ProAgio / ProDa BioTech - LARVOL DELTA

ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC) (clinicaltrials.gov) - P1 | N=46 | Recruiting | Sponsor: ProDa BioTech, LLC | N=28 ➔ 46

Enrollment change • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Trial of ProAgio in Advanced/Metastatic Colorectal Cancer (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: University of Alabama at Birmingham | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

ProAgio in Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=58 | Active, not recruiting | Sponsor: ProDa BioTech, LLC | Recruiting ➔ Active, not recruiting | Trial primary completion date: May 2025 ➔ Oct 2025

Enrollment closed • Trial primary completion date • Oncology • Pancreatic Cancer • Solid Tumor • CA 19-9

ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC) (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: ProDa BioTech, LLC | Trial completion date: Oct 2025 ➔ Jun 2028 | Trial primary completion date: Jul 2025 ➔ Jun 2027

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

ProAgio in Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=58 | Recruiting | Sponsor: ProDa BioTech, LLC | Trial completion date: May 2025 ➔ Nov 2025

Trial completion date • Oncology • Pancreatic Cancer • Solid Tumor • CA 19-9

Project Cure CRC: advancing precision medicine in colorectal cancer through innovative research and targeted therapies (AACR 2025) - "Other projects investigate ProAgio, a protein targeting cells that support cancer survival, with the potential to improve therapies for hard-to-treat tumors... These initiatives demonstrate the Alliance's commitment to advancing precision medicine and addressing key gaps in CRC care, particularly for patients with treatment-resistant profiles. By funding high-impact research and fostering collaboration, Project Cure CRC aims to accelerate the development of personalized, effective treatments for CRC patients, transforming the landscape of colorectal cancer care."

IO biomarker • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Trial of ProAgio in Advanced/Metastatic Colorectal Cancer (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: University of Alabama at Birmingham | Phase classification: P1/2 ➔ P1

Phase classification • Colorectal Cancer • Oncology • Solid Tumor

Trial of ProAgio in Advanced/metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=27 | Not yet recruiting | Sponsor: University of Alabama at Birmingham

New P1/2 trial • Colorectal Cancer • Oncology • Solid Tumor

ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=51 | Recruiting | Sponsor: ProDa BioTech, LLC | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Modulating Tumor Immunity by Targeting Tumor Fibrotic Stroma and Angiogenic Vessels for Lung Cancer Treatment. (PubMed, Cancers (Basel)) - "The depletion of dense fibrotic stroma (CAFs) by ProAgio decreases the Programmed Death Ligand 1 (PDL-1) levels in the stroma areas surrounding the tumors, and thus strongly increases the delivery of anti-PDL-1 antibody to the target cancer cells. The impact of ProAgio on tumor immunity provides strong synergistical effects of checkpoint inhibitors on lung cancer treatment."

Journal • Stroma • Fibrosis • Lung Cancer • Oncology • Solid Tumor • CAFs • CD4 • CD8

Depletion of Activated Hepatic Stellate Cells and Capillarized Liver Sinusoidal Endothelial Cells Using a Rationally Designed Protein for Nonalcoholic Steatohepatitis and Alcoholic Hepatitis Treatment. (PubMed, Int J Mol Sci) - "We report a strategy for NASH and AH treatment involving the induction of integrin αvβ3-mediated cell apoptosis using a rationally designed protein (ProAgio)...The reversal of sinusoid remodeling reduces the expression of leukocyte adhesion molecules on LSECs, thus decreasing leukocyte infiltration/activation in the diseased liver. Our studies present a novel and effective approach for NASH and AH treatment."

Journal • Cardiovascular • Fibrosis • Hepatology • Hypertension • Immunology • Inflammation • Liver Cirrhosis • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Portal Hypertension

ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=51 | Not yet recruiting | Sponsor: ProDa BioTech, LLC

Combination therapy • Metastases • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer