Misetionamide-gemcitabine combination demonstrates very good safety profile and potential therapeutic benefit in the challenging treatment of pancreatic adenocarcinoma

Interim results show ~40% of patients achieved either a partial response or stable disease

Ongoing Phase 1 dose-selection study with final results expected in 2025

BERWYN, PA, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Panavance Therapeutics Inc. (“Panavance” or the “Company”), a clinical-stage pharmaceutical company advancing the development of a novel oncology therapeutic intended to improve the outcomes and quality of life for patients, today announced the presentation of interim data from its Phase 1 clinical study evaluating misetionamide (GP-2250) in combination with gemcitabine at the 2024 Visceral Medicine Congress in Leipzig, Germany.

This open label, single arm, multicenter Phase 1 dose escalation clinical trial is enrolling patients with advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) as a second line therapy for patients who have previously received a first line 5FU containing regimen (e.g. FOLFIRINOX/NALIRIFOX). The study is underway, and this interim data presented includes 49 patients across 11 cohorts. Goals are to establish safety, tolerability, and preliminary efficacy. The safety profile to date has shown zero grade ≥3 adverse events in an initial monotherapy treatment. During the combination therapy with gemcitabine, a total of 5 grade 3 events, and a total of 10 grade 4 events have been observed with all definitely attributed to gemcitabine, and one possibly attributed to misetionamide.

The progression free survival of patients treated with the misetionamide-gemcitabine combination compares favorably to historical comparison to gemcitabine alone. There have been 6 partial responders (>30% tumor reduction) thus far including one partial response patient who remained on study 24 months.

Anup Kasi, MD, MPH, Associate Professor, Medical Oncology, University of Kansas Cancer Center and primary investigator for the ongoing Phase 1 clinical trial, presented an update at the conference on the clinical trial data to date. “Based on the synergistic effects of misetionamide in combination with gemcitabine, with approximately 40% of patients achieving either a partial response or stable disease, and the degree of tumor regression by this drug combination, compares favorably to historical results with gemcitabine alone. Data from this interim update of the ongoing trial, including initial efficacy together with a very acceptable safety and tolerability profile, support the promise of the misetionamide-gemcitabine combination as a potential new option for the treatment of pancreatic cancer patients,” said Dr. Kasi.

“We are pleased to share, for the first time, an interim look at the data from our ongoing Phase 1 dose escalation study. The trial is now at cohorts where the dose levels are in the range (on a mg/kg basis) where effectiveness was observed in the preclinical models. We continue to focus on completing the Phase 1 study with 4 US clinical trial sites and look forward to providing further clinical data updates in 2025,” said Greg Bosch, Chairman and CEO.

About Panavance Therapeutics
Panavance Therapeutics Inc. is a privately held, clinical-stage pharmaceutical company developing a novel oncology asset, misetionamide (GP-2250). Panavance was formed in 2021 as a US-based, wholly owned carve out of Geistlich group, a family-owned Swiss company, to focus on misetionamide and the oncology business.

Misetionamide is a broadly active small molecule with a unique mechanism of action that inhibits two oncogenic transcription factors, c-MYC and NFκB. Acting through c-MYC, misetionamide selectively disrupts the energy metabolism of cancer cells leading to cancer cell death. Through NFκB inhibition, misetionamide inhibits cancer cells’ ability to proliferate and survive. This mechanism makes misetionamide an attractive tumor cell selective agent.

The Company plans to initiate a clinical trial of misetionamide for the treatment of platinum-resistant ovarian cancer and a clinical trial as a first-line maintenance therapy for non-BRCA mutated pancreatic cancer patients. Extensive preclinical studies have demonstrated that misetionamide’s broadly anti-neoplastic MOA has the potential to be effective in additional tumor types, including melanoma, squamous cell, breast, and colorectal cancers.

For more information, please visit panavance.com and connect with the Company on Twitter, LinkedIn, and Facebook.

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