Announcement • 7h
Aim Immunotech Reports Positive Mid-Year Interim Clinical Progress from Phase 2 Study Evaluating Ampligen in Combination with Astrazeneca’S Imfinzi for the Treatment of Pancreatic Cancer AIM ImmunoTech Inc. reported positive progress in a mid-year update from 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). AIM recently announced enrollment of the final patient in the clinical trial, barring any disqualifying pre-treatment circumstances. The Company remains on track for a planned December 2026 evaluation of the clinical trial’s primary endpoint, Clinical Benefit Rate (CBR), defined as stable disease, partial response or complete response (progression-free disease) at 6 months (24 weeks) after start of combination therapy. DURIPANC is a follow-up to a 57-subject Named Patient Program (NPP) of Ampligen as a monotherapy in late-stage pancreatic cancer, where Ampligen was associated with median survival of 19.7 months, which is an extension of median overall survival of 8.6 months when compared to the standard of care. The EAP subjects also reported improved quality of life. In the NPP stratification of subjects with immune marker Neutrophil/Lymphocyte ratios less than 4.5, overall median survival of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months – and with positive measures of quality of life. The DURIPANC study 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 in the Netherlands. The primary objective of the study is the clinical benefit rate of the combination therapy. The secondary/exploratory objectives include assessing overall survival (OS) and progression-free survival (PFS); exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life. Announcement • Jun 02
AIM ImmunoTech Inc. Completes Enrollment in Phase 2 DURIPANC Clinical Trial for Ampligen Combined with Imfinzi in Metastatic Pancreatic Cancer AIM ImmunoTech Inc. announced a significant milestone in its pancreatic cancer development program, with enrollment of the final subject, barring disqualifying pre-treatment circumstances. The final planned subject is scheduled for treatment in mid-June, surpassing the Company's original enrollment target of July 2026 in the Phase 2 clinical trial of 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). The ahead-of-schedule enrollment milestone reinforces AIM’s emphasis on accelerating momentum and keeps the Company on track for a planned December 2026 evaluation of the study's primary endpoint, Clinical Benefit Rate (CBR), a key measure of treatment effectiveness in one of the deadliest and most difficult-to-treat cancers. AIM previously reported positive year-end interim results in DURIPANC and intends to publish its next interim report in the next two to three weeks. AIM remains on track to complete Ampligen dosing for all subjects in August, which should allow evaluation of the study's critical primary endpoint of Clinical Benefit Rate in December 2026. Clinical Benefit Rate is defined as stable disease, partial response, or complete response six months after initiation of combination therapy. The enrollment milestone further advances AIM's broader pancreatic cancer strategy, which includes ongoing Phase 3 clinical trial planning and continued expansion of its global regulatory and intellectual property position. The planned Phase 3 program is supported by positive published data from a Dutch government-approved Named Patient Program involving Ampligen-treated pancreatic cancer patients, as well as encouraging findings from the ongoing DURIPANC study. Collectively, these programs have generated clinical experience in more than 100 pancreatic cancer patients treated with Ampligen and continue to support the Company's strategy of advancing Ampligen toward pivotal-stage development. DURIPANC is an investigator-initiated, exploratory, open-label, single-center study conducted through a collaboration among AIM ImmunoTech, AstraZeneca, and Erasmus Medical Center in the Netherlands. The primary objective of the study is to evaluate the CBR of the combination therapy. Secondary and exploratory objectives include assessing overall survival and progression-free survival, evaluating immune-monitoring through tissue biopsies and peripheral immune profiling, and measuring patient quality of life. Pancreatic cancer remains one of the most lethal malignancies worldwide and is projected to become the second leading cause of cancer-related deaths in the United States. Despite decades of research, treatment options remain limited, highlighting the urgent need for innovative therapeutic approaches that can improve survival and quality of life for patients. Announcement • May 22
AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.443789 million. AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.443789 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 7,519,351
Price\Range: $0.325
Transaction Features: Registered Direct Offering