Cybrexa Therapeutics has successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its proposed IND and Phase I/II study for its lead candidate, CBX-12 (alphalexTM-Texan).
CBX-12 includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates (ADCs) ENHERTU® and TRODELVY™. In contrast to these ADCs, CBX-12 is able to target cancer cells independent of antigen overexpression. alphalexTM conjugates have efficacy in the substantial patient populations that cannot be effectively treated with ADCs, as ADCs can be used only in patients that overexpress antigens.