Covid-19 roundup: Kate Bingham to lead UK taskforce; Federal judge to Shkreli: You’re not going to save the world, stay in prison
A top biotech venture capitalist has been named to chair a UK government taskforce on developing and equitably distributing a vaccine.
Kate Bingham, managing partner of SV Health Ventures, will lead the taskforce, helping coordinate efforts across industry, academia and government. Those efforts are now backed by £250 million ($303 million) in commitments from the UK government.
As one of five managing partners at SV, Bingham founded the £250 million Dementia Discovery Fund five years ago. She has also at times been a voice for a change in biopharma, in 2016 penning an open letter eventually signed by dozens of scientists and executives pillorying a biotech for hosting a party that used women to woo male clients.
The taskforce, announced at the end of last month, also includes noted immunologist John Bell and executives from Wellcome Trust and AstraZeneca. AstraZeneca is leading the UK’s principal vaccine effort, manufacturing a vaccine developed at Oxford, with the promise of giving the country early access to the vaccine should it prove effective.
World summit to play host to vaccine and treatment fight
The simmering fight over access to existing and eventual Covid-19 drugs and vaccines will get another arena today.
Officials from every country will meet via link today for a summit that is widely expected to center on a single issue: A voluntary patent pool where companies and research institutes could place their Covid-19 inventions, allowing other countries to make cheap versions. Although voluntary, the pool could put pressure on vaccine and drug developers to make their intellectual property accessible.
The resolution is expected to be approved, but with softer wording after pushback from countries with major pharmaceutical companies, including the US, the UK and Switzerland, The Guardian reported. A similar debate emerged 20 years ago as the first AIDS drugs became available, leading to a declaration from the World Trade Organization to reaffirm the rights of countries in some situations to circumvent patents for essential medicines.
Gilead ending trials on Covid-19
Three months after they started testing remdesivir in China, Gilead is ending its remaining clinical trials for the Covid-19 antiviral, Reuters reported. They will reportedly wind down by the end of the month.
The two open-label trials have enrolled over 8,000 patients. The yawning number that attracted critics, who said the drugmaker was pulling patients from randomized controlled trials that could yield data faster, but Gilead said was designed to assure greater access.
Now, per Reuters, hospitals are concerned the end of the trials will cut off access to the drug.
Although with the data from a randomized NIH trial, the drug has now been authorized by the FDA – in theory obviating part of the need for clinical trials. Doctors have raised concerns about how the Trump administration has distributed the drug so far. First, they did not announce criteria or a plan for which hospitals would receive the drug, and the first shipments overlooked some hospitals with a high number of patients and gave to hospitals with few patients. Later, HHS announced state governments would be responsible for deciding which hospitals in their state would receive the drug, but they did not outline how they would decide how many doses to give to each state.
Those doses are from Gilead, which has pledged to donate 1.5 million doses of remdesivir – about 40% of which are for patients in the US. The company has said it is actively ramping manufacturing.
Federal judge to Shkreli: You’re not going to save the world, stay in prison
Last month, Martin “Pharma Bro” Shkreli posted a paper online with an unusual addendum.
“I am asking for a brief furlough (3 months) to assist in research work on Covid-19,” Shkreli wrote in a PDF published to the otherwise empty site of a company he founded in 2015, Prospero Pharma. “As a successful two-time biopharma entrepreneur, having purchased multiple companies, invented multiple new drug candidates, filed numerous INDs and clinical trial applications, I am one of the few executives experienced in ALL aspects of drug development from molecule creation and hypothesis generation.”
At the time, few in the industry were impressed with either the quality of Shkreli’s scientific paper — which detailed an effort to screen compounds for ones active to Covid-19, a practice already commonplace — nor his capacity to make unique contributions in a coronavirus fight that was already enlisting some of the country’s top scientists and biotech executives.
And now, it seems, a judge was similarly unimpressed with his plea.
In a 9-page ruling Saturday, US District Judge Kiyo Matsumoto sided with prosecutors who described Shkreli’s plea for release as indicative of the “delusional self-aggrandizing behavior” that landed him in jail to begin with.
”The court does not find that releasing Mr. Shkreli will protect the public, even though Mr. Shkreli seeks to leverage his experience with pharmaceuticals to help develop a cure for Covid-19 that he would purportedly provide at no cost,” Matsumoto wrote. “In any event, Mr. Shkreli’s self-described altruistic intentions do not provide a legal basis to grant his motion.”
Although the conditions in some prisons during the pandemic have become the subject of significant criticism, with many inmates unable to secure home transfers despite outbreaks within the facility and urgings from the Justice Department, Matsumoto determined that wasn’t the case for Shkreli, who was “healthy” and whose low-security prison in Allenwood, PA has not experienced an outbreak.
“Defendant requests to be released into, among other places, an apartment in New York City, the epicenter of the covid-19 pandemic,” Matsumoto wrote.
Shkreli, 37, was given a 7-year sentence in 2017 for defrauding investors.
UK unveils plan to get early access to 30 million vaccines by September
Forget 12-18 months. The British government is hoping to vaccinate half its population by September, or 9 months after the initial outbreak — an aggressive timeline that is among the fastest put forward by world leaders or public health officials.
Business Secretary Alok Sharma said Sunday that the government would fund AstraZeneca with an additional £84 million ($102 million) as part of an agreement that will see the British drugmaker give the UK 30 million doses by September, should it prove effective in trials over the summer.
”The UK will be first to get access,” Sharma said. “We can also ensure that in addition to making the vaccine available to developing countries at the lowest possible cost.”
The UK plan slots into a larger debate over how to distribute the vaccine when it becomes available. The US has funded companies’ vaccine efforts at a larger scale, and have similarly secured rights to make certain orders as part of those funded agreements. AstraZeneca, which is producing a vaccine developed at Oxford University, had already announced that the UK would get early timeline.
These plans have so far not sat well with other world leaders. Last week, Sanofi CEO Paul Hudson caused a stir among his board and in the French government when he told Bloomberg that the US would get “the right to the largest pre-order.” And UNAIDS and Oxfam released a letter from current and former world leaders, calling for a “people’s vaccine” that was accessible “first for front-line workers, the most vulnerable people, and for poor countries with the least capacity to save lives.”
The UK–AstraZeneca plan is of course contingent on the vaccine proving effective — no sure thing. A study in non-human primates showed the vaccine appeared to elicit an immune response and protect the monkeys from serious lung damage, but it did not entirely stop infection. The developers are now in Phase I, but have said they plan to move into a combined Phase II/III this month. Public health officials have warned a vaccine could take 12-18 months, or significantly longer, and that some vaccine candidates are likely to fail in the clinic.
The new funding includes £38 million pounds for the erection “rapid-deployment facility” to begin manufacturing over the summer, before a larger factory, the Vaccines Manufacturing and Innovation Centre, opens at Oxford next summer.
Europe nears remdesivir okay
The US authorized it, Japan has approved it, and now Europe may soon clear it as well.
The head of the EMA, Guido Rasi, said that an initial authorization for remdesivir could come in the next few days, Reuters reports. The Gilead antiviral was shown in an NIH trial last month to reduce the time it takes patients to recover from Covid-19.
The EMA began their review process for remdesivir a day after the NIH results became public on April 29, but indicated the process could take time — a contrast with the FDA, who was rumored to be nearing an emergency use authorization the day the trial came out and ultimately issued one two days later. The drug is already authorized on the continent to be given under compassionate use.
Okaying remdesivir, though, will only be half the battle. Acquiring and distribution will be the rest. In the US, that process has been marred by confusion, as the federal government failed to detail a criteria for which hospitals got access and an inadequate supply left some doctors scrambling. Gilead, though, has been working since the early days of the outbreak to scale up production and have accelerated their efforts since the NIH trial.
Last week, the California company signed deals with 5 generics manufacturers in Pakistan and India, although those contracts are largely for distribution in low and middle income countries.
Vir Biotechnology publishes antibodies in Nature
Vir Biotechnology, the George Scangos-led infectious disease company, published in Nature the details for the monoclonal antibody they are bringing into the clinic for Covid-19 this summer.
The paper, published initially as a preprint last month, is the first by one of the three major companies developing monoclonal antibodies against Covid-19 to detail their lead candidate. It describes an antibody called S309 that neutralizes both SARS-CoV-2, the virus that causes Covid-19, and the SARS virus that caused a major outbreak in East Asia and other parts of the world in 2002 and 2003. The idea is that by targeting an epitope — a part of the spike protein — that is present in multiple different viruses, you’re likely targeting an essential part that won’t change as the virus mutates. Vir will bring two versions of the antibody forward, one with edits to make it last longer and one with edits to make it both longer lasting and generate a stronger T cell response
Vir, along with Abcellera and Regeneron, are expected to enter the clinic with their antibodies this summer, testing them both as a prophylaxis and as a protection against Covid-19. Antibodies from Regeneron and Humabs — now a subsidiary of Vir — were the two drugs that proved effective last year against Ebola.
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