BlueWillow’s Non-Viral Intranasal Vaccine Enhances Immunity and Broadens Options
BlueWillow Biologics demonstrated the safety and immunogenicity in humans of the company’s intranasal technology, which CEO Chad Costley said is the only adjuvanted intranasal platform that is not virus-based.
BlueWillow’s Non-Viral Intranasal Vaccine Enhances Immunity and Broadens Options
Intranasal vaccines have an advantage over intramuscular vaccines in that they confer both systemic and mucosal immunity, but past development challenges have been significant, so only a very few companies are working on them.
Now, BlueWillow Biologics® has demonstrated the safety and immunogenicity in humans of its intranasal technology, which CEO Chad Costley, M.D., said is the only adjuvanted intranasal platform that’s not virus-based. The company is on the cusp of multiple clinical trials in its lead commercial programs.
BlueWillow currently has vaccines in development for anthrax, pandemic flu, COVID-19, RSV, HSV (herpes) and peanut allergy. The anthrax vaccine is the furthest along, with positive interim data already announced from a Phase I trial showing safety and immunogenicity.
“BW-1010 is a single-antigen recombinant protective antigen (rPA) for anthrax combined with our adjuvant,” Costley said. “Because it’s a single antigen vaccine, it doesn’t have the side-effects of intramuscular anthrax vaccines.” Side-effects were a huge complaint among those receiving intramuscular injections of the anthrax vaccine in the early 2000s. The BlueWillow vaccine caused no significant side-effects, he added.
“Intranasal delivery also is easier and more acceptable to the patient. It’s less expensive, and it scales more easily than intramuscular vaccines,” he added. At this stage of development, the intranasal anthrax vaccine is administered in two doses, four weeks apart.
“The Phase I trial was primarily focused on safety, and wasn’t powered to show superiority versus other vaccines, but we are seeing a very good indication of immunogenicity, and both systemic and mucosal immunity,” he said. “We will prove efficacy through the animal rule in Phase II and III trials, so there will be no direct challenge against anthrax in humans,” Costley said. Anthrax is a Tier 1 biological agent and, as such, poses among the highest risks to national security and public health if it were to be used as a bioweapon.
BlueWillow began its anthrax program in response to the strong need to improve bioterror preparedness, Costley said. This program, supported by Public Health England and the National Institutes of Health, provided the foundation to de-risk the company’s other vaccine programs by proving the safety of the intranasal platform in humans.
The NanoVax® platform is based on a water-in-oil emulsion containing droplets approximately 400 nm to 500 nm in diameter combined with specific antigens to induce immunity. “We have a very safe, very flexible platform. It can be combined with a single antigen or multiple antigens.
“It may, potentially, be possible to make split-virus vaccines,” Costley added. Split-virus vaccines would include all the antigens that are present in the virus, such as the nucleocapsid, rather than only the spike protein and its mutations, potentially resulting in a vaccine that is more effective against mutated versions of SARS-CoV-2 or other relevant viruses.
A partnership with the Biomedical Advanced Research and Development Authority (BARDA) and possibly industry to advance this anthrax vaccine into Phase II trials, is BlueWillow’s next step for that program.
Such a versatile platform provides a solid foundation for its wide range of vaccines. The company is developing an intranasal booster vaccine for COVID-19. In animal challenge studies, it is giving both mucosal and systemic immunity, boosting the response in previously vaccinated subjects. “Omicron (a recent variant of SARS-CoV-2) is proving that mucosal immunity is critical to protecting individuals from carrying and spreading the virus, as well as from becoming ill from it,” Costley noted.
BlueWillow also is developing vaccines to protect against herpes simplex virus and peanut allergies – “the most common food allergy,” he said. “We can develop vaccines for multiple food allergies (such as dairy, tree nuts or shellfish), as well as for environmental allergies.” Once the vaccine is sprayed into the nose, the body’s response shifts from inflammatory (Th2) to protective (Th1).
“We’re seeing long-lasting responses in sensitized animal models,” he said. “How this translates to humans remains to be seen, but we envision this as an immunotherapy that would last longer than the daily oral immunotherapies that currently are available,” perhaps enabling monthly or yearly administration.
In addition to the induction of both mucosal and systemic immunity, advantages of an intranasal approach include the lack of needles, low cost and thermostability under normal refrigeration temperatures (2-8°C), which eases distribution.
“Needle phobia is real,” Costley pointed out. Eliminating the use of needles can overcome some vaccine hesitancy, and it also makes it easier to protect people in developing countries. For example, intranasal administration doesn’t necessarily require a healthcare provider. “That’s a very big deal in low-income countries. Needles are expensive when scaled by the hundreds of millions.” Intranasal vaccines can resolve such problems for a variety of indications.
BioSpace source:
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Manufacturing and construction vs. the still-inverted yield curve
– by New Deal democratProf. Menzie Chinn at Econbrowser makes the point that the yield curve is still inverted, and has not yet eclipsed the longest…
- by New Deal democrat
Prof. Menzie Chinn at Econbrowser makes the point that the yield curve is still inverted, and has not yet eclipsed the longest previous time between onset of such an inversion and a recession. So he believes the threat of recession is still on the table.
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Half Of Downtown Pittsburgh Office Space Could Be Empty In 4 Years
Half Of Downtown Pittsburgh Office Space Could Be Empty In 4 Years
Authored by Mike Shedlock via MishTalk.com,
The CRE implosion is picking…
Authored by Mike Shedlock via MishTalk.com,
The CRE implosion is picking up steam.
Check out the grim stats on Pittsburgh.
Unions are also a problem in Pittsburgh as they are in Illinois and California.
Downtown Pittsburgh Implosion
The Post Gazette reports nearly half of Downtown Pittsburgh office space could be empty in 4 years.
Confidential real estate information obtained by the Pittsburgh Post-Gazette estimates that 17 buildings are in “significant distress” and another nine are in “pending distress,” meaning they are either approaching foreclosure or at risk of foreclosure. Those properties represent 63% of the Downtown office stock and account for $30.5 million in real estate taxes, according to the data.
It also calculates the current office vacancy rate at 27% when subleases are factored in — one of the highest in the country.
And with an additional three million square feet of unoccupied leased space becoming available over the next five years, the vacancy rate could soar to 46% by 2028, based on the data.
Property assessments on 10 buildings, including U.S. Steel Tower, PPG Place, and the Tower at PNC Plaza, have been slashed by $364.4 million for the 2023 tax year, as high vacancies drive down their income.
Another factor has been the steep drop — to 63.5% from 87.5% — in the common level ratio, the number used to compute taxable value in county assessment appeal hearings.
The assessment cuts have the potential to cost the city, the county, and the Pittsburgh schools nearly $8.4 million in tax refunds for that year alone. Downtown represents nearly 25% of the city’s overall tax base.
In response Pittsburgh City Councilman Bobby Wilson wants to remove a $250,000 limit on the amount of tax relief available to a building owner or developer as long as a project creates at least 50 full-time equivalent jobs.
It’s unclear if the proposal will be enough. Annual interest costs to borrow $1 million have soared from $32,500 at the start of the pandemic in 2020 to $85,000 on March 1. Local construction costs have increased by about 30% since 2019.
But the city is doomed if it does nothing. Aaron Stauber, president of Rugby Realty said it will probably empty out Gulf Tower and mothball it once all existing leases expire.
“It’s cheaper to just shut the lights off,” he said. “At some point, we would move on to greener pastures.”
Where’s There’s Smoke There’s Unions
In addition to the commercial real estate woes, the city is also wrestling with union contracts.
Please consider Sounding the alarm: Pittsburgh Controller’s letter should kick off fiscal soul-searching
It’s only March, and Pittsburgh’s 2024 house-of-cards operating budget is already falling down. That’s the clear implication of a letter sent by new City Controller Rachael Heisler to Mayor Ed Gainey and members of City Council on Wednesday afternoon.
The letter is a rare and welcome expression of urgency in a city government that has fallen in complacency — and is close to falling into fiscal disaster.
The approaching crisis was thrown into sharp relief this week, when City Council approved amendments to the operating budget accounting for a pricey new contract with the firefighters union. The Post-Gazette Editorial Board had predicted that this contract — plus two others yet to be announced and approved — would demonstrate the dishonesty of Mayor Ed Gainey’s budget, and that’s exactly what’s happening: The new contract is adding $11 million to the administration’s artificially low 5-year spending projections, bringing expected 2028 reserves to just barely the legal limit.
But there’s still two big contracts to go, with the EMS union and the Pittsburgh Joint Collective Bargaining Committee, which covers Public Works workers. Worse, there are tens — possibly hundreds — of millions in unrealistic revenues still on the books. On this, Ms. Heisler’s letter only scratched the surface.
Similarly, as we have observed, the budget’s real estate tax revenue projections are radically inconsistent with reality. Due to high vacancies and a sharp reduction in the common level ratio, a significant drop in revenues was predictable — but not reflected in the budget. Ms. Heisler’s estimate of a 20% drop in revenues from Downtown property, or $5.3 million a year, may even be optimistic: Other estimates peg the loss at twice that, or more.
Left unmentioned in the letter are massive property tax refunds the city will owe, as well as fanciful projections of interest income that are inconsistent with the dwindling reserves, and drawing-down of federal COVID relief funds, predicted in the budget itself. That’s another unrealistic $80 million over five years.
Pittsburgh exited Act 47 state oversight after nearly 15 years on Feb. 12, 2018, with a clean bill of fiscal health.
It has already ruined that bill of health.
Act 47 in Pittsburgh
Flashback February 21, 2018: Act 47 in Pittsburgh: What Was Accomplished?
Pittsburgh’s tax structure was a much-complained-about topic leading up to the Act 47 declaration. The year following Pittsburgh’s designation as financially distressed under Act 47 it levied taxes on real estate, real estate transfers, parking, earned income, business gross receipts (business privilege and mercantile), occupational privilege and amusements. The General Assembly enacted tax reforms in 2004 giving the city authority to levy a payroll preparation tax in exchange for the immediate elimination of the mercantile tax and the phase out of the business privilege tax. The tax reforms increased the amount of the occupational privilege tax from $10 to $52 (this is today known as the local services tax and all municipalities outside of Philadelphia levy it and could raise it thanks to the change for Pittsburgh).
The coordinators recommended an increase in the deed transfer tax, which occurred in late 2004 (it was just increased again by City Council) and in the real estate tax, which increased in 2015.
Legacy costs, principally debt and underfunded pensions, were the primary focus of the 2009 amended recovery plan. The city’s pension funded ratio has increased significantly from where it stood a decade ago, rising from the mid-30 percent range to over 60 percent at last measurement.
The obvious question? Will the city stick to the steps taken to improve financially and avoid slipping back into distressed status? If Pittsburgh once stood “on the precipice of full-blown crisis,” as described in the first recovery plan, hopefully it won’t return to that position.
The Obvious Question
I could have answered the 2018 obvious question with the obvious answer. Hell no.
No matter how much you raise taxes, it will never be enough because public unions will suck every penny and want more.
On top of union graft, and insanely woke policies in California, we have an additional huge problem.
Hybrid Work Leaves Offices Empty and Building Owners Reeling
Hybrid work has put office building owners in a bind and could pose a risk to banks. Landlords are now confronting the fact that some of their office buildings have become obsolete, if not worthless.
Meanwhile, in Illinois …
Chicago Teachers’ Union Seeks $50 Billion Despite $700 Million City Deficit
Please note the Chicago Teachers’ Union Seeks $50 Billion Despite $700 Million City Deficit
The CTU wants to raise taxes across the board, especially targeting real estate.
My suggestion, get the hell out...
International
A popular vacation destination is about to get much more expensive
The entry fee to this destination known for its fauna has been unchanged since 1998.
When visiting certain islands and other remote parts of the world, travelers need to be prepared to pay more than just the plane ticket and accommodation costs.
Particularly for smaller places grappling with overtourism, local governments will often introduce "tourist taxes" to go toward things like reversing ecological degradation and keeping popular attractions clean and safe.
Related: A popular European city is introducing the highest 'tourist tax' yet
Located 900 kilometers off the coast of Ecuador and often associated with the many species of giant turtles who call it home, the Galápagos Islands are not easy to get to (visitors from the U.S. often pass through Quito and then get on a charter flight to the islands) but are often a dream destination for those interested in seeing rare animal species in an unspoiled environment.
This is how much you'll have to pay to visit the Galápagos Islands
While local authorities have been charging a $100 USD entry fee for all visitors to the islands since 1998, Ecuador's Ministry of Tourism announced that this number would rise to $200 for adults starting from August 1, 2024.
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According to the local tourism board, the increase has been prompted by the fact that record numbers of visitors since the pandemic have started taking a toll on the local environment. The islands are home to just 30,000 people but have been seeing nearly 300,000 visitors each year.
"It is our collective responsibility to protect and preserve this unparalleled ecosystem for future generations," Ecuador's Minister of Tourism Niels Olsen said in a statement. "The adjustment in the entry fee, the first in 26 years, is a necessary measure to ensure that tourism in the Galápagos remains sustainable and mutually beneficial to both the environment and our local communities."
These are the other countries which are raising (or adding) their tourist taxes
While the $200 applies to most international adult arrivals, there are some exceptions that can make one eligible for a lower rate. Adult citizens of the countries that make up the South American treaty bloc Mercosur will pay a $100 fee while children from any country will also get a discounted rate that is currently set at $50. Children under the age of two will continue to get free access.
In recent years, multiple countries and destinations have either raised or introduced new taxes for visitors. Thailand recently started charging all international visitors between 150 and 300 baht (up to $9 USD) that are put toward a sustainability budget while the Italian city of Venice is running a test in which it charges those coming into the city during the most popular summer weekends five euros.
Places such as Bali, the Maldives and New Zealand have been charging international arrivals a fee for years while Iceland's Prime Minister Katrín Jakobsdóttir hinted at plans to introduce something similar at the United Nations Climate Ambition Summit in 2023.
"Tourism has really grown exponentially in Iceland in the last decade and that obviously is not just creating effects on the climate," Jakobsdóttir told a Bloomberg reporter. "Most of our guests visit our unspoiled nature and obviously that creates a pressure."
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