CytomX Therapeutics Announces FDA Clearance of IND Applications for CX-2051, a Probody Antibody Drug Conjugate (ADC) Targeting EpCAM and CX-801, a Conditionally Activated Interferon Alpha-2b

- Initiation of CX-2051 Phase 1 clinical study in EpCAM positive tumors including colorectal cancer anticipated in 1H 2024 -

- Initiation of CX-801 Phase 1 clinical study in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma also anticipated in 1H 2024 -

SOUTH SAN FRANCISCO, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today 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.

“The parallel advancement of these programs toward the clinic demonstrates the continued high productivity of the CytomX team and the versatile, multi-modality nature of our Probody platform. The product design principles behind CX-2051 and CX-801 integrate over a decade of continuous innovation and experience at CytomX,” said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics. “We look forward to the clinical initiation of these programs as we enter a potentially milestone-rich period for the company in 2024 and 2025.”