aDC1 vaccine / Roswell Park, University of Pittsburgh - LARVOL DELTA

Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov) - P2 | N=1 | Active, not recruiting | Sponsor: Roswell Park Cancer Institute | Recruiting ➔ Active, not recruiting | N=24 ➔ 1 | Trial completion date: Nov 2027 ➔ Apr 2026 | Trial primary completion date: Nov 2027 ➔ Apr 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

Phase IIa study of αDC1 vaccines targeting HER2/HER3 combined with pembrolizumab in patients with asymptomatic brain metastasis from breast cancer. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT04348747 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • P2a data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ERBB3 • HER-2

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

Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Roswell Park Cancer Institute | N=19 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

A phase 2 study of intravenous pembrolizumab and intratumorally injected autologous dendritic cells (DCs) in refractory colorectal cancer (CRC). (ASCO-GI 2025) - P2 | "Eligible patients must have prior treatment with, or contraindication to fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF, and anti-EGFR therapy (if RAS wild type), be anti-PD-1/PD-L1 therapy naïve, have ECOG PS ≤1, and have at least two target lesions, one amendable to biopsy and injection...A Simon two-stage Optimal design will enroll 9 patients in stage 1, and if ≥1 response occurs, 8 more patients will be added in stage 2. If ≥3 responses are observed, the treatment will be deemed promising for further study."

P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD4 • CD8 • FOXP3 • IL12A • MSI

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

Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=19 | Not yet recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Oct 2026 ➔ Feb 2027 | Trial primary completion date: Oct 2026 ➔ Feb 2027

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

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

Effects of Injectable Solutions on the Quality of Monocyte-Derived Dendritic Cells for Immunotherapy. (PubMed, J Immunol Res) - "Alpha-type-1-polarized dendritic cells (aDC1s) have been shown to induce type-1 immunity with a high capacity to produce interleukin-12p70 (IL-12p70)...Cellular morphology was observed by electron microscopy, and the production of IL-12p70 by aDC1s was evaluated by ELISA. Compared with normal saline, Ringer's lactate solution was more effective at maintaining DC viability for up to 8 hr of incubation at 4 or 22°C."

Journal • Immunology • Infectious Disease • Oncology • CSF2 • IFNA1 • IFNG • IL1B • IL4 • TNFA

Autologous Dendritic Cell Vaccine in Kidney Cancer (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: Jodi Maranchie | Phase classification: P2a ➔ P2

Combination therapy • Phase classification • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • ANXA5 • BTLA • CD31 • CD8 • ER • GZMB • IFNG • LAG3 • LAMP3 • NRP1 • PD-1 • PECAM1 • RGS5 • TIGIT

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: Dec 2025 ➔ Aug 2025

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

Activating anti-MDS immunity with polarized dendritic cell vaccines (AACR 2024) - "We hypothesized that restoration of this population using a novel DC vaccination approach - alpha-type-1 polarized dendritic cells (αDC1) - might compensate for this deficiency and restore immunity...To date, our results suggest that generation of MDS patient-derived αDC1 cells is feasible and additional work is being performed to fully characterize their ability to activate anti-MDS immune responses. Since αDC1s have an established safety profile in patients with solid tumors, we anticipate that we will be able to rapidly translate our results to the clinic."

IO biomarker • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Solid Tumor • CD40LG • CD80 • CD86 • CSF2 • IFNA1 • IFNG • IL1B • IL4 • TNFA

Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=19 | Not yet recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: May 2026 ➔ Oct 2026 | Trial primary completion date: May 2026 ➔ Oct 2026

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

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 | Suspended ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor • CD8

Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=19 | Not yet recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Sep 2025 ➔ Jan 2026 | Trial primary completion date: Sep 2025 ➔ Jan 2026

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

Specialized Immune Cells (nCTLs) and a Vaccine (Alpha-type-1 Polarized Dendritic Cells) in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Roswell Park Cancer Institute | N=18 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CD8

Specialized Immune Cells (nCTLs) and a Vaccine (Alpha-type-1 Polarized Dendritic Cells) in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P1/2 | N=18 | Not yet recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Aug 2025 ➔ Dec 2025

Immune cell • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CD8 • NKG2D

Targeting the pericyte antigen DLK1 with an alpha type-1 polarized dendritic cell vaccine results in tumor vascular modulation and protection against colon cancer progression. (PubMed, Front Immunol) - "Our pre-clinical data demonstrate the αDC1 vaccine's ability to induce anti-tumor effects by facilitating cytotoxic T lymphocyte activity and ablating the tumor vasculature. This work, overall, provides a foundation to further interrogate immune-mediated mechanisms of protection in order to help devise efficacious αDC1-based strategies for patients with CRC."

Journal • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • DLK1

Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=19 | Not yet recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: May 2025 ➔ Sep 2025 | Trial primary completion date: May 2025 ➔ Sep 2025

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Immune Modulation • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

Autologous Dendritic Cell Vaccine in Kidney Cancer (clinicaltrials.gov) - P2a | N=42 | Recruiting | Sponsor: Jodi Maranchie | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD31 • HES1 • NRP1 • PECAM1 • RGS5

Phase IIa study of αDC1 vaccines targeting HER2/HER3 combined with pembrolizumab in patients with asymptomatic brain metastasis from triple negative breast cancer or HER2+ breast cancer. (ASCO 2023) - P2a | "Exploratory endpoints include changes in intratumoral biomarkers (CTLs, PDL1, chemokines) in pre- and post-treatment peripheral tumor biopsies and immune changes in the blood. Clinical trial information: NCT04348747."

Clinical • IO biomarker • P2a data • Brain Cancer • Breast Cancer • CNS Tumor • Glioma • HER2 Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CCR5 • CXCL10 • CXCL11 • CXCL9 • CXCR3 • ERBB3 • HER-2 • PD-L1

Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=19 | Not yet recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Dec 2025 ➔ May 2025

Metastases • Trial completion date • Breast Cancer • Immune Modulation • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

Polarized Dendritic Cell (aDC1) Vaccine, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov) - P2 | N=24 | Suspended | Sponsor: Roswell Park Cancer Institute | Recruiting ➔ Suspended

Combination therapy • Trial suspension • Melanoma • Oncology • Solid Tumor

Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=19 | Not yet recruiting | Sponsor: Roswell Park Cancer Institute | Trial primary completion date: Dec 2024 ➔ Apr 2025

Metastases • Trial primary completion date • Breast Cancer • Immune Modulation • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1