MINNEAPOLIS, May 22, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced it has entered into a clinical trial agreement with Moffitt Cancer Center for a Phase I/II program in STK11 mutant non-small cell lung cancer (NSCLC). The initial goal of the Phase I trial will be to ascertain the maximum tolerated dose of eflornithine, while evaluating efficacy and then moving into a Phase II efficacy trial. We anticipate data from the Phase I trial by the end of this year with a look to start the Phase II trial at the end of the year or early 2024.
“The relationship between polyamines and the immune system has been highlighted in peer-reviewed journals. This clinical trial with Moffitt seeks our first clinical proof of concept to evaluate the modulation of the immune system by polyamines in combination with standard of care cancer therapy,” said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. “The STK11 mutant NSCLC population has historically had a poor response to checkpoint inhibitor therapy. If the trial is successful, it opens the door for combining polyamine targeted therapies, such as eflornithine and ivospemin, with checkpoint inhibitors in other tumor types where response rates have been poor, or even improve upon reasonable response rates. It would also open the possibility of exploring combinations of eflornithine and ivospemin with other immunotherapies, such as CAR-T therapy.”
“There is a huge unmet need for new therapies for STK11 mutant non-small cell lung cancer patients, given their low survival rates. We know that STK11 mutant tumors have reduced levels of T cells that direct immune surveillance, and they can avoid immune detection. We are excited to partner with Panbela to determine if modulating polyamines can restimulate the immune system to target these hard-to-treat tumors.” said Jhanelle Gray, M.D., lead investigator of the trial, Chair of Moffitt’s Department of Thoracic Oncology and Co-Leader of Moffitt’s Molecular Medicine Program.
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 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.
Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase III 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 III 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), 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) is being developed as a single agent tablet or high dose powder sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase I or Phase II investigator-initiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.
Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. Panbela’s lead assets are Ivospemin (SBP-101) and Flynpovi. Further information can be found at www.panbela.com . Panbela’s common stock is listed on The Nasdaq Stock Market LLC under the symbol “PBLA”.
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Panbela Therapeutics, Inc.