Vaxxinity COVID-19 Vaccine Candidate Produces High Levels of Neutralizing Antibodies Against Omicron Oth,er Variants

 

• Investigator-sponsored studies show UB-612 induces high antibody activity against multiple variants, including Alpha, Beta, Delta, Gamma and Omicron, at levels similar to or higher than approved vaccines
   
• UB-612 elicits >3 times higher titers of neutralizing antibodies against Omicron variant than reported by an approved mRNA vaccine

Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today announced results from studies demonstrating the ability of UB-612, its COVID-19 vaccine candidate, to elicit a broad immune response against multiple variants of concern, and specifically more than three-times higher titers of neutralizing antibodies against the Omicron variant of SARS-CoV-2 than an approved mRNA vaccine with boosters.

“The ability of these sera to neutralize Omicron at these high levels is extraordinary and unprecedented considering that Omicron has more than 30 potential immune evading mutations and deletions across its spike protein, 15 of which are in the RBD region where our UB-612 vaccine is directed. Such data show that UB-612 could potentially be a unique vaccine candidate that is highly effective at mobilizing the immune system against a broad range of both current and future SARS-CoV-2 variants,” said Farshad Guirakhoo, Ph.D., Chief Scientific Officer at Vaxxinity.

The studies were conducted by David Goldblatt, M.B. Ch.B., Ph.D., at University College London (UCL) and VisMederi, a Coalition for Epidemic Preparedness Innovations (CEPI)-centralized laboratory.

Sera from 92 participants from UB-612’s Phase 2 study including 8 placebos (randomized and tested blinded) and up to 36 participants in the Phase 1 study, half of the latter boosted with a third dose of UB-612, were used in these studies to analyze binding of IgG and neutralization against multiple Variants of Concern and Variants of Interest, including Omicron.

https://www.biospace.com/article/releases/vaxxinity-s-covid-19-vaccine-candidate-ub-612-produces-high-levels-of-neutralizing-antibodies-against-omicron-and-other-variants-of-concern/

ProQR Shares Crater After Disappointing Sepofarsen Data In Vision Loss Disorder

 ProQR Therapeutics N.V. 

PRQR -75.53%

 (Get Free Alerts for PRQR) shares are plunging after disappointing data from its pivotal Phase 2/3 Illuminate trial of sepofarsen for CEP290-mediated Leber congenital amaurosis 10 (LCA10).

• The trial failed to meet its primary endpoint of Best Corrected Visual Acuity (BCVA) at Month 12.
• Illuminate trial enrolled 36 participants aged eight years or older with genetically confirmed LCA10. 
• Participants were randomized to three equal groups - sepofarsen (160 μg/80 μg loading dose/maintenance doses), a low dose of sepofarsen for masking (80 μg/40 μg loading dose/maintenance doses), or sham procedure.
• At Month 12, the mean change from baseline in BCVA in the 160/80 μg dose group was -0.11 logMAR (p=0.96), in the 80/40 μg group -0.13 logMAR (p=0.97), and the sham group -0.12 logMAR. 
• For secondary endpoints full-field stimulus test and mobility, there was also no difference between the treated and sham groups in the top-line analysis.
• Sepofarsen was observed to be generally well-tolerated. 

https://www.benzinga.com/general/biotech/22/02/25563914/proqr-shares-crater-after-disappointing-sepofarsen-data-in-inherited-vision-loss-disorder

Pfizer, BioNTech to delay FDA request for vaccines for children under 5

 Pfizer and BioNTech on Friday said they are delaying their request for the Food and Drug Administration to authorize the vaccine for children under five years old, because there's not enough data on the efficacy of a third dose.

An FDA advisory panel meeting scheduled for next week has been postponed, the agency said.

"Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge," Pfizer said in a statement. 

https://thehill.com/policy/healthcare/593897-pfizer-biontech-to-delay-fda-request-for-vaccines-for-children-under-5

Ontario declares state of emergency over ongoing trucker protests

 The Canadian province of Ontario has declared a state of emergency due to ongoing protests against COVID-19 mandates. 

"I will convene Cabinet to use legal authorities to urgently enact orders that will make crystal clear it is illegal and punishable to block and impede the movement of goods, people and service along critical infrastructure," the province's Premier Doug Ford said Friday, Reuters reported.

Ford added that protesters could face jail time and fines if they do not comply with the orders.

The "Freedom Convoy" demonstrations began as a protest against COVID-19 mandates and protocols affecting truck drivers and have since spread to cities around Canada, while also drawing a "significant element" from the U.S. They have disrupted three major border crossings between the U.S. and Canada.

In a series of tweets on Thursday, Canadian Prime Minister Justin Trudeau called the protests illegal, saying he'd had meetings with officials and that the government is prepared to help local authorities disperse the protests. 

“They’re harming the communities they’re taking place in – and they’re hurting jobs, businesses, and our country’s economy,” he said. 

The mayor of Canadian capital Ottawa also spoke out against the demonstrations on Thursday, warning that those participating in the protests blocking the city's streets "could be arrested without a warrant."

https://thehill.com/policy/international/593882-ontario-declares-state-of-emergency-over-ongoing-trucker-protests

Biggest Rate Shock Since Volcker's Intermeeting Rate Hike In 1979

 When commenting on yesterday's post-Bullard VaR Shocknado, we pointed to the stunning move in 2Y rates which jumped by 22bps - a move the kinds of which we last saw when Bear Stearns wasn't fine.

And while there were more charts addressing the historical context of yesterday's bond rout in our market wrap on Thursday, this morning DB's Jim Reid has truly excelled in showing just how striking the market reaction was to two one-two punch of soaring CPI and Bullard's "unprofessional" comments, with the following two charts.

First, the dramatic US curve flattening yesterday, meant that US 2s10s dipped below the German equivalent for the first time since the pandemic hit. The market is getting comfortable that while the Fed is likely to be aggressive upfront on hikes, the ECB will be more measured.  As such Reid notes that "there is probably more concern about the sustainability of the US cycle than the European one at the moment." On this measure the US has flattened -36.5bps YTD and the German curve has actually steepened +17bps.

Second, and more important, yesterday’s 2yr US move (+21.4bps) was a truly historic event. Similar to the October spike in Australian front-end rates, which was a 6 standard deviation event, Reid compares the standard deviation of daily moves with the movement seen over the previous 12 months, and finds that yesterday’s was the biggest "shock" since October 1979 when Volcker announced his intentions on the world (a couple of months after taking office) with an inter-meeting weekend hike.

Concludes that "like the Aussie market, this is a feature when forward guidance gets attacked. If the Fed hadn’t still been in a position where they were systematically winding down QE before hiking rates then they would likely have already raised a few months ago. As such when the dam breaks, the water floods aggressively through."

https://www.zerohedge.com/markets/was-biggest-rate-shock-volckers-intermeeting-rate-hike-1979

Why Is The Fed Suddenly Holding Unscheduled 'Expedited, Closed' Board Meeting Monday?

With Fed speakers and their media proxies scrambling to walk-back St.Louis Fed's Jim Bullard's calls for an inter-meeting liftoff and uber-hawkish rate-hike trajectory, it is notable that all of a sudden, The Fed has called for an "Expedited, Closed" Board Meeting on Monday Feb 14th (at 1130amET).

The goal of the meeting is: "Review and determination by the Board of Governors of the advance and discount rates to be charged by the Federal Reserve Banks."

We are sure this is 'probably nothing', right?

But it got us thinking about the last time The Fed held such a meeting...

In late November 2015, The Fed held an "expedited" meeting to "Review and determination by the Board of Governors of the advance and discount rates to be charged by the Federal Reserve Banks. "

Shortly thereafter, this happened... (The Fed hiked rates for the first time since 2006)

February rate-hike expectations have fallen today but remain elevated over recent norms...

So, will The Fed surprise the world on Monday?

https://www.zerohedge.com/markets/why-fed-holding-expedited-closed-board-meeting-monday

Senseonics wins FDA OK for next-gen Eversense 180-day CGM, 2022 outlook disappoints

 Senseonics (NYSE:SENS) announced today that the FDA approved its next-generation continuous glucose monitor system, which lasts up to half a year.

Germantown, Maryland–based Senseonics designed the Eversense E3, which includes proprietary sacrificial boronic acid (SBA) technology, to extend longevity to six months (180 days). Senseonics previously offered the system with a 90-day wear time.

Data presented in 2021 showed strong accuracy with the fully implantable, 180-day sensor. The next-generation platform matched performance levels compared to the 90-day version, but with calibration reduced to essentially once per day. One of the sensor’s tests produced a mean absolute relative difference (MARD) of 8.5%, representing high accuracy.

Eversense E3 features a third-generation sensor with SBA technology that enhances sensor longevity to make it what the company says is the longest-lasting CGM system. The sensor is fully implantable and requires just two sensor insertion and removal procedures per year, according to a news release.

“The Eversense E3 CGM system is an exciting advancement in diabetes management,” Senseonics CMO Dr. Francine Kaufman said in the release. “We believe patients and providers are waiting for this step forward. I want to take this opportunity to thank the Promise Study investigators, study participants, and the Senseonics team for helping us reach this important milestone and the diligence of the FDA reviewers in this difficult environment. We are excited to begin making this next-generation product available in the U.S. to people with diabetes.”

The system also includes a removable smart transmitter, held in place with a mild silicone-based adhesive, offering discreet, on-body vibratory alerts and data transmission to a mobile app where users can view glucose values, trends and alerts.

Senseonics plans to make the Eversense E3 CGM available to patients in the U.S. through its global commercial partner, Ascensia Diabetes Care, beginning in the second quarter of 2022.

“Further extending the duration of the longest-lasting CGM system to 6 months represents a massive leap forward for patients and towards our mission of transforming lives in the global diabetes community,” Senseonics President and CEO Tim Goodnow said. “The review was delayed by one year due to COVID-19 priorities, and now together with our partner Ascensia, we can execute our launch plan to deliver the Eversense E3 CGM System to U.S. patients beginning in the second quarter.

“We look forward to initiating Eversense E3 sales and believe that, with Ascensia’s newly dedicated CGM commercial organization, the launch of the new 6-month product will establish the foundation for growth in our installed base later in 2022 and beyond.”

Following the delayed FDA reviewal process and the achievement of approval, Senseonics today also confirmed its 2022 financial outlook, projecting full-year revenues to range between $14 million and $18 million.

BTIG analyst Marie Thibault wrote in a report that Senseonics’ projection falls well short of the $30.7 million that Wall Street forecast, although that shortcoming is “understandable in light of the lengthy wait for FDA approval.”

Analysts were surprised by the company’s lack of meaningful net revenue growth in 2022 due to an anticipated sequential decline in the first quarter as Senseonics navigates through remaining inventory and the transition for payor contracts to begin covering the Eversense E3. They expect patients and prescribers to show heightened interest in Eversense E3, but the low revenue outlook “disguises this enthusiasm.”

https://www.drugdeliverybusiness.com/senseonics-wins-fda-approval-for-next-generation-eversense-180-day-cgm-provides-2022-outlook/