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

ALBUQUERQUE, N.M.–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/NCI?src=hash" target="_blank"gt;#NCIlt;/agt;–AgilVax,
Inc., a biotechnology company developing targeted antibody-based
therapies for the treatment of various cancers, including metastatic
breast cancer (MBC), announced today 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.”

About AgilVax

AgilVax innovates targeted antibody-based therapeutics to cure cancer.
AgilVax’s lead product, AX09, produces antibodies that specifically
inhibit the function of xCT, a protein that is overexpressed on many
different tumor types including breast cancer, colorectal cancer,
hepatocellular cancer, lung cancer, and pancreatic cancer. AgilVax is
developing AX09 initially for the treatment of metastatic breast cancer.

Contacts

Federica Pericle
[email protected]
505-200-9541