AIM Doses First New Subject in Phase 2 Study of Ampligen and Imfinzi as a Potential Combination Therapy for Late-Stage Pancreatic Cancer
Rhea-AI Summary
AIM ImmunoTech (NYSE American: AIM) has dosed the first new subject in Phase 2 of their Phase 1b/2 clinical trial studying the combination of Ampligen (rintatolimod) and AstraZeneca's Imfinzi (durvalumab) for treating late-stage pancreatic cancer. The trial, known as DURIPANC, is being conducted at the Erasmus Medical Center in the Netherlands.
Several subjects from Phase 1 who received the highest dose will also be included in Phase 2. The investigator-initiated, exploratory, open-label, single-center study expects to enroll up to 25 patients in the Phase 2 portion.
AIM CEO Thomas K. Equels expressed confidence in steady enrollment, noting that unlike many pancreatic cancer studies where accrual can be challenging, they expect consistent patient recruitment for this trial combining the TLR-3 agonist rintatolimod with the anti-PD-L1 immune checkpoint inhibitor durvalumab.
Positive
- First new subject dosed in Phase 2 of pancreatic cancer trial
- Partnership with AstraZeneca for combination therapy
- CEO expects steady patient enrollment unlike typical pancreatic cancer trials
- Phase 2 will include high-dose responders from Phase 1
Negative
- Still in early/mid-stage clinical trials with no efficacy data reported
- Pancreatic cancer is known for poor treatment outcomes
- No mention of preliminary results from Phase 1
Insights
AIM ImmunoTech has reached a significant clinical milestone with the dosing of its first new subject in Phase 2 of the DURIPANC trial, testing Ampligen in combination with AstraZeneca's Imfinzi for late-stage pancreatic cancer. For a micro-cap biotech with a market capitalization of just $9.3 million, this advancement represents a important validation point that could substantially impact the company's valuation trajectory.
The transition from Phase 1 to Phase 2 is particularly noteworthy in pancreatic cancer—a notoriously difficult indication with a dismal 5-year survival rate below 10%. What's especially encouraging is the inclusion of several Phase 1 subjects who received the highest dose, suggesting preliminary safety and potentially efficacy signals that warranted their continuation in the program.
From a mechanistic perspective, this combination leverages a dual immunotherapeutic approach: Ampligen activates TLR-3 receptors to stimulate innate immunity within the tumor microenvironment, while Imfinzi prevents cancer cells from evading immune detection by blocking PD-L1. This complementary mechanism tackles pancreatic cancer's immunosuppressive environment from multiple angles—a strategy that could potentially overcome the resistance that has plagued single-agent immunotherapies in this indication.
The CEO's confidence in steady enrollment rates shouldn't be overlooked. In the clinical development economics, faster enrollment translates directly to accelerated timelines and reduced cash burn—critical factors for a company with resources. The pancreatic cancer treatment market, valued at approximately $2.5 billion globally, represents a substantial commercial opportunity despite being considered a smaller oncology indication.
While this news demonstrates promising progress, investors should recognize that Phase 2 results likely remain at least 12-18 months away, and the path to market would still require a successful Phase 3 program. Additionally, the investigator-initiated nature of the study means AstraZeneca's level of commitment to the combination remains to be fully determined.
This advancement also positions AIM to potentially expand Ampligen's applications across multiple cancer indications through similar immunotherapy combinations, creating a pipeline-in-a-product strategy that could multiply the asset's value beyond this single indication.
Several subjects who received the highest dose in Phase 1 will also be included in Phase 2
OCALA, Fla., Feb. 25, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the first new subject has been dosed in Phase 2 of the Phase 1b/2 clinical trial involving AIM’s Ampligen (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer (“DURIPANC”). Several subjects from Phase 1 who received the highest dose will also be included in Phase 2.
DURIPANC is an investigator-initiated, exploratory, open-label, single-center study in the Netherlands at the Erasmus Medical Center. Up to 25 patients are expected to be enrolled in the Phase 2 portion of DURIPANC.
AIM CEO Thomas K. Equels stated: “Unlike with many pancreatic cancer studies where accrual can be a major obstacle, we expect to continue to enroll subjects in Phase 2 of DURIPANC at a steady pace.”
Read more at about DURIPANC at ClinicalTrials.gov NCT05927142 – “Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy efficacy (DURIPANC)“
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.
For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.
Cautionary Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy for pancreatic cancer. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
FAQ
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