1
May
2020

A Time for Empathy

Luke Timmerman, founder & editor, Timmerman Report

This is a fragile moment.

It’s May 1. Some of us have been in social isolation for two solid months. Everyone’s at some point on the continuum of stir crazy. More than 30 million people are out of work. Tempers are flaring. Protestors are carrying guns. It’s obvious we can’t sustain a maximalist social-distancing policy much longer.

Today, we have half of the 50 states doing some kind of partial lifting of stay-home orders, some variations on gradual re-opening of their economies – even though only 14 states are reporting declines in new cases. Masks, regular deep cleaning, shift work, and physical spacing in normally crowded spaces are all being tried out to mitigate the spread.

This virus is so befuddling, it’s hard to say much of anything about it with certainty. But it seems safe to say that some places will be more successful than others at keeping infection rates down with a careful turning of the dial.

The curves are deeply disappointing. We’re in what looks like a long plateau of steady infection and death. We now have more than 1 million confirmed cases of COVID19, and more than 63,000 confirmed deaths. More than 2,000 people are dying per day.

Our failure to run adequate diagnostic testing leaves us flying blind, unable to execute on the classic test/trace/isolate strategy that everyone agrees is essential, and which South Korea and others have shown works.

We had the tiniest glimmer of encouraging news this week about an antiviral medicine, remdesivir. It was shown in a rigorous NIH-sponsored study to reduce hospitalization time by four days. It’s not much in the grand scheme of things. An improvement in survival rates would be a bigger deal. Still, the result counts for something, because it can relieve some pressure on hospitals.

Really good news, in the near-term, would be the US getting its act together on testing, tracing and isolation. If we do that, then it should be possible for as little as 7 percent or so of the population to be isolated at any one time, allowing the rest of us to go about our business. Betz Halloran, an outbreak modeler at Fred Hutch working with collaborators at Northeastern University, made that remark in a panel discussion I moderated for Life Science Washington a week ago.

How much work needs to be done to get to adequate testing? As of May 1, we have done 6.5 million tests in the US. Grand total since late January. A Harvard group says we need to do 5 million tests A DAY by early June, and 20 million A DAY by midsummer.

We have our work cut out in more ways than one. We can’t duck the testing issue, because vaccines or seriously good treatments in the form of neutralizing antibodies will almost certainly not magically appear before the second wave.

Which brings me to my final point.

Our society needs to take a look in the mirror about how we treat each other, because we’re going to be in this betwixt-and-between mode, with partial re-opening and partial re-tightening, for a while. It’s a psychological tension we will all have to manage for longer than any of us would like.

Pathological selfishness, cruelty, and callousness has been coursing through our information ecosystem for years. Bad faith has been ascendant. A 24/7 information war has been raging, driving millions of people to extreme views that were unthinkable not that long ago.

The virus has struck us at a dark time.

The infowar has depleted our society’s empathy reservoir. You see it in popular Internet memes, like “Boomer Remover.” You see a guy in the Michigan state capitol, taunting National Guardsmen by breathing in their face, as if to blow smoke from a cigarette. You do see acts of kindness and empathy and courage on the news, but they are offset by this ugly behavior. It’s like a stain on our soul.

This is a test for our society.

This moment reminds me of something passed down from my Dad. He was idealistic at first, and then disillusioned, like many Vietnam veterans. He didn’t want his son to enlist in the Army. And yet, he was deeply patriotic. He instilled that spirit in me. It’s still there with me every day. I believe in our institutions like NIH, CDC, FDA. In our universities. In our entrepreneurial spirit. In our form of democratic self-governance – of the people, by the people, for the people. In our Bill of Rights. In our checks and balances that protect us from monarchy and tyranny.

It’s painful to see people traffic in abject cynicism, thumbing their noses at CDC guidance, clamoring for hydroxychloroquine without evidence, and injecting bleach. The erosion of support for and belief in science — as the best rational means for understanding the world — is a devastating indictment of life in the 21st century.

Now we can see how this cynicism about our institutions and our fellow citizens compounds.

We see it in sharp relief in a pandemic that disproportionately harms the most vulnerable. The elderly. Veterans. Prisoners. Black and brown people who can’t flip the switch and work from home. Low-wage workers in meat-packing plants. Native Americans on reservations.

I remember another thing my Dad taught me.

“A society is judged by how it treats the most vulnerable,” he said.

This quote, or variations of it, have been attributed commonly to Fyodor Dostoevsky, to Mahatma Ghandi, and Harry Truman.

We should remember those wise words, and act on them as best we can.

If we can foster some more humanity toward our fellow citizens, we might just come out the other side of this in a more perfect union. If we can resist the urge to call people names, even when they do things like stick hair dryers up their noses or go to the grocery store without masks, we can begin the process of turning down the cruelty and viciousness and ignorance and extremism. There are plenty of other things to do. Donate to your local food bank. Send a kind letter to an old friend from the other side of the aisle.

We can’t swing a sledgehammer to eliminate the cruelty. We have to radiate kindness.

What are you doing every day to uplift people?

Now, on to the rest of the week in biotech.

The Big Data Readout

The NIH reported results from a randomized study of 1,063 hospitalized patients with COVID19 who got Gilead Sciences’ antiviral drug remdesivir or a placebo. The median time to recovery from illness was 11 days for patients on the drug, and 15 days on the placebo – a 31 percent improvement, which was statistically significant. The drug didn’t show a statistically significant benefit on survival rates, although there was a slight trend in the right direction. Tony Fauci, director of the National Institute of Allergy and Infectious Diseases, called it “quite good news” and the kind of data that will create a new standard of care.

Gilead Sciences separately reported that another study showed that a 5-day course of treatment was about as good as a 10-day course of treatment. That’s meaningful because it means Gilead will be able to treat more patients with whatever supplies it can manufacture.  

Worthwhile Reading From Around the Web

Testing

Vaccines

  • An Oxford Group Takes the Lead in Vaccine Race. NYT. Apr. 27. (David Kirkpatrick)
  • What You Need to Know About a Vaccine. Gates Notes. Apr. 30. (Bill Gates)

Science Features/Commentary

Science

Epidemiology

  • A Grim Milestone at 100 Days. From 1 case to 1 million. Medium. Apr. 30. (WA Dept of Health)
  • Almost half of US – 45 percent of the Population – Is At Increased Risk from COVID19 Because of Co-Morbidities. Centers for Disease Control and Prevention. Apr. 27. (Mary Adams et al)

Investigations

Policy

Communication

  • Journalism Is Under Attack from Coronavirus and the White House. But We’re Winning. NBC News. Apr. 27. (Andy Lack)

Worth a Listen

Non-Covid Science

Feasibility of Blood Testing, Combined with PET-CT, to Screen for Cancer and Guide Early Intervention. Science. Apr. 28. (Bert Vogelstein et al)

Data That Mattered

Regeneron and Sanofi reported a not-so-encouraging update on the IL-6 inhibitor, sarilumab (Kevzara). A Data Safety Monitoring Committee recommended a halt to enrollment in an ongoing Phase III of COVID-19 patients with “severe” disease, but recommended continuing enrollment of the cohort with “critical” disease. The companies will also quit giving the low dose, and give everyone the higher dose.

Regeneron and Sanofi had better news from a trial of their PD-1 inhibitor cemiplimab (Libtayo). The drug reduced the risk of death by 32.4 percent in a study, compared with chemotherapy, when evaluated in patients getting their first round of therapy for locally advanced or metastatic non-small cell lung cancer, and with greater than 50 percent of their tumor cells positive for the PD-L1 protein. The finding was so strikingly positive that a Data Safety Monitoring Committee recommended the study be halted early so all patients could get the drug. The companies said they will take the data to US and EU regulators in 2020.

Roche reported that orally administered liquid risdiplam, a survival motor neuron-2 (SMN2) splicing modifier, passed a Phase II clinical trial for infants ages 1 to 7 months with Type 1 spinal muscular atrophy. Researchers reported a significant increase in motor function after 12 months of therapy. If approved by regulators, it would be an alternative to Novartis’ Zolgensma gene therapy, and Biogen’s Spinraza. For this product, Roche leads clinical development, in collaboration with the SMA Foundation and PTC Therapeutics.

Financings

Cambridge, Mass.-based Rome Therapeutics raised $50 million in a Series A financing from GV, Arch Venture Partners and Partners Innovation Fund. The plan is to make drugs for cancer and autoimmunity based on knowledge of repeat sequences of DNA, aka “the repeatome.”

San Diego-based Erasca Therapeutics, a targeted cancer drug developer, raised $200 million in a Series B financing. Arch Venture Partners and Cormorant Asset Management co-led. Jonathan Lim, former CEO of Halozyme and Ignyta, is the co-founder and CEO.

Shanghai-based Mabwell Biotech raised $280 million in a Series A financing. It’s reportedly a rollup of nine R&D and production companies in China.

Oakland, Calif.-based Dascena, a machine learning for diagnostics company, said it raised $50 million in a Series B led by Frazier Healthcare Partners. The company also announced a publication in the BMJ of an algorithm it made to help doctors treat severe sepsis.

Seattle-based Avalyn Pharma raised $35.5 million in a Series B to continue work on pulmonary fibrosis and chronic lung allograft dysfunction. Norwest Venture Partners led. Bruce Montgomery is CEO.

Dallas-based Taysha Gene Therapies raised $30 million in a seed financing co-led by PBM Capital and a fund led by former AveXis CEO Sean Nolan. The company said it’s working on 15 AAV gene therapy programs.

Personnel File

Nathanael Gray and Priscilla Yang, star chemical biologists, are moving from the Harvard/Longwood Medical universe to Stanford University. See the fist pump below from Stanford’s Carolyn Bertozzi. (See was a guest on The Long Run in 2019).

Sue Desmond-Hellmann joined GV as an advisor. She’s the former CEO of the Bill & Melinda Gates Foundation, chancellor at UCSF, and president of product development at Genentech. See the fist pump below from GV partner David Schenkein, who worked with Sue at Genentech.  

New York-based Health Reveal, a clinical AI company, hired Julie Stern as chief technology officer.

Waltham, Mass.-based Xilio Therapeutics, a cancer immunotherapy company, hired Martin Huber as chief medical officer.

Rosana Kapeller was named CEO of Cambridge, Mass.-based Rome Therapeutics (see above). She’s the former chief scientific officer of Nimbus Therapeutics.

Deals

Vertex Pharmaceuticals struck a research collaboration with Waltham, Mass.-based Affinia Therapeutics to work on novel adeno-associated virus (AAV) capsids for gene therapy. Initial focus will be on Duchenne muscular dystrophy, myotonic dystrophy type 1 and cystic fibrosis. Affinia will get up to $80 million in upfront and milestone payments during the research term.

Just Evotec, a leading biologics manufacturer, agreed to work with Ology Bioservices on antibodies for coronavirus. Ology is supported by a defense contract, and is tapping Just as a subcontractor. Terms weren’t disclosed. (See Just Evotec EVP Jim Thomas, on scaling antibodies and vaccines for COVID-19, in this Apr. 16 editorial on TR).

UK-based AstraZeneca and the University of Oxford, also in the UK, announced plans to collaborate on a recombinant vaccine candidate for SARS-CoV-2. Academics bring the discovery work, while industry brings development, manufacturing and distribution capabilities to the table. The first Phase I trial started last week. Terms weren’t disclosed.

Catalent, a contract drug and biologics manufacturer, agreed to work with Johnson & Johnson on manufacturing scale up for the company’s lead COVID19 vaccine candidate. Catalent said it will hire 300 workers to do the job.

Regulatory Action

San Diego-based Neurocrine Biosciences won FDA clearance to market opicapone (Ongentys) as a once-daily oral pill in addition to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.

GSK secured the FDA green light to start marketing its PARP inhibitor niraparib (Zejula) as monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status. This is one of those anticipated label expansions that GSK anticipated would make its acquisition of Tesaro pay off.

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