On January 15, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported key clinical, regulatory and corporate milestones achieved over 2024 and outlined its expected upcoming milestones (Press release, AIM ImmunoTech, JAN 15, 2025, View Source [SID1234649733]).

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"It is clear that 2024 was a foundational year for AIM on the clinical, regulatory and corporate fronts. Without a doubt, our team continued to drive our strategy forward and deliver results. We believe this progress has positioned AIM for an exciting 2025 and the opportunity to drive value for our stockholders," stated Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech. "Looking ahead, we believe we are poised for an exciting 2025 with a number of key milestones expected over the next 18 months across important clinical trials addressing major unmet medical needs. Certain of these trials are being funded in part by major oncology interests such as the National Cancer Institute, AstraZeneca and Merck, which we believe emphasizes their great potential to change lives for the better. Our team is committed to the seamless execution of our clinical development programs and, if successful, we believe each holds the potential to drive significant value in the near and long term."

2024 Clinical Achievement Highlights

Metastatic Pancreatic Ductal Adenocarcinoma Program

Commenced enrollment and dosing in DURIPANC Phase 1b/2 study combining Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of late-stage pancreatic cancer;
Announced that the first dose level was generally well-tolerated in the DURIPANC Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer; and
Reported positive preliminary data from Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer.
Phase 2 Locally Advanced Pancreatic Adenocarcinoma Program

Received authorization from the Erasmus Medical Center Ethics Committee to open a European site for the ongoing Phase 2 study ("AMP-270") of Ampligen as a therapy for locally advanced pancreatic cancer; and
Announced the publication of new positive data analysis from a long-term Early Access Program studying Ampligen for the treatment of advanced pancreatic ductal adenocarcinoma.
The Company sought FDA guidance on expansion of inclusion criteria and treatment arms, and then subsequently amended the study protocol. The study is recruiting patients. These adjustments are also expected to result in substantial reductions in clinical costs.
Phase 2 Recurrent Ovarian Cancer Program

Reported positive top-line, protocol-planned interim report data from the study of Ampligen combined with pembrolizumab for the treatment of recurrent ovarian cancer.
Phase 2 Post-COVID Conditions Program

Reported positive topline results from the Company’s Phase 2 study evaluating the efficacy and safety of Ampligen as a potential therapeutic for people with the post-COVID condition of fatigue ("AMP-518"); and
Reported an analysis of the AMP-518 clinical trial, based upon statistically significant data, which supports the Company’s belief in Ampligen as a potential therapeutic for people with the moderate-to-severe post-COVID-19 condition of fatigue, and that this would be the likely subject population for AIM’s planned follow-up clinical trial.
Grants of Intellectual Property in 2024
Further, the Company was also granted two important patents covering Ampligen for the treatment of:

Endometriosis, a painful chronic condition that affects nearly 10% of women of reproductive age, or approximately 6.5 million women in the United States. This patent was granted in the United States.
The Post-COVID Condition of Fatigue. This method and compositions patent was granted in the Netherlands.
Additionally, AIM successfully completed cGMP manufacturing of 9,042 clinical vials of Ampligen. The Company announced the publication of new pre-clinical data of Ampligen as part of a combinational therapy in the treatment of melanoma.

Expected Upcoming, Value-Driving Milestones

Metastatic Pancreatic Ductal Adenocarcinoma
Phase 1b/2 Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab with TLR-3 Agonist Ampligen in Patients with Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy (DURIPANC) (NCT05927142); Funded through collaboration of AstraZeneca and Erasmus Medical Center

Q1 2025: Complete Phase 1b
Early Q2 2025: Launch of Phase 2
Q2/Q3 2026: Last patient enrolled in Phase 2
Locally Advanced Pancreas Cancer (LAPC)
Phase 2 Ampligen Combined with Standard of Care (SOC) versus SOC Alone Following First-Line Therapy in Subjects with LAPC (NCT05494697); AIM funded

Q1 2025: Buffet Cancer Center expected to enroll first subject
H1 2025: first subject dosed
Refractory Melanoma
Phase 2 Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Ampligen, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (NCT04093323); Grant funded by National Cancer Institute

H1 2025: First patient dosed
Stage 4 Triple Negative Breast Cancer
Phase 1/2a Study of Ampligen, Celecoxib and Interferon Alpha 2b with Pembrolizumab for the Treatment of Patients with Metastatic or Unresectable Triple Negative Breast Cancer (NCT05756166); Grant funded by Merck and National Cancer Institute

Q2 2026: Expected completion of enrollment
Advanced Recurrent Ovarian Cancer
Phase 2 Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (NCT03734692); Grant funded by Merck

H1 2025: Expected last patient dosed and completion of study
Advanced Recurrent Ovarian Cancer
Phase 2 Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines (NCT02432378); Grant funded by the National Cancer Institute

H1 2025: First patient dosed
Post COVID Chronic Fatigue Conditions / Long Covid
Phase 2 Study to Evaluate the Efficacy and Safety of Ampligen in Patients with Post-COVID Conditions (NCT05592418); AIM funded

Q1 2025: Final approved study results to be published on clinicaltrials.gov