First Patient Enrolled in Phase I Program in STK11 Mutant Non-Small Cell Lung Cancer at Moffitt Cancer Center

Panbela Therapeutics, Inc., formerly Sun Biopharma, a UF startup and a clinical-stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, 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 the 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.

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