Covid-19 roundup: EU‘s top scientist resigns in rebuke to agency’s Covid response; J&J posts negative data for its HIV drug
As the novel coronavirus took root around the globe in early March, the European Union’s top scientist proposed launching a program that would fund the world’s top researchers working on new drugs, vaccines, diagnostic tools and other tools in the Covid-19 response.
But today, Mauro Ferrari, the Italian-American who leads the European Research Council, is resigning. He told the Financial Times that he was met with unanimous opposition from the ERC’s governing Scientific Council, who said they were only allowed to fund “bottom-up” research proposed by scientists and not give “top-down” dictates that reflected EU priorities.
“I have been extremely disappointed by the European response to Covid-19,” he said in a statement provided to and published by FT, citing failures to coordinate on borders, health policies, or targeted scientific reserarch.
“I thought that at times like these, the very best should pick up their best weapons, and go to the frontier, to the front-lines, to defeat this formidable enemy,” he added. “I argued that this was not the time for scientific governance to worry excessively about the subtleties of the distinctions between Bottom-Up versus Top-Down research.”
Ferrari, an early pioneer of nanomedicine, took his post in January. He said he developed a plan with European Commission president Ursula von der Leyen after she asked him about pandemic response, but “the very fact that I worked directly with her created an internal political thunderstorm.”
Ferrari, who retains a teaching post at the University of Washington, said he stepped down to launch an international Covid-19 response initiative. ”I am afraid that I have seen enough of both the governance of science, and the political operations at the European Union,” he said. “Now it is time for me to return to the frontier, to the frontlines of the fight against Covid-19, with real resources and responsibilities, away from offices in Brussels, where my political skills are clearly inadequate, and again at the true service of those who need new medical solutions.” — Jason Mast
J&J researchers: Our HIV antiviral doesn’t work against Covid-19
A J&J HIV antiviral now being used in a couple of trials against Covid-19 has no effect against the novel coronavirus, researchers for the company found.
In a preprint posted today, the researchers said that darunavir, a drug that inhibits HIV proteases, showed “no activity” against SARS–CoV-2. That was in contrast to remdesivir, the Gilead drug that’s been given to thousands of Covid-19 patients and for which clinical data are expected soon. Used as a positive control, remdesivir showed “potent antiviral activity.”
“Overall the data do not support the use of DRV for treatment of Covid-19,” they wrote.
Desperate for approved drugs that might be effective against a new virus, Doctors turned to HIV drugs early in the crisis, although there’s limited evidence that they have since proven effective. A trial published in the New England Journal of Medicine showed two such drugs — a combination of lopinavir and ritonavir that AbbVie markets as Kelatra — offered “no benefit” to patients, although critics noted that the patients in the study may have been given the drugs too late for them to be effective.
J&J warned early on that darunavir was unlikely to work, and some virologists have argued that, in comparison to a broad-spectrum drug like remdesivir, HIV protease inhibitors are too specialized to HIV to be effective for such a different type of virus. Still, Clinicaltrials.gov lists three studies — one in China, one in Thailand, and one in Spain — that are using darunavir as part of their protocol.
Remdesivir’s success in vitro — in test tubes — had already been established. Human data on the drug is expected as early as this week. — Jason Mast
AstraZeneca joins Covid-19 drug hunt with antibody discovery pact
Two days after GlaxoSmithKline reserved a $250 million front row seat in the search for antibodies that can neutralize the virus causing Covid-19, Big Pharma brethren AstraZeneca has unveiled its own discovery effort.
The UK drugmaker may be joining the game almost a month later than Eli Lilly — which enlisted Canadian antibody shop AbCellera for its effort — but it’s intent on moving fast. The aim is to be ready for clinical evaluation in the next 3 to 5 months.
More than 50 of its staffers — with expertise in virology, protein engineering, clinical and bioprocess — have been assigned to the in-house discovery work, leveraging a technology developed in a pact with the US Defense Advanced Research Projects Agency. They will scour several sources, from patients who have recovered from Covid-19 to humanized mice to lab techniques such as phage display, in pursuit of the most promising candidates.
Collaborations with government and academic experts will add to its firepower. The Chinese Academy of Sciences and Vanderbilt University Medical Center, for instance, are providing genetic sequences for antibodies they have identified to be assessed by AstraZeneca. Meanwhile, the United States Army Medical Research Institute of Infectious Diseases and the University of Maryland School of Medicine will help with the preclinical safety and efficacy tests.
It marks AstraZeneca’s first major initiative to develop potential treatments for the coronavirus infections ravaging the world, following face mask donations and a collaboration with GSK to boost testing capacity in the UK.
Antibody-based treatments have been described as a bridge between vaccines and therapeutics as they have the potential to both prevent and treat Covid-19. Regeneron and GSK-partnered Vir were among the earliest and most prominent in the space, though smaller players such as Brii Bio and I-Mab are also pitching in. — Amber Tong
A fourth vaccine technology may go into the clinic in a month
Following the mRNA, DNA and adenovirus-based vaccine candidates against SARS-CoV-2, Novavax said it’s locked in a recombinant nanoparticle vaccine to push into human trials by mid-May.
It’s the same technology behind the flu vaccine, NanoFlu, that produced encouraging immunogenicity data in a Phase III trial read out recently. In that study, NanoFlu appeared non-inferior to Sanofi’s best-selling Fluzone.
The current timeline for its Covid-19 program — dubbed NVX-CoV2373 — is weeks ahead of schedule, said CEO Stanley Erck. Preliminary results on whether it is safe and generates neutralizing antibodies are expected in July. By then, Germany’s BioNTech and CureVac are expected to have entered the clinic with their mRNA vaccine constructs as well.
Animal studies suggest that Novavax’s vaccine did induce the production of spike protein-specific antibodies, which would theoretically block the virus from entering the cell by defending the ACE2 human receptor binding domain.
Placebo-controlled and blinded, their Phase I will recruit around 130 healthy adult volunteers.
Emergent BioSolutions is manufacturing the vaccine for clinical trials. CEPI, the Oslo-based coalition that’s backed a swath of drugmakers pursuing a coronavirus vaccine, gave Novavax $4 million back in March. — Amber Tong
Global trial enrollment sees drastic drop
As the pandemic sweeps around the world, forcing biopharma companies to modify their R&D plans, a new report has captured just how dramatically clinical trials are being disrupted. The average number of new patients entering trials per study site around the world decreased 65% year-over-year in March, the clinical trial service firm Medidata found. Break it down by geographic regions, and you see the UK (80%) and India (84%) hit hardest, followed by the US (67%), France (68%) and Spain (68%).
The two countries that improved between February and March were Argentina and China. In China, we saw a 68% decrease in new patients entering trials YoY during March, but the silver lining was that March was 240% higher than February in terms of new patients added, which could be a leading indicator of China returning to normalcy.
A number of companies, including some of the biggest players, have hit pause on trials to a varying degree, the report noted. But for any remaining activity, a shift to virtualization — or to lower-impacted regions — will be key. — Amber Tong
Funds, equipment and now for some free medicine
As the coronavirus pandemic robs people of their jobs, creature comforts and freedom to meet friends and family in the United States, it often means individuals also lose access to health insurance, which is often linked to employment.
While its Big Pharma compatriots have offered up financial support, equipment and allowed their certified personnel to volunteer their services to combat the outbreak, Bristol Myers Squibb is taking things one step further. In an expansion to its existing patient support programs, the company said it would provide its medicines for free eligible unemployed US patients who have lost their health insurance due to the Covid-19 pandemic.
“At this time, we have not experienced any disruption in our clinical or commercial supply chain due to the pandemic,” chief Giovanni Caforio said in a statement.
Among other efforts, the company has also identified approximately 1,000 compounds in its discovery library that it is making available to collaborators, such as the Bill and Melinda Gates Foundation, for screening for potential treatments for Covid-19, it said, adding that it is also evaluating certain medicines in its portfolio that could be included in near-term clinical trials. — Natalie Grover
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