- CX-801 is a dually masked, conditionally activated IFNα2b cytokine designed using the CytomX Probody® Therapeutic Platform -
- Phase 1 first-in-human study expected to start in first half of 2024 -
- Clinical trial will evaluate CX-801 as monotherapy and in combination with KEYTRUDA in patients with advanced metastatic solid tumors including melanoma, renal cell carcinoma and head and neck squamous cell carcinoma -
May 07, 2024 -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the US and Canada) for CytomX’s first-in-human Phase 1 clinical trial assessing the clinical activity of CX-801, a dually-masked interferon-alpha2b cytokine in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab).
“Interferon-alpha-2b is a potent cytokine with demonstrated clinical activity against multiple cancer types, but its use has been limited by systemic toxicities. CX-801 is designed to overcome these limitations to unlock the full potential of interferon in activating the immune tumor microenvironment. With an improved therapeutic profile, our goal is to establish CX-801 as a cornerstone of immuno-oncology combination regimens, including in combination with checkpoint inhibitors such as Keytruda, for the treatment of a broad range of tumor types,” said Wayne Chu, M.D., chief medical officer of CytomX Therapeutics.
“CytomX is excited to be entering into this agreement with Merck to utilize Keytruda in combination with CX-801. The product design principles behind CX-801 integrate over a decade of continuous innovation and experience at CytomX in masking potent biologic therapies. The mechanistic combination of CX-801 and Keytruda is compelling and has potential to be a highly effective regimen to significantly improve the outcomes of patients with cancer,” said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Interferon-alpha 2b is an immunotherapeutic cytokine that has demonstrated clinical activity and gained regulatory approval previously in multiple cancer types. IFNα2b provides a potentially superior approach to activating anti-tumor immune responses compared to other cytokines. CX-801 is a dually masked, conditionally activated IFNα2b cytokine that has the potential to become a cornerstone of combination therapy for a wide range of tumor types, including in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. Phase 1 initiation for CX-801 solid tumors including melanoma, renal, and head and neck squamous cell carcinoma anticipated in the first half of 2024. Further details on the design and preclinical optimization of CX-801 can be found here:
CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated, masked biologics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY® therapeutic platform, CytomX’s vision is to create safer, more effective therapies for the treatment of cancer. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engagers, and immune modulators such as cytokines. CytomX’s clinical-stage pipeline includes CX-904, CX-2051 and CX-801. CX-904 is a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells. CX-904 is partnered with Amgen in a global co-development alliance. CX-2051 is a conditionally activated ADC directed toward epithelial cell adhesion molecule, EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. CX-2051 was discovered in collaboration with Immunogen, now part of AbbVie. CX-801 is an interferon alpha-2b PROBODY® cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Astellas, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and X (formerly Twitter).
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