Moffitt Cancer Center Launches Pioneering Clinical Trial For STK11 Mutant Lung Cancer Treatment

Panbela Therapeutics Inc. (Nasdaq: PBLA) is thrilled to announce it has taken a bold step forward in treating patients with STK11 mutant non-small cell lung cancer (NSCLC). The company has entered into an ambitious clinical trial agreement with H. Lee Moffitt Cancer Center & Research Institute, with the goal of finding the maximum tolerated dose of eflornithine that can be used to treat the condition.

Encouragingly, data from the Phase I trial is expected by year’s end, with the potential to start the Phase II efficacy trial at the tail-end of the year or early 2024. This marks a welcome development in the quest to provide positive outcomes and hope for those affected by this rarefied form of cancer.

Panbela is working to revolutionize cancer treatment with its clinical trial conducted in collaboration with the Moffitt Cancer Center. This trial aims to test the efficacy of combining polyamines such as eflornithine and ivospemin with standard of care cancer therapy to modulate the immune system in STK11 mutant NSCLC patients, who have historically experienced poor responses to checkpoint inhibitor therapy.

If successful, this combination treatment can greatly improve the responsiveness of this population and potentially pave the way for similar combinations with other immunotherapies, such as CAR-T therapy.

At Moffitt Cancer Center, we are enthusiastic about joining forces with Panbela to explore a promising new therapy for patients with STK11 mutant non-small cell lung cancer. With current treatment options having low survival rates, it is critical that we investigate methods to reinvigorate the immune system to attack these hard-to-treat tumors.

We believe that modulating polyamines may be an effective way to achieve this, as STK11 mutant tumors typically have reduced T cell numbers that leave them open to escaping immune detection. Together, we are determined to make a difference for these patients and are optimistic about the possibility of this novel approach.

About Panbela’s Pipeline

Our pipeline is stacked with cutting-edge assets currently in clinical trials, focused to begin with on Familial Adenomatous Polyposis (FAP). We are also actively working on treatments for first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, and both colorectal cancer prevention and ovarian cancer. With a variety of studies underway, from pre-clinical to registration discussions, we have a jam-packed schedule of anticipated catalysts for success.

Ivospemin (SBP-101)

Ivospemin is an exciting proprietary polyamine analogue that is showing great potential in the treatment of pancreatic cancer. Clinical studies show it has a median overall survival rate of 14.6 months and an impressive objective response rate of 48%. Unlike other standard chemotherapies, it does not worsen bone marrow suppression, peripheral neuropathy, or serious visual adverse events. Studies are continuing on its potential in the ASPIRE trial, exhibiting its powerful ability to fight pancreatic cancer and giving us more insight into the future of cancer treatments.


Flynpovi, the innovative combination of CPP-1X (eflornithine) and sulindac, has been proven to be a powerful inhibitor of pre-cancerous sporadic adenomas in Phase III Clinical trial. The recent Phase III trial investigating FAP patients with lower GI anatomy, comparing Flynpovi to single agents, revealed statistically significant delay in surgical events of up to four years in comparison to single agents. What’s even more remarkable is Flynpovi’s safety profile which is on-par with the single agents, enabling the continued evaluation of Flynpovi among FAP patients.


CPP-1X (eflornithine) is a promising treatment for a variety of conditions, ranging from the prevention of gastric cancer to the treatment of neuroblastoma and Type 1 diabetes. Based on preclinical studies and initial trials, CPP-1X has been found to be well-tolerated and has the potential to provide significant clinical benefits. As such, it has been developed into a single agent tablet or high dose powder sachet for convenient administration.

About Panbela

Panbela Therapeutics, Inc. is a pioneering biopharmaceutical company on the cutting-edge of medical science, seeking to revolutionize healthcare with disruptive therapeutics for patients with urgent, unmet needs. Ivospemin (SBP-101) and Flynpovi, Panbela’s flagship products, are spearheading this innovative frontier of medicine, and the company’s common stock is listed on The Nasdaq Stock Market LLC under the symbol “PBLA”.

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