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The Readout Damian Garde & Meghana Keshavan

A third Covid-19 vaccine is effective

AstraZeneca said this morning that its coronavirus vaccine reduced the risk of Covid-19 infection by an average of 70.4%, according to an interim analysis of large Phase 3 trials conducted in the U.K. and Brazil.

The AstraZeneca vaccine, developed in partnership with Oxford University, is the third vaccine to announce positive clinical trial results this month. Two vaccine candidates from Moderna and a partnership of Pfizer and BioNTech, showed 95% efficacy against Covid-19 infections in their respective clinical trials.

The interim analysis was based on a total of 131 Covid-19 cases. Two different dosing regimens were used, which yielded different results. The vaccine, called AZD122, was 62% effective in participants who received two “full” doses one month part. For participants who received a half dose followed a full dose one month later, the vaccine was 90% effective, AstraZeneca said.

Read more.

Resilience launches with $800 million to transform biotech manufacturing

Biotech venture capitalist Robert Nelsen began sounding the Covid-19 alarm as early as January — “pissed off,” in part, because he was concerned the industry lacked the manufacturing capacity that would be needed to develop new therapies and vaccines for the pandemic. This rage has resulted in a new company: Resilience, backed with $800 million from Nelsen’s ARCH Venture Partners and others, STAT’s Matthew Herper and Damian Garde report

The goal: Hire the best experts in one company and plow R&D dollars into learning how to more efficiently manufacture treatments that are made from viruses (gene therapy), genetic material (some vaccines), or a patient’s own cells.

“We want to own the next generation of [manufacturing] technology,” Nelsen told STAT.

Read more

Merck buying OncoImmune for its Covid-19 drug

Merck is paying $425 million to acquire Maryland-based OncoImmune — with aims to get access to its Covid-19 drug, STAT’s Matthew Herper writes. The experimental treatment, dubbed CD24Fc, has shown promise in clinical trials, according to Merck R&D chief Roger Perlmutter — but manufacturing could be tricky. The company hopes to offer the medicine, if shown to be safe and effective, in the first half of 2021. 

When tested in 203 patients, the medicine showed a 60% higher probability of improvement in clinical status — and reduced the risk of respiratory failure by 50%. Before Covid-19, the drug, which works by tamping down the immune system, has been tested in graft-versus-host disease.

Read more. 

Progeria treatment approved

The FDA has approved a medication for progeria, an ultra-rare genetic disorder that causes premature aging in children, the Boston Globe writes. The life expectancy for the disease is 14 years; children tend to die from hardening of the arteries.

The new drug, lonafarnib — to be sold by Eiger BioPharmaceuticals under the brand name Zokinvy — works by preventing the buildup of the defective progerin protein, which triggers the premature aging. Clinical trials have demonstrated a mortality reduction of 60 percent, and children live longer — on average, another two and a half years. The drug has been tested in nearly 100 children since 2007. 

“It’s tremendously energizing,” said Leslie Gordon, medical director of the Progeria Research Foundation — and mother to a child with the condition. “Now when somebody finds out that their child has progeria, they will immediately find out there is a treatment.” 

FDA grants EUA for Regeneron’s antibody cocktail

Regeneron’s antibody cocktail — famously used to treat President Trump — has been granted an emergency use authorization by the FDA. A similar drug made by Eli Lilly was given the same green light earlier this month. 

The EUA is a bit narrow: It’s meant for patients over 12 who have a confirmed case of Covid-19 and are at high risk for developing a severe form of the disease. The drug seems most effective in patients earlier in the course of their disease, so it’s not currently authorized in people who are hospitalized or need oxygen. 

There’s still a supply issue: Regeneron said it would have enough antibodies for 80,000 people by the end of November, 200,000 by the first week of January, and 300,000 by the end of January. After that, it plans to ramp up production with the help of Roche, the New York Times writes

More reads

  • Make list price the touchstone for drug pricing across the supply chain. (STAT
  • NIH fails to disclose enough details about drug licensing, watchdog report finds. (STAT)
  • Lilly, Precision Biosciences team up on Duchenne gene therapy in $135 million deal. (FierceBiotech)

Thanks for reading! More tomorrow,

Damian

Monday, November 23, 2020

STAT

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