CytomX Therapeutics announces FDA clearance of IND applications for CX-2051

CytomX Therapeutics announced that it has received clearance from the U.S. Food and Drug Administration, FDA, for its Investigational New Drug, IND, applications for the conditionally activated Probody therapeutics CX-2051, an EpCAM-directed ADC, and CX-801, a dually-masked version of interferon-alpha 2b. CX-2051 has been cleared for the initiation of Phase 1 dose escalation in solid tumors with known EpCAM expression and CX-801 has been cleared for the initiation of Phase 1 dose escalation in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma. Both programs are expected to start Phase 1 studies in the first half of 2024. “CX-2051 and CX-801 have the potential to address major unmet needs in oncology and we are excited to advance these programs into Phase 1 clinical studies. CX-2051 is an ADC conjugated to a next-generation topoisomerase-1 inhibitor payload that we believe is tailored to certain EpCAM-expressing tumors, including colorectal cancer,” said Wayne Chu, M.D., chief medical officer of CytomX Therapeutics. “CX-801 is designed to overcome previous limitations of interferon-directed therapies due to systemic toxicity and establish CX-801 as a cornerstone of combination regimens, including with checkpoint inhibitors, across a wide range of tumor types,” continued Dr. Chu.