Cybrexa Therapeutics to Begin Cancer Trial of CBX-12

FDA has given Cybrexa Therapeutics the green light to begin a clinical trial for solid tumor therapy CBX-12 (alphalex-exatecan). “Preclinical studies of CBX-12 show a strong efficacy and safety profile, and we expect that the Phase 1 clinical trial will help us learn more about the potential applications of this therapeutic candidate,” the company says. CBX-12 is described by Cybrexa as a novel treatment for solid tumors that includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates Enhertu (Daiichi Sankyo) and Trodelvy (Immunomedics). CBX-12 is able to target cancer cells independent of antigen expression unlike Enhertu and Trodelvy, it says, adding that this could greatly expand the addressable patient populations. The planned Phase 1 trial of CBX-12 is expected to begin next month.