HOUSTON -- ImmunoMet Therapeutics, Inc., (“ImmunoMet”, or the “Company”), a clinical stage biotechnology company committed to giving patients a novel approach to fight cancer, today provided a data update from the ongoing single-arm Phase 1b trial of the Company’s Lixumistat in combination with gemcitabine and nab-paclitaxel as frontline therapy in patients with advanced pancreatic cancer (NCT05497778). The study is led by Shubham Pant, MD, Professor of Gastrointestinal Medical Oncology and Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center.

This clinical trial includes a dose escalation phase followed by an expansion phase, evaluating the potential of Lixumistat, an inhibitor targeting metabolism, in combination with gemcitabine and nab-paclitaxel to address resistance and improve patient outcomes. Of the fourteen patients that have been treated, 8 received Lixumistat at 400 mg QD and 6 at 800 mg QD dose. When combined with gemcitabine and nab-paclitaxel for the treatment of advanced pancreatic adenocarcinoma, the recommended Phase 2 dose (RP2D) of Lixumistat was 400 mg once daily.

Among the 8 response-evaluable patients treated at the RP2D: 5 (62.5%) achieved an objective Partial Response (PR), 3 (37.5%) had Stable Disease (SD), and the Disease Control Rate was 100%. The estimated median Progression-free Survival (PFS) was 9.7 months (5.75-NA) and median Overall Survival (OS) was 18 months (8.5-NA). This group of patients had a mean age of 66.5 + 8 years and five (63%) were females.

Dr. Pant described the study’s results as follows: “Our study of Lixumistat at its RP2D in combination with gemcitabine/nab-paclitaxel shows quite encouraging clinical effects in this small signal-finding study. These findings suggest that the Lixumistat combination may provide a viable novel therapeutic option for advanced PDAC, warranting further investigation in larger studies.”

“Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive malignancy defined by high unmet need, morbidity, and mortality; currently the third-leading cause of cancer mortality in the US. There is substantial evidence that differential cancer cell metabolism, and oxidative phosphorylation (OxPhos) in particular, plays a key role in the development of resistance to current therapies. Based on these early clinical data we are hopeful that this best-in-class OxPhos inhibitor can improve outcomes for these patients,” said Dean Welsch, CEO of ImmunoMet Therapeutics.” Additional information about the trial, which is recruiting patients, can be found at clinicaltrials.gov, the abstract presented at the ASCO-GI meeting at ASCO-GI Abstract, and poster at ASCO-GI Poster.

ImmunoMet is also pleased to announce that it has received Orphan Drug Designation status for Lixumistat in patients with pancreatic cancer and glioblastoma multiforme (GBM). ImmunoMet continues to investigate additional indications using a precision medicine-guided approach where emerging data implicate OxPhos inhibition will demonstrate anti-tumor activity.