US-based biotechnology company Trishula Therapeutics has reported positive results from its Phase I clinical trial of TTX-030, an anti-CD39 antibody designed to treat first-line metastatic pancreatic cancer.
The study assessed TTX-030 as a first-line treatment in combination with gemcitabine/nab-paclitaxel, both with and without the investigational anti-PD-1 antibody budigalimab, in patients with pancreatic adenocarcinoma.
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The results showed an objective response rate (ORR) of 30%, median progression-free survival of 7.5 months, and median overall survival of 19.1 months in the efficacy-evaluable population.
Patients with high expression of the immune-associated biomarker HLA-DQ experienced a 46% ORR, as well as a median progression-free survival of 9.6 months and 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 were in line with those expected from the standard chemotherapy used.
TTX-030 is now undergoing a global Phase II trial, ELTIVATE, which aims to further evaluate it as a first-line treatment for metastatic pancreatic adenocarcinoma.
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By GlobalDataThe trial will enrol around 180 patients and focus on progression-free survival in a biomarker-enriched population.
TTX-030 operates by inhibiting CD39, an enzyme involved in converting adenosine triphosphate (ATP) to adenosine monophosphate (AMP), a process that can suppress immune response in the tumor microenvironment.
Trishula is developing the drug in partnership with AbbVie, with the aim of providing a new therapeutic option for patients with metastatic pancreatic cancer.
Trishula Therapeutics CEO Anil Singhal said: “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 marked benefit in those with high levels of tumour HLA-DQ biomarker expression.
“These findings have led to our currently enrolling global, randomised Phase II ELTIVATE study, with results expected in 2026.”
