Lixumistat

HOUSTON, TX, USA I January 24, 2025 I 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. About Lixumistat Lixumistat is a Protein Complex 1 (PC1) inhibitor that targets the oxidative phosphorylation (OXPHOS) pathway that is required to drive tumor growth and proliferation in some tumors. Lixumisat, ImmunoMet’s lead drug candidate, is solely owned by ImmunoMet and is currently in development for the treatment of selected cancers. About ImmunoMet Therapeutics ImmunoMet is a clinical stage biotechnology company targeting metabolism for the treatment of selected cancers and fibrotic diseases. ImmunoMet’s lead molecule, Lixumistat, is the first PC1 inhibitor to complete Phase 1 with good tolerability. In addition to Lixumistat, ImmunoMet owns a large library of biguanides with the potential for development, internally or with partners, for multiple indications. The company was founded in 2015, is headquartered in JLABS @ TMC in Houston and has raised $38M to date. For more information about the company, please visit immunomet.com SOURCE: ImmunoMet Therapeutics

HOUSTON--(BUSINESS WIRE)--ImmunoMet Therapeutics, Inc., a clinical stage biotechnology company targeting metabolism to develop novel anti-cancer and anti-fibrotic therapies, today announces that the first patient has been dosed in the single-arm Phase 1b trial of IM156 in combination with gemcitabine and nab-paclitaxel as frontline therapy in patients with advanced pancreatic cancer. The study is led by Shubham Pant, MD, Professor in Department of Gastrointestinal (GI) Medical Oncology and Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. This clinical trial evaluates the potential of IM156 in combination with gemcitabine and nab-paclitaxel to address resistance and improve patient outcomes. The trial includes a dose escalation phase followed by an expansion phase, treating a total of approximately 25 patients with advanced pancreatic cancer. The primary endpoint is to evaluate the safety and tolerability of the combination. Exploratory efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) using RECIST v1.1 criteria. “Pancreatic cancer continues to be defined by high unmet need, morbidity, and mortality. 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. We are hopeful that this potentially 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 on clinicaltrials.gov using the identifier NCT05497778. ImmunoMet is also pleased to announce that it has received Orphan Drug Designation status for IM156 in patients with pancreatic cancer and closed a Series C-1 financing in October 2022. ImmunoMet continues to investigate additional indications where emerging data implicate OxPhos inhibition will demonstrate anti-tumor effects. About IM156 IM156 is a Protein Complex 1 (PC1) inhibitor that targets the oxidative phosphorylation (OXPHOS) pathway that is required to drive tumor growth and proliferation in some tumors. IM156, ImmunoMet’s lead drug candidate, is solely owned by ImmunoMet and is currently in development for the treatment of selected cancers. About ImmunoMet Therapeutics ImmunoMet is a clinical stage biotechnology company targeting metabolism for the treatment of selected cancers and fibrotic diseases. ImmunoMet’s lead molecule, IM156, is the first PC1 inhibitor to complete Phase 1 with good tolerability. In addition to IM156, ImmunoMet owns a large library of biguanides with the potential for development, internally or with partners, for multiple indications. The company was founded in 2015, is headquartered in JLABS @ TMC in Houston and has raised $34M to date. For more information about the company, please visit www.immunomet.com.