Pfizer starts dosing patients with its Omicron COVID shot

 Pfizer and partner BioNTech have started their clinical trial of a new version of their COVID-19 vaccine that has been specifically designed to protect against the Omicron variant.

The trial in 1,420 adult patients aged 18 to 55 will include dosing with the partners’ existing Comirnaty mRNA-based vaccine with the Omicron-based jab in a mix-and-match approach that will be used to determine the best combination.

One group will involve subjects who have received two doses of Comirnaty between 90 and 180 days before enrolment, who will receive either one or two doses of the new Omicron version.

A second – in people who have been given three doses of Comirnaty – will compare a single booster dose with either Comirnaty or the new shot, and a third will look at three doses of the Omicron vaccine in unvaccinated individuals.

The start of the trial comes right on schedule, helping Pfizer and BioNTech to keep their earlier pledge of being ready for a possible launch of the Omicron version in March.

They  have said that even if they do need to switch to producing a new version there will be no change expected to their four billion dose capacity for 2022.

The new trial has been able to get going quickly because some participants have been borrowed from the companies’ ongoing phase 3 trial of a booster dose of Comirnaty.

Last week, anther investigator-led study found that a third shot of Comirnaty raised antibody levels against Omicron to a level previously reached against Delta after two doses.

“Current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalisation with Omicron,” said Pfizer’s head of vaccines R&D Kathrin Jansen.

“We recognise the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” she added.

The Omicron variant is estimated to account for more than 99% of cases in the US as of 15 January, according to data from the Centres for Disease Control and Prevention (CDC), and is also dominating across Europe and other parts of the world.

BioNTech chief executive Ugur Sahin said that while vaccines continue to offer protection against severe disease caused by Omicron, “emerging data indicate vaccine-induced protection against infection and mild to moderate disease wanes more rapidly than was observed with prior strains.”

Moderna has also said it has started work on an Omicron-directed version of its mRNA vaccine, saying earlier this month that is also about ready to start clinical testing and could be available in the autumn.

Both companies are running the risk of a new variant emerging that could render their new Omicron-directed shots obsolete, although new versions may still be closer to the new variant than the original strain.

Some companies – including Moderna – have started work on multivalent shots that could provide cover against multiple variants, while Valneva has said its whole, inactivated vaccine could have an advantage as it stimulates the immune system to recognise multiple viral proteins and could be less vulnerable to escape variants.

https://pharmaphorum.com/news/pfizer-starts-dosing-patients-with-its-omicron-covid-shot/

QIAGEN Completes U.S. Federal Contract

 QIAGEN N.V. announced it has completed a U.S. government contract to equip public health laboratories across the country with the QIAcuity digital PCR system to monitor the spread of the COVID-19 pandemic by testing wastewater for the presence of SARS-CoV-2 pathogens. QIAGEN has shipped more than 35 QIAcuity systems to state and local health laboratories as part of a multi-million-dollar contract with the U.S. National Institutes of Health (NIH) to supply COVID-19 instruments and consumables through the end of 2021. More than 70% of all U.S. states now have at least one laboratory – either public health or privately-owned – with a QIAcuity system for wastewater surveillance. The ultra-sensitive digital PCR platform has set new standards for delivering rapid results in two hours rather than the six required by competitive systems based on a proprietary nanoplate-based system. Surveillance testing allows public authorities to collect data from broad sweeps of the population, including people who are not reflected in public-health statistics because they lack access to healthcare. It can potentially reveal dynamic changes in infections – and mutations – earlier than traditional diagnostic testing, providing public-health officials with near-real-time data about the presence and intensity of the disease.

https://www.marketscreener.com/quote/stock/QIAGEN-N-V-40135659/news/QIAGEN-Completes-U-S-Federal-Contract-to-Equip-Local-Public-Health-Authorities-with-QIAcuity-Digita-37635799/

Checkpoint's low-cost oncology project inches towards the market

 Fortress Biotech's subsidiary Checkpoint Therapeutics has promised to lower prices in the highly competitive anti-PD-(L)1 space, but how much of a threat it presents to incumbents remains unclear. The company took one step towards the market today: it needed an objective response rate of at least 36% to support a filing of its anti-PD-L1 MAb, cosibelimab, in metastatic cutaneous squamous cell carcinoma, and a 47.4% ORR crosses that threshold comfortably. How effectively cosibelimab will compete with existing agents – Sanofi/Regeneron’s Libtayo and Merck & Co’s Keytruda – remains uncertain, however, with executives declining to detail complete responses, or many other aspects of the data. At Esmo 2020 CRs reached 13.5% among 37 patients but all Checkpoint said on a call today was that the data were “competitive with what’s out there”; Libtayo and Keytruda have CRs of 17% and 11% on their labels respectively. On a topline, cross-trial comparison, with all the normal caveats, the agents do look similar. Another potential issue is that Checkpoint’s data were generated in a phase 1 open-label basket study conducted outside the US. To compete on price cosibelimab must get to market first, a prospect that still feels some way off. 

Source: Company presentation.

https://www.evaluate.com/vantage/articles/news/trial-results-snippets/checkpoints-low-cost-oncology-project-inches-towards

J&J looks to be bolder on deals

 Add Johnson & Johnson to the growing list of big pharma groups that could soon be going shopping. Today’s third-quarter call was dominated by questions about M&A after the company, which is in the process of spinning off its consumer business, said it would “be bolder” in strategic acquisitions in the coming years. 

The preference is for small tuck-ins, but J&J’s new chief executive officer, Joaquin Duato, is not ruling out large deals, saying: “We don’t have an artificial ceiling as far as deal size.” Takeouts look likely across both pharma and medical devices, with the chief exec stating that both will be core to the new-look J&J.

Still, the bar for justifying a big deal is higher, Mr Duato said, given that these are harder to make work from an operational and financial perspective.

However, the group does not seem too hopeful of getting a bargain. When asked whether prices looked attractive given the recent pullback in biotech valuations, J&J’s chief financial officer, Joe Wolk, replied: “It’s really hard to say whether there’s been a capitulation. I think we probably need to see [it for] a little bit longer.”

He added that targets were not “necessarily on sale”, but concluded: “It just takes two parties to agree on a valuation that makes sense.”

Covid vaccine sales

Unlike Pfizer, however, J&J’s spending money has not come from its Covid vaccine. The J&J jab sold just $2.4bn in 2021 and is forecast to net another $3.0-3.5bn next year, mainly from use in low and middle-income countries.

As well as what is seen as suboptimal efficacy, J&J could also be suffering from its pledge to provide its vaccine on a non-profit basis. The group has said that it expects to shift to for-profit sales at the end of 2022 or early 2023, although by then this might not make too much difference.

Selected Covid vaccine sales forecasts for 2022
Vaccine	Company/ies	2022 forecast sales ($bn)
Comirnaty	Pfizer/Biontech	29.0*
Spikevax	Moderna	17.0-22.0*
JNJ-78436735	Johnson & Johnson	3.0-3.5**
*Forecast made during Q3 2021; **forecast made during Q4 2021. Source: company releases.

Another potential rival at the M&A negotiating table could be Novartis, which recently sold its stake in Roche and could have even more cash if it also offloads its Sandoz generics business.

And Glaxosmithkline is also spinning off its consumer unit this year; the UK group could do with a boost after several recent disappointments and the departure of its chief scientific officer, Hal Barron.

Consumer timings

J&J is further behind in separating its consumer unit, a move it announced in November. The group provided some more detail today: in the first half it will name the leaders of the new consumer company, with details on its name and location to follow around mid-year. The second half of 2022 will see more information on costs and “potential short-term dyssynergies”.

Mr Duato said the separation would not stop J&J from “forging ahead” with deals, however. The chief exec has only been in the job since January 3, but it seems that his stall is already clearly laid out.

https://www.evaluate.com/vantage/articles/news/deals/jj-looks-be-bolder-deals

Progenity Strengthens IP for Single-Molecule Detection Tech with Additional Patent

  Progenity, Inc. (Nasdaq: PROG), an innovative biotechnology company, today announced the award of another new patent related to its single-molecule detection assay platform under development. The USPTO has issued U.S. Patent No. 11,230,731 entitled, “Methods, Systems, and Compositions for Counting Nucleic Acid Molecules.” The issued claims are directed to detecting a labeled target molecule on a solid support.

“We have added another important patent to our IP portfolio for the single-molecule detection platform, which is designed to enable sequence-free counting of target analytes including cell-free nucleic acids. We believe this approach may have important near-term impact in the fields of noninvasive prenatal testing (NIPT) and liquid biopsy. This latest patent covers key compositions and methods for labeling target molecules,” said Matthew Cooper, General Manager, Diagnostics. “This platform has the potential to greatly reduce operating costs and reduce turnaround times for genomic tests, with potential utility extending from nucleic acids to proteins. We are committed to maximizing the value of our patent portfolio and are actively assessing partnerships and other approaches that may expedite a path to market.”

The patent portfolio supporting Progenity’s single-molecule detection platform includes six distinct patent families covering different aspects of the molecular counting platform and a separate family directed to detecting nucleosomal positioning patterns, such as assessment of cell-free DNA tissue-of-origin. These patents are part of Progenity’s corporate patent estate consisting of 96 patent families, including 180 issued patents and more than 220 pending applications. The portfolio includes patents and applications directed to methods and devices for drug delivery, methods and devices for GI sampling and diagnostics, methods and compositions for treating disease, and molecular and protein tools, assays and diagnostics.

https://finance.yahoo.com/news/progenity-strengthens-intellectual-property-single-210500136.html

Biden administration withdraws its vaccine-or-test mandate for businesses

 The Biden administration on Tuesday said it is withdrawing its vaccine-or-test mandate for businesses with at least 100 employees after the Supreme Court earlier this month blocked the requirement from being enforced, ruling that it was a federal overreach.

Given the Supreme Court's decision, the Biden administration filed a motion on Tuesday to have the existing lawsuits that were filed against the employer vaccine mandate dismissed. Twenty-seven Republican-led states and a coalition of businesses had brought those legal challenges against the mandate.

“The federal government respectfully moves to dismiss the petitions challenging the Vaccination and Testing emergency temporary standard (Vaccination and Testing ETS) issued by the Occupational Safety and Health Administration (OSHA) to address the grave danger of COVID-19 in the workplace,” the Biden administration said in a motion.

The Biden administration said that it would be withdrawing the mandate, effective on Wednesday, asking for the existing lawsuits against it to be considered moot.

The vaccine-or-test mandate, which was created by OSHA and published in early November, required businesses with at least 100 employees to mandate that employees get vaccinated or undergo regular testing and wear masks. 

The mandate was expected to apply to 84 million people, and officials said early on that it would protect thousands of workers from hospitalization or death.

“OSHA estimates that this rule will save thousands of lives and prevent over 250,000 hospitalizations during the six months after implementation,” one official said in November.

But the mandate was immediately hit with legal challenges, including from more than two dozen Republican attorneys general who argued in multiple lawsuits that the Biden administration did not have constitutional authority to implement the OSHA mandate.

The vaccine-or-test mandate was temporarily stayed by a 5th Circuit panel, but a separate federal court revived the rule before it was ultimately blocked by the Supreme Court.

The Supreme Court's conservative majority in mid-January ultimately decided that the 27 Republican-led states and coalition of businesses were likely to succeed in challenging the mandate on the merits and ruled that the OSHA-crafted mandate was an overreach by the government.

The Biden administration’s move to withdraw its vaccine-or-test mandate is a formality at this point given the Supreme Court’s decision and likely marks a final resolution to the legal challenge.

Some Republican lawmakers cheered the news of the administration saying that it would withdraw the mandate.

“OSHA plans to withdraw Biden’s vaccine mandate for biz/workers. Today’s news is the result of months of pressure in both the House & Senate, during which time @SenatorBraun and I built a coalition around our Congressional Review Act resolution to eliminate this mandate,” Rep. Fred Keller (R-Pa.) tweeted on Tuesday.

Sen Mike Braun (R-Ind.) on Twitter called the news a “huge win for liberties and livelihoods everywhere!”

A Labor Department spokesperson said in a statement that the ruling would not affect the mandate’s status as a proposed rule.

“OSHA is evaluating the record and the evolving course of the pandemic. OSHA has made no determinations at this time about when or if it will finalize a Vaccination and Testing rule. The agency intends to work expeditiously to issue a final standard that will protect healthcare workers from COVID-19 hazards,” the spokesperson said.

https://thehill.com/homenews/administration/591260-biden-administration-plans-to-withdraw-its-emergency-vaccine-or-test

White House dismisses DeSantis calls to reverse decision on antibody therapies

 White House press secretary Jen Psaki on Tuesday dismissed criticism from Florida Gov. Ron DeSantis (R) and other Republicans who are demanding the Biden administration continue to allow states to use a COVID-19 treatment that doesn't work against the omicron variant.

The Food and Drug Administration (FDA) on Monday said it is limiting the use of two monoclonal antibody therapies from Eli Lilly and Regeneron because they are ineffective at treating the omicron variant. As a result, Florida health officials closed the state's antibody treatment centers.

DeSantis was quick to blast the move, saying ​​in a statement that Biden "has forced trained medical professionals to choose between treating their patients or breaking the law." 

"There are real-world implications to Biden’s medical authoritarianism — Americans’ access to treatments is now subject to the whims of a failing president," he added.

DeSantis has been one of the most outspoken proponents of antibody treatments, especially the cocktail from Regeneron that was given to former President Trump. 

The treatments were highly effective at keeping out of the hospital people who were infected with the original strain of the coronavirus, as well as the delta variant, but studies in labs have shown they do not work against omicron. According to the Centers for Disease Control and Prevention (CDC), more than 99 percent of infections nationwide are now from omicron.  

Department of Health and Human Services spokesman Ian Sams noted DeSantis has not been nearly as big a proponent of booster shots, and has refused to disclose whether he received one. New evidence from the CDC shows booster shots are 90 percent effective at reducing severe disease and hospitalization from omicron. 

The FDA's decision was also supported by both manufacturers, which said they are working on new treatments that work against all known variants.  

"Let's just take a step back to realize how crazy this is," Psaki said when asked for a response to DeSantis. "We know what works, vaccines and boosters."

Psaki told reporters that the FDA has made it clear the treatments “do not work against omicron and they have side effects.” She also noted the Biden administration has sent Florida other treatments that have proved to be successful against omicron.

The antibody treatment now most recommended is sotrovimab, from GlaxoSmithKline and Vir Biotechnology. The administration will also continue to allocate doses of Pfizer's antiviral drug Paxlovid, as well as one made by Merck called molnupiravir. However, both Paxlovid and sotrovimab are in short supply.

The FDA also did not revoke the emergency authorization for the two treatments in dispute, and said the drugs would be used in the future if needed. 

“We have sent them to — 71,000 doses of treatments that are effective against omicron and are effective also against delta. And they are still advocating for treatments that don’t work,” Psaki said

https://thehill.com/homenews/administration/591293-white-house-dismisses-desantis-calls-to-reverse-decision-on-antibody