AIM ImmunoTech Announces First Subject Dosed in the Netherlands for Phase 1b/2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi (durvalumab) for the Treatment of Pancreatic Cancer

Rhea-AI Summary

AIM ImmunoTech Inc. announced the dosing of the first subject in a Phase 1b/2 clinical trial combining Ampligen with Imfinzi for late-stage pancreatic cancer treatment. The study is expected to be completed within six months.

Oncology Doctor

The commencement of the Phase 1b/2 clinical trial involving the combination of Ampligen and Imfinzi for treating late-stage pancreatic cancer represents a significant step in oncology therapeutics. Pancreatic cancer, known for its poor prognosis and limited treatment options, necessitates the exploration of novel therapies. This trial's primary focus on the safety of the combination therapy is crucial, as the synergy between a TLR-3 agonist and an anti-PD-L1 immune checkpoint inhibitor could potentially modulate the immune system to recognize and combat cancer cells more effectively. Given the aggressive nature of metastatic pancreatic ductal adenocarcinoma, the trial's progression to a Phase 2 study to assess the clinical benefit rate will be of high interest to the medical community. The outcome of this trial could influence future treatment protocols and provide a new avenue of hope for patients.

Medical Research Analyst

Analyzing the strategic collaboration between AIM ImmunoTech and AstraZeneca from a research development perspective, it is evident that the integration of Ampligen with an established therapy like Imfinzi could potentially enhance treatment efficacy. The trial's design, focusing on an exploratory, open-label approach, allows for real-time observation of drug interactions and patient responses. This could accelerate the understanding of the combination's therapeutic potential. The six-month timeline for completing the Phase 1b portion indicates a swift and focused effort, which is essential in a field where time is of the essence. If successful, this could lead to expedited development and, eventually, commercialization, impacting both companies' pipelines and valuation.

Market Research Analyst

From a market perspective, the initiation of a clinical trial assessing the combination of Ampligen and Imfinzi in late-stage pancreatic cancer patients may influence investor sentiment towards AIM ImmunoTech. The collaboration with AstraZeneca and the use of an established drug like Imfinzi lend credibility to the trial. The successful demonstration of safety and subsequent clinical benefit could position AIM as a strong player in the oncology segment, potentially affecting its stock performance. Investors will be closely monitoring the trial's progress, as positive results could lead to significant market opportunities for AIM ImmunoTech. Furthermore, the focus on an aggressive cancer subtype like metastatic pancreatic ductal adenocarcinoma highlights the company's commitment to addressing unmet medical needs, which could resonate positively with stakeholders.

Phase 1b portion of the study expected to be completed within six months

OCALA, Fla., Feb. 14, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the first subject has been dosed at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen® (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer (the “DURIPANC Study”).

The DURIPANC Study is an investigator-initiated, exploratory, open-label, single-center study with the full name “Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy efficacy.” The primary objective of the Phase 1b portion is to determine the safety of combination therapy with Imfinzi and Ampligen. The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination therapy.

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC, commented, “We are working in earnest toward meeting our expected completion of the Phase 1b portion of the study within six months. We continue to be excited about the promise of combining Ampligen with durvalumab and we believe this synergistic approach could make a positive impact on tumor regression and patient survival — potentially changing the treatment landscape for patients with metastatic pancreatic cancer.”

The study is expected to enroll up to 18 subjects in its Phase 1b portion and up to 25 subjects in its Phase 2 portion. Subjects will start with Ampligen 200 mg via IV infusion twice per week for a total of 6 weeks (12 doses). Ampligen dose will be escalated to 400 mg according to a 3+3 DLT design. The first dose of Ampligen will be administered preferably 4-6 weeks after the last chemotherapy FOLFIRINOX dose. After two doses of Ampligen, the first dose of durvalumab 1500 mg via IV infusion will be introduced in week 2. Patients will continue to receive 1500 mg durvalumab via IV infusion every 4 weeks for up to a maximum of 48 weeks (up to 12 doses/cycles) with the last administration on week 48 or until confirmed disease progression according to Response Evaluation Criteria in solid Tumors (RECIST 1.1), unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

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 Twitter, 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. 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 (the “SEC”). 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.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7d75460a-1edc-458d-a4ca-7ff0797cb8d8

What is the name of the clinical trial combining Ampligen and Imfinzi for late-stage pancreatic cancer treatment?

The clinical trial is named the DURIPANC Study.

What is the primary objective of the Phase 1b portion of the study?

The primary objective is to determine the safety of combination therapy with Imfinzi and Ampligen.

Who commented on the progress of the study at Erasmus MC?

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC, commented on the study progress.

When is the Phase 1b portion of the study expected to be completed?

The Phase 1b portion of the study is expected to be completed within six months.