The National Cancer Institute has awarded a Fast Track Small Business Innovation Research grant to Agilvax to support development of the company’s lead immunotherapy candidate, AX09, for an aggressive and difficult-to-treat breast cancer.
The grant, worth about $2.3 million, will go toward preclinical trials, a toxicology study, and the establishment of good manufacturing practices. Ultimately, it aims to enable the submission of AX09’s investigational new drug application (IND) to the U.S. Food and Drug Administration to begin clinical testing.
The three most common types of receptors that fuel breast cancer growth are the estrogen, progesterone, and HER2. In some 20 percent of breast cancer patients, whose cancer is called triple-negative, these receptors are not present in the tumor.
In these patients, treatments like hormone therapy or those that target estrogen, progesterone, and HER-2 are ineffective. Triple-negative breast cancer (TNBC) also tends to be more aggressive.
AX09 is a virus-like-particle immunotherapy aiming to treat TNBC. It targets the stem cell protein xCT, found in a high percentage of breast cancers including TNBC.
“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,” Federica Pericle, PhD, president and chief executive officer of Agilvax, said in a news release. “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.”
Expression of xCT is associated with poorer outcomes in patients, with xCT being linked to tumor growth and cancer spread. Animal studies in TNBC mouse model show that AX09 significantly decreases cancer metastases and the amount of breast cancer stem cells within tumor.
“There is a desperate need for targeted therapies and combinational approaches for patients with TNBC,” said George Peoples, MD, FACS, director of the Cancer Vaccine Development Program at the Metis Foundation, a nonprofit that supports research relevant to military personnel. “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 patients.”
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