China Claims To Have Found Antibody 'Cure' For COVID

 Have the Chinese been sitting on the secret cure for COVID this entire time? One could be forgiven for harboring suspicions - especially now that a team of Chinese researchers has purportedly found the human antibody that helps the human body suppress the virus. This could lead to a widely effective cure for COVID.

In the study, published Tuesday by researchers from Sun Yat-sen University in Guangzhou, Zhejiang University in Hangzhou and a host of other medical schools and institutes (all listed at the top of the paper they published), the researchers explain how they used a cryo-electron 50 microscopy (cryo-EM) to determine how human antibody 35B5 neutralizes SARS-CoV-2 by targeting a 51 unique epitope that avoids the prevailing mutation sites on RBD identified not just in the original "wild" strain of COVID (which initially emerged from Wuhan) but also all the circulating VOCs. The researchers said this antibody could be exploited to create a new vaccine that's more effective at protecting against various strains of the virus.

Or perhaps even new antibody therapies that could offer even stronger protection to the vulnerable than Merck' molnupiravir.

RT explained that "pan-neutralizing efficacy" means the antibody has the capacity to suppress not just the original COVID, but also all the existing variants and potentially even more variants that haven't yet developed. Right now, it appears the antibody targets aspects of the virus that haven't been impacted by the mutations.

These findings, the scientists argue, could be “exploited for the rational design of a universal SARS-CoV-2 [Covid-19] vaccine.”

And while they haven't tested the antibody against the omicron variant, the researchers said that the characteristics of the omicron variant suggest it also has the characteristics that 35B5 requires to suppress the virus.

RT posited that this breakthrough could become "pretty valuable" if omicron does exhibit the ability to produce a surge in 'breakthrough' infections, rendering the first generation of vaccines effectively useless, something the CEO of Moderna appears eager to see.

Readers can find the full paper, which hasn't been peer reviewed, below:

2021.11.29.470356v1.full

https://www.zerohedge.com/markets/chinese-researchers-claim-have-found-antibody-cure-covid

CDC IDs 1st Case Of Omicron Variant In U.S.

 CNN's Chief White House Correspondent Kaitlan Collins has tweeted that the CDC has identified first case of Omicron in the US in California, according to a source.

But, but , but, isn't California all masked up?

The CDC reports that the individual was a traveler returning from South Africa.

The individual was fully vaccinated and had mild symptoms.

The individual is now self-quarantining.

CDC Statement

First confirmed case of Omicron variant detected in the United States

The California and San Francisco Departments of Public Health have confirmed that a recent case of COVID-19 among an individual in California was caused by the Omicron variant (B. 1.1.529).

The individual was a traveler who returned from South Africa on November 22, 2021.

The individual, who was fully vaccinated and had mild symptoms that are improving, is self-quarantining and has been since testing positive.

All close contacts have been contacted and have tested negative.

Genomic sequencing was conducted at the University of California, San Francisco and the sequence was confirmed at CDC as being consistent with the Omicron variant. This will be the first confirmed case of COVID-19 caused by the Omicron variant detected in the United States.

On November 26, 2021, the World Health Organization (WHO) classified a new variant, B. 1.1.529, as a Variant of Concern and named it Omicron and on November 30, 2021, the United States also classified it as a Variant of Concern. CDC has been actively monitoring and preparing for this variant, and we will continue to work diligently with other U.S. and global public health and industry partners to learn more.

Despite the detection of Omicron, Delta remains the predominant strain in the United States.

https://www.zerohedge.com/covid-19/cdc-has-identified-first-case-omicron-variant-us

Moderna could be sued over vaccines as court upholds Arbutus patents

 Moderna Inc (MRNA.O) could face a patent infringement lawsuit over its COVID-19 vaccine after a federal appeals court on Wednesday rejected its challenge to patents belonging to Arbutus Biopharma Corp (ABUS.O).

Arbutus shares nearly doubled following the ruling, up 95% at $6.25. Moderna shares were off more than 10% at $316.43.

The Federal Circuit U.S. Court of Appeals let stand an administrative panel's findings that Arbutus' patents - which may cover technology used in the vaccines - are valid, as the science involved was not previously known.

Moderna and Arbutus did not respond to requests for comment.

Moderna previously said in court filings that it believes Arbutus could bring a lawsuit demanding royalties from its COVID-19 vaccine if the patents were upheld.

The company last month forecast 2021 sales of between $15 billion and $18 billion, and 2022 sales of between $17 billion and $22 billion, for its COVID-19 vaccine.

Jefferies analyst Dennis Ding said an infringement lawsuit was possible, but could drag for years, adding that Arbutus will likely settle for a small royalty.

"When you're thinking about the revenue opportunity from the vaccine, so just like $10 (billion) to $20 billion annually, a small low-single-digit royalty is immaterial to Moderna," he said.

Both patents in question involve the so-called lipid nanoparticles that enclose the genetic material, known as messenger RNA (mRNA), in the vaccine. The technology could prove useful in developing future mRNA-based vaccines against other illnesses as well.

Moderna initially challenged the patents before the U.S. Patent Trial and Appeal Board, part of the federal patent office. The board agreed with Moderna that some portions of one of the patents were invalid but otherwise sided with Arbutus, and the Federal Circuit upheld its findings.

The patents are licensed to Genevant Sciences Inc, a company launched in 2018 by Arbutus and Roivant Sciences Ltd (ROIV.O). Roivant owns about 80% of Genevant and Arbutus owns the remainder.

Moderna is also embroiled in a months-long patent conflict over its COVID-19 vaccine with the U.S. National Institutes of Health (NIH). read more

NIH has asserted that three of its scientists helped design the genetic sequence used in Moderna's multibillion-dollar vaccine and should be named on the patent application, a claim the company disagrees with.

The company maintains that the mRNA sequence in the company's vaccine was selected exclusively by Moderna's scientists, and without input of NIH scientists.

https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-loses-appeal-challenging-arbutus-vaccine-patents-2021-12-01/

Omicron Dragnet: CDC Demands Airlines Hand Over Names Of All Southern African Passengers

 As we wait for President Biden to confirm the new travel restrictions that have been reported Tuesday and Wednesday (the president is expected to announce them on Thursday) Reuters reported Wednesday morning that it has seen a copy of a letter from the CDC asking airlines to turn over the names of all passengers who traveled to the US from any of the southern African nations.

Once it has all the names, the CDC plans to turn them over to state and local public health departments. These authorities may then require these travelers to be retested, or perhaps even ask them to quarantine - measures they intend to enforce. Keep in mind, the US still hasn't confirmed a single case of omicron.

The south African countries in the blue ring believed to pose the highest risk of infection...despite the fact that the UK has reported the highest number of confirmed omicron cases with 22, while the Netherlands has confirmed cases of omicron stretching back at least two weeks ago. Evidence suggests the new variant has likely already gone global.

This dichotomy between how the world is treating southern African countries vs. developed nations like the UK is making some people increasingly uncomfortable.

Others have posited that the EU and US are using omicron as an excuse to tighten restrictions on the border and on society and businesses amid the EU's most recent resurgence in cases.

Some 56 countries were reportedly implementing travel measures to guard against Omicron as of Nov. 28, the WHO said, and WHO head Dr. Tedros Adhanom Ghebreyesus said he was concerned that several member states were "introducing blunt, blanket measures", which "will only worsen inequities".

In Germany, which is battling a surge in COVID cases and deaths, recently announced that four fully vaccinated people had tested positive for omicron in the south, but they had only moderate symptoms.

The CDC lists about 80 foreign destinations as "Level Four" countries, the highest level of COVID transmissibility. The US discourages Americans from traveling to those destinations, and also would prefer if people who live in those countries don't travel to the US right now.

https://www.zerohedge.com/covid-19/biden-admin-unleashes-omicron-dragnet-cdc-demands-airlines-hand-over-names-all-southern

Priority Review for Merck VAXNEUVANCE for Infants and Children

 Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License Application (sBLA) for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age. The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of April 1, 2022.

"VAXNEUVANCE has the potential to provide meaningful protection against invasive pneumococcal disease for children and infants by targeting pneumococcal strains, or serotypes, that contribute to substantial disease burden, including serotype 3, and broadening coverage to additional disease-causing serotypes, 22F and 33F, which are not included in the pneumococcal conjugate vaccine (PCV) currently available for this population," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "We look forward to working with the U.S. FDA as it reviews what would be the first new option in pediatric pneumococcal vaccination in over a decade."

The sBLA is supported by results from Phase 2 and Phase 3 clinical studies in pediatric populations including infants, children, and adolescents. These studies support the potential use of VAXNEUVANCE in a variety of clinical settings, including immunization of infants and toddlers as well as of special populations at increased risk for pneumococcal disease, such as children with HIV infection or sickle cell disease. The submission also includes data supporting the potential use of VAXNEUVANCE as part of a mixed dosing regimen following initiation of an infant vaccination schedule with PCV13 as well as in a catch-up setting for older children who are either pneumococcal vaccine-naïve or who previously received a partial or full regimen of a lower-valency pediatric PCV.

https://finance.yahoo.com/news/u-fda-accepts-priority-review-114500858.html

Why Vertex Is Jumping

 Shares of Vertex Pharmaceuticals ( VRTX 7.79% ) were jumping 8.2% as of 12:01 p.m. ET on Wednesday. The nice gain came after the big biotech announced positive results from a phase 2 proof-of-concept study evaluating VX-147 in treating patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS).

FSGS is a kidney disease caused by variants of the APOL1 gene. Individuals with FSGS can require dialysis or kidney transplants. Some eventually die of the disease, which currently has no approved therapies targeting the underlying cause.

Vertex reported that participants in the phase 2 study who were treated with VX-147 had "statistically significant, substantial, and clinically meaningful mean reduction in proteinuria [proteins in the urine] of 47.6%" at 13 weeks after dosing compared to their baseline levels. The company also stated that the experimental drug was well tolerated with no serious adverse events related to it and no treatment discontinuations due to adverse events.

NASDAQ: VRTX

Vertex Pharmaceuticals Incorporated

Today's Change

(7.79%) $14.56

Current Price

$201.50

KEY DATA POINTS

Market Cap

$48B

Day's Range

$194.10 - $205.85

52wk Range

$176.36 - $242.99

Volume

3,192,067

Avg Vol

1,777,078

P/E (ttm)

22.22

These positive results provided a big boost for Vertex when it was much needed. Prior to today, the biotech stock had fallen nearly 21% year to date. The decline was primarily due to Vertex's disappointing results earlier this year for its alpha-1 antitrypsin deficiency (AATD) program. Investors now have reason to be more confident about Vertex's prospects beyond cystic fibrosis (CF), an indication where the company has achieved tremendous success.

Vertex now plans to advance VX-147 into pivotal development in the first quarter of 2022. The company's clinical studies will target APOL1-mediated kidney disease, including (but not limited to) FSGS.

https://www.fool.com/investing/2021/12/01/why-vertex-pharmaceuticals-stock-is-jumping-today/

Supernus resumed at Buy by Jefferies

 Target to $44 from $40

https://finviz.com/quote.ashx?t=supn&ty=c&ta=1&p=d