AIM ImmunoTech Announces 50% Objective Response Rate (ORR) in UPMC Recurrent Ovarian Cancer Phase 2 Clinical Trial, Suggesting Breakthrough Combination Potential
Rhea-AI Summary
AIM ImmunoTech (NYSE American: AIM) reported final primary endpoint results from a UPMC Phase 2 trial combining Ampligen (rintatolimod) with pembrolizumab and cisplatin in recurrent ovarian cancer. Topline: 50% ORR, 21% complete responses, 79% clinical benefit rate, median OS 32.5 months, durable responses >70 months, and no Grade 4–5 toxicities. Additional secondary endpoint data collection is expected to complete in January 2027.
Positive
- Objective Response Rate of 50%
- Complete responses at 21%
- Clinical Benefit Rate of 79%
- Median Overall Survival of 32.5 months
- Durable responses exceeding 70+ months in select patients
- No observed Grade 4 or 5 toxicities
Negative
- Single-arm Phase 2 design (no randomized control) limits comparative efficacy conclusions
- Collection of additional secondary endpoint data (including PFS) not complete until January 2027
News Market Reaction – AIM
In the May 7 session, AIM gained 16.42%, reflecting a significant positive market reaction. Argus tracked a peak move of +20.0% during that session. Argus tracked a trough of -48.0% from its starting point during tracking. Our momentum scanner triggered 18 alerts that day, indicating notable trading interest and price volatility. Trading volume was exceptionally heavy at 18.9x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 02 | Phase 3 planning | Positive | -14.9% | Agreement to design proposed Phase 3 Ampligen trial in late-stage pancreatic cancer. |
| Feb 23 | Pancreatic trial milestones | Positive | +2.9% | Outlined DURIPANC Phase 2 milestones and timelines for pancreatic cancer study. |
| Feb 05 | Interim trial update | Positive | +16.6% | Year-end interim DURIPANC data with promising PFS/OS and no significant toxicity. |
| Nov 10 | Ovarian cancer data | Positive | -6.4% | Phase 2 ovarian trial reported 50% ORR with Ampligen combination regimen. |
| Aug 04 | Clinical progress & funding | Positive | +6.4% | Mid-year positive DURIPANC data and $8M equity raise supporting Ampligen programs. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial news has produced mixed reactions: three positive same-tag events saw gains, while two similarly positive updates triggered notable selloffs.
Over the past year, AIM’s news flow has centered on Ampligen’s oncology development. Multiple clinical trial updates in pancreatic and ovarian cancer highlighted positive progression-free and overall survival signals, generally low toxicity, and patent protection into 2039. Market reactions were inconsistent: several positive clinical updates saw gains above 16%, but others, including an earlier ovarian cancer data release, drew declines near -6% to -15%. Today’s recurrent ovarian cancer data fits this pattern of strong science but uneven price response.
Key Terms
objective response rate medical
clinical benefit rate medical
overall survival medical
progression-free survival medical
checkpoint inhibition medical
tumor microenvironment medical
pd-1 checkpoint inhibition medical
phase 2 medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Final UPMC Primary Endpoint Report Details Positive Data from Ovarian Cancer Clinical Trial Combining Ampligen, Pembrolizumab and Cisplatin
OCALA, Fla., May 07, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the Final Primary Endpoint Report on Objective Response Rate data from a University of Pittsburgh Medical Center (“UPMC”) Phase 2 clinical trial – in which AIM and Merck Sharp & Dohme (“Merck”) are collaborators – evaluating Ampligen® (rintatolimod) in combination with checkpoint inhibition and chemotherapy in recurrent ovarian cancer—data that may signal a major step forward in overcoming resistance to immunotherapy. The study aimed to improve clinical outcomes by overcoming the immunosuppressive tumor microenvironment characteristic of ovarian cancer through locoregional and systemic immune activation strategies. This clinical trial was financially supported by a Merck grant.
Read more about the study at ClinicalTrials.gov: NCT03734692.
Topline results included:
50% Objective Response Rate (ORR), including21% complete responses79% Clinical Benefit Rate- Median Overall Survival of 32.5 months
- Durable responses exceeding 70+ months in select patients
- No Grade 4 or 5 toxicities observed
Read the full UPMC Primary Endpoint Report here.
Collection of additional secondary endpoint data including progression-free survival, time to disease progression and overall survival is expected to be completed in January 2027.
Robert P. Edwards, MD, McCall Chair of Obstetrics, Gynecology, and Reproductive Science at the University of Pittsburgh School of Medicine, stated: “This single-arm Phase 2 trial is the third in a series of consecutive studies evaluating IP chemotherapy or chemoimmunotherapy using this analytical approach. The addition of IP Ampligen and systemic PD-1 checkpoint inhibition to IP cisplatin chemotherapy resulted in a significant improvement in both clinical response rates and immune activation across highly comparable patient cohorts in the 3 trials.”
AIM Chief Executive Officer Thomas K. Equels stated, “These results represent what we believe is a strong step forward in the potential to enhance treatment of recurrent ovarian cancer, if further studies support findings of relatively low toxicity, clinical benefit and durable response. Once again, data suggests that Ampligen may unlock the full potential of checkpoint immunotherapies. We are particularly encouraged by the durability of the observed responses. This supports our proposition that Ampligen has the potential to play a major role in solid tumor immuno-oncology — expanding the number of patients who benefit from checkpoint inhibitors across multiple cancer types, including ovarian cancer and pancreatic cancer. With strong intellectual property protection extending into 2039 and a growing body of positive clinical evidence, we believe we are well positioned to advance Ampligen into later-stage development and strategic partnerships.”
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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve a number of risks and uncertainties. For those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “believes,” “expects,” “intends,” “may,” “will,” “plans,” “potential,” “anticipates,” or similar expressions. Any forward-looking statements set forth in this press release speak only as of the date hereof. Such forward-looking statements may include: statements relating to the timing of commencement, enrollment, completion, and results of clinical trials; IP expansion and regulatory progress; and timing for receiving government approvals, if at all. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof, except as required by applicable law. The Company is in various stages of seeking to determine whether Ampligen will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders, and disclosures in the Company’s reports filed with the SEC, on its website, and in its press releases set forth its current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of these conditions. Results obtained in preclinical studies do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data, and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, lack of adequate funding, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data. No assurance can be given that the findings in preliminary studies will prove true or that such studies will yield favorable results, or that future studies will not result in findings that are different from those reported in the studies referenced in the Company’s reports filed with the SEC, on the Company’s website, and in its press releases. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks.
For a detailed discussion of risk factors, please review the “Risk Factors” section in the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the SEC. These filings are available at www.sec.gov and www.aimimmuno.com. The information found on the Company’s website is not incorporated by reference into this press release and is included for reference purposes only.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4272224c-2335-4a58-9f30-bf722123ab7f
Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com