AVT001 / Avotres - LARVOL DELTA

Two-Year Follow-up of AVT001 Dendritic Cell Therapy for Type 1 Diabetes—Continued Off-Therapy Functional Effects and Characterization of Responders (ADA 2025) - P1/2 | "AVT001 was safe without dose limiting adverse events and treatment was associated with preserved endogenous insulin secretion at D150, but efficacy waned over time. The disconnect between C-peptide and regulatory effects over time warrants further investigation. Future trials are planned to utilize a booster strategy to prolong efficacy.ClinicalTrials.gov number, NCT03895996."

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD8 • HLA-E

Two-Year Follow-up of AVT001 Dendritic Cell Therapy for Type 1 Diabetes—Continued Off-Therapy Functional Effects and Characterization of Responders (ADA 2025) - P1/2 | "AVT001 was safe without dose limiting adverse events and treatment was associated with preserved endogenous insulin secretion at D150, but efficacy waned over time. The disconnect between C-peptide and regulatory effects over time warrants further investigation. Future trials are planned to utilize a booster strategy to prolong efficacy.ClinicalTrials.gov number, NCT03895996."

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD8 • HLA-E

Safety, Tolerability and Potential Efficacy of AVT001 in Patients With Type 1 Diabetes (clinicaltrials.gov) - P1/2 | N=25 | Completed | Sponsor: Avotres Inc. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Novel Autologous Dendritic Cell Therapy AVT001 for Type 1 Diabetes. (PubMed, NEJM Evid) - P1/2 | "In this phase 1/2 trial, AVT001 did not result in dose-limiting adverse events. Potential signals of efficacy observed here warrant further evaluation in a fully powered trial. (Funded by Avotres Inc. and the Division of Diabetes, Endocrinology, and Metabolic Diseases; ClinicalTrials.gov number, NCT03895996.)."

Clinical • Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD8

Effect of autologous dendritic cell therapy targeting HLA-E restricted CD8+ T regulatory pathway on pancreatic beta cell function in type 1 diabetes (EASD 2023) - P1/2 | "AVT001 treatment was safe and well tolerated with evidence of significant preservation of endogenous insulin secretion at day 150 and less decline in C-peptide than placebo through day 360. These results are the first evidence that a DC-based vaccine targeting HLA-E restricted CD8+ Tregs can delay progression of T1D in people."

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD8 • HLA-E • ITGAX

Novel Autologous Dendritic Cell Therapy AVT001 for Type 1 Diabetes (ADA 2023) - "At day 150, the C-peptide AUCs were significantly different between groups, namely 0.518 (0.430) and 0.472 (0.134) respectively. Per MMRM, the least square mean difference between AVT001 and placebo at day 150, is estimated to be 0.172 (p="

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD8 • HLA-E

Novel Autologous Dendritic Cell Therapy AVT001 for Type 1 Diabetes (ADA 2023) - "At day 150, the C-peptide AUCs were significantly different between groups, namely 0.518 (0.430) and 0.472 (0.134) respectively. Per MMRM, the least square mean difference between AVT001 and placebo at day 150, is estimated to be 0.172 (p="

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD8 • HLA-E

Safety, Tolerability and Potential Efficacy of AVT001 in Patients With Type 1 Diabetes (clinicaltrials.gov) - P1/2 | N=24 | Active, not recruiting | Sponsor: Avotres Inc. | Trial completion date: Sep 2023 ➔ Dec 2023

Trial completion date • Diabetes • Metabolic Disorders • Solid Tumor • Type 1 Diabetes Mellitus • HLA-E