On September 24, 2024 Panbela Therapeutics, Inc. (OTCQB: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported the first patient enrolled in a Phase I dose escalation study to evaluate CPP-1X-S (eflornithine sachets) in STK11 mutant nonsmall cell lung cancer (NSCLC) (Press release, Panbela Therapeutics, SEP 24, 2024, View Source;utm_medium=rss&utm_campaign=first-patient-enrolled-in-phase-i-program-in-stk11-mutant-non-small-cell-lung-cancer-at-moffitt-cancer-center [SID1234646842]). The initial goal of the Phase I trial will be to determine the maximum tolerated dose of eflornithine in combination with the immune checkpoint inhibitor Keytruda, while evaluating efficacy and then moving into a Phase II efficacy trial. Data from the Phase I trial is expected by mid-2025, with a look to start the Phase II trial in 2024.
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The trial entitled "Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) PathwayDeficient NSCLC" is a Phase I/II trial where Phase I is a dose escalation study establishing the safety, toxicity and recommended Phase II dose of CPP-1X-S in combination with Keytruda in patients with STK11 mutant NSCLC at approximately one academic medical center in the United States. Detailed information on the trial can be located at View Source;rank=4.
"Options for combining new agents with standard of care immunotherapy is critical to overcoming the reduced levels of anti-tumor T cells and immune evasion that is observed in STK11 mutant tumors," said Jhanelle Gray, M.D., Principal Investigator of the clinical trial, Chair of Moffitt’s Department of Thoracic Oncology and Co-Leader of Moffitt’s Molecular Medicine Program. "By working with Panbela, we are using CPP-1X-S to modulate polyamine levels and potentially restimulate the immune system, which may be a valuable therapeutic strategy to target these hard-to-treat tumors."
"With the recent approval of CPP-1X (DFMO) for neuroblastoma, the first oncology approval for a polyamine targeted therapy, we’re really excited to have the first patient enrolled in the Phase I trial for CPP-1X-S led by Moffitt Cancer Center," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "Preclinical studies have shown that polyamine modulation has the potential to restimulate the immune system. This trial allows us to explore the potential of CPP-1X-S clinically in the STK11 mutant NSCLC population which historically have a poor response to checkpoint inhibitor therapy. Once the safety of CPP-1X-S in combination with Keytruda is established in this Phase I trial, the planned Phase II trial will determine the potential efficacy of combining polyamine targeted therapies with checkpoint inhibitors hopefully demonstrating the first clinical proof of concept of this unique approach. In addition to the possibility of providing a better treatment option for this patient population, we are excited to evaluate the role of eflornithine and ivospemin as modulators of the immune system in combination with other immunotherapies such as CAR-T therapy for tumors where response rates have been low with immunotherapy."