Evexta Bio Reports Progress towards Clinical Development of Rupitasertib in Advanced Breast Cancer
Retrieved on:
Monday, April 22, 2024
Following a Type B meeting held on March 13, 2024, the U.S. Food and Drug Administration (FDA) provided Evexta Bio with valuable input on various aspects of rupitasertib development, including CMC, preclinical and clinical topics, enabling the company to proceed with the Phase 2 study in advanced breast cancer.
Key Points:
- Following a Type B meeting held on March 13, 2024, the U.S. Food and Drug Administration (FDA) provided Evexta Bio with valuable input on various aspects of rupitasertib development, including CMC, preclinical and clinical topics, enabling the company to proceed with the Phase 2 study in advanced breast cancer.
- Recent preclinical studies in ESR1mt breast cancer models have shown compelling synergistic effects of rupitasertib administered in combination with elacestrant.
- These data support the preliminary clinical efficacy observed in the Phase 1 study and warrant the development of rupitasertib in ESR1mt ER+ HER2- advanced breast cancer patients.
- In addition, S6K has been shown to be closely associated with the emergence of cancer resistance, particularly in breast cancer, through ER modulation.