AIM ImmunoTech Announces First Dose Level is Generally Well-Tolerated in Phase 1b/2 Study of Ampligen and Imfinzi as a Combination Therapy for Late-Stage Pancreatic Cancer

Rhea-AI Summary

AIM ImmunoTech Inc. announced positive results in testing Ampligen and Imfinzi in late-stage pancreatic cancer treatment. The combination was well-tolerated with no severe adverse events. The next safety cohort will start escalated dosing soon. Subjects will be monitored for response for up to 48 weeks.

Positive

• Combination of Ampligen and Imfinzi found to be generally well-tolerated with no severe adverse events.
• Safety evaluation completed for patients in the first dose level of the Phase 1b/2 study.

Negative

• None.

Insights

Oncology Doctor

The initial findings from the Phase 1b/2 study suggest a favorable safety profile for the Ampligen and Imfinzi combination therapy. This is encouraging, particularly for a condition as severe as late-stage pancreatic cancer where treatment options are often limited and come with significant side effects. The absence of severe adverse events in this early phase sets a positive tone for patient tolerance to the therapy. It is important to note that clinical efficacy is yet to be established; this will be critical in determining the potential of this combination therapy to improve survival and quality of life for patients.

Medical Research Analyst

The progression to higher doses without encountering dose-limiting toxicities indicates a robust safety protocol and suggests that researchers may be closer to finding an optimal therapeutic window. The use of RECIST 1.1 for monitoring response is standard practice and will provide a reliable benchmark for comparing the efficacy of this treatment with existing standards. As the study enters its next phase, the data on the efficacy and potential immune-related responses in a larger cohort will be pivotal in shaping the drug's trajectory and its future in the oncology market.

Market Research Analyst

From a market perspective, the collaboration between AIM ImmunoTech and AstraZeneca, leveraging Erasmus MC's research capabilities, demonstrates a strategic approach to drug development. The oncology sector, especially treatments for hard-to-treat cancers like pancreatic cancer, is highly competitive. Early positive safety results could generate investor optimism, but it's the long-term clinical outcomes and potential market penetration that will ultimately drive the stock's performance. The successful development of a new therapy could have significant market implications given the high unmet need in late-stage pancreatic cancer treatment.

Next safety cohort to begin escalated dosing soon

OCALA, Fla., April 29, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that it has taken an essential step forward in testing the combination of AIM’s Ampligen® (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer (the “DURIPANC” study). See: ClinicalTrials.gov NCT05927142.

Investigators at Erasmus Medical Center ("Erasmus MC") in the Netherlands have completed the safety evaluation of patients enrolled in the first dose level of the dose escalation design in the Phase 1b/2 study. The combination of Ampligen and Imfinzi was found to be generally well-tolerated with no severe adverse events (“SAE”) or dose-limiting toxicities (“DLT”).

Based on these positive results, escalation to the next dose will occur according to protocol design and AIM expects the next cohort of patients to begin dosing very soon. Subjects will be in treatment for up to 48 weeks, or until confirmed disease progression or another discontinuation criterion is met. They will be monitored for response according to Response Evaluation Criteria in Solid Tumors (“RECIST 1.1”).

Learn more about the clinical collaboration between AIM, AstraZeneca and Erasmus MC.

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. Publication of this data and clinical success seen to date does not guarantee that Ampligen will be approved for the commercial treatment of 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 study did AIM ImmunoTech announce positive results for?

AIM ImmunoTech announced positive results for the DURIPANC study, testing Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer.

What were the findings of the safety evaluation for the first dose level?

The combination of Ampligen and Imfinzi was found to be generally well-tolerated with no severe adverse events or dose-limiting toxicities.

How long will subjects be in treatment for in the study?

Subjects will be in treatment for up to 48 weeks, or until confirmed disease progression or another discontinuation criterion is met.

Where was the safety evaluation completed for patients enrolled in the study?

The safety evaluation was completed by investigators at Erasmus Medical Center in the Netherlands.

What criteria will subjects be monitored for response according to?

Subjects will be monitored for response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).