Panbela Announces Issuance of New Patent in the US and Canada; Patent is for Claims of a Fixed Dose Combination of Eflornithine and Sulindac

Developed in collaboration with Sanofi.

MINNEAPOLIS, May 06, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: PBLA), a clinical-stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, today announced an Issue Notification for the US continuation patent US 11,925,613 B2 and Canadian patent CA 3003149 titled “EFLORNITHINE AND SULINDAC, A FIXED DOSE COMBINATION FORMULATION”. These patents claim a novel composition of a fixed dose combination of eflornithine and sulindac, which is called Flynpovi. The product was developed in collaboration with Sanofi, an innovative global healthcare company. Flynpovi is Panbela’s lead investigational product for the treatment of patients with Familial Adenomatous Polyposis (FAP). The patents are valid until 2036, have issued in the US, Australia, Mexico, Taiwan, and Chile. The application is under review in additional countries.

Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela Therapeutics, commented, “We’re excited to have this patent in Canada as well as the continuation in the US. Expansion of our patent portfolio further supports our global clinical programs. First issued in the United States in 2021 and now in several other territories, this patent covers the novel co-formulation of Flynpovi, our lead FAP product in development."

Dr. Simpson added, “We are pleased with the continued growth of our patent portfolio with this latest patent issuance. The co-formulated product described in this patent has the potential to be the first pharmacotherapy approved for patients with FAP. By co-formulating eflornithine and sulindac in the same tablet, it provided FAP patients with an easier option for administration and compliance.”

About Panbela’s Pipeline
The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of anticipated catalysts with programs ranging from pre-clinical to registration studies.

Ivospemin (SBP-101)
Ivospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the previous Panbela-sponsored clinical trials provide support for continued evaluation of ivospemin in the ASPIRE trial.