Trishula Therapeutics has announced positive results from its Phase I clinical trial of TTX-030, an anti-CD39 antibody, for the treatment of first-line metastatic pancreatic cancer. The study evaluated TTX-030 in combination with gemcitabine/nab-paclitaxel, both with and without the investigational anti-PD-1 antibody budigalimab, in patients with pancreatic adenocarcinoma.
The Phase I trial demonstrated encouraging outcomes in patients with metastatic pancreatic cancer. The efficacy-evaluable population showed an objective response rate (ORR) of 30%, a median progression-free survival of 7.5 months, and a median overall survival of 19.1 months. Notably, patients with high expression of the immune-associated biomarker HLA-DQ experienced a 46% ORR, a median progression-free survival of 9.6 months, and a median overall survival of 21.9 months.
The treatment regimens were generally well-tolerated, with a low discontinuation rate due to adverse events. The most common side effects observed were consistent with those typically associated with the standard chemotherapy regimen used in the study.
Mechanism of Action and Ongoing Development
TTX-030 functions by inhibiting CD39, an enzyme that converts adenosine triphosphate (ATP) to adenosine monophosphate (AMP). This process can suppress immune responses within the tumor microenvironment. By inhibiting CD39, TTX-030 aims to enhance anti-tumor immunity.
Currently, TTX-030 is being further evaluated in the global Phase II ELTIVATE trial. This trial aims to assess TTX-030 as a first-line treatment for metastatic pancreatic adenocarcinoma in a biomarker-enriched population. The Phase II trial is enrolling approximately 180 patients and is focused on progression-free survival. Results from the ELTIVATE study are anticipated in 2026.
Collaboration and Future Prospects
Trishula Therapeutics is developing TTX-030 in partnership with AbbVie, with the shared goal of providing a novel therapeutic option for patients with metastatic pancreatic cancer.
According to Trishula Therapeutics CEO Anil Singhal, the Phase I results demonstrated a strong median overall survival in patients with metastatic pancreatic cancer following treatment with TTX-030 combinations, as well as a marked benefit in those with high levels of tumor HLA-DQ biomarker expression. These findings have led to the currently enrolling global, randomized Phase II ELTIVATE study, with results expected in 2026.
