Top Stories for Week of May 25, 2020

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CDC issues detailed reopening guidance after initial rejection.

The Centers for Disease Control and Prevention gently released more detailed guidance for schools, businesses, transit systems and other industries hoping to reopen safely amid the SARS-CoV-2 pandemic after fear that the White House had tabled the guidelines.

The 60-page document, which a CDC spokesman said was uploaded over the previous weekend, but which received little notice, adds significant detail to six charts that the CDC had released the prior week, says The New York Times. The guidance provides specific instructions for different sectors to detect and trace the virus based on exposure and risk after the pandemic. Here are some key elements.

1) If a person in a school building tests positive, schools should evaluate the risk and consider a brief dismissal of about 2-5 days to clean and disinfect the building, coordinate with local health officials and contact trace. The CDC offers different measures based on the level of community spread.

2) As restrictions across the country on restaurants and bars ease, the CDC recommends owners give workers–at a higher risk of getting sick–a job that limits the person’s interaction with customers. The agency also suggests opening with limited seating initially to allow for social distancing. Once fully reopened, the CDC recommends having a clear policy about when employees should stay home if sick and rules on hygiene, including at times wearing face coverings.

3) When mass transit resumes its full service, the agency recommends being prepared to adjust routes based on the different levels of virus spread and to coordinate with local health officials about prevention strategies, such as wearing a face covering.

4) For businesses that provide child care during the pandemic, the CDC recommends having plans in place, for example, to have substitute workers if staff members are sick, and requiring staff and children older than two to wear face coverings.

The guidance describes the balance of slowing the virus’s spread with the economic threat of shuttering most businesses, and largely mirrors a draft version that was previously shelved by the White House, but with some changes. The document omits a section on “communities of faith” that had troubled Trump administration officials and also tones down the guidance in several instances. For example, language that initially directed schools to “ensure social distancing” became “promote social distancing,” and the phrase “if possible” was added in several sentences.

COVID-19 Addenda: 1) Hydroxychloroquine ineffective, tied to deaths, heart risk in COVID study; 2) Lockdown delays cost at least 36,000 lives, data show; 3) Don’t expect a vaccine soon says top US scientist; and 4) CDC reports 1.57 million coronavirus cases; over 94,000 deaths.

Antimalaria drugs that President Trump has hyped for treatment of COVID-19 were linked to an increased risk of death and heart disorders in a study. Furthermore, hydroxychloroquine and chloroquine didn’t benefit patients with the coronavirus, either alone or in combination with an antibiotic, according to the study published Friday by The Lancet medical journal.

Researchers are searching available options to treat the coronavirus, including drugs like antimalarials that are already approved to treat lupus and rheumatoid arthritis. Trump’s endorsement has led many people to take the medications without scientific proof of their benefit. The examined the records of 15,000 people who’d been treated with the antimalarials and one of two antibiotics that have sometimes been paired with them. Treatment with any combination of the four drugs was associated with zero benefit and a higher risk of death than in 81,000 patients who didn’t receive them.

Even small differences in timing would have averted the rapidly expanding growth of COVID-19, which by April had belted New York City, New Orleans and other major cities, researchers found. If the US had begun imposing social distancing measures one week earlier than it did in March, about 36,000 fewer people would have died in the coronavirus outbreak, according to new estimates from Columbia University disease modelers. And if the country had begun locking down cities and limiting social contact on March 1, two weeks earlier than most people started staying home, the vast majority of the nation’s deaths–about 83%–would have been avoided, the researchers estimated.

Under that scenario, ~54,000 fewer people would have died by early May.

It was first predicted to take 12-18 months, but some groups like AstraZeneca PLC (London) are now looking at deploying a vaccine (if proven successful) for SARS-CoV-2 by this fall. The record for the fastest ever vaccine developed pre-pandemic was for Ebola, and that was a period of five years, Endpoints reports, so some experts and scientists are understandably skeptical that these fantastically ambitious timelines are realistic.

Echoing that doubt, well-regarded cancer, HIV/AIDS and human genome project researcher William Haseltine has suggested governments should not count on a successful vaccine against COVID-19 being developed anytime soon, Reuters reported. It is not impossible, he indicated but that he wouldn’t “count on it.” The best way to deal with the situation is to conduct rigorous contact tracing, isolate the infected, and persist with social distancing measures, like China and some other Asian countries who have used that strategy successfully. Countries like the US did not do enough to “forcibly isolate” those exposed to the virus, he added.

Globally, the World Health Organization on Sunday reported 5.2 million confirmed cases of COVID-19 and 338,000 deaths. And the US Centers for Disease Control and Prevention (CDC) on Saturday reported 1,595,885 COVID-19 cases, an increase of 24,268 cases from its previous count, and said the number of deaths had risen by 1,852 to 96,002. That means the US has approximately 30% of the global cases and 28% of the deaths. The CDC reported its tally of COVID-19 cases as of late May 22, compared with its count a day earlier. The CDC figures do not necessarily reflect cases reported by individual states.

Moderna COVID-19 vaccine first to show promise in early human trials.

The first coronavirus vaccine tested on humans has yielded positive results, with a small number of people who were tested showing an immunity against the virus, drugmaker Moderna Inc. (Cambridge MA) said last week in a news release. Moderna said the vaccine called mRNA-1273 “was generally safe and well tolerated,” Medscape reports.

The company said it plans to move ahead with the next two phases, in which larger numbers of people will be tested this year. The news release said three different dosage levels–25, 100 and 250 micrograms–were given to 45 participants, and all of them developed detectable antibodies. But the eight people who received doses of 25 and 100 micrograms in March responded best, developing antibodies that were just as high or higher than the antibodies found in people who’d gotten the coronavirus and then recovered, the company said. The vaccine uses something called the messenger RNA approach. It does not require a virus to make the vaccine.

“I think the totality of science tells us that this is the right antigen and it should be protective,” Tal Zaks, Moderna’s chief medical officer, said, according to Business Insider.

The testing is being done in coordination with the National Institutes of Health and the National Institute of Allergy and Infectious Diseases. It has not been peer-reviewed or published in a medical journal. There currently is no vaccine against the coronavirus. Moderna and other companies are racing to develop a vaccine against the virus, which has killed 96,000 people in the US alone.

It’s unclear how soon a vaccine might hit the market. Anthony Fauci, MD, of the White House coronavirus task force, has cited a 12- to 18-month timeline for development. At least 90 potential COVID-19 vaccines are under study, and six of those are already being tested on humans in clinical trials to determine if they’re safe. Moderna closed the week up 3% at $69.00.

AFFIBODY AB (Solna CHE) and Chinese firm Inmagene Biopharmaceuticals Ltd. (Hong Kong) will work together to develop and commercialize Affibody’s Phase 2-stage drug for autoimmune diseases such as psoriasis. Under the agreement, Inmagene will commercialize Affibody’s treatment in the Greater China region and South Korea, as well as develop the drug in the Asia Pacific region excluding Japan, says Labiotech.

Meanwhile, Affibody will be responsible for the manufacturing of the drug for development and commercialization worldwide and will retain global commercial rights outside of Greater China and South Korea. Affibody will receive a €9.2 million ($11.2 million) upfront payment and could receive up to €198.8 million ($242.5 million) in additional regulatory and sales milestones. The two companies will work together to enroll patients in clinical trials and in some cases, share clinical trial costs. Inmagene could also receive payments and royalties from Affibody relating to undisclosed global development milestones.

At present, Affibody’s drug is being evaluated in a Phase 2 trial among patients with moderate-to-severe psoriasis, but its mechanism of action–blocking the inflammatory protein interleukin (IL-)17–means it could potentially be used to treat several other autoimmune diseases such as psoriatic arthritis, axial spondyloarthritis, and Bechet’s Disease. The drug differs from other IL-17 inhibitors because it combines proprietary Affibody molecules with its Albumod technology. The Affibody molecules mimic antibodies but are much smaller and more potent, while Albumod technology extends the amount of time the molecules are active in the body.

“Together, these features provide the potential for best-in-class efficacy in a convenient, less frequent, and at-home subcutaneous administration,” David Bejker, Affibody CEO, told Labiotech. He added: “The key strength in having a small format and high potency is that it opens up the opportunity for better efficacy and more convenient administration of the drug without getting additional side effects.”

This deal follows swiftly after another Sweden-China biotech deal earlier last week. In this other deal, the Umeå-based Lipigon Pharmaceuticals partnered with the Chengdu-based HitGen to develop drugs for blood fat disorders. European–Chinese collaborations such as this may be a lot more common occurrence in the future, says Labiotech.

Last month, Martin “Pharma Bro” Shkreli posted a paper online with an unusual addendum.

“I am asking for a brief furlough (3 months) to assist in research work on COVID-19,” Shkreli wrote in a PDF published to the otherwise empty site of a company he founded in 2015, Prospero Pharma. “As a successful two-time biopharma entrepreneur, having purchased multiple companies, invented multiple new drug candidates, filed numerous INDs and clinical trial applications, I am one of the few executives experienced in ALL aspects of drug development from molecule creation and hypothesis generation.”

At the time, few in the industry were impressed with either the quality of Shkreli’s scientific paper–which detailed an effort to screen compounds for ones active to COVID-19, a practice already commonplace–nor his capacity to make unique contributions in a coronavirus fight that was already enlisting some of the country’s top scientists and biotech executives. And now, it seems, a judge was similarly unimpressed with his plea, says Endpoints.

In a nine-page ruling last Saturday, US District Judge Kiyo Matsumoto sided with prosecutors who described Shkreli’s plea for release as indicative of the “delusional self-aggrandizing behavior” that landed him in jail to begin with.

“The court does not find that releasing Mr. Shkreli will protect the public, even though Mr. Shkreli seeks to leverage his experience with pharmaceuticals to help develop a cure for COVID-19 that he would purportedly provide at no cost,” Matsumoto wrote. “In any event, Mr. Shkreli’s self-described altruistic intentions do not provide a legal basis to grant his motion.”

Although the conditions in some prisons during the pandemic have become the subject of significant criticism, with many inmates unable to secure home transfers despite outbreaks within the facility and urgings from the Justice Department, Matsumoto determined that wasn’t the case for Shkreli, who was “healthy” and whose low-security prison in Allenwood, PA has not experienced an outbreak. Shkreli, 37, was given a 7-year sentence in 2017 for defrauding investors.

IPO Sector: Burning Rock Biotech Co. Ltd., which provides DNA sequencing-based cancer therapy selection tests in China, filed on Friday with the SEC to raise up to $100 million in an initial public offering. The company provides next generation sequencing-based (NGS-based) cancer therapy selection tests that are used to assist physicians in selecting the most effective therapy for cancer patients. It currently offers 13 NGS-based cancer therapy selection tests applicable to a broad range of cancer types, including lung, gastrointestinal, prostate and breast, among others.

China’s NGS-based cancer therapy selection market is expected to grow from 0.3 billion US dollars in 2019 to 4.5 billion dollars in 2030, the company said in its prospectus, citing data from China Insights Consultancy. The Guangzhou, China-based company was founded in 2014 and booked $49 million in revenue for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “BNR.” Burning Rock Biotech filed confidentially on November 4, 2019. Morgan Stanley, BofA Securities, and Cowen are the joint bookrunners on the deal. No pricing terms were disclosed.

Elsewhere, Applied Molecular Transport Inc., a Phase 1 biotech developing novel oral therapies for inflammatory diseases, registered up to $100 million in an initial public offering. Applied Molecular’s pipeline contains lead candidate AMT-101, an oral, selective interleukin 10 that has completed a Phase 1b trial for ulcerative colitis (UC).

The company plans to initiate Phase 2 trials of AMT-101 in UC and related inflammatory indications between 2020 and 2021. The South San Francisco, CA-based company was founded in 2010 and plans to list on the Nasdaq under the symbol “AMTI.” Applied Molecular filed confidentially on February 13, 2020. BofA Securities, Jefferies, and SVB Leerink are the joint bookrunners on the deal. No pricing terms were disclosed.

And Inari Medical Inc., which makes minimally invasive medical devices for venous diseases, raised $156 million by offering 8.2 million shares at $19, above the upwardly revised range of $17 to $18. Inari’s products have been used to treat more than 8,500 patients at approximately 600 US hospitals, with roughly 91% of cases being performed since its commercial launch in the 3Q18.

Despite the slowdown due to the pandemic, the company’s minimally invasive devices were used to treat approximately 2,400 patients in the 1Q20, up from 1,800 in the 4Q19 and 600 in the 1Q19. The Irvine, CA-based company originally filed to offer 7.3 million shares at a range of $14 to $16. Inari Medical was founded in 2011 and booked $71 million in revenue for the 12 months ended March 31, 2020. Inari lists on the Nasdaq under the symbol “NARI.” BofA Securities and Morgan Stanley acted as lead managers on the deal. Shares were than doubled over the week (+124%) the week to $42.51.

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