On October 31, 2023 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical-stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported validation for the European patent 2019213664 titled "METHODS FOR PRODUCING (6S,15S)-3,8,13,18-TETRAAZAICOSANE-6,15-DIOL" in the United Kingdom, Italy, Germany, France, and Spain (Press release, Panbela Therapeutics, OCT 31, 2023, View Source;utm_medium=rss&utm_campaign=panbela-announces-validation-of-european-patent-for-claims-of-a-novel-process-for-the-production-of-sbp-101 [SID1234636548]). This patent, developed in collaboration with Syngene International Ltd., an integrated research, development, and manufacturing services company, claims a novel process with a reduced number of synthetic steps from seventeen to six to produce SBP-101, a lead investigational product. The patent is valid until 2039.

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Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela Therapeutics, commented, "We’re excited to have this European patent now validated in individual countries." First issued in the United States in 2021 and now in several other territories, this patent covers a shorter synthesis of SBP-101, which provides many benefits including a scalable, efficient and cost-effective manufacturing process to enable future commercialization. Jonathan Hunt, Managing Director and Chief Executive Officer, Syngene International Ltd., said, "Our partnership with Panbela exemplifies Syngene’s commitment to fostering innovation and collaboration in the pharmaceutical industry. Reducing the manufacturing steps of SBP-101 from seventeen to just six not only accelerates the delivery of this promising drug to patients but also underscores Syngene’s dedication to improving efficiency. This patent validation in certain European countries is a testament to our combined expertise and commitment to improving patient outcomes.

We are proud to stand alongside Panbela as we continue to push the boundaries of pharmaceutical innovation." Dr. Simpson added, "We are pleased with the continued growth of our patent portfolio with the validation in several European countries. With a pharmaceutical starting material that is more widely available and a process that is effective and scalable, this ensures a stable drug supply for current clinical trials and future endeavors."

About our 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, ovarian cancer and diabetes. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.

SBP-101 Ivospemin

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. For more information, please visit View Source

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X Eflornithine

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.