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Tuesday, November 16, 2021

COVID-19 outbreak at Conn. nursing home leaves 8 dead, dozens infected

 

  • Eight residents with serious underlying health issues have died at the Geer Village Senior Community since late September.
  • A total of 89 residents and staff members have been infected.
  • According to NBC Connecticut, 87 of the 89 people were fully vaccinated.

A recent COVID-19 outbreak at a Connecticut nursing home has left eight residents dead while dozens of additional residents and staff have tested positive for the disease. 

Officials with the Geer Village Senior Community, a nursing home and rehabilitation center in North Canaan, on Friday said eight residents with serious underlying health issues have died since late September when the outbreak was first identified. 

A total of 89 residents and staff members have been infected since Sept. 30. Officials said 48 residents and 21 employees have since recovered. According to NBC Connecticut, 87 of the 89 people were fully vaccinated. Geer Village first publicly announced the outbreak on Oct. 3, when it identified three cases among fully vaccinated residents and staff. The facility houses 70 seniors.

“We are encouraged to see 69 staff and residents already recovered and coming off isolation. While we must continue with COVID-19 prevention protocols, we want to assure everyone we are doing our best to keep residents and staff safe,” the nursing home said in a statement

“We continue to monitor the situation closely and will provide updates for residents, staff, families, and community stakeholders as the situation changes,” the statement said. 

As COVID-19 booster shots are being deployed across the country, the nursing home said residents and staff will be eligible once the facility has gone two full weeks with no new positive cases. Boosters gained approval just before the outbreak occurred. 

Nursing homes were hit hard during the worst of the pandemic as the virus is particularly dangerous to older adults with underlying medical conditions. 

https://thehill.com/changing-america/well-being/581742-covid-19-outbreak-at-connecticut-nursing-home-leaves-8-dead

DC suspends indoor mask mandate

 Washington, D.C., will lift its indoor mask mandate for most locations beginning Nov. 22, Mayor Muriel Bowser (D) announced Tuesday.

The mandate for masks in most indoor locations, which was one of the strictest remaining in the country, has been in place since July, when the delta variant began spreading rapidly across the U.S..

Masks will still be required in schools and on public transportation, as well as in congregate housing facilities and D.C. government facilities with public-facing roles, Bowser said. Private businesses will also be free to instate their own mandates.

Bowser said vaccines are working for preventing severe disease and hospitalization, and D.C. residents will be able to assess their own risks and make their own decisions about wearing masks.

https://thehill.com/policy/healthcare/581753-dc-lifts-indoor-mask-mandate

Times Square reopening for New Year's Eve festivities

 New York Mayor Bill de Blasio (D) announced Tuesday that the Times Square New Year's Eve celebration would be returning next month after being greatly scaled down last year during the coronavirus pandemic.

“We want to welcome all those hundreds of thousands of folks, but everyone needs to be vaccinated,” de Blasio said during the news conference, as reported by The New York Times

“Join the crowd, join the joy, join a historic moment as New York City provides further evidence to the world that we are 100 percent back," he added.

The Times reports that would-be attendees who cannot be vaccinated due to disability will need to have a negative COVID-19 test within 72 hours of the event and will need to be masked, as will children under the age of 5, who are ineligible for vaccinations at this time. Children will also need to be accompanied by a vaccinated adult, said Tom Harris, who is the president of the Times Square Alliance, according to the Times. 

The celebration was limited last year due to the pandemic, with most onlookers prohibited from the usually filled blocks and only a select few first responders and medical workers allowed to be spectators from socially distant, blocked-in pens, reports ABC 7.

“When you’re outdoors with a few hundred thousand people packed close together for hours on end, it’s a different reality,” de Blasio said when asked why vaccination was required despite the event being outdoors. “You’re talking about a lot of people really close for long periods of time. It makes sense to protect everyone.”

https://thehill.com/homenews/state-watch/581747-times-square-reopening-for-new-years-eve-celebration

MyMD OKd for Phase 2 Trial of MYMD-1 for Extending Healthy Lifespan

 Believed to be the only IND application ever cleared by the FDA for a Phase 2 trial of a patented drug for delaying aging

Phase 2 trial recruiting begins immediately; efficacy data expected by the end of the first quarter of 2022

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) ("MyMD" or "the Company"), a clinical stage pharmaceutical company committed to extending healthy lifespan by delaying aging, announced today that it has received U.S. Food and Drug Administration clearance of its Investigational New Drug (IND) application for the Phase 2 trial of MYMD-1 as a therapy for delaying aging and prolonging healthy lifespan. Recruitment for the Phase 2 trial will begin immediately, and efficacy data is expected by the end of first quarter of 2022.

https://finance.yahoo.com/news/mymd-pharmaceuticals-receives-fda-ind-142500188.html

Molecular Partners' Covid-19 therapy proves inactiv

 Ensovibep has become the latest Covid-19 treatment candidate to crash out of the NIH-sponsored Activ-3 basket trial, wiping 34% off Molecular Partners’ share price. A planned futility analysis of the cohort evaluating ensovibep, a darpin Molecular Partners licensed to Novartis, concluded that enrolment should be stopped. Activ-3 is looking at potential therapies for hospitalised patients, but no agent in the trial has yet succeeded. The study's clinicaltrials.gov entry was also edited this month to state that Astrazeneca’s MAb combo AZD7442 was no longer being administered either, but no explanation has been offered for this. As a result, Pfizer’s IV antiviral PF-07304814 (lufotrelvir) is the only project still standing in Activ-3, at least until any new ones are added. There is some comfort for Molecular Partners in that Activ-3 backed ensovibep’s safety profile, which was consistent with the standard of care, Gilead’s Veklury, the company said. Ensovibep is in a separate phase 2/3 trial, Empathy, in Covid-19 outpatients, with interim data on the first 400 expected in early 2022. But in this niche Pfizer’s Paxlovid, an oral drug related to lufotrelvir, has set a standard that will be very hard to beat – as Molecular Partner’s shareholders clearly understand. 

Activ-3: NIH-funded phase 3 trial in hospitalised patients
CompanyProject DescriptionOutcome 
Lilly/AbcelleraBamlanivimabInfused MAb326 pt arm closed for futility Oct 2020
Vir BiotechnologySotrovimabIntramuscular or infused MAb344 pt arm closed for futility Mar 2021
Brii BiosciencesBRII-196 and BRII-198Infused MAb combination 343 pt arm closed for futility Mar 2021
Molecular Partners EnsovibepInfused antiviral470 pt arm closed for futility Nov 2021
AstrazenecaAZD7442 (tixagevimab + cilgavimab)Infused MAb combination Arm closed Nov 2021, reason unclear
PfizerLufotrelvirInfused antiviralArm ongoing
All patients received a backbone of Gilead's Veklury as standard of care. Source: clinicaltrials.gov.

https://www.evaluate.com/vantage/articles/news/snippets/molecular-partners-covid-19-therapy-proves-inactiv

Fate buries bad data and moves on

 It is just as well that the NK cell projects FT500 and FT516 were not a huge part of Fate’s investment case, because clinical trial results revealed quietly yesterday suggest them to be commercially unviable, at least in solid tumours. Perhaps this too explains Fate’s decision to sneak the data into an obscure investor presentation rather than announce them more broadly. The results for FT500, unmodified NK cells, show one partial remission in eight patients, while FT516, an NK cell project with a high-affinity CD16 receptor, has yielded just one PR in nine. Not only is this efficacy poor, the fact that the cells were given with an anti-PD-1 MAb as well as IL-2 makes the data uninterpretable. The enrolment targets for the PD-1 combo studies of FT500 and FT516 have now been reduced, respectively, from 76 to 37 and from 27 to 12, according to clinicaltrials.gov. Fate called FT500 and FT516 “pilot programmes” that “started the journey”, and its focus is switching to FT538, an NK construct with additional CD38 knockout. Meanwhile, investors’ attention remains on a key clinical update for the Car-NK project FT596, due to be presented at Ash next month.

SITC 2021 – Iovance can’t catch a break

 Already reeling from a double delay and the possible non-approvability of its TIL cell therapies, Iovance now has disappointing clinical data to contend with. Presentation at the SITC meeting of results from an NSCLC cohort of a multi-tumour basket study of the company’s lifileucel prompted a 10% selloff on Friday, as investors panicked about a surprising lack of durability. The six remissions previously reported in 24 evaluable patients are down to just two after one previously disclosed relapse was followed by two more disease progressions and one death. Stifel analysts said this suggested three to four months’ response duration – worse than in melanoma, where a US filing is now due next year. A separate cervical cancer filing looks doubtful after Keytruda’s accelerated label was formalised with a confirmatory study in October. A second SITC presentation on Sunday concerned lifilucel/Keytruda combos from two clinical trials in checkpoint inhibitor-naive patients, but this failed to stem the bleeding. ORRs of 60% were reported in melanoma, 57% in NSCLC and 39% in head and neck cancer, with 12 of 19 remissions ongoing at data cutoff. Though this looked better on a cross-trial basis than Keytruda monotherapy Iovance fell another 7% yesterday.