AIM ImmunoTech Reports Positive Preliminary Data in Phase 1b/2 Study of Ampligen and Imfinzi as a Combination Therapy for Late-Stage Pancreatic Cancer

Rhea-AI Summary

AIM ImmunoTech (NYSE American: AIM) reported positive preliminary data from its Phase 1b/2 study of Ampligen and Imfinzi combination therapy for late-stage pancreatic cancer. The study showed stable disease in two out of three patients at 6 months in the first subject cohort. The combination therapy was generally well-tolerated with no severe adverse events. In the second cohort, two of three subjects also have stable disease, though not yet at the 6-month mark. Prof. Casper H.J. van Eijck noted improvements in quality of life and no toxicity, comparing favorably to typical disease progression rates. The data suggests Ampligen's potential synergy with checkpoint inhibitors for treating late-stage pancreatic cancer.

Positive

• Stable disease observed in 2 out of 3 patients at 6 months in the first cohort
• Combination therapy generally well-tolerated with no severe adverse events
• 2 out of 3 patients in the second cohort also show stable disease
• Improvements in quality of life reported by the study's Coordinating Investigator
• Potential synergy demonstrated between Ampligen and checkpoint inhibitors

Negative

• Data is still preliminary and based on a small sample size
• Unable to report on progression-free survival (PFS) yet due to disease progression

Insights

Medical Research Analyst

The preliminary data from the Phase 1b/2 DURIPANC study shows promising results for AIM ImmunoTech's Ampligen in combination with AstraZeneca's Imfinzi for late-stage pancreatic cancer. Two out of three patients in the first cohort maintained stable disease at 6 months, which is significant given that 80% of similar patients typically progress within 3 months. The therapy appears well-tolerated with no severe adverse events.

While it's too early to calculate median progression-free survival (PFS), the stability rate of 67% at 6 months is encouraging. The improved quality of life reported by the coordinating investigator is also a positive indicator. However, it's important to note that this data is very preliminary and based on a small sample size. Further research with larger patient groups is needed to confirm these results and assess long-term efficacy.

Oncology Doctor

The combination of Ampligen (a TLR-3 agonist) and Imfinzi (an anti-PD-L1 immune checkpoint inhibitor) represents an innovative approach in treating late-stage pancreatic cancer. The observed stability in patients at 6 months is particularly noteworthy, as pancreatic cancer is notoriously aggressive with poor prognosis. The lack of severe toxicity is also crucial, as it allows for prolonged treatment.

The reported changes in immune infiltration into metastatic lesions suggest that this combination may be effectively modulating the tumor microenvironment. This could potentially lead to more durable responses or even complete responses in some patients. However, we must remain cautious until we see results from larger cohorts and longer follow-up periods. The potential for this combination to improve both survival and quality of life in this difficult-to-treat cancer is certainly worth further investigation.

Financial Analyst

This preliminary data represents a potential breakthrough for AIM ImmunoTech (NYSE: AIM) in the lucrative oncology market. Late-stage pancreatic cancer has treatment options and any therapy showing promise could capture significant market share. The collaboration with AstraZeneca, a pharmaceutical giant, adds credibility and potential for future partnerships.

However, investors should note that this is early-stage data from a small sample size. The path to market approval is long and uncertain. AIM's financial position will be important to fund further trials. As of their last report, AIM had $29.9 million in cash and cash equivalents, which may not be sufficient for extensive late-stage trials without additional funding. While the news is positive, it's important to consider the high failure rate of oncology drugs in clinical development when assessing the company's long-term prospects and valuation.

Preliminary finding of stable disease in two out of three patients at 6 months in the first subject cohort

Combination of Ampligen and Imfinzi continues to be generally well-tolerated with no severe adverse events or dose-limiting toxicities

OCALA, Fla., Sept. 19, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced positive preliminary data from the Phase 1b/2 study (“DURIPANC”) evaluating 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.

DURIPANC is an investigator-initiated, exploratory, open-label, single-center study. AIM previously announced that investigators at Erasmus Medical Center (“Erasmus MC”) in the Netherlands had completed the safety evaluation of subjects enrolled in the first dose level of the dose escalation design, finding the combination therapy to be generally well-tolerated with no severe adverse events or dose-limiting toxicities. That first cohort has now reached the pre-determined 6-month stability assessment timepoint and AIM is pleased to announce that two of the three subjects remain stable. The subjects will continue to be treated and receive formal assessment of progression every three months. The standard for calculating median progression-free survival (“PFS”) requires that 50% or more of the subjects have seen disease progression. Because 67% of the patients in the cohort evaluated at 6 months have remained stable, AIM cannot yet report on PFS.

Two of the three subjects in the higher-dose second cohort of subjects also have stable disease, although they have not yet reached the 6-month stability assessment timepoint. Investigators continue to treat and monitor these subjects.

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC and Coordinating Investigator for the DURIPANC study, commented: “First of all, we have observed improvements in quality of life and we saw no toxicity at all — with ‘quality of life’ recognized as an indicator of stable disease. As a comparison, approximately 80% of patients at Erasmus with similar disease, but who did not receive the treatment, showed disease progression after only three months. While this new data is extremely preliminary, it is also highly encouraging. To have multiple patients with metastatic pancreatic cancer who still have stable disease after six or seven months of maintenance therapy is remarkable — as is having stable disease for 15 or more months after starting FOLFIRINOX. Based on the changes we have seen in immune infiltration into metastatic lesions, I am optimistic that there is a chance that these patients could still have partial or complete responses to this therapy.”

“Ampligen continues to demonstrate its synergistic potential as a combination therapy with checkpoint inhibitors and these data — following the positive data from the Dutch-government approved Early Access Program — underscore Ampligen’s potential for the treatment of late-stage pancreatic cancer, where there remains a significant and lethal unmet need,” commented AIM Chief Executive Officer Thomas K. Equels.

Read more 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 effect”

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. Data, pre-clinical success and clinical success seen to date does not guarantee that Ampligen will be approved as a combination therapy for late-stage 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 are the preliminary results of AIM ImmunoTech's Phase 1b/2 study for pancreatic cancer?

AIM ImmunoTech (AIM) reported stable disease in two out of three patients at 6 months in the first cohort of their Phase 1b/2 study combining Ampligen and Imfinzi for late-stage pancreatic cancer. The therapy was generally well-tolerated with no severe adverse events.

How does the AIM ImmunoTech (AIM) pancreatic cancer treatment compare to standard outcomes?

According to Prof. van Eijck, approximately 80% of patients with similar disease at Erasmus MC showed progression after only three months without this treatment. In contrast, AIM's study showed stable disease in multiple patients after six or seven months of maintenance therapy.

What is the significance of AIM ImmunoTech's (AIM) preliminary pancreatic cancer study results?

The preliminary results are considered highly encouraging, as maintaining stable disease in late-stage pancreatic cancer patients for 6-7 months is remarkable. It suggests Ampligen's potential synergy with checkpoint inhibitors and its promise for treating this aggressive cancer with significant unmet needs.

What is the next step for AIM ImmunoTech's (AIM) pancreatic cancer treatment study?

The study will continue to treat and monitor subjects, with formal assessments of disease progression every three months. Researchers will also continue to evaluate the higher-dose second cohort, which has shown promising initial results but has not yet reached the 6-month stability assessment timepoint.