On May 22, 2023 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported that 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) (Press release, Panbela Therapeutics, MAY 22, 2023, View Source;utm_medium=rss&utm_campaign=panbela-announces-clinical-trial-with-moffitt-cancer-center-for-phase-i-ii-program-in-stk11-mutant-non-small-cell-lung-cancer [SID1234631919]). 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.
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"The relationship between polyamines and the immune system has been highlighted in peerreviewed 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.