Covid-19 roundup: Yet more doses of the AstraZeneca-Oxford vaccine; A second randomized hydroxychloroquine study fails
Another gene therapy company is offering its facilities to the Covid-19 fight.
Oxford Biomedica, a 90s-era spinout of Oxford University, has signed a 5-year agreement to help manufacture the Covid-19 vaccine being developed by Oxford University’s Jenner Institute and AstraZeneca. The deal is with the Vaccines Manufacturing and Innovation Centre, a government-sponsored non-profit set up 2 years ago to shore up the isle’s vaccine manufacturing capacity.
The partnership works because of the particular type of vaccine the Jenner Institute it’s developing. An adenoviral vector, the vaccine candidate uses a weakened version of a common cold-causing virus to deliver the gene for a coronavirus into human cells. It’s a similar system to the one gene and cell therapy companies like Biomedica or AveXis — which last month agreed to manufacture a vaccine based on a similar technology — use to deliver their therapies. Alongside its own pipeline, the UK biotech helps supply the lentiviral vectors used in Novartis’s CAR-T treatment Kymriah.
Biomedica first announced it was working with the Jenner Institute in early April, when they joined a consortium dedicated to pushing their vaccine forward. But the new agreement finalizes the partnership and calls for the Vaccines Manufacturing and Innovation Centre to help the biotech outfit two new manufacturing sites, with an eye toward satisfying UK and EU demand for a vaccine, should it prove effective.
Chinese biotech brings second antibody into clinic
Junshi dosed their first patient in China, though the company has its own partnership with Lilly and will start a US trial on the drug candidate, known as JS016, in the second quarter of the year. Phase I is in healthy volunteers and will test safety and immunogenicity.
Numerous companies, prominent and obscure, are trying to develop antibodies that can treat or prevent Covid-19. These lab-grown molecules mimic the body’s natural best defense against foreign invaders and have proven the best treatments for other pathogens, including anthrax, RSV, and Ebola. Two of the most watched efforts are the ones from Regeneron and Vir Biotechnology, both of which are set to enter the clinic in the coming weeks and months.
Most recently AbbVie stepped into the race, signing a collaboration with the Chinese biotech Harbour Med and a pair of Dutch academic and medical centers. Antibodies are particularly difficult to manufacture, and, like vaccines, multiple candidates may be needed. Junshi said they can make 100,000 doses by the end of the year.
Second hyrdoxychloroquine RCT fails, this time in hospitalized patients
Days after a large University of Minnesota study found the anti-malarial hydroxychloroquine didn’t prevent exposed patients from developing Covid-19, UK scientists have halted a trial after finding that the drug had no effect on hospitalized patients.
”This is not a treatment for Covid-19. It doesn’t work,” lead investigator and Oxford University professor Martin Landray told reporters, per Reuters. “This result should change medical practice worldwide. We can now stop using a drug that is worthless.”
The results add to a growing, if sometimes muddled body of evidence against a drug that doctors identified early as one of the potential off-the-shelf treatments for the virus and which became one of the most talked-about and studied therapies after President Trump touted it in press conferences, often over the advice of medical experts.
While researchers raced to test the drug in randomized, controlled trials, doctors — boosted by an FDA emergency use authorization for the pill and lacking other good options — prescribed it for their Covid-19 patients. Two of the earliest pieces of evidence against its use as a coronavirus treatment then were publications in the New England Journal of Medicine and the Lancet that tracked medical records of patients worldwide who had been given the drug and found hydroxychloroquine actually raised the risk of death.
Both of those trials were, in a notable and highly unusual event for the prestigious journals, retracted last week after investigators found they were unable to verify the data, which had been collected by a tiny US firm with questionable scientific expertise. Those studies had informed decisions by WHO and several research institutes to halt trials on the drug, and their retraction in theory opened the door for the drug to still prove effective.
But the retractions came just as the first and much-anticipated randomized controlled trials — the gold standard when it comes to evaluating drugs — came out. First, in NEJM, the University of Minnesota found that across 821 patients, hydroxychloroquine didn’t work as post-exposure prophylaxis.
Now, the UK trial found it didn’t work in hospitalized patients. Investigators assigned 1,542 patients to hydroxychloroquine and compared them with 3,132 patients randomly assigned to standard of care. There was no significant difference in death rates after 28 days, length of stay in the hospital or other outcomes.
Trials are for now continuing around the world for the anti-malarial and some doctors continue to see potential benefit, but the investigators in both of the randomized controlled studies were blunt in their assessments.
“Now that we know there is no benefit and we know there are side effects, there is really no reason to take this drug further,” the University of Minnesota’s Radha Rajasingham told Endpoints News last week.
Landray, the Oxford professor, said simply: “If you’re admitted to hospital, don’t take hydroxychloroquine.”
A UK vaccine lab tries to get around the industry
All roads to a Covid-19 vaccine so far have led through Big Pharma. Now a prominent British lab is trying to change that.
Robin Shattock, the scientist behind the vaccine project at the Imperial College of London, told the New York Times today that the college is starting a new “social enterprise” that would ensure Shattock’s vaccine is available at the lowest possible cost both in the UK and in low- and middle-income countries. The Imperial College’s work is one of two academic Covid-19 vaccine projects the UK government has poured tens of millions of pounds into, alongside the much-publicized Oxford University candidate.
The new company will be called VacEquity Global Health and founded in partnership with the Hong-Kong based investment firm Morningside Ventures. While aiming to make the vaccine widely accessible, VacEquity will also be for-profit and may charge higher rates in wealthier countries.
The new venture comes amid a growing debate over how to best to scale up and allocate a Covid-19 vaccine once one (or several) proved effective, particularly for middle-income countries. With the US and the UK funding candidates early and lavishly in exchange for preferential access, the EU has recently signaled they would make similar investments, and GAVI — the Gates-backed nonprofit that works on vaccination across the developing world — is trying to do the same.
Almost all of these efforts, though, go through existing big biotech and pharma companies. Oxford partnered with AstraZeneca on their vaccine, and have since signed agreements with the US, the UK and entities in other countries promising to supply up to 2 billion doses of a vaccine on a “no profit” basis. Moderna, developing a vaccine designed in part at the NIH, signed a deal with the Swiss CMO Lonza to scale up to 1 billion doses by next year.
The college thinks they may have an upper hand on scale because of the technology they use, called self-amplifying RNA. It is similar to the technology used in the vaccines being developed by Moderna and the Pfizer-BioNTech collaboration — delivering the genetic code for the virus antigen — but it can be given in much smaller doses because the RNA makes copies of itself after it’s been injected. Another RNA vaccine effort from CureVac is also designed to be given at much smaller doses, although that one works by triggering an immediate immune response.
Shattock’s vaccine is set to enter a Phase I/II on June 15, followed by a 6,000-person efficacy trial in October.
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