On April 12, 2022 Trishula Therapeutics, Inc., a clinical stage, privately held company developing TTX-030, a first-in-class investigational anti-CD39 antibody in advanced cancers, reported preliminary results from an ongoing Phase 1 trial evaluating TTX-030 in combination with budigalimab (investigational anti-PD-1) and FOLFOX for the first-line treatment of patients with locally advanced/metastatic HER2 negative gastric or gastroesophageal junction cancer (Press release, Trishula Therapeutics, APR 12, 2022, View Source [SID1234612101]). Study results were presented in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans. The data presented demonstrates that TTX-030 combination treatment was generally well-tolerated and showed encouraging signs of anti-tumor activity.

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"The response rates including in patients with PD-L1 low tumors seen in this preliminary analysis are very encouraging and support the potential of TTX-030 to impact the standard of care for patients with gastric and gastroesophageal cancer," said Zev Wainberg, M.D., Professor of Medicine at UCLA and co-director of the UCLA GI Oncology Program. "We look forward to the complete findings from this trial and the further advancement of this promising treatment approach."

Preliminary efficacy and safety results were presented as of an interim data cut of March 1, 2022. A total of 44 patients were enrolled. Twenty-six (26) patients were still on study treatment, and the median duration on study was 214 days (range 8-464+ days). Among 40 efficacy-evaluable patients, 21 patients (25 patients including unconfirmed) achieved best overall response of partial response or better including 4 CRs: ORR=52.5% (62,5% including unconfirmed), and disease-control rate = 92.5%. Thirty-seven (37) of the efficacy-evaluable patients had known PD-L1 Combined Positive Score (CPS); response rates in patients with CPS ≥1 were 65% (77% including unconfirmed).

Twenty-seven of 44 patients (61%) experienced at least one adverse event (AE) of any grade considered related to TTX-030 (investigator assessment), including 9 patients (20.5%) with Grade 3/4 AEs. Adverse events were overall consistent with those seen with standard-of-care (chemotherapy plus anti-PD-1).

"Our data highlighted at AACR (Free AACR Whitepaper) 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," said Anil Singhal, Chief Executive Officer. "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."

AACR Oral Presentation Details:

Title: Safety and efficacy of TTX-030, an anti-CD39 antibody, in combination with chemoimmunotherapy for the 1st line treatment of locally advanced or metastatic gastric/GEJ cancer.

Abstract Number: 8213

About TTX-030 Phase 1 Trial

The ongoing Phase 1 trial is evaluating TTX-030 in different treatment combinations in patients with advanced unresectable or metastatic cancer of the stomach or gastroesophageal junction with HER2-negative disease and no prior treatment for metastatic disease or adjuvant therapy within six months of enrollment. The primary endpoint is safety and tolerability with secondary endpoints of overall response (ORR) assessed using Response Evaluation criteria in Solid Tumors (RECIST/iRECIST) and progression free survival. Patients receive treatment with mFOLOFOX, Budigaglimab and TTX-330 030 on a 28-day cycle until disease progression.