Tizona Therapeutics Expands Phase 1b Trial of TTX-080 with Cetuximab and Chemotherapy for Advanced Colorectal Cancer

On October 31, 2024, Tizona Therapeutics, Inc., a privately held clinical-stage company focused on developing cancer immunotherapies, announced the launch of two new randomized arms in their ongoing Phase 1b clinical trial of TTX-080. TTX-080 is a groundbreaking antibody that targets HLA-G. This trial involves patients suffering from biomarker-defined metastatic colorectal cancer (mCRC). Participants will be divided into two groups: one will receive a combination of TTX-080, cetuximab, and FOLFIRI, while the other group will receive only cetuximab and FOLFIRI as part of their second-line treatment.

Christine O’Brien, the Chief Executive Officer of Tizona Therapeutics, highlighted the persistent challenge of metastatic colorectal cancer, noting that despite advances in screening and early detection, about 25% of patients are diagnosed with metastatic disease. O’Brien expressed optimism based on clinical data presented earlier this year at the American Society of Clinical Oncology (ASCO), suggesting that TTX-080 could significantly improve clinical outcomes for patients with biomarker-defined metastatic colorectal cancer who are in dire need of new treatment options.

The newly added randomized arms in the Phase 1b, open-label trial will assess the efficacy of TTX-080 in combination with cetuximab and FOLFIRI, compared to the treatment with cetuximab and FOLFIRI alone. This trial targets patients who have previously been treated with 5-FU and oxaliplatin either as a first-line treatment or in an adjuvant setting, particularly those who experienced a relapse within six months. Eligible participants are those with metastatic colorectal cancer tumors that are microsatellite stable (MSS), wild-type (WT) for RAS, WT for BRAF, and HER2-negative. The primary goal of the trial is to evaluate the overall response rate, with secondary goals including safety, duration of response, median progression-free survival, and median overall survival. Additional details about the trial are available on clinicaltrials.gov under the identifier NCT04485013.

Tizona Therapeutics is dedicated to developing pioneering immunotherapy treatments designed to bring transformative benefits to cancer patients. The company focuses on turning scientific discoveries into therapeutics that enhance the immune system and combat immune suppression. Tizona’s leading therapeutic candidate, TTX-080, is currently being studied in a Phase 1b clinical trial for advanced colorectal cancer, aiming to deliver a new and effective treatment option for patients battling this aggressive form of cancer.