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A CRISPR-Cas9 gene-editing technology that has shown promise in eliminating HIV from mice is in the process of being tested in humans.
Excision BioTherapeutics will launch CRISPR EBT-101-based therapy in clinical trials after the FDA clears an investigational new drug application, according to the company’s press release.
EBT-101 is in development as a potential virus elimination treatment for HIV-infected patients – or, in the words of the company, “a potential working remedy for chronic HIV.”
We don’t like to throw out the word “healing” here. But Excision believes the therapy could replace standard retroviral therapy, which prevents HIV from replicating but does not eliminate it from the body. This means that the patients continue the treatment, which can cause serious side effects and affect the quality of life. Now, with the start of human testing, the real path to seeing if this new leased technology can really accomplish this really begins.
RELATED: Using CRISPR to Eliminate HIV
HIV integrates its genetic material into the genome of a host cell, which means that available therapies simply cannot eliminate it. A team of scientists from Temple University and the University of Nebraska Medical Center successfully eliminated the virus completely from mice in preclinical testing using a combination of CRISPR and antiretroviral therapy. They also found no adverse events that could be related to the treatment in the study, published in 2019.
“If you only make one cut, the virus can mutate around. We are making several cuts to deactivate the viral genome, ”CEO Daniel Dornbusch told Fierce Biotech in an interview.
EBT-101 has since been tested in non-human primates, showing that it reaches all tissues in the body where HIV reservoirs reside.
Excision has cleared the therapy from universities with the goal of moving it to clinical trials. Now the FDA is on board.
RELATED: Biopharma Tackles COVID-19, HIV, and Other Viruses with Gene and Cell Therapies
Biotechnology plans to launch a phase 1/2 clinical trial later this year, the statement said.
The technology used by Excision has been authorized by the laboratory of renowned CRISPR pioneer Jennifer Doudna. The company is also working on similar treatments for other viruses, including herpes and hepatitis B.
The news of Excision comes the same week that Intellia announced that gene-editing therapy for acute myeloid leukemia had been cleared for human trials by the FDA.
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