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Pharmaceutical giant Merck has announced plans to acquire privately-held OncoImmune for $ 425 million in cash, securing rights to an under-the-radar drug that has shown striking results in hospital patients with Covid-19.
The drug, CD24Fc, was shown in an advanced clinical study in September to reduce the risk of respiratory failure or death by more than 50% in patients hospitalized with Covid-19 and requiring oxygen, said Merck Monday.
The drug was given as an intravenous infusion in addition to the standard treatment, which could include remdesivir and dexamethasone, and was compared to standard treatment alone. The data, in 203 patients, also showed that patients receiving CD24Fc had a 60% higher chance of seeing improved clinical status.
“The results are remarkable,” said Merck Research Director Dr Roger Perlmutter in a telephone interview.
With Covid cases averaging nearly 170,000 per day in the United States and a record number of people in hospital with the disease, a drug that could dramatically speed recovery and reduce the risk of death or patients falling. so seriously ill that they need ventilators could make a major difference in the pandemic.
But there is one problem: supply.
“We realized that this tiny little company wasn’t in a position to make CD24Fc to try to treat everyone who could potentially benefit from this drug,” Perlmutter said. “We decided that the only way, seriously, that this can be brought to the people who need it is if we rely on our abilities.
Merck plans to move some of its manufacturing capacity to start manufacturing the drug. But it is a complex drug to manufacture and it will take time. Perlmutter said it was aiming “before the middle of next year, and ideally well before that”, so that there is sufficient supply.
OncoImmune, founded and led by Yang Liu, director of the Division of Immunotherapy at the University of Maryland School of Medicine, published the main results of the trial on its website in September. They have not yet been published in a peer-reviewed journal. Merck says submission of detailed results is pending.
Although the results received little attention from the world, one person who noticed was Moncef Slaoui, the US government’s chief advisor to Operation Warp Speed. He noted in a telephone interview on Nov. 1 that the data for the drug from OncoImmune “was just amazing”, noting “a relative impact on mortality that is very clear.”
Slaoui explained that the drug prevents the immune system “from being over-activated”. This is the same reason why the steroid dexamethasone was shown to be so effective in a trial in June to treat patients with more severe stages of Covid-19; when patients become so ill, it may be their own immune system that is overworking that is causing problems, not the virus.
“Frankly, no one would have believed it would have such an effect,” said Perlmutter, when asked why the CD24Fc results received so little attention. “If you look at the other anti-inflammatories that have been studied in very sick patients with Covid-19, it has been difficult to show that there is any effect at all.”
In addition to the potential to aid the pandemic, Merck acquired OncoImmune because it sees possibilities for CD24Fc beyond Covid. It has shown promise for graft versus host disease, a dangerous immune reaction that can occur after a bone marrow transplant, and Perlmutter said it may have other applications as well.
The $ 425 million deal comes with potential for additional payments depending on certain regulatory milestones. But Merck only earns CD24Fc, while OncoImmune will transfer other rights and assets to a new company, in which Merck will invest $ 50 million.
The company doesn’t plan to apply for emergency use authorization from the Food and Drug Administration until it has enough drugs for people to actually use it, Perlmutter said. It is now the task of Merck – which is also developing a pill for Covid as well as two vaccines against the disease.
“Now that we have this terrible and terrible increase in Covid-19 cases, and so many people are hospitalized in serious or critical condition, and so many people in intensive care units, tens of thousands, if not hundreds of thousands or more just in US States might need this drug, ”Perlmutter said. “We are going to move heaven and earth to produce the material.”
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