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MINNEAPOLIS, MN / ACCESSWIRE / December 11, 2019 / Celcuity Inc. (CELC), a dynamic cellular analysis company developing diagnostic tests to identify new patient populations for targeted therapies, announced that it presented results from a study of its newly developed CELx PI3K Signaling Function Test at the 2019 San Antonio Breast Cancer Symposium on December 11, 2019.

The CELx PI3K Test identifies HER2-negative breast cancer patients with hyperactive PI3K-involved signaling tumors that respond ex vivo to PI3K inhibitors. Currently, only breast cancer patients with PIK3CA-mutations are eligible to receive treatment with PI3K inhibitors. However, response rates of 20% or less to PIK3 drugs in recent Phase III clinical trials suggest the need to measure other biological factors, such as PIK3-involved signaling, when identifying patients eligible for PI3K inhibitors.

"The studies we presented demonstrate how the measurement of PI3K-involved signaling initiated by G-protein-couple receptors (GPCRs) may provide a more sensitive and specific method of identifying patients most likely to benefit from PI3K inhibitors than PIK3CA-status," said Brian Sullivan, Chairman and Chief Executive Officer of Celcuity.

Abstract #2224, Poster # P1-09-07

Title: Sub-Group of PIK3CA WT breast cancer patients have hyperactive S1P and LPA signaling tumors responsive to PI3K inhibitors: functional signaling test identifies new patient group who may benefit from PI3K inhibitors.

• Using primary patient breast tumor cells and well characterized breast cancer cell lines, this study set out to:

  • Characterize the involvement of the PI3K node in hyperactive S1P and LPA-initiated signaling.

  • Assess whether PI3K-involved hyperactive S1P and LPA signaling is limited to breast cancer cells with PI3KCA mutations.
    

• Found that two of three cell lines with PI3KCA-mutations lacked abnormal PI3K-alpha isoform involved signaling.

  • Suggests a weak correlation between the status of PI3K-involved signaling and PI3KCA gene mutation status.

• Demonstrated that CELx PI3K Test results correlate with xenograft drug study results using two different cell lines with p110α-mutations.

  • Abnormal pan-PI3K signaling corresponded with significant in vivo anti-tumor effect of a pan-PI3K inhibitor.

  • Normal PI3K-alpha isoform signaling corresponded with no in vivo anti-tumor effect of a PI3K-alpha isoform inhibitor.
    

• Found that 4 of 17 (24%) patient tumor cell samples recorded total levels of signaling activity involving PI3K isoforms initiated by S1P activation above the test cut-off.

  • Confirms that abnormal S1P or LPA activity involving PI3K can occur in PIK3CA WT patient primary cells.