Top Stories for Week of August 31, 2020

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Coronavirus reinfections raise concerns about immunity.

Researchers for the first time have identified someone in the US who was reinfected with the novel coronavirus, according to a study that has not yet been reviewed by outside experts. The report, published online and reported by Reuters, describes a 25-year-old man living in Reno, NV, who tested positive for the virus in April after showing mild illness. He got sick again in late May and developed more severe COVID-19, the disease caused by the SARS-CoV-2 virus.

“This study likely represents a clear example of reinfection…reinfections are possible–which we already knew, because immunity is never 100%,” Kristian Anderson, professor of immunology and microbiology at Scripps Research in La Jolla, CA, said.

Cases of presumed reinfection have cropped up in other parts of the world, but questions have arisen about testing accuracy. Earlier last week, University of Hong Kong researchers reported details of a 33-year-old man who had recovered in April from a severe case of COVID-19 and was diagnosed four months later with a different strain of the virus.

And Reuters reported that two European patients in Belgium and the Netherlands are confirmed to have been reinfected with COVID-19. All of which has raised fears about the efficacy of potential vaccines against the virus, which has killed hundreds of thousands of people, though experts say there would need to be many more cases of reinfection for these to be justified. Belgian virologist Marc Van Ranst said the Belgian case was a woman who had contracted COVID-19 for the first time in March and then again with a different coronavirus strain in June. Further cases of re-infection were likely to surface, he said.

Researchers at the University of Nevada, Reno School of Medicine and the Nevada State Public Health Laboratory said they were able to show through sophisticated testing that the virus associated with each instance of the Reno man’s infection represented genetically different strains. They emphasized that reinfection with the virus is probably rare, but said the findings imply that initial exposure to the virus may not result in full immunity for everyone.

“We don’t know at what frequency reinfections occur and how that might change over time,” Anderson said. “Before we have broader studies illuminating these questions, we can’t conclude what a single case of reinfection means for longevity and robustness of COVID-19 immunity and relevance for a future vaccine.”

Separately, according to Johns Hopkins Medical, as of Saturday, Aug. 29, there were over 25 million COVID-19 global cases confirmed, and some 839,000 deaths. Confirmed cases in the US totaled 6 million with over 182,000 deaths. Both of the US figures comprise 24% and 22%, respectively, of the global totals. The US population is about 4% of the global total.

08/31 (2) COVID-19 Addenda: A majority of US states have rejected new Trump administration COVID-19 testing guidance in an extraordinary rebuke of the nation’s top agency for disease prevention, according to officials at state health agencies and public statements reviewed by Reuters.

At least 33 states continue to recommend testing people who have been exposed to COVID-19 and have no symptoms, spurning guidance published by the US Centers for Disease Control and Prevention (CDC) last week that said testing may be unnecessary. Sixteen states did not immediately respond to requests for comment. Among the states breaking with the federal government are conservative-leaning Texas, Oklahoma and Arizona. Public health experts said a rupture of this magnitude with the CDC may be unprecedented and shows deepening distrust of the Trump administration’s response to the pandemic.

Elsewhere, the US FDA late Friday allowed the drug remdesivir to be used on all patients hospitalized with COVID-19, although no published research supports such widespread use. The approval allows doctors freedom to prescribe the antiviral earlier. But it comes less than a week after the agency approved use of convalescent plasma without published scientific support, fueling concerns the agency is yielding to political pressure.

“It seems to be a pattern of approval without science, without data, without evidence,” said Dr. Eric Topol, vice president for research at Scripps Research in La Jolla, CA, and a national expert on the use of data in medical research.

In May, the FDA allowed remdesivir to be used for hospitalized adults who need oxygen, but not those sick enough to require ventilation. A government study published that month in the New England Journal of Medicine found those patients recovered faster than those who hadn’t gotten the drug, though there was no evidence that it saved lives. No other published studies have supported more widespread use of remdesivir.

Two senior public relations experts advising the Food and Drug Administration have been fired from their positions after President Trump and the head of the FDA exaggerated the proven benefits of a blood plasma treatment for COVID-19. On Friday, the FDA commissioner, Dr. Stephen M. Hahn, removed Emily Miller as the agency’s chief spokeswoman, The New York Times reports. The White House had installed her in the post just 11 days earlier.

Ms. Miller had previously worked in communications for the re-election campaign of Senator Ted Cruz and as a journalist for the conservative cable network One America News. The New York Times correspondents Sheila Kaplan and Katie Thomas report that Ms. Miller’s termination comes one day after the FDA’s parent agency, the Department of Health and Human Services, terminated the contract of another public relations consultant, Wayne L. Pines, who had advised Dr. Hahn to apologize for misleading comments about the benefits of blood plasma for COVID-19.

The top US infectious diseases expert is warning that distributing a COVID-19 vaccine under special emergency use guidelines before it has been proved safe and effective in large trials is a bad idea that could have a chilling effect on the testing of other vaccines. Scientists and health experts have expressed concern that President Donald Trump will apply pressure on the US Food and Drug Administration to deliver a vaccine before November to boost his chances of reelection.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, declined to comment on the president, but said there are risks in rushing out a vaccine despite the urgent need, according to Reuters.

“The one thing that you would not want to see with a vaccine is getting an EUA (emergency use authorization) before you have a signal of efficacy,” Fauci told Reuters. “One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” Fauci added.

VBI Vaccines Inc. (Cambridge MA), known for its research in hepatitis B, announced last Wednesday that it will begin a Phase 1/2 trial by the end of the year after preclinical data showed positive results. The company is taking two single-dose candidates into human studies that it hopes can cure not only COVID-19 but other coronavirus diseases like SARS and MERS. The preclinical trials attempted to see the impact of VBI’s enveloped virus-like particle technology against recombinant vaccine candidates, differences in the conformation of the spike protein and other adjuvants. After one dose, the candidate showed four times as many neutralizing antibodies than the GMT of high-titer convalescent sera, which increased to 64 times higher after a second dose. The candidate also induced antibody-binding GMT at a tenfold rate.

Moderna’s COVID-19 vaccine candidate shows promise in older adults.

In a conference call with investors last week, Moderna Inc.’s (Cambridge MA) CEO Stéphane Bancel said the company is on track to complete Phase 3 enrollment of its mRNA-1273 vaccine trial next month (September).

“Our team and the clinical side are working with local communities to enroll a diverse population,” Bancel said.

So far, 15,239 patients have signed up. The anticipated September finish is right in line with the company’s previously established goal. Moderna said earlier that it hopes to read out data by the end of the year, possibly in the fall. Meanwhile, the company is gearing up to produce 500 million to one billion doses of the potential vaccine annually. The candidate would need to be kept at -20 degrees Celsius (-4 degrees Fahrenheit) in distribution centers, and at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) at point-of-care sites. Chief technical operations and quality officer Juan Andres said -20 degrees Celsius is “the regular freezer temperature that we all use for food at home,” and the 2 to 8-degree range is consistent with normal refrigerator conditions.

Bancel also used the call as an opportunity to tout new Phase 1 interim data, which showed a 100 μg dose of the vaccine scored consistently across three age groups: 18-55, 56-70 and 71+. Neutralizing antibody titers were observed in 100% of patients, Bancel told investors. The trial data showed that its experimental vaccine mRNA-1273 was safe and generated an immune response in people over the age of 55. Results from cohorts of older adults aged 56 to 70 years, as well as elderly participants 71 years and older, were detailed at the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

“I’m very happy to report that binding antibodies were comparable across age groups,” CMO Tal Zaks said. “We did not observe a loss of an immune response related to older ages, as can be seen with other vaccines.”

The 100 μg dose induced levels of neutralizing antibodies that exceeded levels found in convalescent sera, Zaks added.

“Now it may be that the levels of neutralizing antibodies in the range that you see in convalescent sera could be enough to provide protection from disease,” Zaks said. “But we always believed that the higher level that we are able to elicit with a vaccine, the higher the likelihood of protection, and the longer we should expect the duration of that protection.”

Abbott inks $760 million HHS contract for rapid COVID-19 testing kits.

The Trump administration will purchase 150 million rapid coronavirus tests from Abbott Laboratories Inc. (Abbott Park IL) for approximately $750 million, a White House spokeswoman said last Thursday. The portable antigen tests, which can deliver results within 15 minutes and will sell for $5, received emergency use authorization (EUA) from the US Food and Drug Administration on Wednesday.

The portable test from Abbott is about the size of a credit card, requires no additional equipment to operate, and can be conducted using a less invasive nasal swab than traditional lab tests. Abbott had said that it plans to ship tens of millions of the tests in September with a goal of producing 50 million in October. By comparison, the US has tested about 22 million people in the last month. The company will not be selling the kits for at-home use as they are intended to be utilized by medical professionals.

Antigen tests are cheaper and faster than molecular diagnostic tests, but somewhat more likely to fail to identify positive cases of the virus than lab-based diagnostic tests. Becton Dickinson and Co. (Franklin Lakes NJ) and Quidel Corp. (San Diego) already market antigen tests. The White House confirmed an earlier report from Politico. Abbott shares closed the week up 8% at $110.79.

IPO Sector: Included among recent SEC filings for initial public offerings, Virios Therapeutic Inc., a Phase 2 biotech developing novel antiviral therapies for fibromyalgia and other diseases, registered up to $35 million worth of common stock. The company’s lead candidate, IMC-1, is a novel combination antiviral therapy designed to synergistically suppress Herpes Simplex Virus-1activation and replication, with the end goal of reducing viral mediated disease burden. In a Phase 2a proof-of-concept trial for fibromyalgia, IMC-1 provided statistically significant improvement versus placebo in the primary endpoint of pain reduction. The company plans to enter a Phase 2b trial in the 1Q21, with topline data expected in the 1Q22. The Alpharetta, GA-based company was founded in 2012 and plans to list on the Nasdaq under the symbol “VIRI.” ThinkEquity is the sole bookrunner on the deal. No pricing terms were disclosed.

Elsewhere, Athira Pharma Inc., a Phase 2/3 biotech developing therapies for neurodegeneration, registered up to $100 million worth of common. The company is developing small molecule therapies to restore neuronal health and stop neurodegeneration through its ATH platform. Athira’s lead candidate, ATH-1017, demonstrated improvements in brain network activity indicating potentially positive effects on brain function in nonclinical studies and Phase 1 clinical trials. The company plans to initiate a Phase 2/3 clinical trial for ATH-1017 by the end of 2020. The Seattle, WA-based company was founded in 2011 and plans to list on the Nasdaq under the symbol “ATHA.” Athira Pharma filed confidentially on July 24, 2020. Goldman Sachs, Jefferies and Stifel are the joint bookrunners on the deal. No pricing terms were disclosed.

Sun BioPharma Inc., a clinical-stage biotech developing small molecule therapies for pancreatic cancer, revised the terms of its upcoming IPO on Thursday. The Waconia, MN-based company now plans to raise $11 million by offering 2.1 million shares at $5, below the last close of its shares on the OTCQB (SNBP). The company had previously filed to offer 1.1 million shares at $8.75, before revising terms yesterday increasing its share offering to 2 million shares at $5. The company is also offering warrants to purchase 2.1 million shares at an assumed exercise price of $6.25 per share (125% of assumed offer price). At the revised price, Sun BioPharma will command a market value of $46 million, a 48% cut from its original terms. Sun BioPharma was founded in 2011 and plans to list on the Nasdaq under the symbol “SNBP.” Craig-Hallum Capital Group is the sole bookrunner on the deal.

Dyne Therapeutics Inc., a preclinical biotech developing therapies for muscular diseases, registered up to $100 million worth of common. The company is using its proprietary FORCE platform to develop a pipeline of programs to address genetically-driven muscle diseases with high unmet need. This includes candidates for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD), and facioscapulohumeral dystrophy (FSHD). Dyne expects to submit investigational new drug applications to the FDA for candidates in its DM1, DMD and FSHD programs between the 4Q 2021 and 4Q 2022. The Waltham, MA-based company was founded in 2017 and plans to list on the Nasdaq under the symbol “DYN.” Dyne Therapeutics filed confidentially on July 23, 2020. J.P. Morgan, Jefferies, Piper Sandler and Stifel are the joint bookrunners on the deal. No pricing terms were disclosed.

American Well Inc., which provides a telehealth platform for insurers and patients, registered up to $100 million worth of common. The Amwell Platform is a complete digital care delivery solution that equips its health system, health plan, and innovator clients with the tools to enable new models of care for their patients and members. Its scalable technology enables care delivery across a wide variety of clinical, retail, school, and home settings. The Boston, MA-based company was founded in 2006 and booked $202 million in revenue for the 12 months ended June 30, 2020. It plans to list on the NYSE under the symbol “AMWL.” American Well filed confidentially on June 1, 2020. Morgan Stanley, Goldman Sachs, Piper Sandler, UBS Investment Bank, Credit Suisse, Cowen and Berenberg are the joint bookrunners on the deal. No pricing terms were disclosed.

Metacrine Inc., a Phase 1 biotech developing FXR agonist therapies for NASH, registered up to $100 million worth of common. The company’s pipeline contains lead candidate MET409, a potent and sustained FXR agonist with the ability to be dosed orally once daily. MET409 demonstrated notable reductions in liver fat and improvements in other NASH biomarkers and was generally well tolerated in its Phase 1b trial as a monotherapy. The company plans to submit an IND in the 4Q20 and initiate a Phase 2a combination trial in the 1H21, with topline data expected in the 1H22. The San Diego, CA-based company was founded in 2014 and plans to list on the Nasdaq under the symbol “MTCR.” Metacrine filed confidentially on July 12, 2018. Jefferies, Evercore ISI and RBC Capital Markets are the joint bookrunners on the deal. No pricing terms were disclosed.

And GoodRx Holdings Inc., which operates a prescription drug price comparison platform, registered on Friday with the SEC to raise up to $100 million worth of common. However, this is likely a placeholder for a deal that Renaissance Capital estimates could raise up to $750 million. From its beginnings as a price comparison tool for prescriptions, GoodRx’s platform now provides access to price transparency and affordability solutions for medications, affordable and convenient medical provider consultations via telehealth, and additional healthcare services and information. The Santa Monica, CA-based company was founded in 2011 and booked $472 million in revenue for the 12 months ended June 30, 2020. It plans to list on the Nasdaq under the symbol “GDRX.” Morgan Stanley, Goldman Sachs and J.P. Morgan are among the joint bookrunners on the deal. No pricing terms were disclosed.

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