AZD8076 / AstraZeneca, Inovio, The Wistar Institute, University of Pennsylvania, Indiana University - LARVOL DELTA

Expanded Analysis of in vivo-delivered SARS-CoV-2 Plasmid DNA-encoded Monoclonal Antibodies (DMAb) in a Phase 1 Clinical Trial in Healthy Adults (ASGCT 2025) - P1 | "In this study, we evaluated in vivo gene delivery of a DMAb cocktail encoding AZD5396 and AZD8076, modified versions of the SARS-CoV-2 neutralizing mAb cocktail Evusheld... In parallel with the durable in vivo expression profile, these data highlight the biologic activity of an in vivo-expressed synthetic DNA-delivered mAb cocktail and are supportive of further development as a strategy for delivery of antibody-based gene-encoded biologic drugs. Disease Focus of Abstract:Infectious Disease"

P1 data • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A FIH dose-escalation trial of the safety and pharmacokinetics of anti-SARS-CoV-2 DNA-encoded monoclonal antibodies (DMAb) formulated for delivery by CELLECTRA in healthy adults (ASGCT 2025) - P1 | " This multi-group Phase 1 dose-escalation study (NCT05293249) investigates the intramuscular (IM) administration of a pDNA cocktail encoding AZD5396 and AZD8076, modified for in vivo delivery and expression of the SARS-CoV-2 neutralizing mAb cocktail Evusheld... This study provides the first clinical proof-of-concept for synthetic pDNA DMAb technology, demonstrating durable in vivo production of functional monoclonal antibodies. The findings underscore the importance of synthetic design, formulation, and delivery in achieving biologically relevant gene-encoded biologics expression. The DMAb platform may represent a valuable strategy for targeting a wide range of diseases treatable with monoclonal antibodies or their derivatives."

Clinical • IO biomarker • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

dMAbs for Prevention of COVID-19 (clinicaltrials.gov) - P1 | N=61 | Active, not recruiting | Sponsor: Pablo Tebas | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • CD4

dMAbs for Prevention of COVID-19 (clinicaltrials.gov) - P1 | N=39 | Recruiting | Sponsor: Pablo Tebas | Active, not recruiting ➔ Recruiting | N=26 ➔ 39 | Trial completion date: Sep 2024 ➔ Sep 2025 | Trial primary completion date: Sep 2024 ➔ Sep 2025

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CD4

dMAbs for Prevention of COVID-19 (clinicaltrials.gov) - P1 | N=26 | Active, not recruiting | Sponsor: Pablo Tebas | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2023 ➔ Sep 2024 | Trial primary completion date: Nov 2023 ➔ Sep 2024

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CD4

dMAbs for Prevention of COVID-19 (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Pablo Tebas | Not yet recruiting ➔ Recruiting | N=18 ➔ 24 | Trial completion date: May 2023 ➔ Nov 2023 | Trial primary completion date: May 2023 ➔ Nov 2023

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CD4