Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company, has just announced that it has regained the North American rights to develop and commercialize its promising drug, Flynpovi (the combination of CPP-1X (eflornithine) and sulindac), for the treatment of patients with familial adenomatous polyposis (FAP).
After the termination of the licensing agreement between Cancer Prevention Pharmaceuticals, Inc. (CPP) and One-Two Therapeutics Assets Limited, Panbela has made a major step forward in providing a much-needed treatment for those suffering from this serious condition.
Panbela is now primed to shape the future of medical treatments and bring life-changing breakthroughs to the world. With their expertise in the field of FAP and global registration trials, the team is uniquely positioned to present a high-quality trial protocol to the FDA and EMA for an agreed-upon registration pathway.
If done successfully, this could allow for the successful global launch of Flynpovi and a revolution in the treatment of FAP. It is a monumental task, but one that Panbela is more than capable of achieving.
The New England Journal of Medicine and Disease of the Colon and Rectum have recently published the highly encouraging results of the FAP-310 trial, demonstrating a 100% risk reduction in the need for surgery for FAP patients with intact lower gastrointestinal anatomy when treated with Flynpovi in comparison to CPP-1X or sulindac alone (Balaguer et al. 2022).
In light of these significant findings, the Company is now launching a new registration trial to further explore the potential of Flynpovi as a treatment option for FAP patients. With currently no approved drug therapies for this condition, the success of this trial could be a game-changer for FAP patients around the world.
Panbela is taking a bold step forward in its mission to unify the global registration process. With our Phase III results in hand, we are confident that the proposed registration study protocol we aim to secure approval from the FDA and EMA on will lead to a successful product approval. Our in-house expertise is ready to take on this challenge and make it happen in the short term.
Panbela is confident that the new FAP registration trial will provide a revolutionary, non-surgical treatment option to both physicians and FAP patients. By collaborating with the FDA, EMA and the FAP community, Panbela hopes to make this innovative program a reality and offer a revolutionary treatment option for FAP patients.
At Panbela Therapeutics, we are dedicated to providing disruptive therapeutics for critical unmet medical needs, and Flynpovi is no exception. We are thrilled to have regained the global rights to Flynpovi for patients with FAP, and we are confident that its potential to truly make a difference in the lives of FAP patients can be realized.
With our expertise in working with health authorities, our relationships with FAP experts, the positive results of the FAP-310 trial, and our commitment to FAP patients and their families, we are well-positioned to design and execute a successful registration trial that can make a difference on a global scale. We are determined to advance this program while maintaining our current cash burn, and exploring every opportunity to maximize the value of this asset.
About Panbela’s Pipeline
Our pipeline is currently in clinical trials with a focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. With a steady cadence of upcoming catalysts, our development programs span a wide range of stages, from pre-clinical to registration studies. We are excited to see what the future holds for our cutting-edge treatments and therapies.
Ivospemin, a proprietary polyamine analogue designed to inhibit polyamine metabolic activity, has shown promising results in clinical studies of metastatic pancreatic cancer patients. Results have demonstrated a median overall survival of 14.6 months and an objective response rate of 48%, both exceeding the typical outcomes of the standard of care gemcitabine + nab-paclitaxel regimen.
Furthermore, ivospemin has shown no exacerbation of bone marrow suppression or peripheral neuropathy, which are common chemotherapy-related side effects. While serious visual adverse events have been evaluated, patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety profile and polyamine metabolic inhibition of ivospemin observed in previous clinical trials offer further support for its evaluation in the ASPIRE trial.
The recent Phase 3 clinical trial comparing Flynpovi to single agent eflornithine and single agent sulindac revealed a remarkable outcome – FAP patients with lower GI anatomy showed statistically significant benefit compared to both single agents in delaying surgical events in the lower GI for up to four years.
Moreover, Flynpovi demonstrated a safety profile that did not significantly differ from the single agents, supporting the continued evaluation of this combination drug for FAP. Additionally, Flynpovi has already been proven to prevent > 90% subsequent pre-cancerous sporadic adenomas versus placebo in a Phase 3 clinical trial in patients with sporadic large bowel polyps. Thus, this combination drug has the potential to be a game-changer in the fight against FAP.
CPP-1X (eflornithine) is a promising single agent tablet or high dose powder sachet being studied for many potential uses. Preclinical and early clinical trials have shown that CPP-1X could be a safe and effective treatment for serious diseases such as gastric cancer, neuroblastoma, and Type 1 diabetes. With further research, CPP-1X may become a valuable therapeutic option for many patients.
Panbela Therapeutics, Inc. is a pioneering biopharmaceutical company dedicated to revolutionizing treatments for patients facing critical unmet medical needs. As the forefront of modern medicine, Panbela’s lead products are Ivospemin (SBP-101) and Flynpovi, which have the potential to vastly improve patient outcomes.