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
News Market Reaction
On the day this news was published, AIM declined 7.47%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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
What is the DURIPANC clinical trial testing for AIM stock?
How many patients will be enrolled in AIM's Phase 2 pancreatic cancer trial?
What advantage does AIM's pancreatic cancer trial have regarding patient enrollment?
Will any Phase 1 patients continue into Phase 2 of AIM's DURIPANC trial?
What is the mechanism of action for AIM's combination therapy in pancreatic cancer?
