Gene therapy in the time of COVID

August 12, 2020
Today, we visit one of our members continuing important gene therapy research, even as the pandemic rages on. We also have news from SAB Biotherapeutics regarding the clinical trial of their antibody therapeutic. Read all the way to the end for Dr. Michelle McMurry…

Today, we visit one of our members continuing important gene therapy research, even as the pandemic rages on. We also have news from SAB Biotherapeutics regarding the clinical trial of their antibody therapeutic. Read all the way to the end for Dr. Michelle McMurry-Heath’s statement on yesterday’s big presidential campaign news. Here are about 780 words, just under 4 minutes.

P.S. Today at 7 PM ET, Dr. McMurry-Heath will join a Black Women’s Health Imperative webinar, Mobilizing for the Survival of Black Women Beyond COVID, moderated by CNN’s Suzanne Malveaux. Click here to register for the free event.

Gene therapy in the time of COVID

In recent months, biotech companies have heroically put resources and talent towards fighting COVID-19. However, we can’t ignore the many other diseases that affect people every day. BIO President and CEO Dr. Michelle McMurry-Heath recently visited a BIO member (with a mask!) that’s been continuing to work on treatments for rare diseases even as the pandemic rages on.

Meet REGENXBIO. Based just outside Washington in Rockville, Maryland, this innovative biotech is working to bring gene therapies to the market to reverse, improve, or even stop the course of a rare disease.

To adapt to the COVID environment, REGENXBIO established best practices regarding safety so lab employees and those involved in clinical studies continue to work onsite. For example, the company has imposed mandatory mask-wearing, social distancing, and plenty of hand sanitizer. 

But the company has not lost sight of its overall mission: to develop and deliver treatments to patients.

During the pandemic, REGENXBIO completed dosing of three patients in its phase 1/2 study of gene therapy for Mucopolysaccharoidosis Type II. And, after reporting positive data for an antibody gene therapy treatment in April, the company expects to continue trials in 2020. 

And there’s more success to come. REGENXBIO is on track to open a new manufacturing facility and expects to make further progress in other programs across its pipeline during the second half of this year. 

Watch this quick video with highlights from Dr. Michelle's visit:

Dr. Michelle McMurry-Heath at REGENXBIO

More Health Care News:

Americans for Tax Reform: ATR leads coalition of 80 groups opposing ‘most favored nation’ executive order
“Adopting these price controls will slow medical innovation, threaten American jobs, and undermine criticism of single-payer systems. In addition, a United States embrace of price controls will make it immeasurably more difficult to get foreign countries to pay their own way in the development of new medicines,” they said. 

The Washington Post: Meet the most important federal official you probably don’t know—the man who holds the fate of the coronavirus vaccine in his hands
“A top Food and Drug Administration career official, [Peter] Marks is likely to decide in the next several months whether a coronavirus vaccine is safe and effective enough to be given to tens of millions of Americans.”


SAB’s therapeutic moo-oves forward

BIO member SAB Biotherapeutics has a big announcement regarding the clinical trial of their polyclonal antibodies to treat COVID-19—another step forward in the fight against the coronavirus.

The background: SAB is a clinical-stage biopharma based in Sioux Falls, South Dakota, using genetic engineering and antibody science to breed cows with fully human antibodies for SARS-CoV-2.  

Why cows? These large animals have robust immune systems and can produce more antibodies than a lot of animals used in biotech—and a LOT more than convalescent human patients.

Now, SAB has announced that they’ve dosed the first participant in the phase 1 clinical trial to evaluate the safety of the antibody therapeutic, SAB-185. They’re getting ready to launch phase 1b soon, too.

What makes it different: SAB’s technology “leverages the native human immune response, offering a differentiated potential high-potency therapeutic option, from conventional monoclonal and monoclonal cocktail approaches, in addressing mutating targets as recently published in Frontiers in Microbiology,” the company said. 

Why it matters: The treatment “could have significant value to protect the military, front-line responders, mission-critical staff, and high-risk populations against COVID-19,” they said. 

What they’re saying: “[P]reclinical data…demonstrate that our novel immunotherapy platform can successfully neutralize mutated strains of viruses,” said SAB’s Co-Founder and CEO Eddie J. Sullivan. “Further, SAB-185 preclinical data has demonstrated highly-potent neutralizing antibodies to SARS-CoV-2 that are more potent than human convalescent plasma serum samples available against the virus. Taken together, these data suggest that SAB-185 may be effective even as SARS-CoV-2 continues to evolve.”

Learn more about SAB’s technology.

SAB Biotherapeutics: SAB Biotherapeutics Awarded $35.6M From U.S. Department of Defense for COVID-19 And Scaling Rapid Response Antibody Program
"SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a proprietary technology to produce fully human polyclonal antibodies without the need for human donors, announced today that it has been awarded an additional $35.6 million in expanded scope for its DiversitAb™ Rapid Response Antibody Program contract from the Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO – CBRND) Joint Project Lead for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnologies (JPL CBRND EB)."
BIO Beltway Report

President Trump’s Wednesday: He’s participating in an event on getting kids back to school safely.

Election Update: By now, you know about former Vice President Joe Biden’s historic pick for his running mate, Sen. Kamala Harris (D-CA). POLITICO dives into her policy positions, including on health care. BIO’s Dr. Michelle McMurry-Heath issued this statement on the selection: 

“As a young woman growing up, it was always gratifying and encouraging to see women of color attain significant education goals and leadership positions. The selection of Senator Harris to be the first woman of color as a nominee for vice president of the United States certainly can be seen as a significant achievement and encouragement for young girls all over America. Whatever ticket is elected as the next president and vice president, we at BIO look forward to working with them as we fight to protect patient access to life-saving treatments and medicines and for biotech solutions to save the planet from global warming and hunger.”

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