Rintatolimod Plus Durvalumab Shows Encouraging Early Outcomes in Metastatic Pancreatic Cancer

Preliminary mid-year safety and efficacy data from the ongoing phase 2 DURIPANC clinical study (NCT05927142) evaluating rintatolimod (Ampligen) in combination with the anti–PD-L1 immune checkpoint inhibitor durvalumab (Imfinzi) for the treatment of metastatic pancreatic cancer patients post FOLFIRINOX chemotherapy have demonstrated encouraging early signs of both a favorable safety profile and superior progression-free survival (PFS) and overall survival (OS).^1,2

These findings, reported by AIM ImmunoTech Inc in collaboration with AstraZeneca and Erasmus Medical Center in the Netherlands, suggest a potential advancement in a disease setting historically challenging for therapeutic intervention.

The DURIPANC study, an investigator-initiated, exploratory, open-label, single-center trial, aims to enroll up to 25 patients in its phase 2 portion. As of the mid-year report, 14 patients have been enrolled. The primary objective of the study is to assess the clinical benefit rate of the combination therapy, with secondary and exploratory objectives including the evaluation of OS, PFS, and the initiation of immune monitoring using tissue biopsies and peripheral immune profiling.

Regarding safety, the combination therapy has demonstrated no significant toxicity, indicating an encouraging safety profile for patients in a post-chemotherapy setting. This is a crucial aspect for a patient population often debilitated by prior intensive treatments.

Approximately 21% of patients (n = 3/14) have achieved PFS exceeding 6 months, with an additional 21% yet to experience disease progression. This early indication of prolonged disease control is noteworthy in metastatic pancreatic cancer, where rapid progression is common. Further, 64% have achieved OS greater than 6 months. This early survival data is considered better than expected in this aggressive disease setting, offering a glimmer of hope for improved patient outcomes.

Pancreatic cancer is notoriously difficult to treat, with limited responsiveness to immunotherapy, particularly in unselected patient populations. Following initial FOLFIRINOX chemotherapy, maintenance or second-line immunotherapies have historically offered only limited survival benefits in comparative trials. Against this backdrop, the DURIPANC study’s preliminary data offers a promising outlook.

"Our preliminary data suggests that the combination of [rintatolimod] and durvalumab is well tolerated in post-FOLFIRINOX pancreatic cancer patients, with encouraging preliminary survival data, especially given the historical difficulty of improving outcomes in this setting,” said Casper van Eijck, MD, PhD, of Erasmus Medical Center, in a press release.

AIM ImmunoTech’s focus on pancreatic cancer treatment with rintatolimod spans several years. Since 2017, over 50 patients with pancreatic cancer have received rintatolimod as an immuno-oncology monotherapy under a Dutch government-approved Compassionate Use/Early Access Program at Erasmus Medical Center, with van Eijck as the lead investigator. This program generated detailed analyses in various abstracts and peer-reviewed medical research publications, suggesting rintatolimod’s potential effectiveness as a monotherapy.

These earlier positive results laid the groundwork for the DURIPANC study, which was initiated in January 2023 through clinical agreements between AIM, AstraZeneca, and Erasmus Medical Center. The combination therapy aims to leverage the innate immune activation properties of rintatolimod with the checkpoint inhibition provided by durvalumab. Furthermore, AIM has secured intellectual property protection specific to pancreatic cancer, including a recently issued US patent for rintatolimod as an oncology treatment in combination with an anti–PD-L1 agent, extending protection to August 9, 2039. The company also holds orphan drug designations for rintatolimod in pancreatic cancer in both the US and the European Union, which could grant years of market exclusivity post commercial approval.

REFERENCES:

1. AIM ImmunoTech Reports Positive Mid-year Safety and Efficacy Data from Phase 2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer. News release. AIM ImmunoTech. July 28, 2025. Accessed July 29, 2025. https://tinyurl.com/yn6dy64n

2. DURIPANC, Mid-Year Interim Clinical Progress Update. AIM ImmunoTech. Accessed July 29, 2025. https://tinyurl.com/4e8pys5p