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Find Clinical Drug Pipeline Developments & Deals by Cybrexa Therapeutics
CBX-12 is a PDC that includes the highly potent topoisomerase I inhibitor exatecan. CBX-12 demonstrated safety and tolerability, without significant gastrointestinal toxicity.
Study evaluating the efficacy of CBX-12 (alphalex™-exatecan) in combination with PD-1- and CTLA4-targeted immune checkpoint inhibitors in preclinical cancer models. CBX-12 is a novel treatment for solid tumors that includes a highly potent topoisomerase I inhibitor.
CBX-12 is 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 (ADCs) ENHERTU® and TRODELVY™.
CBX-12 is 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 (ADCs) ENHERTU® and TRODELVY™.
Proceeds from the financing will be used to support the planned advancement of Cybrexa’s lead candidate CBX-12 (alphalex™-exatecan) into the clinic. The first patient dosing in the Phase 1 study is expected in the first half of 2021.
Cybrexa and NCI to collaborate on clinical development of Cybrexa’s lead candidate, CBX-12, to assess the safety and efficacy in oncology patients with solid tumors.
In the GLP toxicology studies CBX-12 was delivered via IV infusion, and based on multiple parameters, including mortality, clinical observations, body weights and food consumption, the results established a significant therapeutic index of ~20X over exatecan for CBX-12.
The Phase I portion of the study will establish the safety profile and a recommended Phase II dose (RP2D). This initial clinical trial will also evaluate efficacy across a number of solid tumors and establish proof of mechanism for the alphalex™ platform.
CBX-12 demonstrated remarkable efficacy across HER2-negative solid tumors in preclinical models. It displayed enhanced stability in plasma in vivo and demonstrated exquisite selectivity for tumor over normal tissues in mouse tumor models.
Dr. DeCillis will lead the development of the first-in-human study of Cybrexa’s lead program, CBX-12 (alphalexTM-exatecan), and early and late stage clinical programs for the Cybrexa portfolio.