Panbela Announces New Patent for Eflornithine and Sulindac Combination in US and Canada

Panbela Therapeutics, Inc., a clinical-stage biopharmaceutical firm, has announced the issuance of a new US continuation patent (US 11,925,613 B2) and a Canadian patent (CA 3003149) for their fixed dose combination formulation of eflornithine and sulindac, known as Flynpovi. Developed in collaboration with Sanofi, Flynpovi is aimed at treating Familial Adenomatous Polyposis (FAP), and the patents are valid until 2036. The US and Canadian patents expand Panbela’s global intellectual property portfolio, joining previously issued patents in Australia, Mexico, Taiwan, and Chile. Applications are also under review in additional countries.

Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Panbela Therapeutics, expressed enthusiasm about the expanded patent protection, emphasizing the potential of Flynpovi as the first approved pharmacotherapy for FAP. She highlighted the benefits of co-formulating eflornithine and sulindac into a single tablet, which simplifies administration and compliance for patients.

Panbela’s developmental pipeline includes assets in various stages of clinical trials, focusing on multiple cancer types, including FAP, metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention, and ovarian cancer. These programs are strategically designed to produce a steady stream of anticipated clinical milestones.

One of Panbela’s lead products is Ivospemin (SBP-101), a proprietary polyamine analogue. Ivospemin is designed to inhibit polyamine metabolism, targeting pancreatic ductal adenocarcinoma and other tumors. Clinical studies have demonstrated promising results, with a median overall survival of 14.6 months and an objective response rate of 48% in metastatic pancreatic cancer patients. Importantly, Ivospemin did not exacerbate common chemotherapy-related adverse events such as bone marrow suppression and peripheral neuropathy. Despite this, serious visual adverse events have necessitated excluding patients with a history of retinopathy or those at risk of retinal detachment from future studies. The observed safety profile and efficacy support continued evaluation of Ivospemin in the ASPIRE trial.

Flynpovi combines eflornithine (CPP-1X) and sulindac, working through dual mechanisms to inhibit polyamine synthesis and increase polyamine export and catabolism. In a Phase III clinical trial for sporadic large bowel polyps, Flynpovi significantly reduced the occurrence of precancerous adenomas compared to placebo. In FAP patients with lower gastrointestinal tract involvement, Flynpovi showed a statistically significant advantage in delaying surgical interventions up to four years compared to single-agent treatments. The safety profile of Flynpovi was comparable to that of the single agents, supporting its continued evaluation for FAP.

CPP-1X is also being developed as a single-agent tablet or high-dose powder sachet for multiple indications, including gastric cancer prevention, neuroblastoma treatment, and recent-onset Type 1 diabetes. Early-phase clinical trials and preclinical studies suggest CPP-1X is well-tolerated and potentially effective.

Panbela Therapeutics remains committed to developing innovative therapeutics for urgent unmet medical needs. With lead assets Ivospemin and Flynpovi, the company continues to advance its diverse pipeline through various stages of clinical development. Panbela’s common stock is traded under the symbol “PBLA” on the OTCQB market.