COVID-19 creates thicket of legal concerns for providers

Tenet is preparing for potential lawsuits from patients claiming they caught the coronavirus at one of its hospitals. A New York nursing union is suing hospitals claiming inadequate protection for workers on the front lines.
Providers are grappling with a host of novel legal concerns like these as they treat patients amid the COVID-19 pandemic, leading them to seek protections from various levels of government.
From decisions over what qualifies as elective surgery to navigating near-daily CMS updates and fears of doctors claiming unsafe working conditions, doctors and hospitals have little precedent to go on.

“This is such an unknown area,” Damaris Medina, co-chair of the life sciences practice at law firm Buchalter, told Healthcare Dive. “It’s really hard to predict what’s going to happen in terms of litigation.”
Hospitals and physician groups are taking unprecedented economic hits and many have furloughed or laid off staff as they try to weather the storm. That could leave them even more unprepared for legal issues that arise, as they almost inevitably will.
“It’s just a horrible, difficult situation, and there’s not a lot of easy answers here,” Douglas Grimm, healthcare practice co-leader at Arent Fox, told Healthcare Dive. “I’m not sure we’ve experienced something like this before. In fact, I know we haven’t.”

Potential immunities

Provider groups are pushing Congress to include some immunity for those treating COVID-19 patients in relief legislation. The four bills signed into law so far have only extended protections for medical volunteers.
It could be an uphill battle. The last bill approved in the Democratic-controlled House, panned by Republicans in the Senate and the president, does not include any immunity language.
Senate Majority Leader Mitch McConnell and fellow Republicans have said they want future legislation to provide broad-based liability protections to businesses that could face lawsuits from employees or customers who say they became infected with COVID-19 on their premises.
McConnell opposes other provisions in the Democrats’ bill such as extending enhanced unemployment insurance and additional direct payments to citizens.
Mike Stinson, vice president of government relations and public policy for the Medical Professional Liability Association, which represent liability insurance providers and supports the creation of federal legislation providing a form of immunity, contends the idea has broad support.
“Right now, I think there’s fairly unanimous consent that liability protections for healthcare providers are necessary and appropriate,” he said. “We’re not hearing a lot of pushback on that, depending on what the scope is going to be.”
https://www.healthcaredive.com/news/covid-19-creates-thicket-of-legal-concerns-for-providers/578764/

Here come the anti-Covid antibodies

After vaccines and antiviral approaches to tackling the Covid-19 pandemic, it’s time for antibodies to take their turn in the spotlight. This week Lilly seized the lead in this space, starting the first clinical trial of an antibody designed to treat the novel coronavirus.
LY-CoV555, derived from a deal with Abcellera, targets Covid-19’s Spike protein, meaning that unlike projects aiming to reduce the infection’s complications it takes direct aim at the virus itself. While at present this is the only clinical-stage antibody against Covid-19, it will not retain this monopoly for long.
The Spike protein-targeting approach is similar to that of several of Lilly’s competitors. The protein is present on the virus surface, and the virus uses it to dock with the Ace2 receptor on target cells, allowing it to be internalised and infect.
The next project into the clinic with this mechanism could come from Vir’s partnership with Glaxosmithkline, which has so far identified two lead MAbs. Also keenly awaited are a multi-antibody cocktail from Regeneron, and a project under way at Astrazeneca, all of which could be studied in patients within the next few months.
The hope is that these antibodies can prevent the virus docking, or hit another part of it that leads to antibody-mediated destruction.
The last two are noteworthy because they are based in part on plasma derived from patients who have recovered from Covid-19 infection. This approach, it might be surmised, could provide a broader range of targets, some of which might provide a more efficient way of targeting the virus than hitting the Spike protein.

Selected antibodies and related biologicals in development for Covid-19
Companies	Lead, if identified	Mechanistic approach	Clinical development?
Lilly/Abcellera	LY-CoV555	IgG1 MAb vs Spike protein	Safety study in hospitalised subjects
Sab Biotherapeutics	SAB-185	Polyclonal	Clinical trial due mid-2020
Regeneron	REGN-COV2	Multi-Ab cocktail, incl from recovered patients	Clinical trial due Jun 2020
Celltrion	CT-P59	MAb vs Spike protein receptor binding domain	Clinical trial due Jul 2020
Glaxosmithkline/Vir	VIR-7831 & VIR-7832	MAbs vs Spike protein	Clinical trial in Jul-Sep 2020
Astrazeneca	–	MAbs, incl based on recovered patients	Clinical trial in Jul-Sep 2020
Sorrento	STI-1499	Fully human MAb vs Spike protein	Clinical trial due Q3 2020
Brill Bio	–	Fully human MAb	Clinical trial due Q3 2020
Yumab	–	MAbs, incl based on recovered patients	Clinical trial due H2 2020
Molecular Partners	–	Darpin proteins	Clinical trial due H2 2020
Systimmune	SI-F019	Bivalent Ace2 fusion protein vs Spike protein	IND filing due 2020
Xencor/Vir	–	Fc-engineered MAbs	–
Lilly/Junshi	JS016	Fully human MAb vs Spike protein	–
Atreca/Beigene/IGM	–	IgM & IgA MAbs vs novel epitopes	–
Amgen/Adaptive	–	MAbs based on recovered patients	–
Ossianix	–	Single-domain VNAR MAbs vs Spike protein	–
Sorrento	STI-4398	Ace2-Fc protein vs Spike protein	–
Sorrento/Mabpharm	STI-4920	Bispecific vs 2 domains on Spike protein	–
Note: excludes anti-IL6, anti-GM-CSF and other MAbs not directly targeting Covid-19.

The Spike protein is also used as the target for most of the industry’s vaccine approaches seeking to prime the immune system, and indeed Regeneron has suggested that REGN-COV2 could also have a prophylactic role.
And there are other biologicals already in clinical development, such as MAbs against cytokines, GM-CSF and angiopoietin 2, but these are not considered here as they aim to treat the effects of Covid-19, such as cytokine elevations and respiratory complications, rather that the virus itself.
Design
Though many projects have the same target in common, there is additional variability in antibody structure.
For instance, while most are based on IgG, a tie-up between Atreca, Beigene and IGM Biosciences is looking at those derived from IgM and IgA, which, the companies argue, have more binding domains and hence greater binding power than IgG.
A separate tie-up Vir has with Xencor looks to develop MAbs with an engineered Fc domain to give an extended half-life, and a similar thinking lies behind the so-called Darpins in development by Molecular Partners.
There are also bispecific approaches and fusion proteins, for instance SI-F019, in development by Systimmune, a private US group focusing on MAbs, bispecifics and antibody-dug conjugates. This combines two proteins each mimicking Ace2, aiming to take up the relevant binding sites on Covid-19 and prevent its interaction with the endogenous Ace2 receptor.
While many companies are making claims about the superiority of their respective approaches, these are of course all based on animal or in vitro data, and no comparison will be possible until the first clinical trials read out.
After Lilly’s clinical study, primarily testing safety, pharmacokinetics and pharmacodynamics, the designs of competitor trials will be watched with interest.
https://www.evaluate.com/vantage/articles/news/trial-results/here-come-anti-covid-antibodies

Apple reportedly offers coronavirus tests to returning employees

Apple is reportedly offering coronavirus tests to employees at its Bay Area campus as they begin to return to the office after months of working from home.
In addition to having their temperature taken and being required to wear a mask at One Infinite Loop, Apple workers will have the option to get a nasal swab test as well, according to Bloomberg.
Apple was one of the earliest companies to send its employees home, doing so on March 8. But unlike other Silicon Valley giants like Facebook and Twitter — which have publicly spoken about allowing employees to work remotely permanently — Apple needs people in the office to work on its hardware products.
In March it was reported that the launch of the next iPhones may be delayed by “practical hurdles” caused by the coronavirus.
Apple traditionally needs to send engineers back and forth from its offices to its factories in China to finalize designs in the lead-up to the product’s release. But the coronavirus has led Apple to restrict employee travel to hotbeds of the disease, including China.
The Cupertino, Calif., company recently announced that it would be reopening more than 100 of its US retail locations after a months-long closure due to the pandemic.

https://nypost.com/2020/06/05/apple-reportedly-offers-coronavirus-tests-to-returning-employees/

De Blasio can’t explain why NYC saw spike in coronavirus hospitalizations

The number of hospital admissions across the city spiked to 84 Friday, a day after just 48 were recorded, according to Mayor Bill de Blasio.
But it’s unclear whether the startling increase is related to the mass protests and spread of coronavirus, the mayor said.
“That’s a meaningful movement in one day. We’re going to keep a close eye on that,” said de Blasio.
“We do not see evidence that it’s related to everything that happened over the last few weeks because of the time it takes for the disease to manifest.”
The mayor said it would take a week to 10 days to see any manifestation of the coronavirus.
The city has been the scene of numerous crowded protest gatherings in the wake of George Floyd’s police-involved death in Minneapolis.
On Wednesday, the Big Apple recorded zero confirmed deaths from COVID-19 for the first time since March 12.
https://nypost.com/2020/06/05/de-blasio-cant-explain-why-nyc-saw-spike-in-hospitalizations/

Pliant Therapeutics closes $166M IPO

Pliant Therapeutics (NASDAQ:PLRX) has closed its IPO of 10.35M common shares at $16 per share yielding gross proceeds of ~$165.6M.

The offering included underwriters’ full exercise of their over-allotment of 1.35M shares.

https://seekingalpha.com/news/3580900-pliant-therapeutics-closes-166m-ipo

Fusion Pharmaceuticals readies IPO

Fusion Pharmaceuticals (OTC:FUSN) has filed a preliminary prospectus for a $100M IPO.

The Boston, MA-based onclogy company develops next-generation radiopharmaceuticals as precision medicines based on its proprietary platform called Targeted Alpha Therapies (TAT) and its proprietary Fast-Clear linker technology.

Lead candidate is FPI-1434, a humanized monoclonal antibody targeting the insulin-like growth factor 1 receptor (IGF-1R), a well-established tumor target, linked to isotope actinium-225.

2019 Financials: Operating Expenses: $18.2M (+80%); Net Loss: ($16.2M) (-38%); Cash Burn: ($13.7M) (-38%).

https://seekingalpha.com/news/3580912-fusion-pharmaceuticals-readies-ipo

Sarepta to release data on gene therapy for rare type of muscular dystrophy

Sarepta Therapeutics (NASDAQ:SRPT) will host a webcast and conference call on Monday, June 8, at 8:30 am ET to present new data from six-subject Phase 1/2 clinical trial evaluating gene therapy candidate SRP-9003 in patients with beta-sarcoglycanopathy or Limb-girdle muscular dystrophy type 2E, a rare type of muscular dystrophy characterized by weakness in the pelvic and shoulder girdle.

Results will include expression and safety data from the high-dose cohort and one-year functional results from the low-dose cohort.

https://seekingalpha.com/news/3580895-sarepta-to-release-data-on-gene-therapy-for-rare-type-of-muscular-dystrophy