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Wednesday, September 4, 2024

School at center of massacre received phone call this morning warning of multiple shootings: officials

 At least four people are believed to have been killed and nine others were hospitalized in a shooting at Apalachee High School in northern Georgia Wednesday morning, according to a report.

“I have directed all available state resources to respond to the incident at Apalachee High School and urge all Georgians to join my family in praying for the safety of those in our classrooms, both in Barrow County and across the state,” Georgia Gov. Brian Kemp said.

What to know about the school shooting in Georgia

  • At least four people are believed to have been killed and nine others were hospitalized in a shooting at Apalachee High School.
  • The suspected shooter is believed to be  a 14-year-old, law enforcement sources told The Post, though it is unclear if he is a student at the school.
  • The Georgia Bureau of Investigation confirmed the suspect is “in custody and alive.”

Trump calls Georgia school shooter 'sick and deranged monster'

By Christopher Scarglato

Former President Donald Trump ripped the mass shooter at Apalachee High School as a "sick and deranged monster.

“Our hearts are with the victims and loved ones of those affected by the tragic event in Winder, GA," the GOP presidential nominee said in a statement. 

"These cherished children were taken from us far too soon."

15 minutes ago

Parent says many students still trying to get in touch with their families after Georgia shooting

By Christopher Scarglato

Greg Mann, a parent at Apalachee High School, told 11 Alive that many students who fled the site of the mass shooting on Wednesday were still trying to get in touch with their families.

Mann added pupils had left their phone and keys inside the school.

“Nobody’s seen this coming,” he said to 11 Allive. “You don’t really know what to do.”

an hour ago

Kamala Harris blasts Georgia school shooting as 'senseless tragedy' during campaign stop

By Christopher Scarglato

Vice President Kamala Harris blasted the school shooting in Georgia on Wednesday, calling it a "senseless tragedy."

The VP spoke on the mass shooting, which left four dead, at a campaign stop in New Hampshire.

"It's just outrageous that every day in our country, in the United States of America, that parents have to send their children to school worried about whether or not their child will come home alive," she told supporters in Portsmouth.

"We have to end this epidemic of gun violence in our country once and for all. You know, it doesn't have to be this way. It doesn't have to be this way."

an hour ago

Georgia high school received phone call this morning warning about multiple shootings: officials

By Christopher Scarglato

Apalachee High School received a phone call on Wednesday morning warning about multiple school shooting threats, law enforcement officials told CNN.

The high school received a call stating there would be shootings at five schools, with Apalachee being the first, officials said.

It is not known who originally placed the call.

According to law enforcement officials, Apalachee High School recived multiple calls warning about a potential shooting on Wednesday.
According to law enforcement officials, Apalachee High School recived multiple calls warning about a potential shooting on Wednesday.ERIK S LESSER/EPA-EFE/ShutterstockFirst Georgia school shooting victim ID'd as special education math teacher
By Chris Nesi

The first victim in Wednesday's tragic shooting at Apalachee High School in Georgia has been identified as special education math teacher David Phenix.

"We are so thankful for all the texts, calls, and messages about my dad, David Phenix. There was a shooting this morning at Apalachee High School and my dad was shot in the foot and in the hip, shattering his hip bone," his daughter Katie wrote in a Facebook update about her dad's condition.

Special education math teacher David Phenix was identified as the first victim.
Special education math teacher David Phenix was identified as the first victim.Alapachee High School
Alapachee High School Special Education Teacher David Phenix
Phenix was shot in the foot and in the hip, according to a Facebook post from his daughter.Facebook/Katie Phenix
Phenix confirmed on Facebook that her father is out of surgery and is in stable condition.
Phenix's daughter confirmed on Facebook that her father is out of surgery and is in stable condition.Facebook/Katie Phenix

"He arrived to the hospital alert and awake. He just got out of surgery and is stable. We will update as we hear new information. We are so, so lucky, but please keep our family as well as the AHS family in your prayers."

Although Phenix survived the shooting, at least four others died at the hands of the gunman -- believed to be as young as 14 -- who also wounded 30 others.

an hour ago

Student recalls seeing 'huge puddle of blood in the classroom' during Georgia school shooting: 'Dropped my stomach'

By Christopher Scarglato

Miguel Eduardo Perichi Orta, a sophomore at Apalachee High School, recalled seeing "a huge puddle of blood in the classroom" during a mass shooting there on Wednesday.

"That really, it like dropped my stomach," he said to WXIA reporters. "It was heartbreaking to see that."

An injured person getting evacuated by helicopter after the school shooting.
An injured person getting evacuated by helicopter after the school shooting.Fox 5 Atlanta
WINDER, GEORGIA - SEPTEMBER 4: Students wait with others to be picked up by their parents after a shooting at Apalachee High School on September 4, 2024 in Winder, Georgia. Multiple fatalities and injuries have been reported and a suspect is in custody according to authorities.(
A student recalled seeing a "puddle of blood" in the school during the massacre.Getty Images

The student added he was "upset and disappointed" over the massacre, which left four dead and nine hospitalized.

"If something like this can happen here, when you think it's a normal day, it can happen anywhere, and that's what really hurts," he said.

2 hours ago

Frightened Georgia high school student texts mom chilling exchange as shooter roams campus: 'Someone's dead'

By Chris Nesi

A text exchange between an Apalachee High School student and his mother gave a frightening glimpse into the panic that unfolded when a shooter believed to be as young as 14 opened fire Wednesday morning, killing at least four and injuring 30 others.

"School shooting [right now]. I'm scared. Pls. I'm not joking," the student sent his mother in a flurry of messages at 10:23 a.m., minutes after students learned there was an active shooter on the northern Georgia school campus.

Parents walking a child out of the Georgia high school following the shooting.
Parents walking a child out of the Georgia high school following the shooting.AP

"I'm leaving work," the mother replied.

"I love you," the unidentified student wrote.

The conversation then took a chilling turn.

"Love you too baby. Where are you?" his mom asked.

People leaving Apalachee High School after the shooting.
People leaving Apalachee High School after the shooting.ERIK S LESSER/EPA-EFE/Shutterstock

"Class. Someone's dead."

The Georgia Bureau of Investigation said the gunman is in custody, and it was not immediately clear if he attended the high school, which is about 45 minutes outside Atlanta.

2 hours ago

Biden says 'we cannot continue to accept this as normal' following Georgia school shooting

By Christopher Scarglato

President Biden spoke on the shooting at Apalachee High School on Wednesday, saying, "We cannot continue to accept this as normal.

“What should have been a joyous back-to-school season in Winder, Georgia, has now turned into another horrific reminder of how gun violence continues to tear our communities apart," the commander in chief said in a statement.

"Students across the country are learning how to duck and cover instead of how to read and write.

2 hours ago

4 killed, 9 hospitalized in Apalachee school shooting; suspect alive and in custody: Georgia Bureau of Investigation

By Christopher Scarglato

Four people were killed and nine were hospitalized from the Apalachee High School shooting on Wednesday, according to the Georgia Bureau of Investigation.

The agency added the suspect is alive and in custody.

An ambulance departing Apalachee High School at the shooting where four people were killed and nine others injured.
An ambulance departing Apalachee High School at the shooting where four people were killed and nine others injured.AP Photo/Mike Stewart
Barrow County Sheriff Jud Smith speaking to the media after the shooting.
Barrow County Sheriff Jud Smith speaking to the media after the shooting.Photo by Megan Varner/Getty Images

14-year-old student recounts Georgia school shooting: 'I didn't want to die that way'

By Christopher Scarglato

Camille Nelms, a 14-year-old student at Apalachee High School, recalled the harrowing moment a gunman entered her classroom on Wednesday during a mass shooting in Georgia.

"I was crying. I didn't want to die that way," Nelms told WXIA. "I don't want to meet the Lord that way."

A law enforcement officer directing people near the scene of the shooting.
A law enforcement officer directing people near the scene of the shooting.REUTERS2 hours ago

Kamala Harris briefed on Georgia school shooting: White House

By Post Staff

Vice President Kamala Harris was briefed on the deadly school shooting in Georgia on Wednesday, a White House official told CNN.

Harris was notified before she departed Joint Base Andrews for New Hampshire.

Vice President Kamala Harris boarding Air Force Two at Joint Base Andrews in Maryland on Sept. 4, 2024.
Vice President Kamala Harris boarding Air Force Two at Joint Base Andrews in Maryland on Sept. 4, 2024.via REUTERS

“She will receive regular updates from her staff as additional information becomes available. The Biden-Harris administration will continue coordinating with federal, state, and local officials,” the official said.

The VP is expected to address the massacre during her remarks in the Granite State, a campaign official told the network.

2 hours ago

'Devastated' Merrick Garland says FBI, ATF in Georgia to assist after deadly school shooting

By cscarglatonyp1

The FBI and ATF are in Georgia to assist local authorities following the mass shooting at Apalachee High School, Attorney General Merrick Garland said at a news conference on Wednesday.

"I'm devastated for the families who have been affected by this terrible tragedy," Garland said. "The Justice Department stands ready to provide resources or support the Winder community needs in the days ahead."

3 hours ago

Neighbor of Apalachee High School student: 'He probably doesn't want to finish the rest of the year'

By Christopher Scarglato

A neighbor of an Apalachee High School student said the pupil "probably doesn't want to finish the rest of the year" after a mass shooting at his school on Wednesday, they told WXIA reporters.

"I'm sure he's devastated," the neighbor said. "His last year, and this is what happens.

First responders outside Apalachee High School after at least four people were killed in the shooting.
First responders outside Apalachee High School after at least four people were killed in the shooting.ERIK S LESSER/EPA-EFE/Shutterstock
Students gathered in a prayer circle after being evacuated to the football field.
Students gathered in a prayer circle after being evacuated to the football field.WRDW

"He's like, 'They're shooting, they're shooting right across from my classroom,'" they added. "He called his mom devastated, I'm sure."


https://nypost.com/2024/09/04/us-news/georgia-school-shooting-live-updates-from-apalachee-high-school/

Biden Says He's Not Allowed To Go Out Into Crowds Anymore

 After two weeks slumped in a deck-chair on a beach, The (reported) President of The United States of America - Joe Biden - is back baby...

However, when asked by reporters about going out on the trail to campaign for his vice president Kamala Harris, he offered a somewhat surprising response...

“I’m not able to go out in the crowds anymore. The Secret Service doesn’t let me,” Biden told a reporter.

When asked “why not?”

He responded “They say it’s too dangerous.”

Forgive us for questioning this 'narrative' but isn't that what the Secret Service is for?

Is society really so dangerous now that even the US President (and most popular president ever - according to 2020's reported election count) is fearful for his safety in public...

https://www.zerohedge.com/political/biden-says-hes-not-allowed-go-out-crowds-anymore

Infections the Main Cause of Nonrelapse Mortality After CAR-T for Blood Cancers

 Infections were the main cause of nonrelapse mortality among patients who received chimeric antigen receptor (CAR) T-cell therapy for lymphomas and multiple myeloma, according to a systematic review and meta-analysis.

Of 574 reported nonrelapse deaths after CAR T-cell therapy, 50.9% were attributed to infections, reported Kai Rejeski, MD, of Memorial Sloan Kettering Cancer Center in New York City, and colleagues.

Notably, CAR T-cell-specific toxicities -- such as immune effector cell-associated neurotoxicity syndrome/neurotoxicity, cytokine release syndrome, and hemophagocytic lymphohistiocytosis -- were responsible for just 11.5% of nonrelapse deaths. Secondary malignancies accounted for 7.8%, and 7.3% were due to cardiovascular/respiratory events.

"Owing to the critical role of infections as the main driver of NRM [nonrelapse mortality] across CAR T-cell products and disease entities, there is a pressing need for comprehensive evidence-based guidelines that inform infection prevention and management after CAR T-cell therapy," Rejeski and colleagues wrote in Nature Medicineopens in a new tab or window.

"Knowledge of the expected infection risk for each CAR T-cell product may help to guide antimicrobial prophylaxis, immunoglobulin replacement therapy and granulocyte-colony-stimulating factor support, particularly in high-risk patients," they noted.

In a "News and Views" articleopens in a new tab or window accompanying the study, Viktoria Blumenberg, MD, and Marcela V. Maus, MD, PhD, both of Massachusetts General Hospital and Harvard Medical School in Boston, said the study's findings set the stage for further clinical and scientific investigation, particularly as CAR T-cell therapies receive more approvals for various hematologic malignancies, and show promise for solid tumors.

"Future investigations should focus on enhancing efficacy while minimizing toxicity and NRM," they wrote. "The results from [Rejeski and colleagues] highlight the impact of infections on NRM and call for further mechanistic investigations into CAR T-cell-induced hematopoietic suppression, along with clinical monitoring and management strategies to mitigate infection risk and improve patient outcomes in the evolving landscape of CAR T-cell therapy."

This systematic review and meta-analysis included 7,604 patients across 18 clinical trials and 28 real-world studies with various types of lymphoma and multiple myeloma who were treated with the CD19-targeted CAR T-cell products axicabtagene ciloleucel (axi-cel; Yescarta), tisagenlecleucel (tisa-cel; Kymriah), lisocabtagene maraleucel (liso-cel; Breyanzi) and brexucabtagene autoleucel (brexu-cel; Tecartus), or the BCMA-targeted CAR T-cell products ciltacabtagene autoleucel (cilta-cel; Carvykti) or idecabtagene vicleucel (ide-cel; Abecma).

Among the patients, the most common disease types were large B-cell lymphoma (5,806 patients), followed by multiple myeloma (n=1,193), mantle-cell lymphoma (n=340), and indolent lymphoma (n=265).

The authors found that the cumulative incidence rates of nonrelapse mortality were not reported in any of the 18 clinical trials, and in just half of the real-world studies. To compensate for the lack of this type of data in these trials, they determined nonrelapse mortality point estimates using random-effect models based on proportions, and compared them with 1-year nonrelapse mortality rates in the real-world studies that did report them, and found no significant differences.

Across all patients, the median follow-up was 13.4 months, and the overall nonrelapse mortality point estimate across all studies was 6.8%. These point estimates were highest in patients with mantle-cell lymphoma (10.6%), followed by multiple myeloma (8.0%), large B-cell lymphoma (6.1%), and indolent lymphoma (5.7%).

Among all CAR T products, cilta-cel had the highest overall nonrelapse mortality (15.2%), followed by brexu-cel (10.6%), axi-cel (7.3%), and ide-cel (6.3%). The lowest rates were seen with tisa-cel (4.2%) and liso-cel (3.8%).

For the nonrelapse deaths attributed to infections, the specific pathogen was not identified in most cases. Among the 103 nonrelapse deaths with a reported pathogen, 53.4% were related to COVID-19. Others involved fungal infections (19.4%), bacterial infections (21.4%), and non-COVID viral infections (4.8%).

Infections were more likely the cause of death in real-world settings (64.6%) than in clinical trials (59.1%), and this remained true even when excluding COVID-related deaths.

Among deaths attributable to secondary malignancies, one-third resulted from myelodysplastic syndrome or acute myeloid leukemia, 22.2% from carcinoma, and 2.2% from sarcoma. The remaining malignancy-related deaths were not specified.

As for deaths related to cardiovascular or respiratory events, the leading causes were respiratory failure (23.3%) and thromboembolic events (20.9%).

Disclosures

This work was in part supported by DFG: Collaborative Research grants and individual research grants, as well as research funding from Arnold Ventures and a Memorial Sloan Kettering Cancer Center Core grant from the NIH/National Cancer Institute.

Rejeski reported relationships with Kite/Gilead, Novartis, BMS/Celgene, and Pierre-Fabre.

Several co-authors also reported multiple relationships with industry.

Blumenberg reported relationships with BMS, Kite Pharma, Novartis, Roche, and Takeda.

Maus is an inventor on patents related to adoptive cell therapies held by Massachusetts General Hospital and the University of Pennsylvania (some licensed to Novartis); holds equity in Cargo, Model T bio, Oncternal, and Neximmune; serves on the Board of Directors of 2Seventy Bio; and has served as a consultant for multiple companies involved in cell therapies.

Primary Source

Nature Medicine

Source Reference: opens in a new tab or windowCordas dos Santos DM, et al "A systematic review and meta-analysis of nonrelapse mortality after CAR T-cell therapy" Nat Med 2024; DOI: 10.1038/s41591-024-03084-6.

Secondary Source

Nature Medicine

Source Reference: opens in a new tab or windowBlumenberg V, Maus MV "Tracking non-relapse mortality after CAR T-cell therapy" Nat Med 2024; DOI: 10.1038/s41591-024-03212-2.


https://www.medpagetoday.com/hematologyoncology/hematology/111791

Lilly, Haya In Potential $1B Drug Discovery Deal for Obesity and Metabolic Conditions

 

Under a multi-year agreement announced Wednesday, Eli Lilly will leverage Haya Therapeutics’ proprietary RNA-guided genome platform to identify drug targets to address the chronic conditions.

Eli Lilly is diving further into the obesity space with a potential billion-dollar deal with Haya Therapeutics. The companies announced a collaboration Wednesday to utilize the Swiss biotech’s RNA-guided genome platform to target obesity and other metabolic conditions.

Haya scored an undisclosed upfront payment and equity investment and is eligible for up to $1 billion in milestone payments as well as royalties.

Under the terms of the multi-year agreement, Haya’s platform will support preclinical drug discovery for the hot obesity market to identify and validate multiple tissue-, disease- and cell-specific long non-coding RNA targets (lncRNA). Therapeutics developed as part of the collaboration could potentially reprogram disease-driving cell states for better efficacy and less toxicity than current treatments, according to the companies.

”This partnership with Lilly demonstrates the significant advances we have made with our revolutionary regulatory genome RNA-guided platform and validates the potential of targeting lncRNA for chronic conditions,” Haya CEO Samir Ounzain said in a statement.

Long non-coding RNAs make up around 98% of the human genome, dubbed the “dark genome.” LncRNAs regulate disease-associated gene pathways and proteins and trigger a disease-associated cell state.

This is Haya’s first Big Pharma collaboration. Last week, Bayer and NextRNA forged a pact in the up-and-coming space to jointly develop lncRNA therapeutics for oncology. NextRNA received $547 upfront to develop two first-in-class small molecules targeting lncRNAs.

In 2023, Lilly said genetic medicines made up over 25% of its pipeline. The pharma dropped $700 million in 2022 on a new R&D facility in Boston dedicated to these cutting-edge medicines. The company contends that gene therapies have the potential to transform treatment options for diabetes and obesity, with less frequent dosing making the chronic conditions more manageable.

Lilly’s recent efforts have brought it to the forefront of the obesity treatment landscape. Less than a year after hitting the market, Zepbound sales totaled $1.24 billion in the second quarter of this year, exceeding Wall Street expectations.

The collaboration with Haya could lead to the next-generation of obesity medicines, beyond the booming GLP-1 market, which is estimated to be worth $47.4 billion in 2024 with a massive compound annual growth rate of 33% by 2032.

https://www.biospace.com/deals/lilly-haya-ink-potential-1b-drug-discovery-deal-to-target-obesity-and-metabolic-conditions

House Ed panel subpoenas Walz over Minn. nonprofit’s COVID-19 fraud

 The House Education and the Workforce Committee issued a subpoena Wednesday for Minnesota Gov. Tim Walz, the Democratic vice presidential nominee, in relation to a nonprofit in his state that has been charged with defrauding the government during the COVID-19 pandemic.

The Minnesota-based Feeding Our Future (FOF) has been accused of misusing $250 million in taxpayer funds that were meant to go to hungry children.  

The federal government has charged more than 70 people associated with the nonprofit, and five of them have been convicted of fraud. The group allegedly submitted the names of fake children receiving free meals during the pandemic.

Education Chair Virginia Foxx (R-N.C.) issued subpoenas for Walz, Minnesota Commissioner of Education Willie Jett, U.S. Agriculture Secretary Tom Vilsack and Agriculture Inspector General Phyllis Fong.  

“Statements in the press by you and your representatives indicate that you and other executive officers were involved, or had knowledge of, MDE’s [Minnesota Department of Education’s] administration of the FCNP [Federal Child Nutrition Program] and responsibilities and actions regarding the massive fraud,” Foxx said in the letter to Walz.  

The governor was given until Sept. 18 to provide documents and the requested information to the committee.    

The Hill has reached out to the governor’s office and the Harris-Walz campaign for comment.

It is not the first time House Republicans have opened investigations into Walz or Vice President Harris since their run for the presidency began.  

Republicans are also looking into Walz’s ties to China and Harris’s duties at the border and on migration policy.  

Rep. Maxwell Frost (D-Fla.) promptly accused the Education Committee of abusing its power for political purposes.

“Blatant use of official resources for a campaign. Pretty disgusting!” he said on the social platform X in reaction to the subpoena.

https://thehill.com/homenews/education/4861586-house-education-subpoena-walz-minnesota-covid-19-fraud/