The companyâ€™s lead asset is seviteronel (formerly INO-464), a dual mechanism selective CYP17 lyase and androgen receptor (AR) inhibitor. Intervention of these pathways with abiraterone (Zytigaâ„¢), a nonselective CYP17 inhibitor, and enzalutamide (Xtandiâ„¢), an AR antagonist, are approved for the treatment of CRPC, and more recently have demonstrated signs of early clinical benefit for breast cancer. Ongoing clinical studies are evaluating oral seviteronel as a novel therapeutic for estrogen receptor-positive (ER+) and triple negative breast cancer (TNBC) as well as for CRPC.
Seviteronel is a non-steroidal, orally-active, small molecule that is administered once-daily and inhibits sex steroid production. Cardiac signals or liver enzyme elevations have not been observed in the more than 100 men and women treated with seviteronel suggesting the potential to use seviteronel in combination with other promising cancer drugs of complementary classes.
Seviteronel is being investigated in a Phase 2 clinical trial to treat women and men who have ER+ breast cancer or TNBC. Seviteronel is also being evaluated in Phase 2 clinical trials in men with CRPC whose disease has progressed following treatment with abiraterone or enzalutamide or both. Our Phase 2 programs focus on advanced cancers that represent a major unmet medical need for women and men.