The curves are telling the story.

They were flat for a while. Now they’re heading up the exponential slope again.

Texas, Arizona, Florida – and even California, which did so well for so long – are among the couple dozen states that are beginning to look up at those scary curves of new COVID-19 cases.

We still have no idea where this is truly going. The CDC said yesterday that there are probably 10 times more cases in the US than have been officially counted.

Even with pandemic math this grim, nearly four months into the outbreak, we still don’t have enough people wearing masks. Not enough people are respecting social distancing guidelines.

Too many are wallowing in cynicism. Too many are stuck in denial. Too many are blinded by ideology or hatred of the other.

We are reaping what we’ve sown – too much pollution in the information age. The conservative New York Times columnist Ross Douthat would say that’s part of a decadent society.

Responsible public officials who came of age before the infodemic seem befuddled sometimes when people don’t listen.

“We have to realize that we’re a large country that has outbreaks in different regions, different states, different cities, that have different dynamics, and different phases in which they are in,” Tony Fauci, the nation’s top infectious disease official, said as far back as Apr. 23.

After a long plateau of cases in late May and June, we are recording about 38,000 cases a day, according to the CDC (see chart below). The growth trajectory of cases the past two weeks threatens to overrun hospitals in multiple states.

This new surge in the South and West is happening when the US has already recorded 122,000 dead. About 30.6 million people were receiving unemployment checks in the first week of June – about one-fifth of the US workforce. An estimated 28 million renter households are at risk of eviction in the pandemic, according to a May report by Amherst, an investment research firm. Black people in the US, of course, face a disproportionate risk of being evicted.

People are weary of the virus. People are scared about their economic future. Many don’t know how much longer they’ll have a roof over their heads.

Given this state of affairs, it’s sometimes hard to imagine a focused, intelligent, disciplined, collective problem-solving effort to wrestle this virus to the ground and get the economy back on track. The angriest, loudest, most provocative and dishonest voices suck up most of the oxygen on the Internet, drowning out the voices rooted in facts and reason. For now, we don’t seem capable of having grown-up conversations.

Those of us who care about science have to stay steady and focused.

We can be part of the solution.

The protests in the wake of the killings of George Floyd, Armaud Arbery and Breonna Taylor have shown us that people are willing and able to march in the streets. We can demand change, and get it.

We need to keep holding elected officials’ feet to the fire to create a more humane and just and healthier world. It starts with us expecting better, of not just shrugging in resigned acceptance of cynicism and corruption.

This industry is doing its part in the fight against COVID-19. Compiling this column every week fills me with hope and wonder. Read to the bottom and you’ll see why. Every week, it’s a joy to consolidate knowledge and see the remarkably fast progress on drugs, vaccines and diagnostic tests. The money flowing into this industry is breathtaking. The sheer brilliance and energy represented by the partnerships completed each week is inspiring.

I’d like to see this renewed mission-driven industry spirit spill over into other aspects of the way this business operates. The industry can get better in how it hires, develops, and treats every human being that comes to work. We can encourage everyone to vote, and remove obstacles that get in the way of people exercising that right.

We can demand elected officials to reverse disastrous anti-immigrant policies. Instead of going all-in to block changes to the way we pay for drugs, the industry can get to work on a new system that rewards drugs for the value created for patients and the healthcare system.

A lot is happening every day, and much is positive. Let’s keep the conversation going about beating COVID-19 in the near term, about strengthening our public health defenses for the long term, and about creating a more equitable and decent world for our kids forever.

Science

• Effect of Dexamethasone in Hospitalized Patients with COVID-19. Preliminary Report. MedRxiv. June 22. (Peter Horby et al)

Science Features

• How the Virus Won. NYT. June 25. (Derek Watkins et al)

Policy & Politics

• Rules for Clinical Trials in a Pandemic. WSJ. June 21. (Scott Gottlieb and Mark McClellan)
• Three Recent Reversals Highlight the Challenge of COVID19 Science. The Bulwark. June 22. (David Shaywitz)
• The US is Falling Behind Its Peers. Americans – If Not Their Leaders – Are Noticing. Washington Post. June 22. (Catherine Rampell)

Public Health

• CDC Broadens Guidance, Covering a Wider Range of Americans Facing Severe Risk of COVID-19. STAT. June 25. (Helen Branswell)
• We’re Pretending the Virus Is Gone. That Will Make it Worse. Washington Post. June 20. (William Hanage)

Epidemiology

• CDC Chief Says Coronavirus Cases May be 10 Times Higher Than Reported. Washington Post. June 25. (Lena Sun and Joel Achenbach)
• COVID-19 and Cancer. Science. June 19. (Norman Sharpless)
• Medicare Data on Who’s Getting COVID-19. Data Through May 16.

Humanity

• A Dual Degree from Oxford. A Medical Degree from Harvard. Neither Protected Me from Racism. WBUR. June 18. (Tafadzwa Muguwe)
• Why Juneteenth Matters. NYT. June 18. (Jamelle Bouie)
• WHO Chief Calls for Equitable Supplies of Dexamethasone for Severe COVID19 Patients. The Hindu BusinessLine. June 23. (Jyothi Datta)

Communication

• Research Explores How Conservative Media Misinformation May Have Intensified the Severity of the Pandemic. Washington Post. June 25. (Christopher Ingraham)
• Canaries in the Coal Mine. COVID-19 and Black Communities. Harvard Kennedy School, Shorenstein Center on Media, Politics and Public Policy. June 24. (Brandi Collins-Dexter)

Treatments

South San Francisco-based Theravance Biopharma said it dosed the first patient in a Phase II study of its lung-selective nebulized delivery form of a JAK inhibitor for hospitalized patients with COVID-19. The study, in the UK, will look at whether the drug can tamp down cytokine storms that can progress to lung damage, and ultimately help patients avoid Acute Respiratory Distress Syndrome (ARDS).  

Miami-based Ridgeback Biotherapeutics said it’s starting up a pair of Phase II trials with its novel antiviral ribonucleoside analog against SARS-CoV-2. The studies will enroll adults ages 18 and older who are PCR-positive for COVID-19 but non-hospitalized, or newly hospitalized.

Gilead said it’s gotten clearance from the FDA to move ahead with clinical development plans for an inhalable formulation of remdesivir for COVID-19, instead of just the usual intravenous form. The inhalable could be given via nebulizer outside the hospital, and at earlier stages of disease, targeted to the lungs. First patient enrollment is scheduled for August.

Cambridge, Mass.-based Evelo Biosciences said its orally available, microbiome-based therapy EDP1815 is being prepared for a randomized 469-patient Phase II/III clinical trial in the UK. The Evelo drug candidate has been tested already in psoriasis, and has shown an ability to suppress multiple inflammatory cytokines implicated in cytokine storms that have been implicated in so much suffering and death in COVID-19 patients.

Vaccines

Cambridge, Mass.-based Moderna said it formed a deal with Catalent to provide fill & finish work on its COVID-19 vaccine candidate. Catalent will be staffing up to do the fill & finish work needed for 100 million doses for the US market starting in the third quarter of 2020 (before Sept. 30). Work will be done at Catalent’s facility in Bloomington, Indiana, and the companies are looking for capacity to make hundreds of millions of more doses.

Data That Mattered

Somerville, Mass.-based Finch Therapeutics said it passed a randomized 206-patient clinical trial with a microbiome-based therapy for C. difficile infections. The company said it met the Phase II study’s main goal, delivering a cure for 74.5 percent of recurrent C. diff patients after eight weeks, compared with 61.5 percent who did that well on the standard antibiotic treatment. Finch said it’s the first time an oral microbiome therapy has passed a pivotal trial. It’s something of a boon to the field of microbiome therapeutics, which has been perceptually dragged down by the failure of Seres Therapeutics in its first pivotal study a few years ago.

Merck said its experimental 15-valent conjugate pneumococcal vaccine passed a pair of Phase III studies looking at safety and immunogenicity in adults age 50 and older, and in adults age 18 and older living with HIV.

Cambridge, Mass.-based Acceleron Pharma said it passed a 106-patient Phase II, randomized, placebo-controlled study of sotatercept as a treatment for pulmonary arterial hypertension. The drug was tested at a low and high dose, and given by subcutaneous injection every 21 days to patients already on stable background therapy. Acceleron said it was able to reduce pulmonary vascular resistance, the primary endpoint of the study, by 33.9 percent on the high dose, and 20.5 percent on the low dose. The placebo group saw a 2.1 percent reduction.

Financings

• Cambridge, Mass.-based Relay Therapeutics, a computationally driven drug discovery company, filed an S-1 prospectus to raise as much as $200 million in an IPO. For more background, see this December 2018 TR story, and this January 2020 appearance by CEO Sanjiv Patel on The Long Run podcast.
• Cambridge, Mass. and Montreal-based Repare Therapeutics, a synthetic lethal cancer drug developer, raised $220 million in an IPO priced at $20 a share. It traded up above $33 a share at last glance.
• Watertown, Mass.-based Forma Therapeutics, the developer of small molecules for rare blood diseases and cancers, raised $277 million in an IPO at $20 a share. Forma shares immediately doubled in value, and traded near $49 a share yesterday.
• San Diego-based Progenity, a molecular diagnostics company, raised $100 million in an IPO priced at $15 a share. It traded down below $11 a share in its first few days. (Readers of the Progenity IPO preview on TR from June 16 will recall this company’s unusual disclosure that it owes $49 million to settle federal and state investigations into billing irregularities.)
• China-based Genetron Holdings, a cancer diagnostics company in China, raised $256 million in an IPO priced at $16 a share. It traded down in the $12-13 range in the following days.
• Seattle-based Sana Biotechnology said it collected all the tranches of its initial funding round of $700 million. The company is working on allogeneic cell therapies for cancer, and is led by veterans of Juno Therapeutics (now part of BMS).
• Cambridge, Mass.-based Editas Medicine, the gene editing company, raised $187 million in a public offering at $31.25 a share.
• Cambridge, Mass.-based Evelo Biosciences, a microbiome-based therapeutics developer, raised $45 million in a stock offering at $3.75 a share. The financing came after Evelo announced its EDP1815 drug candidate is entering a Phase II/III clinical trial in the UK in high-risk COVID-19 patients.
• Plano, Tex.-based Reata Pharmaceuticals secured a $350 million investment from Blackstone Life Sciences.
• Denver-based Dispatch Health, a tech-enabled home health care provider, raised $135.8 million in growth capital, led by Optum Ventures.
• UK-based Epidarex Capital said it raised a new fund with 102 million pounds to invest in life science startups in the UK.
• New Haven, Conn.-based Simcha Therapeutics secured a $25 million Series A financing to further develop an IL-18 cytokine it has engineered, with directed evolution, to reverse the immunosuppressive environment that allows tumors to grow.
• Friendswood, Texas-based Castle Biosciences, a cancer diagnostics company, raised $74 million in a public offering.
• Cambridge, Mass.-based Magenta Therapeutics, seeking to improve stem cell therapies, raised $60 million in a public offering.
• NantKwest, a company developing Natural Killer cell therapies for cancer, raised $80 million in a public offering.
• Chi-Med secured $100 million in equity financing from General Atlantic.
• Baltimore-based AsclepiX Therapeutics raised $35 million in a Series A led by Perceptive Xontogeny Venture Fund. It’s developing therapies for retinal diseases.
• Cambridge, Mass.-based Leap Therapeutics, an immune-oncology company, raised $45 million in a stock offering.
• Cambridge, Mass.-based Compass Therapeutics, a cancer drug developer, raised $60 million in a private placement.

Deals

Lexington, Mass.-based Translate Bio, the developer of mRNA therapies and vaccines, expanded its 2018 collaboration with Sanofi to encompass vaccine work across broader swaths of infectious disease. Sanofi is getting exclusive worldwide rights to vaccines for infectious disease built on the Translate technology. In return, Translate is getting $425 million upfront, with $300 million in cash, and the rest in the form of a stock purchase. The companies are working on a COVID-19 mRNA vaccine candidate in preclinical development, but the collaboration also includes influenza and a couple of undisclosed viral and bacterial pathogens. Just after the deal, Translate announced plans to raise $125 million in a stock offering. (For background, listen to Translate CEO Ron Renaud on The Long Run podcast, December 2018).

Gilead Sciences, seeking to continue building out its cancer portfolio, agreed to acquire a 49.9 percent ownership stake in South San Francisco-based Pionyr Immunotherapeutics for $275 million. Gilead has an option to acquire the whole company for another $315 million, and could end up paying the Pionyr shareholders $1.15 billion more in milestones if certain goals are met. Pionyr is developing preclinical technology intended to help patients who don’t currently respond to checkpoint inhibitor therapy. (CEO Steve James was a featured speaker at the San Francisco Cancer Summit that I organized last year as a fundraiser for the Fred Hutch Climb to Fight Cancer.)

Lexington, Mass. and Amsterdam-based UniQure pulled in $450 million upfront from CSL Behring as part of a deal to commercialize its gene therapy for hemophilia B.

San Francisco-based Invitae, a genetic testing company, agreed to acquire ArcherDx. The combined company will have strengths in germline testing, somatic testing, liquid biopsy, and tissue genomic profiling for cancer. ArcherDx shareholders are getting 30 million shares in Invitae, plus $325 million in upfront. Another 27 million shares could go to ArcherDx if certain goals are met, bringing the total deal value to $1.4 billion.

Tokyo-based Sosei Heptares formed an agreement with AbbVie to co-develop small molecule drugs against G-protein coupled receptors (GPCRs) implicated in inflammatory and autoimmune diseases. Sosei Heptares is eligible to collect $32 million in upfront and near-term milestones.

Cambridge, Mass.-based Yumanity Therapeutics formed a strategic alliance with Merck, in which the big drugmaker will get access to work on two pipeline programs Yumanity has for amyotrophic lateral sclerosis and frontotemporal lobar dementia. Yumanity is getting an undisclosed upfront payment and is eligible to receive milestone payments worth as much as $500 million.

Cambridge, Mass.-based Codiak Biosciences, the developer of exosome therapeutics, agreed to work with Sarepta Therapeutics on five neuromuscular targets. Codiak stands to collect $72.5 million in upfront and near-term milestone payments. (See TR coverage, June 22, 2020).

Ann Arbor, Mich.-based Esperion Therapeutics amended its collaboration in Europe with Daiichi Sankyo. Esperion will collect its $150 million milestone payment once the companies applications for its cardiovascular drugs are cleared for marketing in Europe, not when the first commercial sale occurs, as was the case in the original deal.

Morristown, NJ.-based Melinta Therapeutics, an antibiotic developer, called off its merger agreement with Tetraphase Pharmaceuticals.

New York-based Schrodinger, the computational drug discovery company, announced a couple deals. One combines the company’s physics-based software with vivid structural imaging from cryo-EM technology from Thermo Fisher Scientific. Schrodinger also said it’s now working on antiviral therapeutic discovery against COVID-19, which could be sped up thanks to a donation of significant cloud computing power from Google Cloud.

Philadelphia-based Century Therapeutics, the developer of induced pluripotent stem cell-derived allogeneic cell therapies, agreed to acquire Empirica Therapeutics – a company with a multi-omics based approach to treating glioblastoma. Financial terms weren’t disclosed. Janelle Anderson, chief strategy officer of Century, was credited with shepherding the deal. (Listen to Janelle describe Century Therapeutics’ strategy on The Long Run podcast, August 2019).

Evotec and Samsara Capital and KCK, a family office, teamed up to invest in seed company projects in a new entity called Autobahn Labs. It has an initial collaboration with UCLA. Plans are to invest as much as $5 million per company.

Personnel File

Terri Young was hired as executive vice president, chief commercial and strategy officer, at Cambridge, Mass.-based Seres Therapeutics. She was previously vice president of global commercial strategy at Sage Therapeutics.

Brent Saunders, Randy Scott and Andrew Lo joined the board of directors at Palo Alto, Calif.-based BridgeBio Pharma, a developer of treatments for genetic diseases.

Brisbane, Calif.-based Sangamo Therapeutics said Adrian Woolfson, the executive vice president of R&D, is leaving the company. Sangamo is splitting research and development into separate functions that will both report in to CEO Sandy Macrae. Jason Fontenot will be interim head of research. The company said it’s looking for a head of development.

Regulatory Action

Cambridge, Mass.-based Epizyme, a cancer drug developer, secured accelerated approval from the FDA to start marketing tazemetostat (Tazverik). It’s for patients with EZH2-mutation positive tumors, getting third-line treatment for relapsed / refractory follicular lymphoma.

Boston-based Akili Interactive secured a CE Mark to allow marketing in the European Union for its video game-based approach to treatment of attention-deficit hyperactivity disorder (ADHD). The European clearance came just days after Akili secured clearance for its first-in-class digital therapeutic from the FDA.

Newton, Mass.-based Karyopharm Therapeutics won FDA clearance to market selinexor (Xpovio) as an oral therapy for third-line treatment of relapsed or refractory diffuse large B-cell lymphoma. It’s a second indication for the drug, which was previously cleared for multiple myeloma.

For 40 days, the numbers on new COVID-19 cases have been traversing along a flat, steady ridgeline.

Now it is back on the ascent.

The President may wish to do less testing to make it appear as though case numbers are coming down. But that won’t make the SARS-CoV-2 virus go away. The 7-day moving average shows new cases are surging – in Texas, Florida, Arizona, Alabama, South Carolina, North Carolina, Oklahoma – in a full 20 states.

This unsettling fact ought to make everyone around the country pay careful attention to our daily habits and future plans. We know this virus has a way of boomeranging back on localities that have done the hard work to flatten the curve.

The numbers are reflecting what many predicted in late May. States reported 27,000 new cases yesterday – the highest number since May 8, according to the COVID Tracking Project.

Our academic scientists, our government agencies, and our biopharmaceutical companies must continue to flat-out fly to develop diagnostics, drugs, vaccines, and practical guidance for us all.

Still, some truly positive things happened.

It’s a tentative result issued by press release, but researchers from the UK reported a surprising survival benefit from an old, generic corticosteroid, dexamethasone, in hospitalized patients with severe COVID-19.

That might help in the short term. But long term, the pandemic has forced everyone to re-assess where they find value and meaning and purpose in life. While sheltering at home with family — depressed and anxious and uncertain — we looked straight into the face of atrocious racial injustice. This country has never fully faced up to this original sin.

What’s different this time is that no one can look away. No one can change the channel. The pandemic created the conditions that are likely to keep the pressure on until we citizens start seeing the change we demand. People of all ages and races and genders are activated, and we can see the pressure being put on elected officials is yielding immediate results.

Corporate America’s past of forming committees, and issuing carefully worded and meaningless statements? Please. Ain’t gonna cut it this time.

We, the people, are keeping our eye on the ball.

The highest levels of government are watching the streets. The US Supreme Court did a couple things this week that everyone in the business community, and everyone in biopharma, ought to cheer. Led by conservative Chief Justice John Roberts, the court ruled in favor of LGBTQ people, and with young immigrants protected from deportation by the DACA program.

Both of these decisions are important to the nation’s competitive advantage, especially if we want to continue building on our 75-year post-World War II history as the No. 1 biomedical superpower. Holding onto that position and building on it depends on recruiting and retaining the best people in the world. Many happen to be immigrants. Many happen to be black. Many happen to be LGBTQ. We need them all, and we need to treat them all like full citizens.

I, for one, anticipate some troubling images of backlash to start flooding the information platforms this weekend. Immense energy on the campaign trail, in Tulsa, will go into venting grievances. Some will revel in taunting and triggering the libs.

Hateful hearts will produce vile words. Those vile words will come out of loud mouths without masks.

This is not the time to take the provocateur’s bait. Not the time to play the flame game. It’s a time for being aware of what’s going on, and making sure our actions are aligned with the outcomes we want to achieve.

Big, hard problems are on the table. Like terrible disparities in how our country treats African Americans in health, education, housing, employment, and criminal justice. Like whether we are serious about creating an equitable healthcare system for everyone.

Like anything really worth doing, this is going to take hard work over a long period of time.

Biotech and pharma had a chance to set things right in the last election cycle. It didn’t step up. In one November 2015 column, when Martin Shkreli made himself the biggest name in biopharma, I wrote:

Recent drug-pricing scandals are forcing the pharmaceutical industry into an identity crisis. The industry has angered every constituency—patients, doctors, hospitals, payers, politicians—through years of self-serving bad behavior. And now leaders need to ask:

Who are we? What are we really about?

Is this business all about ruthless profiteering by a bunch of amoral hedge fund artists with empty slogans about helping patients? Or does it balance its profit obligations with a larger human purpose: to apply the latest science to the reduction of human suffering, as former Merck CEO Roy Vagelos used to say?

This time, with the pandemic and a racial justice awakening, is different. We won’t go about business as usual, in large part because we can’t.

Let’s use this time of reflection to renew the social contract of biopharma. Let’s get to work on the really hard problems worth our time and attention.

Let’s show the world what this industry is really all about.

Treatments

Researchers at Oxford University in the UK delivered some surprising good news. Scientists there said that dexamethasone — the old/cheap/abundant and convenient corticosteroid anti-inflammatory medicine — was able to reduce death rates by about one-third in a randomized trial of 11,500 patients hospitalized with severe COVID-19. Results from the RECOVERY trial were most compelling in patients on ventilators, a little less compelling in patients on oxygen-only, and no benefit was seen in patients who didn’t need respiratory support. Many scientists were optimistic, although noted with caution that the results were issued by press release, not in a peer-reviewed journal. (See the Oxford statement). (NYT coverage)

Testing

• Ginkgo Bioworks on COVID-19 Testing. ‘If We Try, We Can Win.’ CNBC. June 18. (Chrissy Farr)

Our Broken Health Care System

• Most Coronavirus Tests Cost $100. Why Did This One Cost $2,315? NYT. June 16. (Sarah Kliff)

Communications

• We Ran the CDC. Here’s How to Talk to the Public in a Health Crisis. Barron’s. June 11. (Jeffrey Koplan and Richard Besser)
• Scientists As Heroes. Let’s Keep that Image in the Public Eye. STAT. June 18. (Marja Makarow)

Features

• Before Catching Coronavirus, Some People’s Immune Systems Already Appear Primed to Fight It. WSJ. June 12. (Jason Douglas)
• How America’s Hospitals Survived the First Wave of Coronavirus. ProPublica. June 15. (Charles Ornstein)

Humanity

• Health Disparities Among Black Persons in the US and Addressing Racism in Health Care. JAMA Forum. June 18. (Aaron E. Carroll)
• Racial Bias Skews Clinical Algorithms. New England Journal of Medicine. June 17. (Darshali Vyas et al)

Science

• Deep Mutational Scanning of SARS-CoV-2 Receptor Binding Domain Reveals Constraints on Folding and ACE2 Binding. BioRxiv. June 17. (Jesse Bloom Lab at Fred Hutch)
• Project Baby Bear Final Report on Whole Genome Sequencing for Kids With Rare Diseases in California. Rady Children’s Hospital San Diego. June 16. (Margareta Norton)
• Does Tweeting Improve Citations? One-Year Results from Prospective, Randomized Trial. (Answer: Yes). Annals of Thoracic Surgery. June 2020. (Jessica Luc et al)

Politics

• There Isn’t a Second Wave. We Are Far Better Off Than the Media Report. WSJ. June 16. (Mike Pence)
• We’re Finally Talking About Structural Racism. Republicans Are Freaking Out. Washington Post. June 18. (Paul Waldman)

Public Health

• New Rules for Summer. Be Flexible and Vigilant. WSJ. June 12. (Scott Gottlieb and Yuval Levin)
• Protecting Public Health During Protests Against Systemic Racism. June 17. (Open Letter from Harvard T.H. Chan School of Public Health Center for Communicable Disease Dynamics)
• California Mandates Mask Use Statewide. June 18. (California Department of Public Health Statement)
• CDC Urges Organizers of Large Gatherings to ‘Strongly Encourage’ Use of Face Masks. Washington Post. June 12. (Lena Sun and Chelsea Janes)
• 13 University of Texas Football Players Test Positive for COVID-19 Four Days After Resuming Voluntary Summer Workouts. Texas Tribune. June 18. (Raga Justin)

Financings

Watertown, Mass.-based C4 Therapeutics secured $170 million in financing, including $150 million in Series B equity and another $20 million in venture debt from Perceptive Advisors. The company said it is working on advancing its small-molecule protein degrading drugs to clinical proof of concept.

Medtronic collected an investment of up to $337 million from Blackstone Life Sciences to advance its diabetes pump and technology offerings for diabetes management.

UK-based Bit Bio raised an additional $41.5 million to bring its Series A financing to a close with $50 million. Rick Klausner, Bob Nelsen and Jim Tananbaum led. The company aspires to reprogram stem cells to precisely turn them into every cell type in the human body.

Foster City, Calif.-based Vaxcyte, a vaccine developer, announced its total IPO fundraising haul was $287.5 million. The IPO price on June 11 was $16. The stock closed yesterday at more than $34 a share.

Seattle-based Proprio, a computer imaging and enhanced visualization company seeking to aid surgical navigation, raised $23 million in a Series A led by DCVC.

San Diego-based Lassen Therapeutics announced it has raised a $33 million Series A financing from Frazier Healthcare Partners, Alta Partners, and Longwood Fund. It will work to develop an IL-11 directed antibody against fibrosis and cancer.

Regulatory Action

The FDA revoked its Emergency Use Authorization for chloroquine and hydroxychloroquine for COVID-19 after reviewing data that show these drugs don’t work for this indication. Even worse, the FDA said the old malaria drugs could reduce the antiviral activity of remdesivir when given in combo with that recently approved medicine for COVID-19. The US had stockpiled 63 million doses on speculation (amplified for unknown reasons by political actors) that chloroquine / hydroxychloroquine could be the real deal. Now it will have to be dispersed to patients with lupus, or to governments around the world seeking help against malaria – indications where these drugs are known to be useful.

Merck won FDA approval to market Gardasil9, the vaccine to prevent cancers from the human papillomavirus, to prevent HPV-related head and neck cancers. The vaccine has long been approved to prevent cervical cancer.

Without regard for tumor type, Merck secured FDA clearance to market pembrolizumab (Keytruda) for cancer patients with high Tumor Mutational Burden (TMB) as defined by 10 mutations or more. That determination is being made by the FoundationOne CDx companion diagnostic test, which was also approved by the FDA on the same day.

Boston-based Akili Interactive won FDA clearance for EndeavorRx, a video game that represents a first-of-its-kind “digital therapeutic” for kids ages 8-12 with attention-deficit hyperactivity disorder (ADHD). It’s been a long road, building on research from Adam Gazzaley’s lab at UCSF. See my first story on the startup in 2012.

Cambridge, Mass.-based Epizyme won FDA clearance for tazemetostat (Tazverik) as a new treatment for relapsed/refractory follicular lymphoma. It’s an EZH2 inhibitor.

Novato, Calif.-based Ultragenyx and Kyowa Hakko Kirin won FDA clearance for burosumab (Crysvita) for the treatment of tumor-induced osteomalacia (a rare disease that causes softening of the bones and muscle weakness).

Jazz Pharmaceuticals, and its Madrid-based partner PharmaMar, announced the FDA approval of lurbinectedin (Zepzelca) for small cell lung cancer. PharmaMar said it will collect a $100 million payment in connection with the FDA approval.

Data That Mattered

CRISPR Therapeutics and Vertex Pharmaceuticals presented data from the first two patients in a clinical trial of a gene-editing therapy, CTX-001, for beta-thalassemia. One has needed any blood transfusions for 15 months, while the other has been transfusion-independent for five months. Another trial for sickle-cell disease showed that the first patient – who averaged seven vaso-occlusive crises per year and five red-blood-cell packed transfusions per year prior to enrollment – has now gone nine months without any vaso-occlusive crises, no need for transfusions, and has seen hemoglobin levels rise to 11.8 grams per deciliter (pretty darn impressive, although from a single patient).

Genentech reported that risdiplam, its orally available SMN-2 splicing modifier, provided sustained improvement in motor function over a 24-month period in patients with spinal muscular atrophy Type 2 and 3. The updated data were from patients ages 2-25, from the Sunfish trial.

Genentech also said its PD-L1 inhibitor atezolizumab (Tecentriq), given in combination with Abraxane, passed a Phase III trial of patients with triple-negative breast cancer. Patients benefitted regardless of their PD-L1 expression. The primary endpoint was pathological complete response rate.   

Deals

Seattle-based Alpine Immune Sciences secured a $60 million upfront payment from AbbVie, which now obtains the option to develop and market Alpine’s CD28/ICOS costimulation dual antagonist, ALPN-101. Alpine could collect as much as another $805 million if AbbVie exercises its option and hits development and commercial milestones. Alpine will conduct a Phase II study of the drug against systemic lupus erythematosus during the option period. AbbVie said it believes the drug could have potential against other autoimmune diseases as well.

South San Francisco-based Ideaya Biosciences pocketed $100 million in upfront cash, and a $20 million equity investment, through a collaboration agreement with GSK. The two companies will further develop Ideaya’s synthetic lethal cancer drug development programs, specifically against MAT2A, Pol Theta, and Werner Helicase.

Cambridge, Mass.-based Sarepta Therapeutics obtained access to Watertown, Mass.-based Selecta Biosciences’ immune tolerance platform for use in its programs against Duchenne Muscular Dystrophy and limb girdle dystrophy. Sarepta will do research to see whether the platform helps reduce neutralizing antibody formation to the adeno-associated viral vectors it uses for its gene therapy programs. Terms weren’t disclosed.

San Diego-based Neurocrine Biosciences formed a collaboration with Takeda Pharmaceuticals. Neurocrine is paying $120 million upfront cash, plus development and commercial milestones worth up to almost another $2 billion. Neurocrine will be responsible for developing seven pipeline programs, including three clinical stage assets for schizophrenia, treatment-resistant depression and anhedonia. Takeda retains an option to 50-50 profit share, which it can decide to exercise at certain development milestones.

Cambridge, Mass.-based Magenta Therapeutics agreed to provide access to its experimental antibody-drug conjugate to Beam Therapeutics, which is seeking to evaluate the targeted ADC as a conditioning regimen for patients receiving its base-edited cell therapies.

Personnel File

Redwood City, Calif.-based Revolution Medicines added Eric T. Schmidt, the chief financial officer of Allogene Therapeutics, and Peter Svennilson, the managing partner at The Column Group, to its board of directors. Larry Lasky is stepping down from the board, and will remain a scientific advisor.

Boston-based Dewpoint Therapeutics added Olivier Brandicourt, the former CEO of Sanofi, and Jurgen Eckhardt, the SVP and head of Leaps by Bayer, to its board. (See TR coverage by Asher Mullard on Dewpoint and its membraneless organelles for drug discovery. April 2019).

Oxford Sciences Innovation said Luke Williams and Ross Hendron joined the UK-based firm as scientists in residence.

Cambridge, Mass.-based FerGene hired Ambaw Bellette as chief operating officer, Vijay Kasturi as vice president of medical affairs, and Peter Olagunju as senior vice president of technical operations. The company is working on gene therapy for bladder cancer.

Worth Watching

New BIO CEO Dr. Michelle McMurry-Heath introduced herself to members at the BIO Digital Convention in a big way. She interviewed Tony Fauci in one session, and then convened three serious thinkers — Tony Coles, Ted Love and Jeremy Levin — for a discussion on diversity, equity and inclusion. (Videos compiled here).

The information world that we built sometimes has a way of distracting us.

It downplays and marginalizes what’s important.

Not this week.

Let’s start with a few timely, inconvenient truths.

As of this writing on June 11:

• The US has 113,865 dead from COVID-19 and counting.
• 2 million+ confirmed cases.
• 20,000 new cases adding up every day.
• 21 states are seeing new cases on the rise.
• We still have no coordinated national system for testing, tracing, and isolation.
• A heartbreaking 44 million people have filed unemployment claims in 12 weeks.
• Our 400-year history of systemic racism means blacks are, predictably, suffering from much more health and economic pain in the pandemic than whites.
• Our state and national leaders don’t seem focused on creating a safe vote-by-mail system in time for the November elections. Voters of color in Georgia, once again, were disenfranchised in this week’s primary election.

But Don’t Despair. There Were Rays of Light

We have done an inexcusable, terrible job as a country fighting the COVID-19 pandemic. The world’s undisputed No. 1 superpower in biomedicine should perform better than this.

I have despaired in these pages about whether we have the guts as a country to reclaim our rights to citizenship and start getting our act together.

But this week, I saw more glimmers of hope that we will.

White Americans are paying more attention to racial injustice. The protests have moved on from the chaotic and destructive early moments to a more focused and constructive set of demands. The energy has been sustained since George Floyd’s death on May 27.

Protests have been forceful, and peaceful.

Citizens — i.e. people who accept responsibility to be informed and active participants in a democracy, rather than mere passive consumers — are holding police accountable in cities around the country. They’re using cell phone cameras capturing video of injustice on an almost daily basis.

Young and old, white and black and Asian and Latinx are locking arms in solidarity against these ongoing, brutal injustices.

The country, with no live sports and entertainment to distract us from the agony all around, can’t look away. Injustice is right there staring everyone in the face.

Powerful organizations can’t escape their past actions and inactions. Everything must be re-assessed from the ground up, and not just viewed through the lens of profit and loss.

Consider the National Football League. With the President in its corner, the NFL shamefully tried to silence black players like Colin Kaepernick and Eric Reid and Malcolm Jenkins. It got upset when these African American players exercised their First Amendment rights to peacefully protest police brutality. Four years too late, the NFL admitted it was wrong.

NASCAR, another powerhouse of cultural influence, banned displays of the Confederate flag at its events. A popular driver, Bubba Wallace, went a step further. He had “Black Lives Matter” painted on his car.

The Boston Red Sox acknowledged that former outfielder Torii Hunter, an African American, was subjected during his career to racist taunts at Fenway Park. It wasn’t just one bad apple here or there. It happens regularly. In liberal New England.

Mitt Romney, Republican Senator from Utah, isn’t living in denial. He marched with protestors.

The TV show “Cops,” after a 33-year run of glamorizing police who push around the “bad boys,”  raking in tons of ad money along the way, was abruptly cancelled.

Amazon said it would no longer provide facial recognition technology to police departments, at least for the next year. Microsoft said it will end sales of facial recognition technology to police.

Our military leadership is resisting the dangerous idea of deploying active-duty troops against American citizens who protest. Police departments around the country aren’t asking for the military to help. They are banning chokeholds. They are de-militarizing. They are getting re-trained in de-escalation tactics. New York repealed its law that shielded police misconduct records from public scrutiny. Portland and Denver got rid of the police in their schools. Police budgets are being looked at with fresh eyes. Funds are being diverted to social services and mental health agencies, which have been terribly underfunded for decades. Cops aren’t supposed to be mental health officers anyway.

What if we hired a new generation of cops who were trained in community policing, and put in the work to get to know members of the community, rather than threaten them with batons and AR-15s?

What if half of police officers were women? They are just as good at law enforcement, and less violent.

We can re-think everything about law enforcement from the ground up, and a whole lot of how our world works or should work, once citizens become active participants in democracy.

Citizens are definitely getting activated.

About three-quarters of Americans now say that George Floyd’s death is a sign of a national underlying problem with systemic racism, according to a recent ABC News poll. That represents an unheard-of 30-percentage point jump from when that question was asked in late 2014 following the death of Michael Brown at the hands of police in Ferguson, Missouri.

Systemic racism isn’t just in the police department. It’s everywhere. The demands for action are spreading, and it’s about time. Close to home, you can see it in #ShutDownSTEM and #ShutDownAcademia.

Feel the frustration, feel the exhaustion from underrepresented communities. Read this essay by Jasmine Roberts at Ohio State University, titled: “White Academia: Do Better.” Then this one, “Stolen Breaths” by Rachel Hardeman and colleagues at the University of Minnesota.

John Lewis, 80, the civil rights legend who marched across the Edmund Pettus Bridge on Bloody Sunday to fight for the Voting Rights Act of 1965, is feeling that youthful energy again.

Lewis told the Washington Post this week he’s feeling “inspired.” (Lewis, by the way, has Stage 4 pancreatic cancer. He’s focused on making the most of his remaining time.)

What can biotech do? A lot of things, like a few specifics suggested by Rob Perez and Uciane Scarlett in these pages.

Then there’s the work of biotech itself. The development of diagnostics, therapeutics, and vaccines for COVID-19 is urgent and important work for all of us, but especially African Americans who are shouldering a disproportionate burden in the pandemic.

Moderna said this week that it will start a 30,000-patient Phase III study in July with its mRNA vaccine candidate with the NIH. It’s an unimaginably fast sprint from when the SARS-CoV-2 DNA sequence was made publicly available on Jan. 11.

This industry can do amazing things.

We all know this industry has tremendous capacity for good. Biotech hasn’t always exercised its muscles for good. It can choose to do so now.

Those of you who are company leaders, here’s one humble suggestion. Make Election Day a company holiday. Give your employees the time and breathing space necessary to exercise their constitutional right to vote at the local, state and national level.

Those of you with real clout – how about pushing for a national biotech industry day off for Election Day? How about leaning on all your CROs and vendors and partners that operate all around the country to take the day off for Election Day? It’s the right thing to do. Business can take the lead.

The changes that need to happen go way beyond biotech, to the fundamentals of how we organize our society, our economy, what we value, and what we don’t. What kinds of behaviors does our economy incentivize, and what behaviors aren’t incentivized?

I’m hungry for thoughtful ideas.

If you have suggestions on how to organize a more humane, a more just, and a more healthy world, let’s talk. These things are all connected.

As Rob Perez recently said, quoting “The Lorax” by Dr. Seuss:

“Unless someone like you cares a whole awful lot, nothing is going to get better. It’s not.”

luke@timmermanreport.com

 

Vaccines

Moderna said it’s on track to start a Phase III study of its mRNA vaccine candidate against COVID-19 in July. The study, in collaboration with the National Institute for Allergy and Infectious Diseases, will enroll 30,000 subjects with the 100-microgram dose – on the low range of what has been evaluated in smaller studies. The primary endpoint, according to a Moderna statement, “will be prevention of symptomatic COVID-19 disease; while key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2, the virus that causes COVID-19.” The company said that it expects to be able to make 500 million to 1 billion doses per year, by 2021, in partnership with its contract manufacturer, Lonza.

Can a COVID-19 vaccine be developed in record time? Read the transcript of an NYT conversation moderated by Columbia University physician-scientist-author Sid Mukherjee.

Testing

Sunnyvale, Calif.-based Cepheid said it is developing a 4-in-1 test for SARS-CoV-2, Flu A and Flu B and RSV virus from a single sample, in time for the upcoming fall flu season. The test will be compatible with its installed base of 25,000 systems around the world, and can be conducted “in as little as 35 minutes.”  

Treatments

Speculation is out there on what Gilead Sciences is going to charge for remdesivir around the world once the initial donated supply runs out. The pharmaceutical industry has done a lot over the years to shoot itself in the foot and destroy its public trust. Approval ratings for the industry were in Big Tobacco territory prior to COVID-19. This is a chance do better. The decision will reverberate across the industry’s reputation, writes John LaMattina in Forbes.

Public Health

• Public Health Experts Aren’t Hypocrites. The Atlantic. June 11. (Julia Marcus & Gregg Gonsalves)
• COVID19 and Flu, a Perfect Storm. Science. June 12. (Edward Belongia and Michael Osterholm)
• WHO Clarifies Comments on Asymptomatic Transmission of Coronavirus. WSJ. June 9. (Drew Hinshaw)
• Shutdowns Prevented 60 Million Infections in the US, Study Says. Washington Post. June 8. (Joel Achenbach and Laura Meckler)
• Neil Ferguson: Earlier Lockdown Would Have Halved the Coronavirus Death Toll. The Guardian. June 10. (Video)

Science

• Enhanced receptor binding of SARS-CoV-2 through networks of hydrogen-bonding and hydrophobic interactions. PNAS. May 27 (Yingjie Wang et al)
• Effect of Large-Scale Anti-Contagion Policies During the Pandemic. Nature. June 8. (Solomon Hsiang et al)
• Identifying Airborne Transmission as the Dominant Route for Spread of COVID-19. PNAS. June 11. (Renyi Zhang et al)
• Analysis of SARS-CoV-2 Viral Load By Patient Age. MedRxiv. June 9. (Terry Jones et al)
• COVID-19 Coagulopathy: An Evolving Story. The Lancet Hematology.

Science Features

• Females are Still Routinely Left Out of Biomedical Research and Ignored in Data Analyses. STAT. June 9. (Elizabeth Cooney)
• Lots of Coronavirus Antibody Therapeutics News. In the Pipeline. June 9. (Derek Lowe)
• Monster or Machine? Our Enemy, Hidden in Plain Sight. NYT. June 2. (Alan Burdick)
• COVID-19 Patient Gets Double Lung Transplant, Offering Hope. NYT. June 11. (Denise Grady)

Politics

• Exceptionalism is Killing Americans. An Insular Political Culture is Failing the Test of the Pandemic. Foreign Affairs. June 8. (Jeremy Konyndyk)

Communications

• MIT, guided by open access principles, ends Elsevier negotiations. June 11. (MIT Libraries)

Humanity

• Quarantine Has Changed Us All. And It’s Not All Bad. Vox. June 9. (Sigal Samuel)

Deals

AbbVie agreed to make a $750 million upfront payment to Genmab for the right to collaborate with the Denmark-based company on three bispecific antibody candidates in early development, and to work together on discovery of new drugs.

Novo Nordisk agreed to acquire Corvidia Therapeutics, the developer of an IL-6 directed antibody to reduce cardiovascular disease risk in chronic kidney disease patients. The price was $725 million in upfront cash, and as much as $2.1 billion total if milestones are met.

Sherlock Biosciences, the Cambridge, Mass.-based company developing a cheap and fast CRISPR-based test to detect SARS-CoV-2 in samples, formed a large-scale manufacturing agreement with Integrated DNA Technologies of Coralville, Iowa. The test has received Emergency Use Authorization from the FDA.  

CSL Behring agreed to acquire Vitaeris, the company that took over clazakizumab, an IL-6 inhibitor originally developed by Alder Biopharmaceuticals. The drug is now in Phase III testing for chronic active antibody-mediated rejection (AMR), the leading cause of long-term rejection in kidney transplant recipients.

Some investment banker was probably bored at work, and thought it was a good idea to gin up a megamerger between AstraZeneca and Gilead Sciences, and then float the rumor in the financial press to see if it would get any traction. My guess: this idea is Dead on Arrival.

Paris-based Egle Therapeutics, a spinout from Insitut Curie, formed a collaboration with Takeda Pharmaceutical to advance drugs against targets on T regulatory cells.

New York-based Ovid Therapeutics agreed to collaborate with Wendy Chung, a prominent researcher at Columbia University, on rare neurological diseases.

Auburn, Ala.-based SiO2 Materials secured a $143 million federal contract to produce packaging materials for COVID-19 vaccines and therapies. MIT Institute Professor Bob Langer, an advisor to the company, had the lead paragraph in the press release.

UK-based Evox Therapeutics pocketed a $20 million upfront payment from Eli Lilly as part of a collaboration to develop exosome delivery technology for RNAi therapeutics.

Financings

• Cambridge, Mass.-based Verve Therapeutics, a company working on gene editing therapies to reduce the risk of coronary heart disease, raised $63 million in a Series A2 round led by GV. The company has now raised $123 million total.
• San Diego-based Avidity Biosciences raised $259 million in an IPO priced at $18 a share. It’s developing antibody oligonucleotide conjugate drugs.
• Cambridge, Mass.-based Checkmate Therapeutics raised $85 million to advance its lead drug candidate, CMP-001, which it describes as “a differentiated Toll-like receptor 9 (TLR9) agonist delivered as a biologic virus-like particle utilizing a CpG-A oligonucleotide as a key component.” Longitude Capital and Novo Holdings co-led.
• Wayne, Penn.-based NFlection Therapeutics raised a $20 million Series A round to develop a gel therapy for neurofibromatosis type 1. VenBio and F-Prime Capital participated.
• Boston-based CereVasc, the developer of a shunt for hydrocephalus, raised $43.9 million in a Series A financing. Perceptive Xontogeny Venture Fund led.
• Mountain View, Calif.-based DNAnexus, a cloud-based service provider that manages genomic and other biological data sets for life sciences companies, raised $100 million in financing. Perceptive Advisors and Northpond Ventures led.
• Cambridge, Mass.-based Vedanta Biosciences, a microbiome-based drug developer, tacked on another $12 million in financing, bringing its Series C financing to $71.1 million.
• Palo Alto, Calif.-based Autobahn Therapeutics raised a $76 million Series B to develop regenerative medicines for CNS disorders. Arch Ventures and Cowen Healthcare Investments co-led.
• Sweden-based Calliditas Therapeutics raised $90 million in an IPO to support its work on orphan kidney diseases.
• South San Francisco-based Applied Molecular Transport raised $154 million in an IPO to advance development of its oral therapies for inflammatory diseases.
• Dallas-based Lantern Pharma, a cancer drug developer, raised $26 million in an IPO.
• China-based Legend Biotech completed its IPO fundraising haul with $487 million.
• Jazz Pharmaceuticals pulled in $850 million through a convertible debt financing.
• New York-based C2i Genomics raised $12 million in a Series A. It says it’s “dedicated to improving cancer patient lives and outcomes with a breakthrough tumor pattern recognition approach for liquid biopsy.” Casdin Capital led.
• Boston-based Replimune raised $65 million in a stock offering to support its work on oncolytic virus therapy.
• San Clemente, Calif.-based Glaukos, a company focused on treatments for glaucoma and other eye diseases, raised $250 million in a convertible debt offering.
• Boston-based Akouos, the developer of gene therapy for diseases of the ear, issued an S-1 IPO prospectus seeking to raise $100 million.
• San Diego-based Retrophin, a rare disease drug developer, raised $100.8 million in a stock offering.
• Boston-based PatientPing, which provides real-time notifications on patient encounters with healthcare providers, raised $60 million in a Series C financing. Andreessen Horowitz, F-Prime Capital, GV, and Transformation Capital participated.
• South San Francisco-based Kezar Life Sciences raised $45.7 million in a stock offering for its work on autoimmune disease and cancer.
• Rockville, Maryland-based Cerecor raised $33 million in a stock offering to support its work on rare pediatric diseases.
• San Francisco-based Twist Bioscience, the DNA synthesis company, raised $107 million in a stock offering.
• San Diego-based Fate Therapeutics raised $175 million in a stock offering to support its cell therapies for cancer and immune disorders.
• San Diego-based Cue Health, a health tech company, raised $100 million in a Series C financing that included Decheng Capital, Foresite Capital, Madrone Capital Partners, Johnson & Johnson Innovation, and ACME Capital.
• South San Francisco-based Alpha Health raised $20 million in a Series A financing to advance its platform for automation in reimbursement. A16Z led.

Personnel File

• Denmark-based Lundbeck said it will cut 130-160 jobs.
• South San Francisco-based ORIC Pharmaceuticals, a cancer drug developer, named Lori Kunkel to its board of directors.
• Legend Biotech added Corazon (Corsee) Dating Sanders, Darren Ji, and Philip Yau to its board of directors.
• Cambridge, Mass.-based Constellation Pharmaceuticals hired Jeffrey Humphrey as chief medical officer.
• South San Francisco-based NGM Bio added Carole Ho to its board of directors.
• Seal Beach, Calif.-based Dendreon hired Jason O’Neill as CEO.
• Waltham, Mass.-based Affinia Therapeutics, a gene therapy company, named Elliott Sigal to its board of directors.

Regulatory Action

Gaithersburg, Maryland-based Viela Bio secured FDA approval for inebilizumab-cdon (Uplizna) for Neuromyelitis Optica Spectrum Disorder.

San Diego-based Illumina secured an FDA Emergency Use Authorization for a next-gen sequencing test to detect SARS-CoV-2 RNA in respiratory samples.

The emotions this week were especially intense. Anger. Fear. Despair.

But there was also hope. That gets me up in the morning.

In this slice of America, the biotech industry, many people are mission-driven.

People in this industry work every day to improve the human condition by making better medicines.

Not everyone feels the full weight, but many in this part of the scientific problem-solving enterprise didn’t need a news flash that African Americans suffer terrible disparities in things like heart disease, cancer, diabetes, asthma, and now COVID-19.

What I saw this week were glints of new awareness — a growing recognition, let’s say — that the injustice inflicted on African Americans for 400 years is inextricably linked to those health disparities. The mission of biopharma is about improving health. But health is connected to all of those underlying things like housing, education, and criminal justice that are terribly unjust.

If people don’t dig into the root causes to make a better world for everyone, how can we begin to improve health?

The good news is, these protests are starting to move people.

This is a start.

Events move so fast now, it’s easy to lose track of actual progress being made. The police officer that killed George Floyd in Minneapolis had his charge upgraded to second-degree murder. The other three officers — who stood there and didn’t do anything to save him while he cried “I can’t breathe” and begged for his mother — they were charged with aiding and abetting. After days of protestors demanding they be charged.

George Floyd’s family asked for Minnesota Attorney General Keith Ellison to prosecute the case. The attorney general of Minnesota, no less, answered that call.

New investigations into troubling cases of African Americans dying in police custody are being opened up all around the country.

Mayors, Governors, police chiefs, and even some police union leaders all over the country, are speaking out like never before against the horrific acts of the Minneapolis police caught on video. The Republican governor of Maryland called Minneapolis police officer Derek Chauvin a “murderer in a blue uniform.”

Thoughtful executives, like Ken Frazier of Merck, could do the easy thing and say nothing. Or issue a statement with some generic platitudes. Instead Frazier said something real, both about George Floyd’s case and about how his life fortunately went down a different path.

He said it on national TV, on a channel that the powers-that-be actually watch.

This is a start.

If you’re ever going to change laws, change police union contracts, change structures around citizen review boards, and begin to hold cops accountable – you have to start with recognizing there’s a problem and applying pressure.

This is a start.

These things are happening because of the public pressure being brought by protestors.

Young people are demanding action at the local and state level. People in power in Minnesota, and elsewhere, seem to be listening and acting accordingly. They might listen some more, and continue to act accordingly, if the pressure remains relentless.

We need to watch out for the violence and senseless rioting. That’s destructive and wrong. It’s damaging to people’s livelihoods, including livelihoods of African American business owners. It needs to be stopped. Throwing bricks through windows and stealing merchandise? It doesn’t do any good, and we don’t really know who’s doing it and why. Then we watch cops do more abusive things in the heat of the moment, whether it’s because of all-too-human nerves, or because of foolish orders from above.

These past few days have gotten better on these counts. I believe the protestors, as long as they stay peaceful, might just have staying power during this summer of so much pain.

Tremendous acts of community kindness – offerings of water, sunscreen, food and more – are sustaining protestors. See this young woman describe the remarkable generosity she has witnessed in Minneapolis.

Many of us in biopharma are wondering what we can do. It’s easy to surrender to helplessness against a problem this big, this deeply engrained. Where to start? What difference can anyone make? Why bother?

That’s nihilism talking. That’s no way to live.

There are things we can do. Small things, maybe, but things that matter.

Many of you read Rob Perez’s guest article on things biopharma can do to dig deep and fight hard, against injustice. I think people are listening more than in the past.

This is a start.

We can use this moment to teach our children about right and wrong, in terms of racial justice. We can use this surge of energy to vote out dangerous leaders in Washington DC, and vote in a new generation of people willing and able to do the hard work in our communities of dismantling systemic racism – in criminal justice, in housing, in education, in health.

All these things are connected. We need to get our hands dirty, down there at the roots, if we really want to make progress across the board.

Nobody can do this alone. But if everybody digs in – and, crucially, is willing to stick with this long past the end of the news cycle – then we will have accomplished something meaningful.

Politics

The President said he’s pulling the United States out of the World Health Organization in the middle of a pandemic. It will harm people around the world, especially in developing countries. If he follows through with this threat, it will diminish US influence on the world stage. It will create an opening for China and others to seize, gaining more influence over how the pandemic response is run. To say the WHO is perfect would be wrong. It has made serious errors, like not declaring COVID-19 a global pandemic in January. But pulling out of the WHO completely, at this moment, is impetuous and short-sighted and dangerous.

The Pandemic Toll

The pandemic was pushed down in people’s news feeds. But let’s not forget. We have 108,000 deaths in the US, and almost 1.9 million cases. The New York Times reports 17 states where cases were increasing over the past week, and 15 states where cases were decreasing.

Science

• ‘It Opens Up a Whole New Universe.’ CryoEM Sees Individual Atoms for the First Time. Nature. June 3. (Ewen Callaway)
• Effect of Convalescent Plasma in Patients with Severe COVID-19. A Randomized Controlled Trial. JAMA. June 3. (Ling Li et al)

Science Features

• The CDC Waited Its Entire Existence for This Moment. What Went Wrong? NYT. June 3. (Eric Lipton et al)
• COVID-19 Can Last for Several Months. The Atlantic. (Ed Yong)
• The Untold Story of the Moderna Coronavirus Vaccine. Boston magazine. June 4. (Catherine Elton)
• Why Coronavirus Hits Men Harder. Sex Hormones Offer a Clue. Science. June 3. (Meredith Wadman)
• The Global Race for a Coronavirus Vaccine Could Lead to This Generation’s Sputnik Moment. Washington Post. June 3. (Carolyn Johnson and Eva Dou)
• Blood Vessel Attack Could Trigger Coronavirus Fatal ‘Second Phase’. Science. June 2. (Catherine Matacic)

Treatments

Gilead Sciences released some Phase III data from a remdesivir study of patients with moderate forms of COVID-19. These results, as many expected, were more encouraging than the earlier results from a study of more severely ill patients. The 5-day course of treatment was also the way to go, which is good news for stretching out manufacturing supplies around the world.

If you’re looking for important, under-covered stories on the pandemic, look at Eli Lilly’s neutralizing antibody candidate for COVID-19. In collaboration with AbCellera and researchers at the National Institute of Allergy and Infectious Disease, the team picked an antibody from the blood of a recovered patient, made recombinant copies as biopharma companies do so well, and now have it in patients in a clinical trial in the span of about three months. Along with Regeneron and VIR Biotechnology, these therapeutic antibodies have a chance to mitigate the pandemic in the interim period before we get a vaccine.

Hydroxychloroquine failed to prevent healthy people from getting COVID-19 in a clinical trial. The study was conducted at the University of Minnesota, and enrolled healthcare workers. See the Washington Post coverage.

Vaccines

• AstraZeneca Lays Out Plan to Produce 2 Billion Doses of Coronavirus Vaccine. STAT. June 4. (Matthew Herper)
• GAVI, The Global Vaccine Alliance, Launched $2B Advance Market Commitment to Deliver COVID-19 Vaccines Equitably Through the World. (GAVI statement)
• Tony Fauci Didn’t Like the Early Data Release on Moderna Vaccine. STAT. June 1. (Helen Branswell)
• The Five Leading Vaccine Candidates Prioritized by Operation Warp Speed. (See below)

Public Health

• White House and CDC Remove Coronavirus Warnings About Choirs in Faith Guidance. Washington Post. May 28. (Lena Sun and Josh Dawsey)
• Tear Gas Is Way More Dangerous Than Police Let On, Especially in a Pandemic. ProPublica. June 4. (Lisa Song)
• Former CDC Director Says US Led the World Before Becoming a Global Health Laggard. Washington Post. May 29. (Joe Davidson)
• Evidence for COVID-19 Spread in January and February. May 29. CDC. (Greg Armstrong et al)
• Will Protests Set of a Second Wave? NYT. June 4. (Roni Caryn Rabin)
• Zoloft Falls Into Short Supply as Virus Anxiety Strains Supplies. Bloomberg News. June 1. (Anna Edney)

A Big Retraction

The Lancet retracted a widely-read May 22 paper on hydroxychloroquine and chloroquine as treatments for COVID-19. The original article said there was no benefit seen, based on evaluating a registry with records from 96,000 patients. The authors wrote in their retraction, “we can no longer vouch for the veracity of the primary data sources.” Retractions are never good, but especially in a pandemic when we need trustworthy sources of scientific information and guidance. What’s the big takeaway from this? See Ashish Jha below.

Another paper that depended on Surgisphere for raw data collection appeared suspicious enough to generate an “Expression of Concern” in the New England Journal of Medicine. That was for a paper titled “Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19.” Strangely, the authors of that paper “all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor.” Maybe this is just naïvete, but aren’t authors of a scientific paper supposed to have access to raw data so they can properly analyze and summarize? This doesn’t smell right.

Deals

Cambridge, Mass.-based Intellia Therapeutics pocketed $100 million upfront ($70 million cash and $30 million equity investment at $32.42 a share) as part of a collaboration with Regeneron Pharmaceuticals to develop CRISPR-based treatments for hemophilia A and B. The companies have experience working together already, and this is an expansion of the prior collaboration.

Berkeley, Calif.-based Aduro Biotech merged with privately-held Vancouver BC and Seattle-based Chinook Therapeutics. The new company, called Chinook Therapeutics, will be led by Chinook CEO Eric Dobmeier. Chinook now will get a Nasdaq listing, will have $200 million of cash in the bank, and the runway to pursue its precision medicine approach to kidney disease.

Lexington, Mass.-based Accent Therapeutics, the developer of cancer drugs that target RNA-modifying enzymes, secured a $55 million upfront payment as part of a collaboration with AstraZeneca.

Data That Mattered

Waltham, Mass.-based Minerva Neuroscience said its drug candidate for schizophrenia failed in a placebo-controlled Phase III trial of 515 patients. The stock collapsed, down 70 percent.

Gilead Sciences released updated safety data from more than 4,500 patient years of experience with filgotinib, the oral JAK1 inhibitor for rheumatoid arthritis, at the European League Against Rheumatism conference. The drug is part of the collaboration with Galapagos NV of Belgium.

Regulatory Action

AbbVie won FDA clearance to market elagolix estradiol, and norethindrone acetate (Oriahnn) capsules as a treatment for heavy menstrual bleeding due to uterine fibroids. It’s the first oral treatment of its kind.

Eli Lilly won FDA approval for its IL-17 alpha inhibitor, ixekizumab (Taltz) for non-radiographic Axial Spondyloarthritis, including ankylosing spondylitis.

Personnel File

Mark Genovese was hired as senior vice president of inflammation at Gilead Sciences. He was on the faculty at Stanford University for 21 years.

Admiral Brett Giroir, who has been leading coronavirus testing efforts for the federal task force, said he’s being “demobilized” from that effort, and going back to his regular role at the Department of Health and Human Services, according to NPR.

Sanofi Ventures hired Jim Trenkle as head of investments. He was previously with Pivotal Bioventures. Cris de Luca also joined as global head of digital investments. He was previously with Johnson & Johnson Innovation and JLABS.

Financings

• South San Francisco-based Pliant Therapeutics, a developer of treatments for fibrosis, raised $144 million in an IPO priced at $16 a share. See my coverage from its startup days in Forbes ( 2016).
• Cambridge, UK, Seattle and Lexington, Mass.-based NodThera, a developer of anti-inflammatory drugs, received $55 million in a Series B financing. Novo Ventures led.
• Cambridge, Mass.-based Intellia Therapeutics, the CRISPR drug developer, raised $100 million in a stock offering after the positive news of its expanded collaboration with Regeneron.
• Shanghai-based Everest Medicines raised $310 million in a Series C financing.
• Seattle-based Athira Pharma, an Alzheimer’s drug developer, raised $85 million in a Series B. Perceptive Advisors led.

On Grace

Tony Dungy, the Hall of Fame football coach, is a man of deep religious faith. I have respected him for years. He offered some wisdom — that rarest and most valuable of things — on a sports radio call-in show.

Dungy spoke his calm, empathetic words in the middle of the outraged, frenetic aftermath of what New Orleans Saints quarterback Drew Brees said about protests. Brees, a man with some great African American teammates, said something that was clueless and insensitive and self-centered. He later apologized.

We’ve seen this kind of foot-in-mouth moment a million times. In 400 years, we’ve never had an adult conversation about race in the US in which everyone sits and truly listens. If we’re going to take a deep breath and have that necessary conversation, the kind that’s incredibly painful but builds bridges of awareness needed to make things right, then our best bet is to look to community leaders like Dungy.

He’s giving people some space. Allowing them some room to say dumb things. Things that are awkward or tone deaf. Notice, Dungy didn’t excuse what Brees said and didn’t apologize for him. But he’s creating some room where people can listen to each other, and begin to understand why what the great quarterback said was so hurtful to so many of our fellow citizens.

People need to be given the room to make mistakes, and to see the error of their own ways. To begin to realize that perhaps they have blind spots. If people don’t feel they can be open and honest, and let their ignorance and clumsiness be forgiven, then they’ll crawl back into a shell, clam up, or stay in denial.

The worst among us will lash out in performative defensiveness and cash in off their perceived “victimhood.”

If that happens, we’ll stay right where we are, stuck in a rut, with terrible injustice happening all around us every day. With the majority of the country blind to the horror.

I want this terrible racism to end with our generation, and for our kids to grow up in a more humane and empathetic world.

Those of us — like me — who are privileged and don’t walk down the street afraid of police, need to stand shoulder-to-shoulder with those who do. We need to insist on this change, and be relentless about that change, right there with our black brothers and sisters.

It’s our job to have the awkward, painful, tearful conversations with our family members and friends who aren’t yet all the way there with us on this journey.

As Martin Luther King said: “Injustice anywhere is a threat to justice everywhere.”

As Frederick Douglass said: “Power concedes nothing without a demand.”

As John Legend wrote: “Justice for All Ain’t Specific Enough.”

The injustice is so pervasive, and so deep. We need to demand it end. Then we roll up our own sleeves. It’s not someone else’s job. For us to rip out the roots of this enduring injustice, we need to get comfortable with being uncomfortable.

Do everything Rob Perez wrote about this week. When you’ve done all that, think about doing more.

Do it with empathy, with patience. The conversations we need to have to change people’s hearts will happen in unusual places, unusual settings. Not just from a podium or a pulpit.

If you listen to Tony Dungy talking with a sports talk radio host — a young white guy — then you’ll get a feel for the words, the tone, the setting. This is what it’s about. Watch the empathy and respect he has for his conversation partner.

This is change in action.