Ampligen (rintatolimod) / AIM ImmunoTech - LARVOL DELTA

NCI-2019-01192: Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Roswell Park Cancer Institute | Suspended ➔ Recruiting | Trial completion date: May 2026 ➔ Nov 2026 | Trial primary completion date: May 2026 ➔ Nov 2026

Biomarker • Enrollment open • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Expected Upcoming, Value-Driving Milestones (GlobeNewswire) - "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....Phase 2 Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (NCT03734692); Grant funded by Merck: H1 2025: Completion of study, publication of data."

P2 data • Trial status • Ovarian Cancer • Triple Negative Breast Cancer

Expected Upcoming, Value-Driving Milestones (GlobeNewswire) - "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: Q2/Q3 2026: Last patient enrolled in Phase 2...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."

Trial status • Melanoma • Pancreatic Ductal Adenocarcinoma

AIM ImmunoTech Inc. Participates in the Virtual Investor “Top 5 for ‘25” On-Demand Conference (GlobeNewswire) - "As part of the event, AIM CEO Thomas K. Equels presented his...reasons why he believes the investment community and industry colleagues should pay attention to the Company in 2025: Progress in late-stage pancreatic cancer treatment with significant advancements in the Phase 1b/2 DURIPANC trial at Erasmus Medical Center in the Netherland...Rapid advancement across oncology pipeline with multiple key trials reaching or approaching major milestones....Ampligen’s overall potential as a broad-spectrum immunotherapy."

Pipeline update • Trial status • Pancreatic Cancer

AIM ImmunoTech Inc. Participates in the Virtual Investor “Top 5 for ‘25” On-Demand Conference (GlobeNewswire) - "AIM ImmunoTech Inc...announced its participation in the Virtual Investor “Top 5 for ‘25” On-Demand Conference...investment community and industry colleagues should pay attention to the Company in 2025...Expanding research in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) research and post-COVID conditions, including the Company’s early recognition of the link between COVID-19 and ME/CFS-like conditions....Plans to advance Ampligen as a vaccine adjuvant for the growing and serious threat of bird flu as part of the Company’s antiviral priority development pipeline."

Pipeline update • Infectious Disease • Novel Coronavirus Disease

Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC (clinicaltrials.gov) - P2 | N=90 | Suspended | Sponsor: AIM ImmunoTech Inc. | Recruiting ➔ Suspended

Trial suspension • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Nov 2025 ➔ Nov 2027 | Trial primary completion date: Nov 2025 ➔ Nov 2027

IO biomarker • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • CD8

AIM Doses First New Subject in Phase 2 Study of Ampligen and Imfinzi as a Potential Combination Therapy for Late-Stage Pancreatic Cancer (GlobeNewswire) - "AIM ImmunoTech Inc...announced that the first new subject has been dosed in Phase 2 of the Phase 1b/2 clinical trial involving AIM’s Ampligen (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of late-stage pancreatic cancer ('DURIPANC'). Several subjects from Phase 1 who received the highest dose will also be included in Phase 2....DURIPANC is an investigator-initiated, exploratory, open-label, single-center study in the Netherlands at the Erasmus Medical Center. Up to 25 patients are expected to be enrolled in the Phase 2 portion of DURIPANC."

Trial status • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Erasmus Medical Center Safety Committee Grants Approval to Proceed with Phase 2 Study of Ampligen and Imfinzi as a Potential Combination Therapy for Late-Stage Pancreatic Cancer (GlobeNewswire) - "AIM ImmunoTech Inc...today announced Safety Committee approval to proceed with the Phase 2 portion of the Phase 1b/2 clinical trial involving AIM’s Ampligen (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of late-stage pancreatic cancer (DURIPANC)....The approval to proceed to Phase 2 was granted following the Safety Committee’s review of the complete Phase 1 safety data, which found the combination therapy to be generally well-tolerated with no treatment-related severe adverse events or dose-limiting toxicities....It is one of the highest unmet needs in oncology, and we are excited to see this clinical study at Erasmus Medical Center in the Netherlands move to Phase 2."

DSMB • Trial status • Pancreatic Cancer

Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: AIM ImmunoTech Inc. | Trial completion date: Jul 2028 ➔ Oct 2028 | Trial primary completion date: Jun 2028 ➔ Sep 2028

Trial completion date • Trial primary completion date • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

AIM ImmunoTech Highlights Key 2024 Achievements and Outlines Upcoming 2025-26 Value-Driving Milestones (GlobeNewswire) - "Phase 2 Ampligen Combined with Standard of Care (SOC) versus SOC Alone Following First-Line Therapy in Subjects with LAPC: Q1 2025: Buffet Cancer Center expected to enroll first subject; H1 2025: first subject dosed."

Trial status • Gastrointestinal Cancer • Pancreatic Cancer

AIM ImmunoTech Highlights Key 2024 Achievements and Outlines Upcoming 2025-26 Value-Driving Milestones (GlobeNewswire) - "Phase 2 Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Ampligen, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma: H1 2025: First patient dosed; 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: Q2 2026: Expected completion of enrollment."

Trial status • Breast Cancer • Melanoma • Triple Negative Breast Cancer

AIM ImmunoTech Highlights Key 2024 Achievements and Outlines Upcoming 2025-26 Value-Driving Milestones (GlobeNewswire) - "Phase 2 Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer: H1 2025: Expected last patient dosed and completion of study; Phase 2 Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines: H1 2025: First patient dosed."

Trial status • Ovarian Cancer • Solid Tumor

AIM ImmunoTech Highlights Key 2024 Achievements and Outlines Upcoming 2025-26 Value-Driving Milestones (GlobeNewswire) - "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): Q1 2025: Complete Phase 1b; Early Q2 2025: Launch of Phase 2; Q2/Q3 2026: Last patient enrolled in Phase 2."

Trial status • Gastrointestinal Cancer • Pancreatic Ductal Adenocarcinoma

Ampligen Co-Inventor and Former CEO Agrees to Join AIM Scientific Advisory Board if Kellner Group Nominees Are Elected (GlobeNewswire) - "The Kellner Group is pleased to announce that Dr. William A. Carter, MD, F.A.C.P., the founder and former CEO of AIM and inventor of Ampligen, has agreed to become Chairman of AIM’s Scientific Advisory Board in the event that the Kellner Group Nominees control the Board of Directors of AIM following the upcoming annual meeting. After meeting with Dr. Carter recently, Mr. Kellner remains convinced that Ampligen has great potential but only with a new AIM Board of Directors, and he asked Dr. Carter if he would be willing to serve on the intended Scientific Advisory Board, to which Dr. Carter agreed."

Clinical • Oncology • Solid Tumor

Systemic chemokine-modulatory regimen combined with neoadjuvant chemotherapy in patients with triple-negative breast cancer. (PubMed, J Immunother Cancer) - P1 | "Combined paclitaxel/CKM regimen was safe, with desirable TME changes and preliminary indications of promising pCR+ypTmic of 66%, comparable to the combination of NAC with pembrolizumab."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • FOXP3 • IFNA1 • TLR3

AIM ImmunoTech Announces Publication of Breast Cancer Data from Roswell Park Comprehensive Cancer Center in The Journal for ImmunoTherapy of Cancer (J Immunother Cancer, GlobeNewswire) - P1 | N=9 | NCT04081389 | "AIM ImmunoTech Inc...announced that data were published on Roswell Park Comprehensive Cancer Center’s Phase 1 study evaluating AIM ImmunoTech’s drug Ampligen...as a component of a chemokine-modulating (CKM) regimen in early-stage triple-negative breast cancer (TNBC). Results of the study were reported in The Journal for ImmunoTherapy of Cancer....'The results of this pilot study suggest that the Ampligen-containing chemokine modulation regimen is capable of modifying the tumor microenvironment and releasing cytokines that attract killer T-cells into the early-stage triple-negative breast cancer tumor.'"

P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

AIM ImmunoTech Announces Publication of Breast Cancer Data from Roswell Park Comprehensive Cancer Center in The Journal for ImmunoTherapy of Cancer (J Immunother Cancer, GlobeNewswire) - P1 | N=9 | NCT04081389 | "AIM ImmunoTech Inc...announced that data were published on Roswell Park Comprehensive Cancer Center’s Phase 1 study evaluating AIM ImmunoTech’s drug Ampligen...as a component of a chemokine-modulating (CKM) regimen in early-stage triple-negative breast cancer (TNBC). Results of the study were reported in The Journal for ImmunoTherapy of Cancer....'The results of this pilot study suggest that the Ampligen-containing chemokine modulation regimen is capable of modifying the tumor microenvironment and releasing cytokines that attract killer T-cells into the early-stage triple-negative breast cancer tumor.'"

P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: AIM ImmunoTech Inc. | Trial completion date: Apr 2028 ➔ Jul 2028 | Trial primary completion date: Mar 2028 ➔ Jun 2028

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

AIM ImmunoTech Reports Positive Preliminary Data in Phase 1b/2 Study of Ampligen and Imfinzi as a Combination Therapy for Late-Stage Pancreatic Cancer (GlobeNewswire) - P1b/2 | N=43 | DURIPANC (NCT05927142) | "Combination of Ampligen and Imfinzi continues to be generally well-tolerated with no severe adverse events or dose-limiting toxicities...That first cohort has now reached the pre-determined 6-month stability assessment timepoint and AIM is pleased to announce that two of the three subjects remain stable. The subjects will continue to be treated and receive formal assessment of progression every three months...The standard for calculating median progression-free survival ('PFS') requires that 50% or more of the subjects have seen disease progression. Because 67% of the patients in the cohort evaluated at 6 months have remained stable, AIM cannot yet report on PFS. Two of the three subjects in the higher-dose second cohort of subjects also have stable disease, although they have not yet reached the 6-month stability assessment timepoint."

P1/2 data • Gastrointestinal Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

AIM ImmunoTech Announces Print Publication and Further Positive Findings from a Study Evaluating Ampligen in the Treatment of Pancreatic Cancer in the Journal Clinical Cancer Research (GlobeNewswire) - P= NA| N=NA | "AIM ImmunoTech...announced the official print publication of the data analysis from a long-term Early Access Program...studying the company’s drug Ampligen (rintatolimod) for the treatment of advanced pancreatic ductal adenocarcinoma ('PDAC')...Researchers at the Erasmus University Medical Center...found that Ampligen treatment in pancreatic cancer patients enhances peripheral immune activity at the transcriptomic and proteomic levels, particularly involving type 1 conventional dendritic cells (cDC1s) and T cells. Post-Ampligen, the increased peripheral abundance of BTLA+XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical outcomes. Patients with stable disease exhibited pronounced overexpression of genes related to DC and T cell activation. Notably, the expression of immune checkpoints PD-L1 and PD-L2 decreased post-Ampligen across all patients."

Clinical data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines (clinicaltrials.gov) - P1/2 | N=25 | Recruiting | Sponsor: Roswell Park Cancer Institute | Suspended ➔ Recruiting

Enrollment open • Metastases • Oncology • Ovarian Cancer • Solid Tumor • CCL2 • CCL22 • CCL3 • CD4 • CXCL10 • CXCL11 • CXCL12 • CXCL9 • FOXP3 • IFNG • IL10 • ITGAM • ITGAX

Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Aug 2025 ➔ Nov 2025 | Trial primary completion date: Aug 2025 ➔ Nov 2025

Combination therapy • IO biomarker • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • CD8

Ampligen Compared to No Treatment Following FOLFIRINOX in Subjects With Locally Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: AIM ImmunoTech Inc. | Trial completion date: Jul 2027 ➔ Apr 2028 | Trial primary completion date: Jun 2027 ➔ Mar 2028

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

AIM ImmunoTech Announces Release of the Next CEO Corner Segment (GlobeNewswire) - "AIM ImmunoTech Inc...today announced the next CEO Corner segment has been published on the Company’s website. In the CEO Corner segment, AIM Chief Executive Officer Thomas Equels provides an overview of the positive data from the Phase 1 clinical trial investigating an Ampligen-containing chemokine modulation therapy in conjunction with the chemotherapy drug paclitaxel in the treatment of early stage, triple-negative breast cancer."

P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer