Trishula Therapeutics has reported encouraging initial data from an ongoing Phase I trial of its anti-CD39 antibody TTX-030 with budigalimab (investigational anti-PD-1) and FOLFOX for gastric cancer.
The TTX-030 combination therapy is being evaluated for the first-line treatment of locally advanced/metastatic HER2 negative gastric or gastroesophageal junction cancer patients.
It was generally well-tolerated and showed encouraging anti-tumour activity signs in the trial.
Trishula Therapeutics CEO Anil Singhal said: “Our data highlighted at AACR represents the first promising clinical findings of an anti CD39 antibody in patients with gastric cancers and supports the role of TTX-030 in reversing adenosine-mediated immunosuppression.
“We look forward to the continued advancement of this clinical study of TTX-030, which we believe has the potential to significantly improve the treatment paradigm for cancer patients.”
The trial is evaluating the antibody in various treatment combinations in patients with advanced unresectable or metastatic stomach cancer or gastroesophageal junction with HER2-negative disease.
These patients did not receive any treatment earlier for metastatic disease or adjuvant therapy within six months of enrolment.
According to the preliminary efficacy and safety data presented, 26 of the total 44 patients enrolled were still on study treatment. The median duration on the trial was 214 days.
Furthermore, 21 patients among 40 efficacy-evaluable patients achieved best overall response of partial response.
Known PD-L1 Combined Positive Score (CPS) was reported in 37 of the efficacy-evaluable patients.
At least one adverse event (AE) of any grade was observed in 27 of the total 44 patients, including nine subjects with Grade 3/4 AEs.
Safety and tolerability are considered the primary endpoint and secondary endpoints of overall response (ORR) were assessed using response evaluation criteria in solid tumors and progression-free survival.