP manufacturing and a nonclinical toxicology study that will enable an investigational new drug application (IND) submission for Agilvax’s lead immunotherapy product, AX09. The SBIR award is the result of a highly competitive federal grant program supporting significant innovations that address critical unmet needs in public health.

AX09 is being developed as an immunotherapeutic agent for the treatment of TNBC by inhibiting the function of xCT, which is associated with tumor growth and metastatic progression. xCT has known metabolic functions in normal and cancer cells, where it plays a critical role in cellular defenses, detoxification and intracellular balance. 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 important role of xCT in cancer metastasis.

“We are delighted to receive this grant award from the National Cancer Institute (NCI) to advance the development of AX09 in TNBC, which is one of the lead indications for this product,” said Federica Pericle, Ph.D., president and chief executive officer of Agilvax, and the Principal Investigator of the award. “The SBIR award is an important indication of the significant clinical and commercial opportunity of AX09. We are extremely grateful to the NCI and our investors as we execute our development of this novel immunotherapy.”

In addition to AX09, Agilvax has two other candidates in pre-clinical development.