Member News

January 19, 2022

SOUTH SAN FRANCISCO, Calif.,  (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated therapeutics, announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for CX-904, an EGFRxCD3 T-cell-engaging bispecific antibody being co-developed by CytomX and Amgen.

“The impressive innovation of CX-904’s design and its advancement into the clinical setting underscores our commitment to destroying cancer differently. The CX-904 IND also marks the sixth therapeutic candidate and the third treatment modality overall to enter the clinic from our versatile and tunable Probody platform, reinforcing our leadership in the field of conditional activation of biologic therapeutics,” said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. “Our masked Probody T-cell engagers are designed to harness the power of this highly potent modality. We are eager to initiate the Phase 1 dose-escalation study for CX-904 as the leading edge of our broad efforts to bring conditionally activated bispecifics to patients with advanced solid tumors.”

T-cell-engaging bispecific antibodies have tremendous potential for the treatment of solid tumors by directing T cells against tumor antigens, including the epidermal growth factor receptor (EGFR). However, the extraordinarily high potency of these agents can narrow their therapeutic window significantly when their target is present on normal tissues. CX-904 is a conditionally activated T-cell bispecific antibody designed to bind to both EGFR on cancer cells and to the CD3 receptor on T cells selectively in the tumor microenvironment. In preclinical studies, CytomX's conditionally activated Probody EGFRxCD3 bispecific therapeutics demonstrated potent anti-tumor activity and strong improvement in safety versus EGFRxCD3 bispecifics without Probody masking.1

About CytomX Therapeutics, Inc.
CytomX is a clinical-stage, oncology-focused biopharmaceutical company dedicated to destroying cancer differently. By pioneering a novel class of conditionally activated biologics, powered by its Probody® technology platform, CytomX’s goal is to transcend the limits of current cancer treatments and successfully leverage therapeutic targets that were once thought to be inaccessible. CytomX’s robust and differentiated pipeline includes the wholly-owned praluzatamab ravtansine (CX-2009), an investigational conditionally activated antibody-drug conjugate (ADC) directed toward CD166, and CX-2029, an investigational conditionally activated ADC directed toward CD71 co-developed with AbbVie. These two programs are currently being evaluated in Phase 2 studies, targeting a variety of late-stage, difficult-to-treat cancer types, including breast cancer for praluzatamab ravtansine, and squamous non-small cell lung cancer, and head and neck squamous cell carcinoma for CX-2029. CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, and our wholly-owned conditionally activated anti-PD-L1 antibody, pacmilimab (CX-072), as well as the Amgen-partnered CX-904, a conditionally activated T-cell-engaging bispecific antibody against the epidermal growth factor receptor on tumor cells and the CD3 receptor on T cells. In addition, CytomX has a diverse preclinical portfolio and strategic collaborations with other leaders in oncology, including AbbVie, Amgen, Astellas, and Bristol Myers Squibb.