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Sunday, June 5, 2022

Former Judge Killed In 'Targeted' Attack Against Judicial System: Officials

 by Lorenz Duschamps via The Epoch Times,

A retired judge was shot and killed at his home in Wisconsin on Friday in what has been described by officials as a “targeted” attack against the judicial system.

John Roemer, a former circuit judge in Juneau County, is believed to be the victim of the murder that happened in New Lisbon at around 6:30 a.m. on June 3, according to reports. The 68-year-old man was found in a residence that a neighbor and public records said belonged to a retired county judge.

A second person, identified as a 56-year-old male and the alleged suspect, was discovered in the basement of the home with an apparent self-inflicted gunshot wound, Wisconsin Attorney General Josh Kaul said during a news conference on Friday, also noting that a firearm was recovered from the scene.

Upon recovering the man, law enforcement started life-saving measures and the individual has been transported to a medical facility in critical condition.

Kaul, who refused to name the victim or the suspect, said the shooter had selected targets who were “part of the judicial system” and had other planned victims. The attorney general did not identify them.

“This incident appears to be a targeted act … and the suspect appears to have had other targets as well. It appears to be related to the judicial system,” Kaul said.

“At this point, we are not aware of any evidence indicating that there is any active danger to other individuals. Those who may have been other targets have been notified,” he said, adding that if the investigation finds additional threats against other individuals, authorities will notify those people.

Kaul stressed that officials are currently “limited in what information we can provide,” citing the ongoing investigation.

The judge’s death was also confirmed in a statement by State Sen. Howard Marklein (R-Spring Green), who represents Juneau County, the Wisconsin State Journal reported.

The Juneau County Sheriff’s Office received a call that two shots were fired at a home in New Lisbon at approximately 6:30 a.m. on Friday, according to the Division of Criminal Investigation. The caller had fled the home where the gunman had entered and made the call from another nearby home.

Donna Voss, a neighbor, told The Associated Press that local police instructed her to stay in her home Friday morning. She said she heard law enforcement on a loudspeaker telling the man to surrender and leave the home.

Kaul said during Friday’s press briefing that law enforcement officers stationed outside the home tried to negotiate with the gunman, but after they failed to make contact, a special tactic and response team entered the residence and found the homeowner dead and another man in the basement.

For Voss, the shooting came as a shock in a usually quiet neighborhood where houses sit alongside farmland and wooded lots, about 80 miles northwest of Madison.

“It’s unbelievable and really freaky,” she told The Associated Press.

https://www.zerohedge.com/political/former-judge-killed-targeted-attack-against-judicial-system-officials-say


Sapience, Intensity, Kazia and Transcenta Tout Early Success at ASCO

 Four life sciences companies posted updates on their respective programs ahead of the American Society of Clinical Oncology (ASCO) annual meeting, taking place June 3-7 in Chicago.  

Sapience Lead Cancer Asset Shows Early Potential 

Sapience Therapeutics shared that its Phase I trial exploring efficacy proof-of-concept for its lead cancer drug ST101 is seeing an ongoing clinical benefit in three of 25 patients who started treating on May 5. ST101, a first-in-class peptide antagonist of C/EBPβ, is being observed in the Phase II part of a Phase I-II clinical trial in people diagnosed with advanced unresectable and metastatic solid tumors. 

The primary objective is to assess the drug's tolerability and safety, as well as determine the dose levels for Phase II. The secondary objectives include pharmacodynamic evaluation, pharmacokinetics and preliminary efficacy. 

"The Phase II expansion portion of the study is going very well, with all cohorts enrolling and a confirmed partial response in a patient with recurrent glioblastoma, which is very exciting. We believe that ST101's unique mechanism of action targeting C/EBPß represents a potentially transformative approach to treating cancer," Dr. Alice Bexon, chief medical officer of Sapience said in a statement. 

Intensity Phase I/II Study Validates Proof of Concept

Intensity Therapeutics shared that its ongoing Phase I/II clinical trial of  INT230-6 is showing efficacy and tolerability in patients with relapsed, refractory and metastatic solid tumors. 

INT230-6, a combination of cisplatin and vinblastine, is being explored either as a monotherapy or in combination with pembrolizumab. It is designed for direct intratumoral injection. 

"The biomarker and clinical data generated in this study provide strong proof-of-concept evidence for our approach and underscore the potential of this new, potential treatment. As recent data readout events in the field of oncology have shown, there remains a high unmet need for novel therapeutic approaches. With that in mind, we are planning for later stage studies in order to advance INT230-6 toward potential future commercialization," Lewis Bender, president and CEO of Intensity Therapeutics, said. 

INT230-6 is currently being studied in several Phase II cohorts in patients with various types of advanced solid tumors. 

Kazia Encouraged by Glioblastoma Data  

Kazia Therapeutics announced positive final data from its Phase II trial of paxalisib as a first-line treatment for patients living with glioblastoma. 

In a trial involving 30 participants, the researchers observed a median overall survival rate of 15.7 months in those who received paxalisib versus the 12.7 months reported in the temozolomide group. Temozolomide is the only existing FDA-approved product for first-line treatment. In terms of median progression-free survival, the paxalisib group reported 8.6 months compared to the temozolomide group's 5.3 months. 

"The directionality of these analyses gives us greater confidence in the efficacy signals observed and appear encouraging for future development. We are immensely grateful to the investigators and patients whose hard work and engagement has ensured the success of this trial," Dr. James Garner, CEO of Kazia, commented. 

Transcenta Touts "Encouraging Clinical Response" in Phase I

Transcenta shared promising clinical data for the dose-escalation part of its ongoing Phase I study of TST001 as a first-line treatment for advanced and metastatic gastric cancer or gastroesophageal junction cancer. TST001, a humanized anti-Claudin18.2 monoclonal antibody, is being assessed for its capabilities when used in combination with Capox. 

"From the dose-escalation phase, we are very pleased to show that TST001 is well tolerated and displayed encouraging clinical response in combination with chemotherapy in Claudin18.2 unselected first-line gastric cancer patients. We will continue to evaluate the safety and efficacy of this combination and plan to initiate a multi-center global registration enabling trial in Claudin18.2 positive first-line gastric cancer patients," Dr. Michael Shi, EVP, head of global R&D and CMO at Transcenta, noted in a press release. 

TST001 already has an Orphan Drug Designation from the FDA. 

https://www.biospace.com/article/asco-updates-proposed-drugs-for-solid-tumors-glioblastoma-and-gastric-cancer-showcase-positive-early-outcomes/


Aurinia: LUPKYNIS® (voclosporin) Effective in Treatment Targets in Lupus

 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune disease, presented data demonstrating the efficacy of LUPKYNIS® (voclosporin) for the treatment of people with lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE), in achieving the proteinuria treatment targets recommended by the European Alliance of Associations for Rheumatology (EULAR) and the European Renal Association (ERA). A post-hoc analysis of pooled data from the similarly designed 48-week AURA-LV and 52-week AURORA 1 studies were presented in an oral session at the EULAR 2022 European Congress of Rheumatology by Hans-Joachim Anders, M.D., Professor of Nephrology at the University of Munich (LMU).

The pooled analysis from the Phase 2 AURA-LV and Phase 3 AURORA 1 studies assessed the efficacy of voclosporin, in addition to mycophenolate mofetil (MMF) and low-dose steroids, to reduce urine protein creatinine ratio (UPCR) to achieve the following EULAR/ERA treatment targets updated in 2019: ≥25% reduction in UPCR by three months, ≥50% reduction in UPCR by six months, UPCR ≤0.7 mg/mg by 12 months, as well as steroid dose of ≤7.5 mg/day at 12 months.

https://finance.yahoo.com/news/aurinia-presents-data-demonstrating-lupkynis-110500197.html

Intercept: New Clinical Trial, Real-World Data for Ocaliva in Liver Disease

 COBALT study in advanced PBC, previously terminated early due to feasibility challenges, did not demonstrate a statistically significant difference in clinical endpoints between Ocaliva® and placebo

HEROES-US real-world analysis demonstrated statistically significant improvement in event-free survival in patients receiving Ocaliva for PBC

Intercept plans to include these data in an evidence package that will be submitted to U.S. FDA in 2H 2022 to support post-marketing regulatory requirements

https://finance.yahoo.com/news/intercept-announces-clinical-trial-real-113000483.html

PTC: Prelim Results Demonstrated Promising Clinical Efficacy with Unesbulin in Leiomyosarcoma

 PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced encouraging preliminary safety and efficacy results from its Phase 1B study of unesbulin (PTC596) in advanced leiomyosarcoma (LMS) patients. The results demonstrated that treated patients achieved an 18.2 percent objective response rate and a 51.5 percent disease control rate. In addition, unesbulin was generally well tolerated. The results from the dose escalation study which evaluated unesbulin in combination with dacarbazine (DTIC), will be presented on Saturday, June 4, during the Sarcoma Oral Abstract Session beginning at 1:15 p.m. CDT at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

https://finance.yahoo.com/news/preliminary-results-presented-asco-demonstrated-120000856.html

Resetting the Clock on Aging through Gene Manipulation

 The fountain of youth might be more than folklore, as scientists develop tools to reverse age-related cellular dysfunction. While these tools haven’t yet reached the masses, two research studies have emerged this week that hint at progress.

Adenine Base Editing for Hutchinson-Gilford Progeria Syndrome

Researchers at the Karolinski Institutet collaborating with fellow scientists at the Institute for Basic Science in South Korea looked deeply into the rare genetic disorder, Hutchinson-Gilford progeria syndrome. The majority of people diagnosed with this genetic disorder have a point mutation that changes the cytosine nucleotide to a thymine nucleotide. This mutation is seen to cause genetic disorders, making it an ideal target for Hutchinson-Gilford progeria syndrome research.

The research team decided to use an adenine base editor to experimentally correct the nucleotide mutation believed to cause the syndrome. Past research has shown that this type of editing can affect non-target regions, so the researchers only used the editing tool long enough to reverse the cytosine to thymine nucleotide mutation. Using the editing tools for only a short time was shown to be effective, despite only correcting the mutation in 21 to 24% of the skin cells. The corrected skin cells replicated to create new, non-mutated cells as well as correct the mutation in existing cells. The correction spread across other areas of skin.

Maria Eriksson, who led this study and serves as a professor at Karolinski Institutet’s department of biosciences and nutrition commented on the findings.

"In this particular study, we have used gene editing to correct the mutation in the skin, but in future studies, we want to test the method in other tissues," she said. "A short-term expression, without detectable toxicity, also opens up the possibility of adding the gene editing tools on several occasions and thus increasing the amount of repaired cells. "

While adenine base editing was effective in this model, the experiment was limited to skin cells. In the future, this research team hopes to expand and find out whether editing can be done throughout the body’s other tissues.

Harvard Scientist Makes Discovery Using Yamanaka Factors

In 2007, a Nobel Prize was awarded to Dr. Shinya Yamanaka for the discovery of a method that reverses human skin cells back to stem cells, permanently resetting the clock on the aging cells. The induced pluripotent stem cells were later named Yamanaka factors. The only caveat to the remarkable findings is the fact that the stem cells were reset without keeping the functionality they were assigned to. Essentially, the cells had become blank slates without duties.

These stem cells became the focal point of researchers who hoped to revert the cells back to stem cells while maintaining the functionality that is required for bodily homeostasis. According to an article published Friday by CNN, David Sinclair, a researcher at Harvard Medical School, may have found the technique necessary to accomplish this goal.

Sinclair commented on his theory on aging before explaining his research.

“I call it the information theory of aging…it’s a loss of information that drives aging cells to forget how to function, to forget what type of cell they are. And now we can tap into a reset switch that restores the cell’s ability to read the genome correctly again, as if it were young," he said.

Using three of the four main Yamanaka factors and a benign virus vector, Sinclair delivered a dose of the factors directly into a mouse subject’s eye. The mouse had age-related retinal cell degeneration before the administration. To switch the three genes into the “on” state, an antibiotic was given to the mouse. The effect was astonishing. The cells in the subject’s eyes began to grow new axons, a strong sign of rejuvenation.

The next steps will be to find out how applicable this process is to humans, before moving toward clinical trials.

https://www.biospace.com/article/scientists-reset-the-clock-on-aging-through-gene-manipulation/

Saturday, June 4, 2022

Baby-Formula Ingredient Supplies Are Limited by War in Ukraine

 Baby formula makers rushing to address shortages in the U.S. are facing another big obstacle: A key ingredient comes largely from Ukraine.

Many formula manufacturers use sunflower-seed oil to add critical fats to products. Ukraine has been the No. 1 exporter of the oil, according to the U.S. Department of Agriculture. Yet shipments have slowed to a trickle during since Russia invaded the country.
The bottleneck has added a tricky complication to frantic efforts to increase U.S. stocks of formula, which ran short for several months due to supply-chain issues, then worsened after Abbott Laboratories shut down a plant.
Companies have been scrambling to increase supply of sunflower oil, as Russian soldiers hold up Ukrainian supplies at ports, according to industry consultants. Yet finding alternative sources, or rewriting recipes to replace sunflower oil with similar oils will take time, the industry experts said.

A sunflower-seed processing plant in Velyka Kostromka, Ukraine, was damaged by a Russian attack last week.

PHOTO: FRANCISCO SECO/ASSOCIATED PRESS
It will also cost more. Sunflower oil sold for $2,276 per metric ton in April in Rotterdam, up from $1,500 in February, according to the World Bank.
“It does just add an additional cost, complexity and in some cases delays,” said Lyman Stone, director of research for Demographic Intelligence, which consults for formula manufacturers including Abbott and Nestlé SA .
Reckitt Benckiser Group PLC, which makes the Enfamil brand formula, said the war in Ukraine has impacted sunflower oil supplies, but is working with suppliers “to continue sourcing this ingredient in the quantities necessary to help us address the formula shortage.” Other major U.S. formula manufacturers declined to comment.
“Without question it’s high on their list” of problems, said Per Hong, senior partner at Kearney, a global management consultant. Formula makers could eventually find U.S. sources of sunflower oil, he said, but that could take months.
The Biden administration announced plans last week to invoke the Defense Production Act to get critical ingredients to formula makers, but a senior administration official said there weren’t plans to use the act for sunflower oil.

The first air shipment of baby formula, originating from Zurich, was delivered at Indianapolis International Airport on Sunday.

PHOTO: KAITI SULLIVAN/BLOOMBERG NEWS
Baby formula includes a blend of oils to add the healthy fat that babies need to grow. Sunflower has been a popular option because historically it was easy to source, has a high amount of essential fatty acids and doesn’t throw off the taste of the drink too much, said Kristi King, a senior pediatric dietitian at Texas Children’s Hospital.
Ukraine had been one of the major—and least expensive—sources of sunflower oil for many U.S. food manufacturers. The country was known as a good source of sunflower oil high in oleic acids, a source of healthy fats.
Michael Bleyzer, president of SigmaBleyzer LLC, a Houston-based private-equity firm with investments in Ukrainian agriculture, said his company normally produces 50,000 tons of sunflower seeds a year, but this growing season, working around cratered fields and shelled equipment in the Kharkiv region, he expects to grow only half that.
Russia’s blockade of Ukraine’s ports has meant that much of the oil in the country can’t get out. That has pushed up prices for sunflower oil and its typical replacements, such as palm and rapeseed oils.
The issues arose amid a shortage of baby formula in the U.S. partly due to supply-chain issues created by the pandemic. The situation worsened after Abbott recalled some formula and closed its Sturgis, Mich., plant in February, after Food and Drug Administration inspectors found bacteria and other violations. Abbott reached an agreement with the FDA this month that would allow it to reopen the plant in coming weeks under agency supervision while making improvements to the facility.

Abbott Laboratories’ baby formula plant in Sturgis, Mich., last week.

PHOTO: SYLVIA JARRUS FOR THE WALL STREET JOURNAL
To ease the formula shortage, companies have been looking for new sunflower-oil suppliers outside Ukraine, according to industry consultants. The second biggest exporter of sunflower oil, however, is Russia. Other sources include Turkey, Germany and several Eastern European countries. Securing new supplies takes time, to sign contracts and assure the quality of the product, industry experts say.
Farmers in the U.S. grow sunflower seeds but much fewer than in Ukraine, and most wind up as snacks or get crushed into oil used to make popcorn and potato chips. The National Sunflower Association, a U.S. trade group, expects growers to plant about 20% more of the crop this year than they normally do.
“There’s more demand for sunflower oil right now than there is product,” said John Sandbakken, executive director of the association. “Growers are definitely looking at taking advantage of the opportunity.” Yet the plantings won’t increase supplies until October, when the harvested seeds would first be crushed for oil, Mr. Sandbakken said.

VIDEO

How a Shortage of Sunflower Oil From Ukraine Is Pushing Up Food Prices
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How a Shortage of Sunflower Oil From Ukraine Is Pushing Up Food Prices
How a Shortage of Sunflower Oil From Ukraine Is Pushing Up Food PricesPlay video: How a Shortage of Sunflower Oil From Ukraine Is Pushing Up Food Prices
The sunflower – normally seen as a symbol of hope and peace in Ukraine – has come to represent surging food inflation since Russia’s invasion began. WSJ’s Shelby Holliday explains why a global shortage of sunflower oil is sending prices of cooking oil to record highs. Photo: Alexander Ryumin/Zuma Press
Formula makers are also looking at substituting another oil for sunflower, industry experts said. But palm oil, another popular choice for infant formula, is also hard to come by. Indonesia, the top producer of palm oil, cut off exports of the product in April after price pressure from the Ukraine war began to make the oil scarce for its own citizens, though the country rescinded the ban Monday.
Rewriting formula recipes to use a different oil can take months for a closely regulated health product, industry experts said. Recipe changes must meet FDA standards and often require safety testing in animals. It also could change the taste and odor of the formulas, industry experts said, which could upset babies and their parents.
Sourcing other oils would have the same supply-chain issues that sunflower oil faces: few trucks, few workers, few available shipping routes.
“Not only is the formulation sensitive but there is not an existent supply chain to get those things,” said Amy David, clinical associate professor of supply-chain management at Purdue University. ”You don’t have a lot of real good options.”