An Insider View of PICI’s Pancreatic Clinical Trial PRINCE

PICI takes on cancers of high need. Cancers that are difficult to treat and unresponsive to immunotherapy and other treatments. Pancreatic cancer is currently the third deadliest cancer in the nation, with only an 8.5% survival rate five years after diagnosis. These statistics don’t intimidate us. They compel us.

That’s why we’re tackling pancreatic cancer with our PRINCE clinical trial. At AACR this year, we presented results from our Phase 1b trial that combined immunotherapy with chemotherapy. The regimen showed early promise, shrinking tumors in the majority of patients—20 out of 24—in our interim analysis of the trial.

To continue this conversation, we’ve asked two experts from the trial to tell us more. Here’s what they had to share:

Q: What is unique about the PRINCE trial?

Jaclyn Lyman, MSc, Clinical Scientist: PRINCE was PICI’s first clinical trial where we executed entirely using our resources. We built everything from the ground up, and these are some notable qualities.

a.  Bold Action – The typical clinical trial does not often move quickly or efficiently enough for patients, so we took matters in-house. PRINCE is the first PICI-managed trial. Beyond overseeing regulatory and logistical aspects, we centralized our clinical and molecular analyses to learn more about pancreatic cancer and the immune response in real-time. Building these capabilities resulted in paving a more efficient path for clinical trials, shattering silos and timelines along the way.

b.  Collaboration – The trial’s overall principal investigator and PICI scientist Robert Vonderheide, MD, DPhil, from the University of Pennsylvania, had studied the trial’s novel antibody for years. To get the trial off the ground, PICI convened a group of experts from various disciplines across academia, nonprofit and industry. With the right partners in place—including Cancer Research Institute, Bristol-Myers Squibb and Apexigen—we launched the clinical trial Dr. Vonderheide had wanted to do for a decade. The results speak for themselves.

c.  Speed – Collaborations with academic and industry partners enabled us to launch the trial faster and bypass barriers typically faced in academic environments. We assembled key industry partners, our in-house team and established a centralized institutional review board. This enabled us to treat our first patient within four months of receiving the green light from the FDA. Our dedicated collaborators also helped successfully transition the trial to Phase 2 within one year and complete enrollment in under two years.

Q: Now that we’ve seen promising results from the Phase I study, what’s next?

Christopher Cabanski, PhD, Director of Biostatistics: The Phase 1 results are very exciting.

So far, we’ve tested this treatment regimen in 30 patients and want to ensure these results can be replicated in a larger set of patients.

To do this, we are enrolling 100 additional patients. We’ll follow all of the patients for at least one year, with the goal of demonstrating that patients on this treatment live longer than taking chemo alone.

In addition, we plan to analyze molecular data from blood and tumor samples of patients to help determine which patients are most likely to benefit from this therapy. We also want to gather insights into the biology of the patients who do not respond to inform new ideas for therapies to test.

Jaclyn Lyman: The PRINCE team is eager to continue using our clinical and biomarker data to inform next steps of PICI’s expanding pancreatic cancer program. We will build off the promising results of PRINCE to develop new, science-driven approaches and combat this deadly disease.

Learn more about the PRINCE trial here.