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Agilvax Awarded $2.3 Million SBIR Fast Track Grant to Advance the Development of AX09 for Triple Negative Breast Cancer


, a biotechnology company developing a novel cancer
immunotherapy for the treatment of triple negative breast cancer
(TNBC), announced today 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."

"There is a desperate need for targeted therapies and combinational
approaches for patients with TNBC," said George Peoples, M.D., F.A.C.S.,
Director, Cancer Vaccine Development Program, Metis Foundation. "AX09
shows promise in preclinical studies to inhibit an exploitable target
and its novel mechanism of action makes AX09 a potentially powerful
combination therapy to achieve durable responses for breast cancer


Agilvax discovers and develops targeted cancer immunotherapies using its
proprietary discovery and development technology. Agilvax's lead
product, AX09, is being developed as an immunotherapy for the treatment
of triple-negative breast cancer (TNBC) by inhibiting the function
of xCT, a novel molecular mechanism responsible for tumor growth and
metastatic progression. The Company was founded in 2011 and has
headquarters in Albuquerque, New Mexico, with offices in El Paso, Texas
and JLABS @ TMC in Houston, Texas.

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