SAN FRANCISCO, Oct. 19, 2023 (GLOBE NEWSWIRE) — Excision BioTherapeutics, Inc., a clinical-stage biotechnology company developing CRISPR-based therapeutics to treat viral infectious diseases, today announced mid-stage clinical safety and Biodistribution data will be presented at the 30th European Society for Gene and Cell Therapy (ESGCT) 2023 Annual Meeting, which will be held from October 24 to 27, 2023 in Brussels, Belgium.
Dr. Rachel Presti of Washington University School of Medicine, principal investigator of the clinical evaluation of EBT-101, will present for the first time interim safety and biodistribution data from the Phase 1/2 clinical trial of EBT-101-001. EBT-101 is being evaluated in a first-in-human clinical study to evaluate its safety and efficacy in HIV patients receiving antiretroviral therapy.
Details of the demonstration are listed below, and the full program is available at ESGCT website.
Meeting: 5A Infectious Diseases and Vaccines
Appointment time: Wednesday, October 25, 2023, 14:30-16:30 pm (Central European Summer Time)
title: First-in-human trial of systemic CRISPR-Cas9 multiplex gene therapy for functional HIV cure (OR31)
Room: Shed 2A Parallel
About EBT-101
EBT-101 is top notch in vivo CRISPR-based therapies aim to cure HIV infection after a single intravenous infusion. EBT-101 uses an adeno-associated virus (AAV) to deliver CRISPR-Cas9 and dual guide RNA to achieve multiple in vivo The editing method simultaneously targets two distinct and conserved sites in the latent HIV genome that differ from the human genome. This allows excision of a large portion of the HIV genome, thereby minimizing potential viral escape.
About the EBT-101 Clinical Program
The EBT-101-001 Phase 1/2 trial is an open-label, multicenter, single-dose ascent study designed to evaluate the safety, tolerability, biodistribution and efficacy of EBT-101 in approximately nine HIV-1 patients. Pharmacodynamically, antiretroviral therapy has undetectable viral loads. A preliminary efficacy assessment will also be conducted. Participants in EBT-101-001 will be followed for 48 weeks after EBT-101 administration. All eligible participants will be assessed at an analytical treatment interruption (ATI) beginning at Week 12 to assess continued viral suppression beyond background ART. Following EBT-101-001, participants will participate in a long-term follow-up study, EBT-101-002.For more information, see ClinicalTrials.gov Identifiers NCT05144386 (Phase 1/2 trial) and NCT05143307 (Long-term follow-up study).
The EBT-101 Phase 1/2 clinical trial was funded by the California Institute for Regenerative Medicine (CIRM). For more information about CIRM, please visit www.cirm.ca.gov.
About Excision BioTherapeutics, Inc.
Excision BioTherapeutics, Inc. is a clinical-stage biotechnology company developing CRISPR-based therapies as potential treatments for viral infectious diseases. EBT-101 is the company’s leading project and is a in vivo CRISPR-based therapies aim to cure HIV infection after a single intravenous infusion. Excision’s pipeline combines next-generation CRISPR nucleases with novel gene-editing methods to develop treatments for herpes viruses, JC virus that causes PML, and hepatitis B virus. Excision’s underlying technology was developed in the laboratories of Dr. Kamel Khalili of Temple University and Dr. Jennifer Doudna of the University of California, Berkeley.For more information, please visit www.excision.bio.
