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Monday, July 13, 2020

Mallinckrodt up on prospects for Ad Com thumbs up on terlipressin

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet virtually on Wednesday, July 15, to review and discuss Mallinckrodt’s (MNK +12.1%) marketing application seeking approval to use terlipressin to treat hepatorenal syndrome type 1 (HRS-1), a type of progressive kidney failure in patients with severe liver damage, typically from cirrhosis.
Based on the agency’ briefing document, it looks promising for a positive vote backing approval.

Immunomedics expands Roche partnership with two new trials

Immunomedics (NASDAQ:IMMU) will extend its clinical collaboration with Roche (OTCQX:RHHBY) with two new clinical trials evaluating the combination of anti-Trop-2 antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) and Tecentriq (atezolizumab) in bladder and lung cancer patients.
Roche will conduct two open-label randomized Phase 1b/2 studies using its MORPHEUS platform.
MORPHEUS-mUC will randomize checkpoint inhibitor (CPI)-naïve metastatic urothelial cancer patients who have failed to respond to platinum-based chemo to receive either the combo or Tecentriq alone.
MORPHEUS-Lung will randomize CPI-experienced metastatic non-small cell lung cancer patients who failed to respond to platinum-based chemo to receive either the combo or docetaxel alone.
On another note, IMMU announces that the first subject has been enrolled in a Phase 2 study, NeoSTAR, evaluating presurgical administration of Trodelvy in patients with localized triple-negative breast cancer. The primary endpoint is pathological complete response rate at week 12.

Market reverses sharply to end in red; California rollbacks spur selling

July 13, 2020

Stocks ended the day down as California’s decision to roll back some opening measures accelerated selling into the close.
The S&P closed down 0.9%, the Dow was flat and the Nasdaq fell 2.1%.
All California counties must close indoor activity in certain areas like restaurants and bars, while LA and San Diego counties will start the school year with online classes in August.
The California moves shook a market that was already struggling with a reversal in momentum stocks, which had charged higher midday. Apple, down 0.4%, and Amazon, off 3.3%, had been more than 4% higher earlier.
Tesla, which hard charged above $1,600, ended down 3.2%.

Hypothesis to explain the severe form of COVID-19 in Northern Italy

  1. Luca Cegolon1,2,
  2. Jennifer Pichierri3,
  3. Giuseppe Mastrangelo4,
  4. Sandro Cinquetti1,
  5. Giovanni Sotgiu5,
  6. Saverio Bellizzi6,
  7. Giuseppe Pichierri7

Author affiliations

Summary box

What is already known about this subject?

  • Human coronaviruses are known to cause respiratory re-infections, regardless of pre-existing humoural immunity.
  • There is evidence suggesting that severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) had been circulating in Italy before the first COVID-19 case was detected in the country.

What are the new findings?

  • Prior infections with SARS-CoV-2 (or other viruses/coronaviruses) may arguably predispose to more severe forms of the disease following re-infection with SARS-CoV-2, with an immunological mechanism known as Antibody-Dependent-Enhancement, already observed with infections sustained by other coronaviruses (MERS-CoV and SARS-CoV) or other viruses such as the West Nile Virus and Dengue.

What are the recommendations for policy and practice?

  • If confirmed by in vivo studies, this hypothesis may have relevant implications for the treatment of severe forms of COVID-19, yet the possibility to produce an effective vaccine against SARS-CoV-2 might be hampered.

Cal. Gov. Orders Indoor Movie Theaters, Restaurants to Close

As the coronavirus cases and hospitalizations continue to rise, Newsom also announced that effective immediately, indoor operations such as fitness centers, hair salons and more in additional sectors be closed in “all the counties on our county monitoring list.”

As coronavirus cases and hospitalizations continue to rise, California Gov. Gavin Newsom announced a statewide order Monday requiring indoor operations to close effective immediately.
Indoor operations required to close statewide in all counties include: Restaurants, movie theaters, family entertainment centers, wineries and tasting rooms, zoos and museums, cardrooms and bars.
Meanwhile, Newsom announced that indoor operations in additional sectors be closed in “all the counties on our county monitoring list.” Indoor operations include: Fitness centers, places of worship, offices for non-critical sectors, personal care services, hair salons and barbershops and malls.
Counties impacted on that list include: Colusa, Contra, Costa, Fresno, Glenn, Imperial, Kern, Kings, Los Angeles, Madera, Marin, Merced, Monterey, Napa, Orange, Placer, Riverside, Sacramento, San Benito, San Bernardino, San Diego, San Joaquin, Santa Barbara, Solano, Sonoma, Stanislaus, Sutter, Tulare, Yolo, Yuba and Ventura.
“We’re seeing an increase in the spread of the virus, so that’s why it’s incumbent upon all of us to recognize soberly that COVID-19 is not going away any time soon until there is a vaccine or an effective therapy,” Newsom said Monday.
“We’ve made this point on multiple occasions, and that is, we’re moving back into a modification mode of our original stay-at-home order, but doing so utilizing what we commonly refer to as a dimmer switch, not an on/off switch,” he said.
As of July 12, 8,358 cases have been reported in the state with an 8,211 seven-day average.
The new order comes shortly after Newsom reiterated that cases “continue to spread at alarming rates.” “This virus is not going away anytime soon,” Newsom stressed, adding that the virus is not “taking summer off.”
“This continues to be a deadly disease,” Newsom said, as he warned people that the virus is “still killing people” across the state.
California has recently begun reopening the economy, with most counties allowing people to shop, dine in at restaurants, work out in gyms, visit hair salons and attend church services, among other things. But concern has grown as coronavirus cases continue to increase.
Last month, Newsom ordered the closing of bars in seven counties, including Los Angeles, due to the rising spread of COVID-19. Newsom also began mandating that Californians wear masks in most indoor settings and outdoors when distancing isn’t possible.
Strict restrictions were also ordered ahead of the July 4 holiday as beaches, piers, beach bike paths, and beach access points were closed.
During a press briefing last month, Barbara Ferrer, the director of public health for L.A. County, explained that while officials predicted an increase in cases occurring as soon as the economy began reopening, she said they didn’t expect to “see this steep of an increase this quickly.” She said that there are a number of businesses and individuals that have not followed directives and warned: “At this point, if you’re not part of the solution to slowing the spread, you’re ending up a part of the problem.”

Humoral, circulating follicular helper T cell responses in recovered covid patients

Abstract

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has dramatically expedited global vaccine development efforts1,2,3, most targeting the viral ‘spike’ glycoprotein (S). S localizes on the virion surface and mediates recognition of cellular receptor angiotensin-converting enzyme 2 (ACE2)4,5,6. Eliciting neutralizing antibodies that block S–ACE2 interaction7,8,9, or indirectly prevent membrane fusion10, constitute an attractive modality for vaccine-elicited protection11. However, although prototypic S-based vaccines show promise in animal models12,13,14, the immunogenic properties of S in humans are poorly resolved. In this study, we characterized humoral and circulating follicular helper T cell (cTFH) immunity against spike in recovered patients with coronavirus disease 2019 (COVID-19). We found that S-specific antibodies, memory B cells and cTFH are consistently elicited after SARS-CoV-2 infection, demarking robust humoral immunity and positively associated with plasma neutralizing activity. Comparatively low frequencies of B cells or cTFH specific for the receptor binding domain of S were elicited. Notably, the phenotype of S-specific cTFH differentiated subjects with potent neutralizing responses, providing a potential biomarker of potency for S-based vaccines entering the clinic. Overall, although patients who recovered from COVID-19 displayed multiple hallmarks of effective immune recognition of S, the wide spectrum of neutralizing activity observed suggests that vaccines might require strategies to selectively target the most potent neutralizing epitopes.

Atlanta mayor orders city back to Phase 1 as Ga. breaks record for daily covid cases

Georgia set a new single-day record for new coronavirus cases on Friday, reporting more than 4,400 new infections. The skyrocketing case numbers prompted Atlanta Mayor Keisha Lance Bottoms to order the city to reverse its reopening plan and return to Phase 1.
Georgia reported 4,484 cases on Friday, bringing the state’s total to 111,211, according to the Georgia Department of Public Health. The state’s total deaths increased to 2,965.
Georgia is far from the only state facing an uptick in cases. The United States reported 63,200 coronavirus cases on Thursday – another all-time, single-day high for new confirmed infections.
Bottoms issued an order on Friday evening that says Atlanta will return to Phase 1, effective immediately, “in response to the alarming increase” in cases. The city was previously in Phase 2.
“Based upon the surge of COVID-19 cases and other data trends, pursuant to the recommendations of our Reopening Advisory Committee, Atlanta will return to Phase I of our reopening plan,” the mayor said in a press release. “Georgia reopened in a reckless manner and the people of our city and state are suffering the consequences.”
Earlier this week, Bottoms announced that she had tested positive for COVID-19, but showed no symptoms. 
As part of Phase 1, individuals are required to stay home except for essential trips and wear a face mask in public. The order also prohibits gatherings of any kind on city property.
Businesses must continue teleworking, and restaurants and retail stores can only remain open for to-go and curbside pickups. All non-essential city facilities will remain closed.
Following the announcement, Governor Brian Kemp criticized Bottoms’ decision and said it was “legally unenforceable.”
“Atlanta Mayor @KeishaBottoms’ action today is merely guidance – both non-binding and legally unenforceable,” Kemp tweeted. “As clearly stated in my executive orders, no local action can be more or less restrictive, and that rule applies statewide.”
“If the Mayor actually wants to flatten the curve in Atlanta, she should start enforcing state restrictions, which she has failed to do,” he continued.