Tillkännagivande • May 10
Aim Immunotech Inc Announces 50% Objective Response Rate in Upmc Recurrent Ovarian Cancer Phase 2 Clinical Trial AIM ImmunoTech Inc. announced the Final Primary Endpoint Report on Objective Response Rate data from a University of Pittsburgh Medical Center Phase 2 clinical trial – in which AIM and Merck Sharp & Dohme 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. Topline results included: 50% Objective Response Rate (ORR), including 21% complete responses; 79% 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. 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. Tillkännagivande • Apr 17
AIM ImmunoTech Enters Pivotal Value Inflection Phase with Planned Phase 3 Study of Ampligen in Pancreatic Cancer, Backed by Positive Clinical Signals, Orphan Drug Status, and Global IP AIM ImmunoTech Inc. highlighted accelerating momentum in its pancreatic cancer program, underscored by Phase 3 trial planning underway, encouraging Phase 2 clinical signals, and a rapidly strengthening global regulatory and intellectual property position. The Company recently announced a strategic agreement with the PPD clinical research business of Thermo Fisher Scientific to design its planned Phase 3 clinical trial of Ampligen in late-stage pancreatic cancer. This collaboration brings world-class clinical development expertise to support trial design and positions AIM to efficiently advance Ampligen into late-stage development. The planned Phase 3 program is supported by very positive published data from a Dutch government-approved Named Patient Program with Ampligen as a monotherapy in late-stage pancreatic ductal adenocarcinoma and reported encouraging data from the ongoing Phase 2 DURIPANC study, which is evaluating Ampligen in combination with AstraZeneca’s durvalumab. That ongoing study is showing promising improvement in progression-free survival and overall survival, as well as a favorable safety profile. Conducted in collaboration with AstraZeneca and Erasmus Medical Center, the study is expected to complete enrollment later this year and represents a key clinical validation step for our upcoming pivotal trial. As mentioned above, similar positive data was observed in the NPP, where Ampligen as a monotherapy was administered to 82 total patients and which had a significant positive findings on both progression-free and overall survival compared to historical controls. Pancreatic cancer represents a large and rapidly growing global market opportunity, with incidence rising and limited innovation over several decades. It is projected to become the second leading cause of cancer-related deaths in the United States, underscoring both the urgency and the commercial potential for new therapeutic options.
Ampligen, a selective TLR3 agonist, is designed to activate innate immunity and improve tumor responsiveness, making it a strong candidate for use as both a monotherapy and in combination with checkpoint inhibitors in multiple solid tumor types, and specifically with positive Phase 1/2 safety and efficacy data in combination with AstraZeneca’s durvalumab and Merck’s pembrolizumab in pancreatic cancer. The Company continues to expand its global IP portfolio. AIM recently obtained final approval of a Japanese patent covering Ampligen in combination with checkpoint inhibitors, which is set to expire in 2039. Existing patents in the United States and Europe also extend to 2039, with broad claims supporting combination use across multiple oncology indications. This IP estate positions Ampligen for long-term commercial protection across major markets. AIM’s IP portfolio includes orphan drug designations for pancreatic cancer in both the United States and Europe, and the Company announced in March 2026 that it would seek similar status in Japan. These designations provide potential market exclusivity upon approval, regulatory incentives, reduced development costs, and opportunities for accelerated development pathways, reinforcing the Company’s strategy and enhancing long-term value creation. AIM anticipates several near-term milestones that may serve as significant value drivers. These include the completion of Phase 2 DURIPANC enrollment and additional data updates; continued clinical data readouts; further IP expansion and regulatory progress; the potential for new developments from existing strategic collaborations; and the design, IND approval and commencement of a Phase 3 pivotal study in pancreatic cancer. Tillkännagivande • Mar 18
AIM ImmunoTech Inc Announces Final Approval Of Novel Cancer Therapy Patent In Japan Combining Ampligen With Checkpoint Inhibitors AIM ImmunoTech Inc. announced that the Japan Patent Office has fully approved a Japanese patent covering the Company’s proprietary use of Ampligen (rintatolimod) in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer. The patent was granted in September 2025, but had to then pass a 6-month opposition period. Japan is one of the largest health markets in the world, with Japan and the United States expected to experience the greatest increase in global pancreatic cancer burden by 2030. The Japan patent expires December 20, 2039. The allowed claims in Japan cover an agent for treating cancer consisting of Ampligen in combination with a checkpoint inhibitor. The claims are broad and encompass multiple cancer types – including pancreatic cancer. AIM also holds a U.S. patent (expires August 9, 2039) for methods involving the use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab). AIM also intends to expand its intellectual property portfolio by pursuing orphan drug designation in Japan for Ampligen in the treatment of pancreatic cancer. The Company already holds Orphan Drug designations for pancreatic cancer in the United States and the European Union. While the details of the designations vary by region, the purpose is to incentivize the development of therapies for unmet health needs, by providing various benefits and market exclusivity after a drug receives market approval. Tillkännagivande • Mar 05
AIM ImmunoTech Inc. has completed a Composite Units Offering in the amount of $12 million. AIM ImmunoTech Inc. has completed a Composite Units Offering in the amount of $12 million.
Security Name: Units
Security Type: Preferred Equity/Derivative Unit
Securities Offered: 12,000
Price\Range: $1000
Discount Per Security: $80
Transaction Features: Rights Offering Tillkännagivande • Mar 03
AIM ImmunoTech Signs Agreement for Planning of A Proposed Phase 3 Clinical Trial of Ampligen in the Treatment of Late-Stage Pancreatic Cancer AIM ImmunoTech Inc. announced an agreement with the PPD™? clinical research business of Thermo Fisher Scientific to design AIM's anticipated Phase 3 clinical trial in the use of the Company's drug Ampligen in the treatment of late-stage pancreatic cancer. AIM recently published an updated corporate presentation that emphasizes the Company's priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM's research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of pancreatic Cancer; and why AIM believes that pancreatic cancer research and development holds the most potential for AIM's stockholders. AIM has thus far reported positive progress in Progression-Free Survival ("PFS"), Overall Survival ("OS") and safety in the DURIPANC study, which is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands. Tillkännagivande • Feb 24
Aim Immunotech Announces Planned Milestones in the Ongoing Phase 2 Trial of Ampligen and Astrazeneca's Durvalumab in the Treatment of Metastatic Pancreatic Cancer AIM ImmunoTech Inc. announced milestones in the expected timeline for the ongoing Phase 2 clinical study evaluating AIM's drug Ampligen (rintatolimod) combined with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the "DURIPANC" study). DURIPANC is an investigator-initiated, exploratory, open-label, single-center study, and 18 subjects have enrolled in the study so far. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands. Planned DURIPANC milestones: July 2026 - Complete subject enrollment. Reporting of Quality of life (EORTC QLQ-C30) based upon evaluations at baseline, 6 weeks, 3 months, 9 months and 1 year after the start of immunotherapy. AIM is committed to releasing mid-year and year-end interim progress reports on DURIPANC, with the most recent update released at the beginning of February. Lead investigator Marjolein Y. V. Homs, MD, PhD, Department of Medical Oncology, Erasmus MC Cancer Institute, emphasized that the promising Progression-Free Survival and Overall Survival seen in Phase 1 of the study - which supported advancement to the ongoing Phase 2 portion of the study - continue to be seen and that enrollment is ongoing. According to Erasmus MC, there has also been no significant toxicity - an encouraging safety profile for a post-chemo setting - and Ampligen subjects are consistently reporting "high quality of life" during treatment. Additionally, AIM has published on its website an updated corporate presentation that emphasizes the Company's priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM's research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of these conditions. Results obtained in animal models 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, 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 or require additional funding. Among the studies are clinical trials are clinical trials, the Company is currently being conducted in the United States. 
