Excision BioTherapeutics Doses First Participant in EBT-101 Phase 1/2 Trial Evaluating EBT-101 as a Potential Cure for HIV

• EBT-101 is an in vivo CRISPR-based therapeutic designed to remove HIV proviral DNA from affected cell reservoirs
• First-in-human study will evaluate the safety and efficacy of EBT-101 in participants who chronically suppress HIV with daily antiretroviral therapy
• EBT-101 has been well tolerated to-date and the trial is proceeding as planned

Excerpt from the Press Release:

SAN FRANCISCO, Sept. 15, 2022 (GLOBE NEWSWIRE) — Excision BioTherapeutics, Inc., a clinical-stage biotechnology company developing CRISPR-based therapies intended to cure viral infectious diseases, today announced that the first participant has been dosed in the Phase 1/2 clinical trial of EBT-101 for human immunodeficiency virus type 1 (HIV-1). The participant was dosed in July 2022, with initial findings indicating EBT-101 has been well tolerated to-date. The participant continues to be monitored for safety and is expected to qualify for analytical treatment interruption (ATI) of their background anti-retroviral therapy (ART) in an evaluation of a potential cure.

“Dosing the first participant with EBT-101 is a landmark event that solidifies Excision’s position as a pioneer in gene editing,” said Daniel Dornbusch, Chief Executive Officer of Excision. “It is the first time a CRISPR-based therapy targeting an infectious disease has been administered to a patient and is expected to enable the first ever clinical assessment of a multiplexed, in vivo gene editing approach. We were able to reach this watershed moment thanks to years of innovative work by leading scientists and physicians, to whom we are immensely grateful. With this achievement, Excision has taken a major step forward in developing a one-time treatment that could transform the HIV pandemic by freeing affected people from life-long disease management and the stigma of disease.”

EBT-101 is a unique, clinical-stage in vivo CRISPR-based therapeutic designed to cure HIV infections after a single intravenous infusion. EBT-101 employs an adeno-associated virus (AAV) to deliver CRISPR-Cas9 and dual guide RNAs, enabling a multiplex editing approach that simultaneously targets three distinct sites within the HIV genome. This allows for the excision of large portions of the HIV genome, thereby minimizing potential viral escape.

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