AIM ImmunoTech Inc. (NYSE American: AIM) has announced key achievements from 2024 and outlined upcoming milestones for its lead drug candidate, Ampligen (rintatolimod), across several clinical programs. The company is focusing on areas with critical unmet needs, particularly pancreatic cancer and Long-COVID.
Thomas K. Equels, CEO of AIM ImmunoTech, stated, "2024 was a foundational year for AIM on the clinical, regulatory and corporate fronts... We believe this progress has positioned AIM for an exciting 2025 and the opportunity to drive value for our stockholders."
Pancreatic Cancer Programs
The DURIPANC Phase 1b/2 study, evaluating Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for late-stage metastatic pancreatic ductal adenocarcinoma, has commenced enrollment and dosing. Initial results indicated that the first dose level was generally well-tolerated. Positive preliminary data from this study have been reported.
AIM ImmunoTech also received authorization from the Erasmus Medical Center Ethics Committee to open a European site for the ongoing Phase 2 study (AMP-270) of Ampligen for locally advanced pancreatic cancer. Furthermore, new positive data analysis from a long-term Early Access Program studying Ampligen for advanced pancreatic ductal adenocarcinoma has been published.
Ovarian Cancer Program
Positive top-line interim data were reported from a Phase 2 study of Ampligen combined with pembrolizumab for recurrent ovarian cancer.
Post-COVID Conditions Program
AIM ImmunoTech reported positive topline results from its Phase 2 study (AMP-518) evaluating the efficacy and safety of Ampligen for post-COVID fatigue. An analysis of the AMP-518 clinical trial, based upon statistically significant data, supports the company's belief in Ampligen as a potential therapeutic for people with moderate-to-severe post-COVID-19 condition of fatigue.
Intellectual Property and Manufacturing
The company was granted two patents covering Ampligen for the treatment of endometriosis and the post-COVID condition of fatigue. AIM ImmunoTech also successfully completed cGMP manufacturing of 9,042 clinical vials of Ampligen and announced the publication of new pre-clinical data of Ampligen as part of a combinational therapy in the treatment of melanoma.
Upcoming Milestones
Key milestones expected over the next 18 months include:
- Completion of Phase 1b of the DURIPANC study in Q1 2025, followed by the launch of Phase 2 in early Q2 2025, with last patient enrollment expected in Q2/Q3 2026.
- First subject enrollment at the Buffet Cancer Center in Q1 2025 for the Phase 2 study of Ampligen combined with standard of care for locally advanced pancreas cancer.
- First patient dosed in H1 2025 for the Phase 2 study of Ampligen, Interferon Alpha-2, and Celecoxib for refractory melanoma, grant funded by the National Cancer Institute.
- Expected completion of enrollment in Q2 2026 for the Phase 1/2a study of Ampligen, Celecoxib and Interferon Alpha 2b with Pembrolizumab for Stage 4 Triple Negative Breast Cancer, grant funded by Merck and National Cancer Institute.
- Expected last patient dosed and completion of the Phase 2 study of systemic immune checkpoint blockade and intraperitoneal chemo-immunotherapy in recurrent ovarian cancer in H1 2025, grant funded by Merck.
- First patient dosed in H1 2025 for the Phase 2 study of intensive locoregional chemoimmunotherapy for recurrent ovarian cancer plus intranodal DC vaccines, grant funded by the National Cancer Institute.
- Final approved study results to be published on clinicaltrials.gov in Q1 2025 for the Phase 2 study evaluating the efficacy and safety of Ampligen in patients with Post-COVID Conditions.
