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Sanofi Shutters Principia’s San Francisco Labs After BTK Failure

According to a California WARN notice, Sanofi is shuttering Principia Biopharma’s laboratories in San Francisco and laying off about three dozen employees after the Phase III PEGASUS trial failure of rilzabrutinib for pemphigus.

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Sanofi Shutters Principia’s San Francisco Labs Days After BTK Failure

 

When Sanofi acquired Principia Biopharma in 2020 for $3.68 billion, many analysts were skeptical, with Kerrisdale Capital calling Principia’s pipeline “worthless.” Not much has happened since to change their minds. On September 9, the company announced that its Phase III PEGASUS trial of rilzabrutinib for pemphigus flunked the study, failing to meet primary or key secondary endpoints. The drug was part of the Principia acquisition.

According to a California WARN notice, Sanofi is shuttering Principia’s laboratories in San Francisco and laying off about three dozen employees. The pink slips will take effect on October 8. And according to a Sanofi spokesperson, they are re-evaluating their plan for the South San Francisco location after high turnover rates. The labs will be completely vacated by April 2022.

The Principia deal was largely around its Bruton tyrosine kinase (BTK) inhibitors. BTK is found in the signaling pathways of key innate and adaptive cell types in the immune system. Inhibiting or blocking these pathways has the potential of halting inflammation and tissue damage caused by autoimmune diseases. The pipeline also included ’168, which Sanofi had previously licensed from Principia in 2017. In addition to rilzabrutinib, it also picked up PRN473, a topical BTK inhibitor.

On September 8, Sanofi acquired New York-based Kadmon Holdings for about $1.9 billion. The deal is intended to grow Sanofi’s General Medicines core assets. Kadmon has a recently approved drug, Rezurock (belumosudil), a first-in-class drug for chronic graft-versus-host disease (cGVHD) for adults and pediatric patients 12 years and older who have failed at least two previous lines of systemic therapy.

“We are excited that Sanofi has acknowledged the value of Rezurock and the deep potential of our pipeline,” said Harlan Waksal, M.D., president and chief executive officer of Kadmon. “By leveraging Sanofi’s global resources and long-standing expertise in developing and commercializing innovative medicines, Rezurock is now well-positioned for global accessibility, faster. I want to thank the entire Kadmon team, including management and the Board of Directors, and the Sanofi organization, for their ongoing commitment to patients and their caregivers.”

Kadmon’s pipeline compounds include drugs for immune and fibrotic diseases and immuno-oncology treatments.

And on September 14, Sanofi announced it had completed its acquisition of Translate Bio for about $3.2 billion. Translate Bio has an mRNA technology platform, one of the hot new areas for development not just for vaccines, such as those for COVID-19 developed by Pfizer, BioNTech and Moderna, but potentially cancer and other indications.

Although the future of rilzabrutinib is in question, the multiple sclerosis drug tolebrutinib is being evaluated in four pivotal clinical trials, although data is not expected until 2023. Sanofi is undoubtedly hoping the drug is worth the money they invested in it, particularly since in March 2021, the U.S. Food and Drug Administration (FDA) approved Janssen, a Johnson & Johnson company, MS drug Ponvory (ponesimod), which, in a head-to-head Phase III trial, proved to be superior to Sanofi’s MS drug Aubagio (teriflunomide). The FDA first approved Aubagio for MS in 2012.

ricochet64/Shutterstock

In April 2020, tolebrutinib met both the primary and secondary endpoints in a Phase IIb trial in relapsing forms of MS, significantly reducing disease activity associated with MS as measured by magnetic resonance imaging (MRK). That sounds promising, but the data isn’t quite as clear-cut since they used a surrogate endpoint, and other critics have noted its complex trial design and the low number of patient participants.

As Jacob Plieth, writing for Evaluate Vantage, noted in February 2020, “SAR442168’s mid-stage study had such a convoluted design that a detailed analysis is needed to tease out its real benefit. … The study toplined today enrolled only 128 subjects with relapsing multiple sclerosis, yet had no fewer than eight cohorts, comprising four different doses given either before or after placebo. Moreover, its primary endpoint did not relate to relapse rates or MS progression, but the number of new Gd-enhancing T1 hyperintense lesions. Investors should ask themselves on what basis a trial with such a complex design, measuring an MRI surrogate endpoint, can be said to have yielded a positive result.”

 
BioSpace source:
 
 
 

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Spread & Containment

Huge Dock Worker Protests In Italy, Fears Of Disruption, As Covid ‘Green Pass’ Takes Effect

Huge Dock Worker Protests In Italy, Fears Of Disruption, As Covid ‘Green Pass’ Takes Effect

Following Israel across the Mediterranean being the first country in the world to implement an internal Covid passport allowing only vaccinated citize

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Huge Dock Worker Protests In Italy, Fears Of Disruption, As Covid 'Green Pass' Takes Effect

Following Israel across the Mediterranean being the first country in the world to implement an internal Covid passport allowing only vaccinated citizens to engage in all public activity, Italy on Friday implemented its own 'Green Pass' in the strictest and first such move for Europe

The fully mandatory for every Italian citizen health pass "allows" entry into work spaces or activities like going to restaurants and bars, based on one of the following three conditions that must be met: 

  • proof of at least one dose of Covid-19 vaccine

  • or proof of recent recovery from an infection

  • or a negative test within the past 48 hours

Via AFP

It's already being recognized in multiple media reports as among "the world's strictest anti-COVID measures" for workers. First approved by Italian Prime Minister Mario Draghi's cabinet a month ago, it has now become mandatory on Oct.15.

Protests have been quick to pop up across various parts of the country, particularly as workers who don't comply can be fined 1,500 euros ($1,760); and alternately workers can be forced to take unpaid leave for refusing the jab. CNN notes that it triggered "protests at key ports and fears of disruption" on Friday, detailing further:

The largest demonstrations were at the major northeastern port of Trieste, where labor groups had threatened to block operations and around 6,000 protesters, some chanting and carrying flares, gathered outside the gates.

    Around 40% of Trieste's port workers are not vaccinated, said Stefano Puzzer, a local trade union official, a far higher proportion than in the general Italian population.

    Workers at the large port of Trieste have effectively blocked access to the key transport hub...

    As The Hill notes, anyone wishing to travel to Italy anytime soon will have to obtain the green pass: "The pass is already required in Italy for both tourists and nationals to enter museums, theatres, gyms and indoor restaurants, as well as to board trains, buses and domestic flights."

    The prime minister had earlier promoted the pass as a way to ensure no more lockdowns in already hard hit Italy, which has had an estimated 130,000 Covid-related deaths since the start of the pandemic.

    Meanwhile, the requirement of what's essentially a domestic Covid passport is practically catching on in other parts of Europe as well, with it already being required to enter certain hospitality settings in German and Greece, for example. Some towns in Germany have reportedly begun requiring vaccination proof just to enter stores. So likely the Italy model will soon be enacted in Western Europe as well.

    Tyler Durden Sat, 10/16/2021 - 07:35

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    Government

    4 In 10 TSA Employees Remain Unvaccinated As Deadline Looms

    4 In 10 TSA Employees Remain Unvaccinated As Deadline Looms

    While we wait to see what remains of the US army after hundreds of thousands of unvaccinated troops are told to pack up for not complying with Biden’s executive order (and whether…

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    4 In 10 TSA Employees Remain Unvaccinated As Deadline Looms

    While we wait to see what remains of the US army after hundreds of thousands of unvaccinated troops are told to pack up for not complying with Biden's executive order (and whether that's the moment China will decided to attack), we wonder if soon nobody will be able to fly as a few weeks from now the Transportation Security Administration may simply cease to exist.

    According to CNN, the TSA says 4-in-10 members of its workforce, including screeners, remain unvaccinated against Covid-19 just weeks ahead of a looming deadline. The deadline for civilian federal government workers to be fully vaccinated is November 22 - the Monday before Thanksgiving, which just happens to be the busiest travel time of the year.

    "We have about 60% of our workforce has been vaccinated, that that number needs to go quite a bit higher over the next few weeks," TSA Administrator David Pekoske told CNN.

    The November 22 deadline for being fully vaccinated is still six weeks away, but the deadlines for receiving the vaccines are rapidly approaching or, in the case of the Moderna vaccine, have already passed, since an individual has to receive the full schedule of doses and wait two weeks before being considered fully vaccinated.

    In order to meet that deadline, the last possible date for receiving the first dose of the Pfizer vaccine is October 18, while the latest possible date for the first dose of Moderna was October 11. According to CNN, the Pfizer vaccine requires a three-week waiting period in between first and second doses. Moderna requires a four-week wait. The last possible date to receive the single-dose Johnson & Johnson vaccine is November 8, two weeks before the November 22 deadline.

    Pekoske said he is "very hopeful" that the agency's employees can meet the deadline and that there will not be worker shortages, however in light of mandatory requirements that clearly will not happen.

    "We are building contingency plans, for if we do have some staffing shortages as a result of this, but I hope to avoid that," he said.

    It wasn't clear what, if any, these contingency plans are.

    Tyler Durden Fri, 10/15/2021 - 18:50

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    Government

    “Expert” Calls For Denying Life-Saving Hospital Treatment To The Unvaccinated

    "Expert" Calls For Denying Life-Saving Hospital Treatment To The Unvaccinated

    Authored by Paul Joseph Watson via Summit News,

    An “expert” whose work on cybersecurity has been cited by the NY Times and the Washington Post announced on…

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    "Expert" Calls For Denying Life-Saving Hospital Treatment To The Unvaccinated

    Authored by Paul Joseph Watson via Summit News,

    An “expert” whose work on cybersecurity has been cited by the NY Times and the Washington Post announced on Twitter that the unvaccinated should be denied life-saving hospital treatment because they are “not fit for life on earth.”

    Chris Vickery, who describes himself as a “data breach hunter” also brags about how his “findings have contributed to investigations conducted by the FTC, FBI, SEC, Secret Service, HHS, SSCI, and more.”

    During an unhinged Twitter rant, Vickery asserted that a time limit of December 1st should be put on people refusing to take the COVID-19 vaccine.

    “Set a date now. After that date, no hospital services for the willingly unvaccinated,” he screeched.

    “Then, after the chosen date, anyone choosing to refuse the covid-19 vaccine can deal with the consequences of that choice alone,” added Vickery.

    After claiming there was no “legitimate” reason for anyone to refuse the shot, Vickery ended his rant with a demented call for such people to “separate from the surviving world.”

    “Human society isn’t a suicide pact. If you are too dumb to get the covid vaccine, then you are not fit for continued life on Earth.”

    “That’s your choice, but the consequences of refusing to get the vaccine is you having to wave a fond farewell and separate from the surviving world.”

    Some joked that this was yet another example of the familiar trend of blue checkmarks on Twitter aggressively displaying their virtue while actually calling for mass genocide.

    Others directly savaged Vickery for his heartless inhumanity.

    “When you were a child, did you ever envisage what a terrible person you would be in adulthood?” asked one.

    “So much for “healthcare is a human right,” quipped another.

    Vickery later bragged about the number of people he had blocked on Twitter in the aftermath of his comments.

    How brave of him.

    As we previously highlighted, numerous hospitals across America are already denying life-saving organ transplants to unvaccinated patients.

    Meanwhile, in the UK, patients deemed to be “racist,” “sexist” or “homophobic” can also be denied treatment under NHS rules.

    As we document in the video below, similar rhetoric is being spewed by Keith Olbermann and others who are intent on whipping up ‘New Normal’ cult members into a frenzied, hysterical hatefest targeting those who choose not to take the jab.

    *  *  *

    Brand new merch now available! Get it at https://www.pjwshop.com/

    In the age of mass Silicon Valley censorship It is crucial that we stay in touch. I need you to sign up for my free newsletter here. Support my sponsor – Turbo Force – a supercharged boost of clean energy without the comedown. Get early access, exclusive content and behinds the scenes stuff by following me on Locals.

    Tyler Durden Fri, 10/15/2021 - 15:43

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