AIM ImmunoTech & AstraZeneca's Ampligen-Imfinzi Combo Shows Promising Data in Pancreatic Cancer Trial (DURIPANC)
The landscape of medical innovation is constantly evolving, with dedicated researchers and pharmaceutical companies striving to tackle some of the most challenging diseases known to humankind. One such formidable adversary is pancreatic cancer, a condition often dubbed a "silent killer" due to its aggressive nature and typically late diagnosis. The urgent need for more effective treatments for this highly lethal disease is palpable, as it claims the lives of over 100,000 people annually in the American and European Union markets alone, and more than 500,000 worldwide. In this critical context, new research, such as that reported by GlobalData, offers a glimmer of hope, highlighting encouraging developments in combination therapies aimed at improving outcomes for patients battling metastatic pancreatic cancer.
At the heart of this promising research is AIM ImmunoTech, a company that has been diligently focusing on the development of Ampligen (rintatolimod) for pancreatic cancer treatment since 2017. Ampligen is a drug that has shown potential in various medical contexts. The current buzz surrounds its application in combination therapy. The DURIPANC trial, an exploratory, open-label, investigator-initiated, single-centre Phase II clinical trial, is evaluating Ampligen's effectiveness when used in conjunction with AstraZeneca's Imfinzi (durvalumab). This combination therapy is specifically targeting metastatic pancreatic cancer patients who have achieved stable disease after receiving prior treatment with Folfirinox.
The DURIPANC trial is a collaborative effort, stemming from a partnership between AIM ImmunoTech, AstraZeneca, and the Erasmus Medical Center (Erasmus MC) in the Netherlands. These clinical agreements were formalized in January 2023, signaling a concerted effort to advance the understanding and treatment of this aggressive cancer. The trial is designed to enroll up to 25 participants in its Phase II segment, and as of the mid-year report, 14 participants had already been enrolled.
The primary objective of the DURIPANC trial is to assess the clinical benefit rate of this combination therapy. This is a crucial measure that looks at how many patients experience a positive outcome, such as tumor shrinkage or stabilization, after receiving the treatment. Beyond this primary goal, the trial also has several secondary objectives that aim to provide a more comprehensive picture of the therapy's impact:
Evaluating Progression-Free Survival (PFS): This measures how long patients live without their disease getting worse.
Evaluating Overall Survival (OS): This tracks the total length of time patients live from a certain point, typically the start of treatment.
Commencing Immune-Monitoring: This involves utilizing tissue biopsies and peripheral immune profiling to understand how the combination therapy interacts with the body's immune system. This aspect is particularly vital for identifying potential "mechanistic insights or predictive biomarkers".
The early data emerging from the mid-year report of the DURIPANC trial has been described as "encouraging" and showing "promising early signs". Crucially, the trial has reported no significant toxicity, which suggests a favorable safety profile for the combination of Ampligen and Imfinzi. This is a vital piece of information in drug development, as a treatment's safety is as important as its efficacy, especially when dealing with patients who are already battling a severe illness.
Beyond safety, the early efficacy data also provides reasons for optimism:
Progression-Free Survival (PFS) greater than six months: Approximately 21% of subjects have experienced PFS longer than half a year. An additional 21% of subjects had not yet progressed, indicating that the disease was still stable or improving for them at the time of the report.
Overall Survival (OS) for more than six months: The majority of eligible subjects (64%) have seen OS extend beyond six months. These early indicators, while from a relatively small sample size, are significant in the context of metastatic pancreatic cancer, a disease notorious for its poor prognosis.
The potential impact of these findings is not lost on the researchers. Thomas Equels, the CEO of AIM ImmunoTech, expressed his hope that the ongoing immune-monitoring data analysis by Professor van Eijck and the team at Erasmus MC will indeed "identify additional mechanistic insights or predictive biomarkers". The identification of such biomarkers is critical because they can help predict which patients are most likely to respond to a particular treatment, allowing for more personalized and effective therapeutic strategies in the future. Equels views this as a "potentially groundbreaking clinical trial," bringing "hope for a future therapy for this highly lethal and clearly unmet medical need".
It's also worth noting AIM ImmunoTech's prior experience with Ampligen in pancreatic cancer treatment. Since 2017, the company has been dedicated to its development in this area. Before the current combination trial, Ampligen was used as a single agent (monotherapy) to treat more than 50 subjects under a Compassionate Use/early access programme. This program, approved by the Dutch government, was also conducted at Erasmus MC, with Professor van Eijck as the lead investigator. This earlier experience provides a foundation of understanding regarding Ampligen's use in pancreatic cancer patients and underscores the long-standing commitment to finding solutions for this disease.
While the focus of this report is on pancreatic cancer, AIM ImmunoTech is also involved in other clinical programs. For instance, in 2023, the company completed subject dosing in a Phase II trial of Ampligen for the treatment of post-Covid fatigue, demonstrating the drug's potential versatility across different medical conditions. This broader engagement highlights AIM ImmunoTech's commitment to exploring the full therapeutic range of Ampligen.
In conclusion, the data reported by GlobalData regarding the DURIPANC trial represents a significant step forward in the fight against metastatic pancreatic cancer. The combination therapy of Ampligen and Imfinzi has shown promising early signs, particularly concerning its favorable safety profile and initial indications of clinical benefit, progression-free survival, and overall survival. The collaborative efforts of AIM ImmunoTech, AstraZeneca, and Erasmus MC underscore the power of partnership in tackling complex medical challenges. While these are early results and the trial is ongoing, the hope that this research could lead to "additional mechanistic insights or predictive biomarkers" and ultimately provide a much-needed "future therapy" for this devastating disease remains strong. This ongoing research is a beacon of hope for patients and their families, signifying a continuous pursuit of innovative solutions for one of the most challenging unmet medical needs globally.
Pancreatic Cancer Researchers:
Dr. Janielle Maynard, Ph.D.: An assistant professor of Pathology and Oncology at Johns Hopkins University School of Medicine, Dr. Maynard received a 2022 PanCAN Career Development Award to study genetic and biological factors that may contribute to health disparities in pancreatic cancer. Her research focuses on analyzing the tumor microenvironment (the tissue surrounding the tumor) to understand potential differences between Black and White patients, according to the Pancreatic Cancer Action Network. Her ultimate goals include identifying biological and socioeconomic factors influencing disparities, improving patient outcomes and quality of life, and developing targeted diagnostic and treatment strategies.
Dr. Howard Crawford, Ph.D.: As the scientific director of the Henry Ford Health Pancreatic Cancer Center in Detroit, Dr. Crawford is a leading expert on the cell and molecular origins of pancreatic cancer. His research team is investigating whether genetic and cellular differences account for higher rates and poorer outcomes observed in Black patients. They are also studying molecular subtypes of pancreatic cancer to tailor treatment approaches. He and his team are conducting a retrospective study analyzing tumor samples from Black and non-Black patients to identify genomic and cellular differences potentially contributing to these disparities.
Dr. Jose G. Trevino, M.D.: Serving as the surgeon-in-chief at VCU Massey Cancer Center, Chair of Surgical Oncology at the VCU School of Medicine, and associate professor of Surgery, Dr. Trevino is a senior author of research on the underrepresentation of minority groups in pancreatic cancer clinical trials. His study highlighted the persistent lack of diversity in trials, noting the importance of inclusion for a comprehensive evaluation of treatment efficacy across a wider range of patients with varying genetic compositions, according to VCU Massey Comprehensive Cancer Center. He actively advocates for concrete steps to address the issues contributing to this lack of diversity
