J and J BARDA set early 2021 finish line for $1B vaccine race; FDA allows emergency drug use, ahead of pivotal data
J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.
That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.
The J&J candidate (as well as two other backups) was created on an adenovirus vector-based platform in a collaboration between its Janssen unit and researchers at Harvard’s Beth Israel Deaconess Medical Center. They began working with multiple constructs back in January, the company added, selecting the ones producing the largest immune response in preclinical experiments. Initial safety and efficacy data are available by the end of the year.
According to the website, the technology used here has been deployed during the Ebola epidemic.
With production to begin imminently, the company is also scaling up its global manufacturing capacity so that it will eventually be able to supply 1 billion doses of the coronavirus vaccine, which will be affordable and available “on a not-for-profit basis for emergency pandemic use.”
Officials have long appealed for Big Pharma to lend their muscles to the frantic vaccine race. Even though Moderna has begun work to create millions of doses, demand around the world will likely be higher by multiple factors.
In addition to a prophylactic, J&J said it’s also expanding its partnership with BARDA, or Biomedical Advanced Research and Development Authority, on its antiviral work. Scientists in Belgium are helping screen its and others’ compound libraries. Undisclosed additional funding has been poured into this project.
FDA authorizes emergency use of controversial (hydroxy)chloroquine — donations from Novartis, Bayer flood in
The FDA has endowed chloroquine and hydroxychloroquine — the pair of malaria drugs in the spotlight thanks largely to President Trump’s feeling about it — with its first emergency use authorization for a Covid-19 treatment, paving the way for hospitals to prescribe the million doses of the medicines that have been donated to the national stockpile.
The OK comes ahead of any pivotal data on the drugs’ efficacy and safety for Covid-19 patients, something that FDA chief Stephen Hahn has insisted would be required for any drug approved to fight Covid-19.
On the same day CEO Vas Narasimhan told Swiss newspaper SonntagsZeitung that hydroxychloroquine sulfate is Novartis’ biggest hope against the coronavirus, the pharma giant’s generics unit, Sandoz, has donated 30 million doses of it to the HHS. Germany’s Bayer contributed 1 million doses of chloroquine phosphate.
BARDA, the HHS department tasked with preparedness and response, submitted the EUA request. The FDA noted that this authorization is intended to benefit adult and teen patients who are hospitalized and can’t participate in the handful of clinical trials underway in the US.
Based upon limited in-vitro and anecdotal clinical data in case series, chloroquine phosphate and hydroxychloroquine sulfate are currently recommended for treatment of hospitalized COVID-19 patients in several countries, and a number of national guidelines report incorporating recommendations regarding use of chloroquine phosphate or hydroxychloroquine sulfate in the setting of COVID-19. […]
Based on the totality of scientific evidence available to FDA, it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of chloroquine phosphate and hydroxychloroquinesulfate when used to treat COVID-19 outweigh the known and potential risks of suchproducts.
“The safety profile of these drugs has only been studied for FDA approved indications, not COVID-19,” the agency added, referring to malaria, lupus and rheumatoid arthritis.
Others have also questioned the efficacy of the drugs, poking holes in the study results being offered up as proof that they might work.
While the EUA covers only FDA-approved hydroxychloroquine sulfate, regulators are also opening up to chloroquine phosphate that has not gotten the OK in the US for any indications.
The suggested dose for chloroquine phosphate is 1 gram on day 1 followed by 500 mg for 4 to 7 days. As for hydroxychloroquine sulfate, the suggested dose is 800 mg to start and then 400 mg on subsequent days.
Moderna pauses rare, infectious disease trials amid expected trial delays
The Covid-19 pandemic is hitting every biotech player with products in clinical trials — including those pressing full-speed ahead with efforts to battle it. Moderna disclosed that it’s pausing enrollment for a number of studies in rare and infectious diseases, and cautioned that even the trials that remain open will run into delays.
Programs affected include mRNA-1653 for human metapneumovirus and parainfluenza virus 3 infections, mRNA-3704 for methylmalonic acidemia and mRNA-3927 for propionic acidemia. Enrollment to the chikungunya virus antibody trial, which provided Moderna with some of its earliest human data, has been halted by the site.
Three oncology studies will go on, though the biotech acknowledged delays in enrollment. Even for two fully enrolled studies — a Phase II in CMV and Phase I for Zika — some participants will not be able to receive their next vaccine dose on time.
Like many fellow biotechs, Moderna instituted a remote work plan as early as March 12, while having lab and manufacturing personnel continue to come in on altered policies.
Vir enlists Generation Bio and its gene therapy platform as a new arm of antibody program
Just days after nominating lead antibody candidates for testing within months, George Scangos has a new idea for what his team at Vir can do to fight and protect against SARS-CoV-2. The biotech is embarking on research to see if Generation Bio’s gene therapy tech can be used to deliver instructions for making neutralizing antibodies within the body and keeping them there for years.
The hope is that this approach can provide broad and longer-lasting protection for population-wide prevention and treatment.
The platform that Generation Bio offers — comprising close-ended DNA, cell-targeted lipid nanoparticle delivery and a scalable capsid-free manufacturing process — also promises to supplement Vir’s own manufacturing capabilities for antibodies, Scangos said.
Gottlieb offers criteria for beginning to reopen economy
When can the US move on from the strict lockdown measures currently in place? It won’t be by Easter; Trump has abandoned his goal of reopening the economy in two weeks, extending social distancing guidelines for another month. But in lieu of a consensus on a concrete timeframe, Scott Gottlieb — the former FDA commissioner who’s been dubbed the “shadow coronavirus czar” — and a few colleagues have offered up a road map.
In a new report published by the American Enterprise Institute, Gottlieb, writing with two ex-FDA officials and two Johns Hopkins researchers, argues that the national response must be rolled out in four phases. The aim in Phase I is to slow the spread; Phase II will see a state-by-state reopening, with some distancing measures still in place; those can be lifted once immune protection including vaccines and therapeutics is established and the country enters Phase III; and Phase IV is all about rebuilding readiness for the next pandemic.
The US is in Phase I now, with community transmission observed in every state. A few conditions must be met before a state decides to reopen (and enter Phase II):
A sustained reduction in cases for at least 14 days,
Hospitals in the state are safely able to treat all patients requiring hospitalization without resorting to crisis standards of care,
The state is able to test all people with COVID-19 symptoms, and
The state is able to conduct active monitoring of confirmed cases and their contacts.
Mask wearing, voluntary isolation and quarantine, massive scaling of contact tracing, comprehensive surveillance systems, increased supply of personal protective equipment, a functional healthcare system and increased diagnostic capacity would help us get there, the authors wrote.
If the US manages to stop the virus by adopting a nationwide shelter-in-place for the next eight to 10 weeks, UPenn health policy expert Ezekiel Emanuel believes that the economy can be restarted in June — provided that a mass education campaign and a Covid-19 certification system are also in place.
Outbreak in New York claims the life of Jefferies CFO Peg Broadbent
As the state of New York marked the grim milestone of 1,000 deaths due to Covid-19, investment bank Jefferies mourned the death of Peg Broadbent, its longtime CFO, on Sunday morning. Having served in the post since 2007, Broadbent had helped build the firm up from less than half its current size, CEO Rich Handler and president Brian Friedman wrote in a joint statement. “His decency, calmness and dry wit were always there, always making things better.”
Teri Gendron, currently CFO of the parent group’s financial services arm, has been named his interim successor.
Machines approved to clean hospital workers’ PPE amid fears of shortage
In an attempt to address hospitals’ urgent need for personal protective equipment, the FDA has sanctioned a mask sterilization technology developed by private nonprofit Battelle. The Ohio-based group has designed its critical care decontamination system to clean up to 80,000 pieces of PPE (from masks to gloves and goggles) at a time. It intends to send one machine to New York City and one to Stony Brook, NY, with additional machines to be dispatched to Washington.
→ It’s been a hectic week for Gilead, which first halted its compassionate use program for remdesivir and then came under fire for obtaining orphan drug status, which it swiftly withdrew. So CEO Dan O’Day took some time to explain the clinical path and new expanded access program going forward. (Endpoints link)
→ Continuing to target patients with severe cases of Covid-19, Sanofi and Regeneron have cooked up a second pivotal trial to test their Kevzara in 300 patients. The theory is that by blocking IL-6, the drug can tamp down a dangerous overreactive immune response. (Endpoints link)
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AUTHOR Amber Tong, Endpoints News