AIM ImmunoTech’s reports positive Phase II for Ampligen + Imfinzi in pancreatic cancer

Edited by Robert McTiernan··2 min read

US-based AIM ImmunoTech announced positive interim results from its Phase II clinical trial evaluating a combination immunotherapy approach for metastatic pancreatic cancer. The DURIPANC study, a collaborative effort with AstraZeneca and Erasmus Medical Center, is exploring the potential of Ampligen (rintatolimod) combined with Imfinzi (durvalumab) to improve treatment outcomes for patients with pancreatic cancer who have stable disease following standard chemotherapy.

Trial specifics

The ongoing Phase II clinical trial, registered as NCT05927142, is designed to enroll up to 25 patients with metastatic pancreatic cancer. Currently, 18 patients have been enrolled in this investigator-initiated, open-label study. The primary objective focuses on assessing the clinical benefit rate of the combination therapy, with secondary endpoints including overall survival, progression-free survival, and quality of life measurements.

Lead investigator Dr. Marjolein Y. V. Homs from Erasmus MC emphasized that the study continues to show promising progression-free and overall survival results. Notably, the research team has observed no significant toxicity, particularly encouraging in a post-chemotherapy treatment setting.

Research context

Ampligen is a double-stranded RNA molecule that acts as a selective Toll-like receptor 3 (TLR3) agonist, designed to activate both innate and adaptive immune responses. When combined with durvalumab, an anti-PD-L1 immune checkpoint inhibitor, the approach aims to overcome the typically immunosuppressive environment of pancreatic tumors.

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Professor Casper van Eijck from Erasmus MC noted that the clinical team is observing immune system changes suggesting a coordinated activation of immune responses. “The combination of Ampligen and Durvalumab seems to be enhancing the body’s natural immune system,” he explained.

The pancreatic cancer treatment market remains challenging, with limited therapeutic options for metastatic patients. Key competitors in the immunotherapy space include:

  • Merck’s Keytruda (pembrolizumab)
  • PDS Biotechnology’s PDS0101 (TLR7/8 agonist)
  • Dynavax’s SD-101 (CpG oligonucleotide)

AIM ImmunoTech has positioned itself strategically, securing a U.S. patent for Ampligen as an oncology treatment in combination with anti-PD-L1 therapies, with protection extending to August 2039. The company has also received orphan drug designations from both the US and European Union, potentially providing years of market exclusivity.

The research team expects to publish detailed data later this year, with continued enrollment in the DURIPANC study. AIM ImmunoTech CEO Thomas K. Equels highlighted the significant unmet need, noting that pancreatic cancer claimed over 450,000 lives worldwide in 2022.