Panavance Updates Phase 1 Misetionamide Trial in Pancreatic Cancer at 2024 Congress

Panavance Therapeutics Inc., a clinical-stage pharmaceutical company focused on advancing oncology treatments, has revealed promising interim data from its ongoing Phase 1 clinical trial combining misetionamide (GP-2250) with gemcitabine. This announcement was made at the 2024 Visceral Medicine Congress held in Leipzig, Germany. The trial targets patients with advanced, unresectable, or metastatic pancreatic ductal adenocarcinoma (PDAC) who have already undergone a first-line 5FU-based treatment.

The open-label, single-arm, multicenter Phase 1 study is designed to determine the safety, tolerability, and preliminary efficacy of the combination therapy. So far, 49 patients have been recruited across 11 different cohorts. The safety profile of the combination has been very promising, showing no grade 3 or higher adverse events in the initial monotherapy phase. In the combination therapy phase with gemcitabine, five grade 3 events and ten grade 4 events were observed, with most side effects attributed to gemcitabine and only one possibly linked to misetionamide.

The interim results indicate that around 40% of the patients experienced either a partial response or stable disease, showcasing the potential effectiveness of the combination. Specifically, six patients showed partial tumor reduction, including one who remained in the study for 24 months. The combination therapy's progression-free survival rates are favorable when compared to historical data on gemcitabine alone.

Dr. Anup Kasi, an Associate Professor of Medical Oncology at the University of Kansas Cancer Center and the primary investigator for the trial, presented the findings. He emphasized the significant tumor regression and the positive safety and tolerability profile of the combination therapy. Dr. Kasi highlighted that the synergistic effects of misetionamide and gemcitabine could offer a new therapeutic option for pancreatic cancer patients.

Greg Bosch, Chairman and CEO of Panavance Therapeutics, expressed satisfaction with the interim data. He noted that the trial has reached dose levels where effectiveness was observed in preclinical models. The company aims to complete the Phase 1 study, which includes four US clinical trial sites, and plans to provide further updates in 2025.

Panavance Therapeutics, established in 2021 as a carve-out from the Swiss Geistlich Group, is dedicated to developing misetionamide, a novel oncology asset. Misetionamide is a small molecule with a unique mechanism of action that inhibits the oncogenic transcription factors c-MYC and NFκB. By targeting these factors, the drug disrupts cancer cell metabolism and inhibits proliferation, making it a selective agent against tumor cells.

The company is also planning to explore the potential of misetionamide in treating platinum-resistant ovarian cancer and as a first-line maintenance therapy for non-BRCA mutated pancreatic cancer patients. Preclinical studies have shown that the drug could be effective against various other cancer types, including melanoma, squamous cell carcinoma, breast cancer, and colorectal cancer.

Panavance Therapeutics continues to advance its clinical programs and aims to bring new treatment options to patients battling challenging cancers. The final results of the ongoing Phase 1 trial are expected in 2025, potentially paving the way for new therapeutic strategies in oncology.