On November 9, 2023 Trishula Therapeutics, Inc., a clinical stage, privately held biotechnology company, reported the initiation of a randomized Phase 2 trial to evaluate the efficacy and safety of TTX-030, a potential first-in-class, anti-CD39 antibody (Press release, Trishula Therapeutics, NOV 9, 2023, View Source [SID1234637447]). The trial will evaluate TTX-030 in combination with chemotherapy, with or without budigalimab (an investigational anti-PD-1 antibody), compared to chemotherapy alone, as first-line treatment for metastatic pancreatic ductal adenocarcinoma patients.
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"There is significant unmet need for new treatment options for pancreatic cancer," said Anil Singhal, Chief Executive Officer of Trishula Therapeutics. "We look forward to building on the promising Phase 1 results to potentially advance the treatment landscape with TTX-030, which may bring benefit to patients with advanced pancreatic cancer."
The study is designed to enroll approximately 180 patients globally. Patients will be randomized equally into three study arms, receiving TTX-030 and chemotherapy (gemcitabine and nab-paclitaxel); TTX-030 and chemotherapy plus budigalimab; or chemotherapy alone. The primary endpoint of the trial is progression free survival (PFS) in a biomarker-enriched population. Secondary endpoints include PFS in the overall population, safety, objective response rate, duration of response and overall survival. Further information on the study can be found at (clinicaltrials.gov link).
Trishula will continue to develop TTX-030 in collaboration with AbbVie Inc. Per the terms of the collaboration agreement, at the conclusion of this Phase 2 study, AbbVie will have an exclusive option to license TTX-030 for further development.
About TTX-030TTX-030 is a potential first-in-class, anti-CD39 antibody designed to inhibit the activity of CD39, an enzyme that converts adenosine triphosphate (ATP) to adenosine monophosphate (AMP), the initial step in the generation of adenosine in the tumor microenvironment. TTX-030 prevents the formation of immune-suppressive extracellular adenosine and maintains high levels of immune-activating extracellular ATP, stimulating dendritic and myeloid-derived cells promoting both innate and adaptive anti-tumor immunity.