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BMS, Inspirna to Study Yervoy, RGX-104 Combination in Endometrial Cancer

NEW YORK – Bristol Myers Squibb and Inspirna on Thursday announced a collaboration to study Inspirna's RGX-104 with BMS's checkpoint inhibitor ipilimumab (Yervoy) in patients with metastatic endometrial cancer who harbor the APOE2 or APOE4 biomarker.

The Phase Ib/II trial will investigate the combination as a second- and third-line treatment for advanced endometrial cancer patients who have progressed on checkpoint inhibitors. Inspirna will sponsor the study and cover study costs.

RGX-104 is an agonist of the Liver X Receptor (LXR) pathway, which activates expression of the apolipoprotein E (APOE) tumor suppressor protein. When the APOE expression is dysregulated, however, it plays a role in promoting tumor growth. RGX-104 is designed to counteract this dysregulation.

Approximately 40 percent of the population harbor the E2 and E4 variants of APOE, according to Inspirna. APOE4 variants are also known to increase carriers' risk for developing late-onset Alzheimer's disease.

In a Phase I study of RGX-104 involving patients with various tumor types, including endometrial cancer, those carrying the APOE2 or APOE4 variant were more likely to respond to the drug. Earlier research exploring the activity of RGX-104 in combination with other drugs showed a 60 percent response rate in patients with the APOE2 or APOE4 biomarker who had progressed on checkpoint inhibitor therapy, Inspirna CEO Masoud Tavazoie said in a statement.

RGX-104 is also being studied with chemotherapy in a Phase I/II trial involving lung cancer patients with APOE dysregulation.