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CRISPR gene editing therapy for HIV is heading into human testing after FDA clearance

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.

emerging technologies

Blood test spots multiple cancers without clear symptoms, study finds

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.

emerging technologies

First genetically modified mosquitoes released in the United States

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.

research news

Did coronavirus come from a lab?

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.

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The world’s first Gattaca baby tests are finally here
SickKids scientist calls for ‘national strategy’ to get genome sequencing covered in Canada
World’s first living organism with fully redesigned DNA created
Scientists may have found a way to treat cancer without chemotherapy by replicating our body’s own self-destruct system
Despite CRISPR baby controversy, Harvard University will begin gene-editing sperm
AP Exclusive: First gene-edited babies claimed in China
FDA approves first gene therapy for an inherited disease
U.S. scientists try 1st gene editing in the body
Memphis Meats rolls out first lab-grown poultry
DIY Gene Editing: Fast, Cheap—and Worrisome
New study shows cloned sheep are living long lives with few health problems
Crispr: Chinese scientists to pioneer gene-editing trial on humans
Genes can’t be patented, rules Australia’s High Court
Kuwait makes DNA tests mandatory after Islamic State bombing
research news

No one knew why the kids in 2 Amish families were dying suddenly. Now researchers have some answers

By: Editor | January 17, 2020

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 →

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genomic privacy

Pentagon warns military members DNA kits pose ‘personal and operational risks’

BY JENNA MCLAUGHLIN AND ZACH DORFMAN YAHOO NEWS EXCLUSIVE The Pentagon is advising members of the military not to use consumer DNA kits, saying the information collected by private companies could pose a security risk, according to a memo co-signed by the Defense Department’s top intelligence official. A growing number of companies like 23andMe and Ancestry sell testing kits that allow buyers to get a DNA profile by sending in a cheek swab or saliva sample.

Cops Now Using Warrants To Gain Access To DNA Services’ Entire Databases

BY TIM CUSHING TECHDIRT Cops have discovered a new source of useful third-party records: DNA databases. Millions of people have voluntarily handed over personal information to a number of services in exchange for info on medical markers or distant family members.

research news

Scientists win historic Nobel chemistry prize for ‘genetic scissors’

BY PAUL RINCON BBC SCIENCE Two scientists have been awarded the 2020 Nobel Prize in Chemistry for developing the tools to edit DNA. Emmanuelle Charpentier and Jennifer Doudna are the first two women to share the prize, which honours their work on the technology of genome editing.

Quest to use CRISPR against disease gains ground

BY HEIDI LEDFORD NATURE The prospect of using the popular genome-editing tool CRISPR to treat a host of diseases in people is moving closer to reality. Medical applications of CRISPR–Cas9 had a banner year in 2019.

professional regulation

There Still Aren’t Any Rules Preventing Rogue Scientists From Making Gene-Edited Babies

EMILY MULLIN MEDIUM / ONE-ZERO Around this time last November, Chinese scientist He Jiankui stunned the world when he revealed the birth of the first known gene-edited babies. Working in relative secrecy, he had used CRISPR to modify human embryos in the lab and then established pregnancies with those embryos.

Genetically modified mosquitoes breed in Brazil

BY FABIAN SCHMIDT DW.COM SCIENCE An attempt to contain the populations of the yellow fever mosquito Aedes aegypti in Brazil may have failed. It appears that gene mutations have been transferred to the local population.

emerging technologies

Gene therapy partially restores vision in rare blindness disorder

BY IAM SAMPLE THE GUARDIAN Two men with progressive blindness have regained some of their vision after taking part in the first clinical trial of a gene therapy for the condition. The men were among six patients to have experimental treatment for a rare, inherited, disorder called choroideremia, which steadily destroys eyesight and leaves people blind in middle age.

Britain gives scientist go-ahead to genetically modify human embryos

BY KATE KELLAND REUTERS Scientists in Britain have been give the go-ahead to edit the genes of human embryos for research purposes, using a technique that some say could eventually be used to create "designer babies". Less than a year after Chinese scientists caused an international furor by saying they had genetically modified human embryos, Kathy Niakan, a stem cell scientist from London's Francis Crick Institute, was granted a license to carry out similar experiments.

gene patents

Like air and water, DNA should not be patentable

BY ANDRÉ PICARD THE GLOBE AND MAIL ‘Gene patents no longer need to stand in the way of diagnosing life-threatening disease.” That’s how Alex Munter, president and chief executive officer of the Children’s Hospital of Eastern Ontario, summed up the impact of an out-of-court settlement in the lawsuit CHEO launched against Transgenomic Inc. in 2014. Transgenomic, a biotechnology company based in Omaha, Neb., owns five gene patents related to the potentially deadly heart condition Long QT syndrome.

End of the road for Myriad gene patent fight

BY KELLY SERVICK SCIENCE The molecular diagnostics company Myriad Genetics has put an end to a long battle to defend controversial patents on genetic tests for cancer risk. Several of the companies Myriad was suing for patent infringement announced settlements this week, and The New York Times reports that the company is in discussions to settle the remaining suits.

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In case you missed it…

Russian biologist plans more CRISPR-edited babies

BY DAVID SYRANOSKI NATURE A Russian scientist says he is planning to produce gene-edited babies, an act that would make him only the second person known to have done this. It would also fly in the face of the scientific consensus that such experiments should be banned until an international ethical framework has agreed on the circumstances and safety measures that would justify them.

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