genomics.ca (https://genomics.ca/page/2/)
BY ANNALEE ARMSTRONG
FIERCE BIOTECH
A CRISPR-Cas9 gene editing technology that has shown promise in clearing HIV from mice is headed into human testing.
Excision BioTherapeutics will usher the CRISPR-based therapy EBT-101 into clinical trials after the FDA cleared an investigational new drug application, according to the company’s press release.
EBT-101 is under development as a potential virus-clearing treatment for patients with HIV—or, put in the company’s words, “a potential functional cure for chronic HIV.”
We don’t like to throw the word “cure” around here. But Excision thinks the therapy could replace standard-of-care retroviral therapy, which keeps HIV from replicating but does not remove it from the body. That means patients stay on the treatment, which can cause serious side effects and affect quality of life. Now with the start of human testing, the real path to see if this new and lauded tech can accomplish this really begins.
HIV integrates its genetic material into the genome of a host cell, meaning available therapies just can’t remove it. A team of scientists at Temple University and the University of Nebraska Medical Center managed to remove the virus completely from mice during preclinical testing using a combination of CRISPR and antiretroviral therapy. They also found no adverse events that could be linked to the therapy in the study, published back in 2019.
“If you just make a single cut, the virus can mutate around it. We make multiple cuts to deactivate the viral genome,” CEO Daniel Dornbusch previously told Fierce Biotech in an interview.
EBT-101 has since been tested in nonhuman primates, which showed it reached every tissue in the body where HIV reservoirs reside.
Excision licensed the therapy from the universities with a goal of moving it into clinical trials. Now, the FDA is on board.
The biotech plans to initiate a phase 1/2 clinical trial later this year, according to the statement.
The technology used by Excision was licensed from the lab of famed CRISPR pioneer Jennifer Doudna. The company is also working on similar treatments for other viruses, including herpes and hepatitis B.
Excision’s news arrives the same week that Intellia announced a gene editing therapy for acute myeloid leukemia had been cleared for human trials by the FDA.
BY IAN SAMPLE
THE GUARDIAN
Doctors have told health services to prepare for a new era of cancer screening after a study found a simple blood test could spot multiple cancer types in patients before they develop clear symptoms.
The Pathfinder study offered the blood test to more than 6,600 adults aged 50 and over, and detected dozens of new cases of disease. Many cancers were at an early stage and nearly three-quarters were forms not routinely screened for.
It is the first time results from the Galleri test, which looks for cancer DNA in the blood, have been returned to patients and their doctors, to guide cancer investigations and any necessary treatment.
BY EMILY WALTZ
NATURE
After a decade of fighting for regulatory approval and public acceptance, a biotechnology firm has released genetically engineered mosquitoes into the open air in the United States for the first time. The experiment, launched this week in the Florida Keys — over the objections of some local critics — tests a method for suppressing populations of wild Aedes aegypti mosquitoes, which can carry diseases such as Zika, dengue, chikungunya and yellow fever.
BY MICHAEL MARSHALL
NEWSCIENTIST
Researchers led by Shan-Lu Liu at the Ohio State University say there is “no credible evidence” of genetic engineering. The virus’s genome has been sequenced, and if it had been altered, we would expect to see signs of inserted gene sequences. But we now know the points that differ from bat viruses are scattered in a fairly random way, just as they would be if the new virus had evolved naturally.
BY HARMEET KAUR
CNN HEALTH
About 15 years ago, an Amish family in the eastern US was hit by an unexplainable tragedy — one of their children died suddenly while playing and running around. Just a few months later, the same fate befell another one of their children. Continue Reading →