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The Readout Damian Garde & Meghana Keshavan

The FDA gets a chance to be normal in public

There is, in objective terms, nothing extraordinary about FDA meetings. There are no insults, few interruptions, and no dramatic helicopter entrances. And in a year full of walkbacks, misstatements, and political pressure, a little banality might be just what the FDA needs.

As STAT’s Helen Branswell reports, Thursday brings a special meeting of the agency’s Vaccines and Related Biological Products Advisory Committee, or VRBPAC, which will discuss, in public, what kind of evidence is necessary to declare a Covid-19 vaccine safe and effective. It will probably be boring, and that’s a good thing, said Jason Schwartz, an assistant professor of health policy and management at the Yale School of Public Health.

“It shows the public that this is how FDA is going about its decisions,” Schwartz said. “It's not the White House. It's not the President driving the train, but it's these processes, these very technical and sometimes dry processes that will be driving the review of vaccines in the months ahead.”

Read more.

The U.K. is one step closer to giving people Covid-19, for science

The U.K. has taken the first step toward running a so-called challenge study for Covid-19 vaccines, one in which healthy volunteers would willfully contract the virus in the name of quickly testing potential medicines.

The government signed a deal with a contractor called Open Orphan to develop a safe model for future challenge studies. In the coming months, Open Orphan will run a study to determine just how big a dose of Covid-19 a person must receive to get infected. Once that’s sorted out, the company will design its challenge trial and, pending approval, start it some time in 2021.

That’ll be too late for the many potential Covid-19 vaccines already in late-stage development, but that doesn’t mean challenge studies can’t be a vital help in dealing with the pandemic, said Andrew Catchpole, chief scientist at Open Orphan’s challenge study subsidiary. Covid-19 is likely to be a lingering problem, Catchpole said, creating demand for a quick, replicable way to vet new vaccines.

“While one hopes the first generation of SARS-CoV-2 vaccines are efficacious, we can’t plan on that,” he said. “The reason for setting this up is to have a model available for the next generation.”

Hong Kong’s next big biotech IPO is on the way

Weeks after engineering a $451 million IPO for the Hong Kong drug maker Everest, the investment outfit CBC Group is piecing together its next big biotech debutant.

As STAT’s Jonathan Chan reports, CBC just merged two of its portfolio companies, AffaMed Therapeutics and EverInsight Therapeutics, with the plan of taking the combined firm public. AffaMed is focused on ophthalmology, while EverInsight has a pipeline of treatments for central nervous system disorders, making for what CBC CEO Wei Fu said is a complementary pairing.

CBC, formerly known as C-Bridge Capital, has been among the biggest beneficiaries of Hong Kong’s embrace of biotech IPOs. Prior to Everest’s listing, CBC portfolio companies Ascletis, Innovent Biologics, and I-Mab BioPharma all went public on the Hong Kong Stock Exchange.

Read more.

Martin Shkreli might have developed a drug for Covid-19 after all

Back in 2015, a company called KaloBios suspended the development of its lead drug after its CEO, Martin Shkreli, got arrested. Five years and a name change later, that same drug is now a potential treatment for Covid-19, and that same company has quintupled in value.

As Bloomberg reports, KaloBios is now called Humanigen, and it’s under new leadership and ownership. Its drug, lenzilumab, is an antibody to an inflammatory protein called GM-CSF. In cancer, blocking GM-CSF could be a way to avert the immune side effects of CAR-T therapy. In Covid-19, it might tamp down the inflammatory reactions that can lead to lung damage and death.

Humanigen will find out later this quarter, with the results from a trial involving 300 patients hospitalized with Covid-19. If the trial succeeds, Humanigen will seek an emergency use authorization for lenzilumab, which would make for a remarkable third act for a company once rescued from bankruptcy by a man now in federal prison for securities fraud.

More reads

  • Get your ticket for the November 2020 STAT Summit. (STAT)
  • Evotec secures grant to evaluate antibody drugs for Covid-19. (Reuters)
  • Super-secretive anti-aging biotech Calico tees up the first visible clinical trial of an experimental drug. (Endpoints)

Thanks for reading! Until tomorrow,

Tuesday, October 20, 2020


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