Centivax and US Naval Medical Research Center to begin Phase I clinical trial of antibody therapeutics

Centivax Inc. announced today that it has entered into a strategic partnership with the U.S. Naval Medical Research Center (NMRC) for Phase I clinical development of Centi-B9, Centivax’s SARS-CoV-2 broad-spectrum injectable antibody therapeutic and prophylactic.

Centi-B9 has been engineered to broadly neutralize the mutated emerging coronavirus variants, with demonstrated broad-spectrum reactivity against 99.5% of all coronavirus variants in the U.S.A, and over 98% of coronavirus variants globally, including critical mutations found in the UK B.1.1.7, South African B.1.351, Brazilian P.1, New York B.1.526 and California B.1.429 strains.

Rather than requiring an IV infusion, Centi-B9 has been bioengineered for high stability, low viscosity high concentration (250mg/ml) delivery, enabling a prophylactic or therapeutic dose of Centi-B9 to be delivered in a non-hospital setting through a single injection. Centi-B9 has been further engineered for enhanced safety and enhanced half-life, using Xencor Xtend technology.

Broad-spectrum. High-concentration. Enhanced safety. The Centi-B9 biosuperior represents the first clinical example from the Centivax portfolio of next generation antibody therapeutics bespoke engineered to specific needs of patient populations and the diseases that they confront. With discovery research supported by Medical Technology Enterprise Consortium, and now clinical development supported by our remarkable collaboration with the Naval Medical Research Center, this biotech-government partnership is proud to advance this molecule into clinical development and closer to the patients and doctors that need a better medicine to end the pandemic.”

Dr Jacob Glanville, CEO, Centivax

In the strategic partnership Centivax and NMRC will each contribute a Principal Investigator to the clinical study, and NMRC will host the Phase I clinical trial site for intramuscular and subcutaneous delivery of Centi-B9, as well as providing support for protocol development and medical oversight. The Henry Jackson Foundation is providing $4.2M US in non-dilutive funding support for the trial. The Phase I trial will demonstrate safety and pharmacokinetics of the Centivax monoclonal in healthy volunteers and is planned to begin in July of this year. These Phase I studies will enable a Phase II/III adaptive trial to begin later this year. The Phase II/III trial will study efficacy in several patient populations, including hospitalized COVID-19 patients, pre-hospitalized COVID-19 cases, post-exposure prophylaxis and pre-exposure prophylaxis. Given the unmet need for a broad-spectrum injectable, Centivax will seek Emergency Use Authorization during interim analysis.

While vaccines appear to be very effective against some strains of the virus, they known to provide reduced protection against many of the emerging variant strains, with further reductions in protection anticipated to continue as the virus continues to mutate. This is particularly important to the Navy, since individuals on long deployments may come into contact with these variants at international ports of calls.

“Our highly concentrated, thermostable, neutralizing antibody fits the needs of the Navy, and DOD in general, in that it can be administered intramuscularly to warfighters in cramped quarters or austere environments to boost and extend protection already afforded by vaccination,” said Dr. David Gangemi, Ph.D., Chief Government Relations Officer for Centivax. “Our antibody is highly effective against over 98% of the currently circulating variants and is a good fit for use in prolonged deployments when prophylaxis and/or post-exposure treatment is needed.”

Centi-B9 can be used either prophylactically to protect against COVID-19, or as an adjunct to vaccines to provide complete protection, or as an early interventional therapy for those who chose not to be vaccinated and subsequently became infected with SARS-CoV-2. Centi-B9 is a highly stable product that can be stored for extended periods in standard refrigeration conditions and can be administered ship-board prophylactically to prevent the risk of transmission.

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First COVID lockdowns, now de Blasio NYC storm travel bans. Thanks, Ida! (opinion)

STATEN ISLAND, N.Y. – Government’s desire to dictate every aspect of our lives truly never ends.

Especially in New York City.

Mayor Bill de Blasio has taken a lashing for the city being unprepared for the deadly, historic rainfall that drowned New York City as the remnants of Hurricane Ida blew through on Wednesday night.

De Blasio’s response? Cracking down on New Yorkers when severe weather is in the forecast.

In other words, get ready for more lockdowns that could come on a whim based on how government officials with limited expertise view the “facts” and the “science” of a developing situation that they have no control over.

Sound familiar?

De Blasio on Friday said that New Yorkers could face mandatory travel bans and evacuations from basement apartments when big storms are in the forecast.

We’re facing a “new paradigm,” de Blasio said. We’re in a whole new world.

Appearing on MSNBC, de Blasio said, “We would historically not think of telling people, ‘Don’t go on the streets don’t go on the subways’ — literally banning travel. This is the kind of thing we’re going to have to use more often.”

Remember how former Gov. Andrew Cuomo got slammed when he preemptively shuttered the subway and bus systems with a blizzard bearing down on the city in 2015?

The only problem was that the blizzard never materialized in all its predicted fury. Cuomo looked like he’d jumped the gun.

Weather forecasts are like that. There’s no way to tell for sure what any weather system is going to do. Storms erupt out of nowhere. Powerful storms suddenly weaken or change direction. Small storms gather power.

It leaves government with a lot of leeway if elected officials are now going to be able to demand that we shelter in place or evacuate because snow or wind or rain is on the way.

They’re more likely than not going to err on the side of extreme caution, whether the conditions truly call for it or not.

Hmm, this storm could be a bad one. Better close the buses and subways. Better tell people to stay in their homes. Better tell businesses to shut down. Better keep cars off the roads.

Because, after all, it can’t hurt for you to stay in your home.

It’s the same thing we were told about one pandemic stricture after another: It “can’t hurt” for you to stay in your homes for months on end. It “can’t hurt” to wear a mask. It “can’t hurt” to get vaccinated. It “can’t hurt” to get a booster shot.

“Can’t hurt” isn’t a basis for public policy affecting millions of people.

As for warnings about Hurricane Ida, I don’t know about you, but my phone was blowing up for hours with alerts about the coming storm.

And in de Blasio’s defense, the most dire warnings that I saw involved the possibility of tornadoes. Footage of funnel clouds and destruction seen in Philadelphia and parts of New Jersey only reinforced that hellish wind, not rainfall, was the threat.

But in classic fashion, it looks like de Blasio won’t let a good crisis go to waste. But the conversation should about improving infrastructure, not shutting things down.

They want us to get vaccinated and present proof when asked. They want us to mask up.

They want us to drive only so fast. They want us to pay in order to drive into certain parts of the city.

And now they want to shut the city down whenever a bad storm is on the way. That could be in summer, winter, fall or spring.

And just like they’ve told us during the pandemic or when talking about road safety: It’s all for our own protection.

It truly never ends.

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3 Vancouver schools placed on lockdown after Proud Boys try to enter during masks protest

Vancouver Public Schools officials confirmed on Friday that the Skyview High School, Alki Middle School and Chinook Elementary were put in lockdown after members of the far-right Proud Boys tried to gain access to school grounds, according to witnesses.

Pat Nuzzo, communications director for the district, called the lockdown’s a “safety precaution.”

“This is related to yesterday’s protest against Washington state’s requirement for staff and students to wear masks or face coverings in schools and on buses,” Nuzzo wrote to OPB.

Patriot Prayer, a far-right group led by Southwest Washington’s Joey Gibson, and other far-right activists made posts online incorrectly claiming that a student at the school who did not want to wear a mask would face arrest if they entered school grounds.

Parents of other students at Skyview joined the anti-mask protest, holding signs and calling for the student to be given a medical exemption to mask requirements. Nearby, teachers and students held signs supporting masks.

One video posted online showed a group of people outside the school chanting “U-S-A.” Several people in the crowd were wearing black and yellow clothing of the Proud Boys, a far-right group best known for their participation in the Jan. 6 insurrection and for inciting violence during protests against anti-fascists.

Protesters yell at passing cars during an anti-mask demonstration in front of Skyview High School on September 3, 2021in Vancouver, Washington.

Jonathan Levinson / OPB

VPS school board president Kyle Sproul said locking down the schools was the proper decision to ensure student safety.

“Regardless of one’s stance on mask mandates, I think most parents in our community agree that protesting at our school campuses and disrupting the school day is not in the best interest of students,” Sproul told OPB.

The school went on lockdown after members of the Proud Boys attempted to escort the freshman seeking the medical exemption into the building.

That student has been diagnosed with post-traumatic stress disorder and anxiety, according to her mother, Megan Gabriel. She requested an exemption from the school’s mask mandate because she said the mask can trigger panic attacks.

Gabriel told OPB she was willing to have her daughter come to school early, change classrooms before or after other students, and stay as separate as possible from other students to accommodate her daughter’s medical condition. Gabriel said the school would not exempt her daughter from the mandate.

Gabriel’s daughter has only been to school one day since classes resumed this week, she said.

“Yesterday, they locked her out of the building and I had no idea,” Gabriel said. “She was locked out of the building for an hour.”

The demonstration itself at times became vitriolic. Security guards at the school said some of the protesting women called female students derogatory names.

But Gabriel said she isn’t ant-mask or anti-vaccine. Her son wears a mask at school, she said, and she wears her mask when indoors.

There is an ongoing anti-mask right-wing protest going on in North Vancouver at Skyview High School, which started small and has now attracted open white supremacists who are encroaching school property.
Video taken by a friend on scene, not my own. pic.twitter.com/rxXL4TrvgI

— Triss Winters (@TrissWinters) September 3, 2021

Nuzzo said she couldn’t discuss specific students due to confidentiality laws but said Vancouver Public Schools is required to follow state health and safety measures, including mask mandates.

“Some students qualify for a medical or disability mask accommodation,” Nuzzo said. “To provide accommodations, we work through a process with the student’s family to consider all necessary information including documentation from the health provider.”

She did not say why Gabriel’s requested exemption was denied. Nuzzo said accommodations are available for mental health needs, and that Vancouver provides a fully remote learning option.

One student told OPB that teachers and faculty at the schools guarded doors inside the building during the lockdown, while security guards addressed the Proud Boys.

“All the learning gets disrupted. We have to sit down quietly, not make noise, and we were hunkered down in our classrooms for around an hour to an hour-and-a-half,” said Lucas, a 16-year-old high school student at Skyview. OPB is withholding Lucas’ last name to protect his identity.

He compared the lockdown to school shooter drills. Lucas also said some students were harassed by the anti-mask demonstrators outside the school building.

“They’ve gotten pretty wild out here recently. It’s kind of crazy,” Lucas said.

Lucas and other students handed out masks at the school as a counterdemonstration to the far-right activists.

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The Immortal Life of Henrietta Lacks by Rebecca Skloot

read

Read about the woman whose cells have revolutionised medical research, including Covid-19 research

Published 04.09.21, 12:16 AM

Henrietta Lacks, an African-American woman, died of cervical cancer in 1951. Cells harvested from her cervix gave rise to the ‘immortal’ HeLa line which revolutionised biomedical research, in everything from the polio vaccine to cancer, hepatitis and HIV medicines. This is a fascinating dive into the history of the world’s most famous cell line and the woman they came from, raising important ethical issues of race, class, consent and ownership in medical research. 

Published in 2011, the book has become even more relevant now, with scientists using HeLa cells to discover an important aspect of the infectivity and viral spread of SARS-CoV-2, which causes Covid-19.

 

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Soaring COVID-19 infections restrain U.S. job gains in August

A sign advertising job openings is seen while people walk into the store in New York City, New York, U.S., August 6, 2021. REUTERS/Eduardo Munoz

• Nonfarm payrolls increase 235,000 in August
• July payrolls gain raised to 1.053 million from 943,000
• Unemployment rate falls to 5.2% from 5.4%
• Average hourly earnings jump 0.6%

WASHINGTON, Sept 3 (Reuters) – The U.S. economy created the fewest jobs in seven months in August as hiring in the leisure and hospitality sector stalled amid a resurgence in COVID-19 infections, which weighed on demand at restaurants and other food places.

But other details of the Labor Department’s closely watched employment report on Friday were fairly strong, with the unemployment rate falling to a 17-month low of 5.2% and July job growth revised sharply higher. Wages increased a solid 0.6% and fewer people were experiencing long spells unemployment.

This points to underlying strength in the economy even as growth appears to be slowing in the third quarter because of the soaring infections, driven by the Delta variant of the coronavirus, and relentless shortages of raw materials, which are depressing automobile sales and restocking.

Nonfarm payrolls increased by 235,000 jobs last month, the smallest gain since January. Data for July was revised up to show a whopping 1.053 million jobs created instead of the previously reported 943,000.

That left the level of employment about 5.3 million jobs below its peak in February 2020. Economists polled by Reuters had forecast nonfarm payrolls increasing by 728,000 jobs.

The initial August payrolls print has undershot expectations and been slower than the three-month average job growth through July over the last several years, including in 2020. August payrolls have been subsequently revised higher in 11 of the last 12 years.

Employment in the leisure and hospitality sector was unchanged as restaurants and bars payrolls fell 42,000, offsetting a 36,000 gain in arts, entertainment and recreation jobs. Retailers shed 29,000 jobs.

There were gains in professional and business services, transportation and warehousing, as well as manufacturing, which added 37,000 jobs. Factory hiring remains constrained by input shortages, especially semiconductors, which have depressed motor vehicle production and sales.

Raw material shortages have also made it harder for businesses to replenish inventories. Motor vehicle sales tumbled 10.7% in August, prompting economists at Goldman Sachs and JPMorgan to slash third-quarter GDP growth estimates to as low as a 3.5% annualized rate from as high as 8.25%.

Government payrolls fell in August as state government education lost 21,000 jobs. The Bureau of Labor Statistics, which compiles the employment report cautioned that “recent employment changes are challenging to interpret, as pandemic-related staffing fluctuations in public and private education have distorted the normal seasonal hiring and layoff patterns.”

U.S. stocks opened lower. The dollar slipped against a basket of currencies. U.S. Treasury prices fell.

HOUSEHOLD DETAILS STRONG

Details of the smaller household survey from which the unemployment rate is derived were fairly upbeat.

The unemployment rate fell to 5.2%, the lowest since March 2020 from 5.4% in July. It has, however, been understated by people misclassifying themselves as being “employed but absent from work.” Without this problem, the jobless rate would have been 5.5%.

Though the participation rate was steady at 61.7%, about 190,000 people entered the labor force last month. Even more encouraging, the number of permanent job losers declined 443,000 to 2.5 million. The number of long-term unemployed dropped to 3.2 million from 3.4 million in the prior month. They accounted for 37.4% of the 8.4 million officially unemployed people, down from 39.3% in July. The duration of unemployment fell to 14.7 weeks from 15.2 weeks in July.

The employment report will be parsed by investors trying to gauge the timing of the Federal Reserve’s announcement on when it will start scaling back its massive monthly bond buying program. Fed Chair Jerome Powell last week affirmed the ongoing economic recovery, but offered no signal on when the U.S. central bank plans to cut its asset purchases beyond saying it could be “this year.”

Some economists do not believe the below-expectations payrolls count is weak enough for the Fed to back away from its “this year” signal.

There were a record 10.1 million job openings at the end of June. Lack of affordable childcare, fears of contracting the coronavirus, generous unemployment benefits funded by the federal government as well as pandemic-related retirements and career changes have been blamed for the disconnect.

There is cautious optimism that the labor pool will increase because of schools reopening and government-funded benefits expiring on Monday. But the Delta variant could delay the return to the labor force by some of the unemployed in the near term.

Reporting by Lucia Mutikani;
Editing by Chizu Nomiyama and Andrea Ricci

Our Standards: The Thomson Reuters Trust Principles.

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For Patients to Trust Medical AI, They Need to Understand It

AI holds great promise to increase the quality and reduce the cost of health care in developed and developing countries. But one obstacle to using it is patients don’t trust it. One key reason is they perceive medical AI to be a black box and they think they know more about physicians’ decision-making process than they actually do, the authors research found. A remedy: Provide patients with an explanation of how both types of care providers make decisions.

Artificial intelligence-enabled health applications for diagnostic care are becoming widely available to consumers; some can even be accessed via smartphones. Google, for instance, recently announced its entry into this market with an AI-based tool that helps people identify skin, hair, and nail conditions. A major barrier to the adoption of these technologies, however, is that consumers tend to trust medical AI less than human health care providers. They believe that medical AI fails to cater to their unique needs and performs worse than comparable human providers, and they feel that they cannot hold AI accountable for mistakes in the same way they could a human.

This resistance to AI in the medical domain poses a challenge to policymakers who wish to improve health care and to companies selling innovative health services. Our research provides insights that could be used to overcome this resistance.

In a paper recently published in Nature Human Behaviour, we show that consumer adoption of medical AI has as much to do with their negative perceptions of AI care providers as with their unrealistically positive views of human care providers. Consumers are reluctant to rely on AI care providers because they do not believe they understand or objectively understand how AI makes medical decisions; they view its decision-making as a black box. Consumers are also reluctant to utilize medical AI because they erroneously believe they better understand how humans make medical decisions.

Our research — consisting of five online experiments with nationally representative and convenience samples of 2,699 people and an online field study on Google Ads — shows how little consumers understand about how medical AI arrives at its conclusions. For instance, we tested how much nationally representative samples of Americans knew about how AI care providers make medical decisions such as whether a skin mole is malignant or benign. Participants performed no better than they would have if they had guessed; they would have done just as well if they picked answers at random. But participants recognized their ignorance: They rated their understanding of how AI care providers make medical decisions as low.

By contrast, participants overestimated how well they understood how human doctors make medical decisions. Even though participants in our experiments possessed similarly little factual understanding of decisions made by AI and human care providers, they claimed to better understand how human decision-making worked.

In one experiment, we asked a nationally representative online sample of 297 U.S. residents to report how much they understood about how a doctor or an algorithm would examine images of their skin to identify cancerous skin lesions. Then we asked them to explain the human or the algorithmic provider’s decision-making processes. (This type of intervention that has been used before to shatter illusory beliefs about how well one understands causal processes. Most people, for instance, believe they understand how a helicopter works. Only when you ask them to explain how it works, do they realize they have no idea.)

After participants tried to provide an explanation, they rated their understanding of the human or algorithmic medical decision-making process again. We found that forcing people to explain the human or algorithmic provider’s decision-making processes reduced the extent to which participants felt that they understood decisions made by human providers but not decisions made by algorithmic providers. That’s because their subjective understanding of how doctors made decisions had been inflated and their subjective understanding of how AI providers made decisions was unaffected by having to provide an explanation — possibly because the had already felt the latter was a black box.

In another experiment, with a nationally representative sample of 803 Americans, we measured both how well people subjectively felt that they understood human or algorithmic decision-making processes for diagnosing skin cancer and then tested them to see how well they actually did understand them. To do this, we created a quiz with the aid of medical experts: a team of dermatologists at a medical school in the Netherlands and a team of developers of a popular skin-cancer-detection application in Europe. We found that although participants reported a poorer subjective understanding of medical decisions made by algorithms than decisions made by human providers, they possessed a similarly limited real understanding of decisions made by human and algorithmic providers.

What can policymakers and firms do to encourage consumer uptake of medical AI?

We found two successful, slightly different interventions that involved explaining how providers — both algorithmic and human — make medical decisions. In one experiment, we explained how both types of providers use the ABCD framework (asymmetry, border, color, and diameter) to examine features of a mole  to make a malignancy-risk assessment. In another experiment, we explained how both types of providers examine the visual similarity between a target mole and other moles known to be malignant.

These interventions successfully reduced the difference in perceived understanding of algorithmic and human decision-making by increasing the perceived understanding of the former. In turn, the interventions increased participants’ intentions to utilize algorithmic care providers without reducing their intentions to utilize human providers.

The efficacy of these interventions is not confined to the laboratory. In a field study on Google Ads, we had users see one of two different ads for a skin-cancer-screening application in their search results. One ad offered no explanation and the other briefly explained how the algorithm works. After a five-day campaign, the ad explaining how the algorithm works produced more clicks and a higher click-through rate.

AI-based health care services are instrumental to the mission of providing high-quality and affordable services to consumers in developed and developing nations. Our findings show how greater transparency — opening the AI black box — can help achieve this critical mission.

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Oklahoma Medical Research Foundation names interim president

The Oklahoma Medical Research Foundation named its longtime chief legal officer as interim president, the foundation announced Monday.

Adam Cohen, an attorney who joined OMRF in 2002, was appointed to the interim role at a Friday meeting of the executive committee of the Oklahoma City nonprofit’s board of directors. 

The executive committee has named a special committee to search for a permanent replacement for Dr. Stephen Prescott, who led OMRF for 15 years. 

Prescott retired at the end of April and died May 28 of cancer complications. 

The search committee will be led by Len Cason, OMRF board chair.

“OMRF has earned national and international recognition for biomedical research excellence,” Cason said in a statement. “That reputation will prove to be key as we seek to find the caliber of proven scientific leader the institution deserves.”

‘He led us to another level.’  Prescott to retire as Oklahoma Medical Research Foundation chief

Also on the committee are: Michael Cawley; Christy Everest; Cathy Keating; Mindy Mahaney; Jim Morris; David Rainbolt; Dr. John Saxon; Jerome Holmes, a federal appeals court judge; Terence Kern, a U.S. District Judge; Don Nickles, a former U.S. senator; and Steven Taylor, a former Oklahoma Supreme Court Justice.

All but two are members of OMRF’s board of directors. Keating and Nickles are on the foundation’s national advisory council.

Dr. Rodger McEver, OMRF’s vice president of research, along with leaders of OMRF’s research programs, will also advise the search committee.

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