China-based Hangzhou DAC Biotech Co., Ltd announced the first patient enrollment and dosing in a Phase I clinical study of its antibody drug conjugate (ADC) DXC007 for relapsed/refractory (r/r) acute myeloid leukemia (AML). The open, multi-center, dosage escalation and expansion trial will assess the drug’s safety, tolerability, and pharmacokinetics.
Drug Profile
DXC007 is an innovative ADC composed of a cysteine-linked Tubulysin B analog (Tub255) attached to a recombinant humanized anti-CD33 monoclonal antibody via interchain disulfide bond reduction. CD33, expressed in ~90% of AML patients, is a key target for AML therapies.
Clinical Trial Details
The Phase I study will evaluate DXC007’s safety and pharmacokinetics in r/r AML patients. The trial’s design includes dosage escalation and expansion cohorts to determine optimal dosing.
Market Context
Pfizer’s Mylotarg (gemtuzumab ozogamicin), another CD33-targeted ADC, was approved in the US in 2000, Japan in 2005, and the EU in 2018. DAC Biotech’s DXC007 aims to offer a next-generation option for AML treatment.-Fineline Info & Tech
