AIM ImmunoTech Announces that the First Subject is Enrolled in the Phase 1b/2 Study Evaluating Ampligen® in Combination with AstraZeneca’s Imfinzi® for the Treatment of Late-Stage Pancreatic Cancer
AIM ImmunoTech Inc. announced the enrollment of the first subject in a Phase 1b/2 clinical trial combining Ampligen with AstraZeneca’s Imfinzi for late-stage pancreatic cancer treatment. Positive clinical data could make AIM an attractive buyout target. AIM secured a U.S. patent for Ampligen's use in combination therapy. The trial aims to determine safety and clinical benefit rates of the combination therapy.
The initiation of the DURIPANC Study at Erasmus Medical Center marks a significant step in the exploration of combination therapies for late-stage pancreatic cancer. Pancreatic cancer is notoriously difficult to treat, with low survival rates and advancements in this area could lead to substantial improvements in patient outcomes. The combination of Ampligen, a TLR-3 agonist and Imfinzi, an anti-PD-L1 immune checkpoint inhibitor, targets the immune system's ability to fight cancer. Ampligen's potential to reduce T cell exhaustion could be pivotal, as it may enhance the body's immune response against tumor cells, while Imfinzi works to inhibit a mechanism that cancer cells use to evade the immune system.
From a clinical perspective, the study's design, which includes a safety evaluation followed by an assessment of the clinical benefit rate, is standard for Phase 1b/2 trials. The dose-escalation approach and the use of RECIST 1.1 criteria for measuring disease progression are also in line with current oncological practices. The potential of this combination therapy to extend progression-free survival or even achieve a cure would be a breakthrough in a field where treatment options are limited and often palliative in nature.
The strategic collaboration between AIM ImmunoTech and AstraZeneca to investigate Ampligen's synergistic effects with Imfinzi underscores the growing interest in immunotherapy combination treatments. The immunotherapy landscape is rapidly evolving and Ampligen's U.S. patent for use in combination with an anti-PD-L1 antibody may position AIM as a key player in this space. From a research standpoint, the study's outcomes could validate the therapeutic synergy suggested by preclinical data, potentially leading to broader applications of Ampligen in combination with other checkpoint inhibitors.
The DURIPANC Study's focus on metastatic pancreatic ductal adenocarcinoma, a common and aggressive form of pancreatic cancer, means that positive results could have substantial implications for the standard of care in this disease. The study's enrollment numbers are modest, which is typical for early-phase trials, but sufficient to provide initial safety data and potentially signal efficacy. Investors and stakeholders will be watching closely for data readouts that could influence AIM's stock value and partnership potential.
The announcement of the first patient enrollment in the DURIPANC Study has potential market implications for AIM ImmunoTech, particularly if the trial results are positive. The market for cancer immunotherapies is highly competitive, but also offers significant growth opportunities. A successful trial could position AIM for strategic partnerships or even acquisition by larger pharmaceutical companies looking to expand their oncology portfolios. The patent securing Ampligen's use in combination therapies adds an intellectual property asset that could enhance AIM's market value.
For investors, the progress of the DURIPANC Study represents a critical milestone that could impact AIM's stock performance. Early-stage clinical trials carry high risk but also the potential for high reward, especially in the oncology sector. Positive safety and efficacy results could lead to an increase in investor confidence and stock valuation, while any setbacks might have the opposite effect. Long-term implications hinge on the trial's ability to demonstrate significant clinical benefits, which would not only be a win for patients but also for AIM ImmunoTech's position in the highly lucrative cancer treatment market.
01/22/2024 - 08:55 AM
First enrollment takes place at Erasmus Medical Center in Rotterdam, Netherlands
OCALA, Fla., Jan. 22, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the first subject has been enrolled 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”).
Data strongly suggests Ampligen has therapeutic synergy when combined with checkpoint inhibitors — potentially increasing cancer treatment efficacy and subject survival rates. A successful DURIPANC Study could make AIM an especially attractive partnership or buyout target for Big Pharma. Data already strongly suggests that Ampligen synergistically enhances anti-PD-1 therapy. Strong positive clinical data from the DURIPANC study would also support our belief that Ampligen could synergistically enhance anti-PD-L1 therapies. Such broad-spectrum success could create value. AIM recently took an important step to secure potential stockholder value when it received a U.S. patent for the use of Ampligen as part of a combination therapy with an anti-PD-L1 antibody, which is an immune checkpoint inhibitor that helps the body attack tumor cells.
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 effect. ” 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.
“We expect to complete the Phase 1b portion of the study within six months,” states Prof. Casper H.J. van Eijck, MD, PhD, the DURIPANC Study’s Coordinating Investigator.
See ClinicalTrials.gov: NCT05927142 for more information.
AIM CEO Thomas K. Equels stated: “Ampligen’s potential as part of a combination therapy is a relatively simple equation. One, elevated PD-L1 expression — which is known to occur in pancreatic cancer — has been associated with increased exhaustion of peripheral and intra-tumoral cytotoxic T cells, commonly called ‘killer’ T cells. Two, data indicate that Ampligen has the potential to mitigate T cell exhaustion. Three, Ampligen can increase the number and activity of immune cells in the blood and tumor. And four, Imfinzi inhibits PD-L1 activity, thereby making those activated immune cells in the tumor microenvironment more effective at fighting the cancerous tumor. Data from our Dutch Early Access Program strongly supports Ampligen’s potential to increase progression-free survival and overall survival. Our hope for the DURIPANC trial is that at a minimum we see an even longer period of stable disease, also called progression-free survival. However, we also believe this combination of drugs has the potential to decrease tumor size or even to cure the cancer, which is defined as being tumor free for at least five years. That would be a dramatic breakthrough in the treatment of a highly lethal and treatment-resistant human 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.
Investor Contact:
JTC Team, LLCAIM@jtcir.com
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What is the purpose of the DURIPANC Study?
The DURIPANC Study aims to determine the safety and clinical benefit rate of the combination therapy of Ampligen and Imfinzi for late-stage pancreatic cancer.
What is the primary objective of the Phase 1b portion of the study?
The primary objective of the Phase 1b portion is to determine the safety of combination therapy with Imfinzi and Ampligen.
What is the primary objective of the Phase 2 portion of the study?
The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination therapy.
What is the expected enrollment size for the study?
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.
What is the dosing regimen for the subjects in the study?
Subjects will start with Ampligen 200 mg via IV infusion twice per week for a total of 6 weeks, with the dose escalating to 400 mg according to a 3+3 DLT design. Durvalumab will be introduced after two doses of Ampligen and continued every 4 weeks for up to 48 weeks.
