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First Patient Enrolled in Phase I Program in STK11 Mutant Non-Small Cell Lung Cancer at Moffitt Cancer Center
First Patient Enrolled in Phase I Program in STK11 Mutant Non-Small Cell Lung Cancer at Moffitt Cancer Center.
About this update from Panbela Therapeutics, Inc.
[{"type":"text","content":"\n MINNEAPOLIS, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced the first patient enrolled in a Phase I dose escalation study to evaluate CPP-1X-S (eflornithine sachets) in STK11 mutant non-small cell lung cancer (NSCLC). 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. The trial entitled “Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway- Deficient 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 https://clinicaltrials.gov/study/NCT06219174?term=DFMO&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 t...