Covid-19 roundup: An old, cheap steroid proves to be a major boon to coronavirus patients; BARDA puts $85M behind Regeneron antibody effort
Researchers today spotlighted data from a clinical study offering the first hard evidence that a treatment can save the lives of patients suffering from Covid-19.
The old generic dexamethasone was tied to a one-third reduction of deaths among ventilated patients with a one-fifth reduction in mortality among a group getting oxygen. There was no benefit for patients who did not require respiratory assistance.
“Dexamethasone is the first drug to be shown to improve survival in COVID-19,” noted Peter Horby, an Oxford professor and a chief investigator in the trial. “This is an extremely welcome result. The survival benefit is clear and large in those patients who are sick enough to require oxygen treatment, so dexamethasone should now become standard of care in these patients. Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide.”
“(I)t is fantastic that the first treatment demonstrated to reduce mortality is one that is instantly available and affordable worldwide,” enthused Oxford’s Martin Landray. — John Carroll
BARDA puts $85M behind Regeneron’s antibody effort
BARDA, the US biodefense agency, is backing Regeneron’s Covid-19 antiviral antibody effort with $85 million.
Although BARDA has already promised over $2 billion to accelerate and scale the development of Covid-19 vaccines, but this is the largest tranche of funding yet for a treatment effort. BARDA worked with Regeneron on their Ebola antibody effort – helping lead to one of the first two successful treatments for the virus in a trial last August – and the pair first announced collaboration on a similar effort for Covid-19 in February.
The news of the funding comes days after Regeneron put their first cocktail of antibodies in the clinic. The Tarrytown-based biotech plans to eventually run 4 trials, 2 of them testing the drug as a treatment and 2 as a prophylactic.
HHS has also funded antibody efforts from AstraZeneca and SAb Biotherapeutics. Roche and J&J, among others, have received funding for other types of treatment. — Jason Mast
Peter Kolchinsky offers Covid-19 player Novavax a thumbs up and $200M
RA Capital’s Peter Kolchinsky is backing Novavax’s Covid-19 play, to the tune of $200 million.
A fund affiliated with RA is buying 4.4 million shares of stock $NVAX in the company at the June 12 closing price.
Covid-19 has been a big help for Novavax, which has had its share of clinical failures to deal with. CEPI stepped up with its largest commitment to date, backing the biotech’s Phase I and Phase II trials for NVX-CoV2373 for up to $384 million while “dramatically” increasing its production capacity for the vaccine antigen as well as the adjuvant needed to boost its efficacy. That money was added on top of the $4 million CEPI sent Novavax to get things going in R&D without any delays for negotiations.
“The global vaccine effort is searching for candidates that are capable of both generating the highest neutralizing antibody titers and large-scale production. We are excited to increase our investment in Novavax, which along with resources from CEPI and the U.S. Department of Defense, will support Novavax in its important work developing an effective, scalable vaccine for SARS-CoV-2,” said Kolchinsky in a statement. — John Carroll
Sanofi sets aside $679M cash for new vaccine sites in France
As Sanofi pushes its parallel R&D efforts on a pair of Covid-19 vaccine candidates, the French drugmaker said it would pour $679.4 million (€610 million) into two vaccine sites on its home turf.
The commitment to “make France its world class center of excellence” comes just weeks after CEO Paul Hudson, a Brit, drew the ire of French ministers by saying in an interview that the US government “has the right to the largest pre-order because it’s invested in taking the risk” — a comment Sanofi swiftly walked back.
“Sanofi’s heart beats in France,” Hudson said in a prepared statement. “Sanofi is a major healthcare player in France, in Europe, and worldwide. It is our responsibility to focus our resources and expertise against the current pandemic, but also to invest in preparing for future ones.”.
French authorities have been working with Sanofi the last several months to achieve this, he added, in a comment that echoed Germany’s decision to buy a stake of mRNA biotech CureVac with €300 million in federal money. And President Emmanuel Macron came through with a pledge of €200 million to fuel domestic research and manufacturing, a boost Hudson has been advocating for.
“Everybody saw that during this crisis some commonly used drugs were no longer produced in France and Europe. So we must no longer just ask questions, but draw the conclusions,” Macron said at Sanofi’s Marcy-L’Étoile facility.
At the same time — and it might have been drowned out by the Synthorx buyout and dramatic cuts in the cardio and diabetes units — the company reminded readers of the press release that vaccines were identified as a key area for growth in the corporate strategy Hudson laid out last year.
Sanofi plans to build a vaccine production site at Neuville-sur-Saône and a research center at Marcy-l’Étoile, creating a whole chain from R&D to manufacturing within the country.
The former facility will cost an estimated €490 million over five years and is expected to create 200 new jobs. The latter will focus on developing future vaccines, with highly-specialized labs focused on emerging diseases and pandemic risks. — Amber Tong
Imperial College of London preps Phase I trial of mRNA vaccine
A new mRNA vaccine effort is entering the clinic.
Three months after Moderna began human Covid-19 vaccine testing with an mRNA candidate, a candidate based on similar technology from the Imperial College of London will go into an early-stage trial this week, Reuters reported.
Unlike virtually every other clinical-stage Covid-19 vaccine, the Imperial College does not have a major industry partner. Instead they’ve received over $56.5 million in funding from parliament and donors, and have set up a new venture for commercializing the vaccine should it prove safe and effective.
Although similar in principle to Moderna’s candidate — putting the genetic code for a coronavirus protein into human cells, which express the protein and trigger an immune response — the college’s technology differs in key ways. Called small-amplifying RNA, the genetic code in the vaccine will replicate itself inside cells, allowing for much smaller doses and thus a potentially much broader scale. It was developed in part by Robin Shattock, who has also designed the Covid-19 candidate.
To commercialize the vaccine, the college set up a new company called VacEquity Global Health with the Hong Kong-based investment firm Morningside Ventures. Its goal will be to make the vaccine as widely available as possible, while still turning a profit — possibly by selling for slightly higher prices in high-income than low-income countries.
The vaccine will be one of several that enter the clinic in the coming weeks and months. CureVac, one of the first biotechs to begin developing a vaccine and which also uses mRNA, said early in the pandemic that they would aim for trials in June. And today scientists in Singapore said they would begin testing an mRNA vaccine from the US biotech Arcturus in August. — Jason Mast
AstraZeneca reveals more of manufacturing plan, adds another partner
The streak of manufacturing and supply deals AstraZeneca has struck for Oxford’s Covid-19 vaccine, coupled with rapid progress on the clinical front, appears to have emboldened the company in dialing up its hopes, with CEO Pascal Soriot predicting that the protection would last for about a year, as reported by Reuters.
Under ideal circumstances — which would involve enough volunteers given placebo get infected by the coronavirus — results of the ongoing Phase III trials will be ready in August or September.
“We are manufacturing in parallel,” he added. “We will be ready to deliver from October if all goes well.”
Through a global network of partners, AstraZeneca said it’s secured capacity for 2 billion doses through 2021. A growing list of partners have reserved more than half of that collectively: 400 million doses for Europe in its latest deal with France, Germany, Italy and the Netherlands; 300 million for the US; 100 million for the UK; and 400 million to low- and middle-income countries by the end of the year.
On Tuesday the pharma giant added Cobra Biologics to the contractor fold, tasking the UK manufacturer with providing GMP manufacture of the vaccine candidate AZD1222.
Cobra had begun working with Oxford’s Jenner Institute in March, before AstraZeneca jumped on board with its powerhouse infrastructure. The scientists who developed the recombinant adenovirus vector immunization were thinking about mass production early on; some of the companies that they had tapped for their manufacturing consortium, such as Oxford Biomedica, have since teamed up with AstraZeneca.
“The agreement with AstraZeneca comes at an opportune time for us as we bring three additional viral vector suites online as part of our ongoing advanced therapies expansion programme,” Peter Coleman, chief executive at Cobra, said in a statement. — Amber Tong
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