Tizona Therapeutics Announces Expansion of Phase 1b Clinical Trial to Evaluate TTX-080 in Combination with EGFR Inhibitor Cetuximab and Chemotherapy in Advanced Colorectal Cancer

– Trial builds upon promising evidence of clinical activity of TTX-080 when combined cetuximab, presented at ASCO 2024 –

South San Francisco, Calif., October 31, 2024 – Tizona Therapeutics, Inc., a privately held, clinical-stage company developing cancer immunotherapies, today announced the initiation of two randomized arms within the ongoing Phase 1b clinical trial of TTX-080, a novel, first-in-class antibody targeting HLA-G. Patients with biomarker-defined metastatic colorectal cancer (mCRC) will be enrolled to receive either TTX-080 plus cetuximab and FOLFIRI or cetuximab and FOLFIRI alone in the second-line setting.

“Although screening and increased awareness have helped clinicians identify colorectal cancer earlier, approximately one in four individuals will still be diagnosed with metastatic disease,” said Christine O’Brien, Chief Executive Officer of Tizona Therapeutics. “Based on clinical data presented earlier this year at ASCO, we believe TTX-080 has strong potential to improve clinical outcomes in patients with biomarker-defined, metastatic colorectal cancer, who urgently need new treatment options.”

The recently added randomized arms within the ongoing Phase 1b, open-label clinical trial will evaluate either TTX-080 plus cetuximab and FOLFIRI or cetuximab and FOLFIRI alone in patients who have previously received 5-FU and oxaliplatin in the front-line or adjuvant setting (relapse within 6 months). Eligible patients are those with mCRC tumors that are MSS, WT RAS, WT BRAF, and HER2-negative. The primary endpoint of the trial is overall response rate with safety, duration of response, median progression-free survival and median overall survival as secondary endpoints. Additional information about the clinical trial can be found on clinicaltrials.gov (NCT04485013).

About Tizona Therapeutics, Inc.

Tizona is a privately held, clinical-stage immunotherapy company that develops first-in-class medicines to deliver transformational benefits for people with cancer. Tizona translates scientific breakthroughs into therapeutics that stimulate the immune system and counter immune suppression. Tizona is advancing its lead therapeutic candidate, TTX-080, which targets HLA-G, in a Phase 1b clinical study in advanced colorectal cancer.

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Lori Murray
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