Coherus, Junshi’s PD-1 Blocker Loqtorzi Aces Phase III Liver Cancer Trial

 Junshi Biosciences and Coherus BioSciences on Wednesday unveiled data from the Phase III HEPATORCH study, showing that its PD-1 inhibitor Loqtorzi (toripalimab)—when used with bevacizumab—significantly improved survival in patients with advanced hepatocellular carcinoma.

The partners did not provide specific data in their announcement, only revealing that the Loqtorzi-based combination regimen significantly improved progression-free and overall survival when used in the first-line setting.

Loqtorzi plus bevacizumab also met key secondary endpoints, such as objective response rate and time to progression. In terms of safety, HEPATORCH found no new signals of concern and Loqtorzi’s overall adverse event profile was consistent with what had been established in prior studies.

According to the companies, Loqtorzi “has met the pre-defined efficacy boundary.”  Junshi plans to file a supplemental New Drug Application to seek approval for advanced hepatocellular carcinoma (HCC) “in the near future.”

HEPATORCH is a randomized, open-label and active-controlled study comparing Loqtorzi plus bevacizumab versus the current standard treatment sorafenib in patients with unresectable or metastatic advanced HCC. Junshi and Coherus will present complete findings and analysis from HEPATORCH at an upcoming international academic congress.

Jianjun Zou, CEO and general manager of Junshi, in a statement said that HEPATORCH’s latest readout underscores Loqtorzi’s potential “as a cornerstone of immuno-oncology, significantly improving survival rates for patients with advanced HCC.”

“We will actively communicate with regulatory authorities to expedite the approval of relevant indications, and we hope our efforts will benefit more patients with advanced liver cancer,” Zou said.

Loqtorzi is a PD-1 receptor inhibitor which works by blocking the pathway that tumor cells use to avoid being detected and attacked by the immune system. The therapeutic monoclonal antibody won its first FDA approval in October 2023 for the treatment of nasopharyngeal carcinoma. Loqtorzi is the first Chinese PD-1 blocker to enter the U.S. market.

However, in China, Loqtorzi has the distinction of being the first domestic PD-1 inhibitor approved for use and is sold under the brand name Touyi. It can be used for eight indications, including unresectable or metastatic melanoma, recurrent or metastatic nasopharyngeal carcinoma and locally advanced or metastatic urothelial carcinoma.

Loqtorzi was initially discovered and developed by Junshi. Coherus bought the U.S. and Canadian rights to the PD-1 inhibitor in February 2021 for $150 million upfront plus up to $380 million in certain milestone payments. As part of the licensing deal, Coherus also gained option rights to several earlier-stage cancer candidates from Junshi.

https://www.biospace.com/article/coherus-junshi-s-pd-1-blocker-loqtorzi-aces-phase-iii-liver-cancer-trial/

NIH Was Feeding Gain-Of-Function Disinfo To Journalists: Documents

 by Paul D. Thacker via The Disinformation Chronicle,

House investigators on the Energy and Commerce Committee released a 73-page report yesterday documenting NIH officials lying about dangerous gain-of-function virus research to reporters and withholding information from Congress. These latest revelations follow reporting last week that Tony Fauci lied to the New York Times about his involvement in a Nature Medicine piece that advanced the theory that the pandemic could not have started in a lab Fauci himself was funding in Wuhan, China.

The House began the investigation following a September 2022 article in Science Magazine that reported on the dangers of monkeypox virus, spreading across the globe with the potential to adapt to humans and become more transmissible or deadly. Bernard Moss, a veteran poxvirus researcher at the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), told Science Magazine that monkeypox evolves to replicate faster in humans.

Science noted that Moss had begun gain-of-function experiments—swapping out genes from various variants—to understand why some are more dangerous or transmissible than others.

Moss has been trying for years to figure out the crucial difference between two variants of monkeypox virus: clade 2, which until recently was found only in West Africa and is now causing the global outbreak, and clade 1, believed to be much deadlier, which has caused outbreaks in the Democratic Republic of Congo for many decades. He’s found that clade 1 virus can kill a mouse at levels 1000 times lower than those needed with clade 2. To find out why, Moss and his colleagues swapped dozens of clade 2 genes, one at a time, into clade 1 virus, hoping to see it become less deadly, but with no luck so far. Now, they are planning to try the opposite, endowing clade 2 virus with genes from its deadlier relative.

Moss’s disclosure that he planned to insert genes from the more deadly clade 1 monkeypox strain into the more common and transmissible clade 2 monkeypox virus triggered a second story in Science Magazine with scientists expressing alarm at the study’s dangers.

On the other hand, Ohio State University researcher Linda Saif told Science Magazine’s Jocelyn Kaiser that she was worried that excessive regulation could “greatly impede research into evolving or emerging viruses” and drive research overseas, where U.S. regulations don’t apply or are looser. Oddly enough, I previously reported that Saif helped orchestrate a February 2020 essay ghostwritten by Shi Zhengli of the Wuhan Institute of Virology that called the possibility of a Wuhan lab accident a “conspiracy.”

Based on a statement from Moss’s NIAID, Science Magazine’s Kaiser later updated her article to claim that Moss’s research would only involve clade 2a, not clade 2b monkeypox virus.

Eight months later, STAT News reporter Helen Branswell wrote that Republicans were “targeting” NIAID researcher Bernie Moss and alleged he had never proposed to move forward with the dangerous virus studies.

But a spokesperson for NIAID told STAT in late May that there had been no formal proposal from Moss to do the research and the institution had no plan to proceed with the study.

Branswell then posted on X that “House Republicans want to interrogate poxvirus scientist Bernie Moss—who has been at NIH for 57 years—for work he did not do.”

The reports by Science Magazine’s Kaiser and STAT’s Branswell are both false.

In their report, House investigators document that—weeks after NIAID claimed to Science Magazine’s Kaiser that Moss’s planned monkeypox research involved clade 2a, not clade 2b monkeypox—Moss posted a preprint reporting he already started research with clade 2a and planned research with clade 2b.

“We have started to investigate the genetic determinants responsible for virulence differences of clade I and IIa viruses and plan to extend this to clade IIb pending institutional approval,” Moss and co-authors wrote in a preprint.

House investigators document several other examples of NIH lying about the nature of Moss’s research and withholding documents demanded for over a year. After investigators threatened a subpoeana, NIH relented and admitted in March that Moss had submitted a formal proposal to insert genes from the more deadly clade 1 monkeypox strain into the more common and transmissible clade 2 monkeypox virus (MPXV).

And the NIH’s Institutional Biosafety Committee (IBC) approved Moss’s research plan to conduct these dangerous studies in 2015.

A March 19, 2024, letter from HHS and documents reviewed on March 20, 2024, in camera by bipartisan Committee staff confirmed what the agencies had been denying for over a year: that a research team led by Dr. Bernard Moss of NIAID submitted a proposal for a bidirectional MPXV approach at a meeting before the NIH IBC on June 30, 2015.35 This bidirectional approach “was considered and approved by the IBC.”36 The research proposal involved bidirectional transfer of genes between clades I and II of the MPXV, including a proposed transfer of genes from the more lethal clade I into the less lethal but much more transmissible clade II.

Despite NIH approving Moss in 2015 to conduct studies they falsely claim he never proposed, NIH now claims Moss never performed the research.

On a final note, pandemic author Laurie Garrett promoted Helen Branswell’s post on X to falsely claim that House Republicans want to “crucify” Bernie Moss for work he never did. “But he mentioned it in an interview with @ScienceMagazine—and that, apparently, is enough to put a target on his back. This is why scientists are clamming up, avoiding media.”

House investigators continue to press the NIH to explain the research Moss actually conducted and said they would like to see lab notebooks to prove which studies he actually performed.

Attempting to flush out who sent Science Magazine false information about Moss’s studies, House investigators demanded last October that NIH turn over all documents related to Science Magazine’s coverage of the controversy “including communications between NIH and American Association for the Advancement of Science (AAAS) or Science magazine.”

NIH has failed to respond to this request and Science Magazine has not corrected their reporting.

However, House investigators have not demanded that NIH explain who provided false information to STAT News reporter Helen Branswell claiming Moss had not proposed the monkeypox research he had actually proposed and was approved to conduct in 2015.

But in a deposition released by the House COVID Select Subcommittee, Tony Fauci’s former chief of staff, Greg Folkers, testified under oath that STAT’s Branswell would call him to get direct access to Fauci.

“So you asked me the names of a couple people who might call me directly,” Folkers told House investigators. “John Cohen of Science who I've known for a long time would sometimes say, ‘Hey, can I talk to Tony?’ And Helen Branswell of Stat, again, would do the same thing.”

https://www.zerohedge.com/medical/nih-was-feeding-gain-function-disinfo-journalists-documents

'About 4% of US adults age 65 and older have a dementia diagnosis, survey finds'

 Some 4% of U.S. adults aged 65 and older say they have been diagnosed with dementia, a rate that reached 13% for those at least 85-years old, according to a report of a national survey released on Thursday.

The report issued by the U.S. Centers for Disease Control and Prevention (CDC) was based on the 2022 National Health Interview Survey, a nationally representative sample of U.S. adults aged 18 and older. The survey in 2019 added the option to report dementia, including Alzheimer's disease, to its questions on doctor-diagnosed health conditions.

The CDC said 1.7% of adults ages 65 to 74 reported a dementia diagnosis, a rate that increased with age. For those ages 75 to 84, the reported dementia rate was 5.7%

The agency conducted in-person or telephone interviews with 8,757 people age 65 and older who were asked whether they have been diagnosed with some form of dementia.

Ellen Kramarow, the report's lead author, said dementia diagnosis estimates were in general similar from 2019 to 2022, adding that they "do not see this as a measure that is going to have large changes year to year."

Alzheimer's is the leading cause of dementia, which involves the loss of memory, language, problem-solving and other cognitive abilities severe enough to interfere with daily life, according to the Alzheimer's Association.

The report accompanies the arrival of new treatments designed to slow progression of the mind-wasting disease, such as Biogen and Eisai's Leqembi, which won U.S. approval last July. Eli Lilly's similar treatment, donanemab, was unanimously endorsed by an advisory panel to the U.S. Food and Drug Administration on Monday and is widely expected to be approved.

The CDC report showed dementia diagnoses were lowest among people with college degrees and highest among people with less than a high school education.

Several studies have suggested that people with higher levels of education have larger cognitive reserves that can temporarily delay dementia symptoms.

The overall estimates are similar to other national surveys, such as the 2021 Medicare Current Beneficiary Survey, which estimated that nearly 3% of Medicare beneficiaries not residing in nursing homes or long-term care facilities had a diagnosis of Alzheimer's or another type of dementia.

https://www.yahoo.com/news/4-us-adults-age-65-040225337.html

Mail-in votes dominate Nev. primary as 1 GOP race too close to call after ‘deepfake’ released

 Voter turnout in Nevada’s Tuesday primary was light — despite most ballots being mailed in — and state insiders believe the final tally will be thinner than the odds at a craps table.

Democrats topped Republicans in voting — 95,346 Dem ballots recorded by midnight Tuesday versus 84,118 GOP ballots cast — but those figures, along with 28,199 “no party” votes, only amount to 14.47% of eligible voters, Nevada Secretary of State Francisco V. Aguilar (D) reported.

The bulk of ballots in the primary came in via mail, Aguilar’s office said.

A total of 121,000 postal ballots were received, with 42,260 cast in person Election Day and 44,399 during early voting.

The overall turnout disappointed observers.Political expert Jon Ralston, editor of The Nevada Independent, predicted the final count would fall short of even one in five voters casting primary ballots.

The thin numbers left one congressional primary — to select a GOP nominee in the state’s 4th Congressional District — dangling like a hanging chad on Wednesday afternoon.

Republican John Lee, a former North Las Vegas mayor, led retired Air Force Lt. Col. David Flippo by 1,124 votes as of Wednesday afternoon.

The race remains uncalled by local media.

“I am grateful for the support we’ve received so far and remain optimistic as we await the final results,” Lee said via email Wednesday.

“It’s crucial that every vote is counted, and we will respect the process until the race is officially called.”

A campaign insider maintained Lee, a Democrat who switched parties in 2021 and earned former President Donald Trump’s coveted endorsement in this race, will emerge victorious: “There’s just not that many votes out there remaining.”

3

A total of 121,000 postal ballots were received, with 42,260 cast in person Election Day and 44,399 during early voting.AP

Lee’s electoral effort was apparently unaffected by the last-minute release on a website of what was purported to be an audio recording of the politician soliciting a mother and her teenage daughter for sex.

The campaign claimed this was a “deepfake,” and Lee sued activist Lou Colagiovanni — who was also connected to former Rep. Anthony Weiner’s scandals — along with Flippo, his campaign and a raft of unnamed individuals, alleging defamation, the “intentional infliction of emotional distress” and “conspiracy.”

A Flippo spokesman said the military vet’s campaign “was not involved in the publication of this website or recording in any way” and had alerted Lee to the recording’s existence “six months ago.”

Whoever wins the district, which stretches from just north of the Las Vegas Strip to a northeast border with Arizona, will challenge Rep. Steven Horsford, a three-term incumbent.

The Democratic congressman won his party’s primary with 90.19% of the vote, per the secretary of state’s office.

3

Republican John Lee, a former North Las Vegas mayor, led retired Air Force Lt. Col. David Flippo by 1,124 votes as of Wednesday afternoon.AP

Election officials said postal ballots received by June 15 will be counted.

Those choosing to mail in ballots had until Tuesday night to get them postmarked.

The question of how mail-in ballots were to be handled this year sparked massive concern over US Postal Service plans to reorganize mail handling and shift some sorting and distribution hubs.

A plan to reroute mail from Reno and northern Nevada to Sacramento, Calif., some 140 miles away, is reportedly on hold until well after the November elections.

“We are unaware of current service issues or delays” in handling primary ballots in Clark and Washoe Counties, where the bulk of Nevada voters live, a USPS spokesman told The Post.

3

Whoever wins the district, which stretches from just north of the Las Vegas Strip to a northeast border with Arizona, will challenge Rep. Steven Horsford, a three-term incumbent.AP

“Further, we have no indications of ballot delays, tampering with or inability to collect Election Mail from boxes or individual Post Offices.”

He said the agency “is committed to the secure, timely delivery of the nation’s Election Mail.”

But at an April 17 Senate Homeland Security and Governmental Affairs Committee hearing, Postmaster General Louis DeJoy was criticized by Missouri Republican Josh Hawley, who said he feared for mail-in voting this year.

“I’ve put together a specific infrastructure within the organization that works with all election boards throughout the year,” DeJoy replied.

He said the USPS lays on extra trips to transport mail, adds “extra people on site” and has “special oversight” areas for mail ballots.

“You should expect the same good service we’ve been delivering since I’ve been here,” he told Hawley.

Reliable postal voting could be important to the Donald Trump campaign, which this month said it will launch a “Swamp the Vote” effort to encourage early and mail-in voting, a marked change from its earlier stance.

The ex-prez said, “Republicans must win and we will use every appropriate tool to beat the Democrats because they are destroying our country. Whether you vote absentee, by mail, early in-person or on election day, we are going to protect the vote.”

https://nypost.com/2024/06/12/us-news/mail-in-votes-dominate-nevadas-primary-as-one-gop-race-remains-too-close-to-call/

Haters are harassing Jews every day in NYC, when will pols protect them?

 How much more are Jews in New York City expected to take?

Earlier this week, a protest in front of the Nova Music Festival Exhibition on Wall Street, which commemorates those slaughtered at a music festival in Israel during the October 7 attacks, waved Hezbollah and Hamas flags and a “Long live October 7th” banner, lit flares and chanted “long live the intifada.”

On Tuesday, a mob took over a New York City subway car and chanted, in a call and repeat fashion, “Raise your hands if you’re a Zionist. This is your chance to get out.”

Two nights ago, the homes of Brooklyn Museum’s director Anne Pasternak and several of the museum’s Jewish board members, were defaced with fake blood and a sign that accused Pasternak of being a “White-Supremacist Zionist.”

I’ve been writing in these pages about the growing antisemitism in New York for years.

But this is the worst it has ever been. It’s no longer random attacks, that could be blamed on the mentally unwell.

There is now a coordinated threat to Jewish presence in this city.

“Hate doesn’t have a home in our city,” former mayor Bill de Blasio said in 2019 after eight attacks on Jews within one week happened in New York.

De Blasio had famously blamed Trump-supporters for these increased attacks saying “I want to be very, very clear, the violent threat, the threat that is ideological, is very much from the right.”

He never explained how the shadowy MAGA fans existed in such large numbers in his deep blue New York and were able to disguise themselves so well.

To his credit, Mayor Adams visited the Nova exhibit after the hateful protest outside.

But he said similar words to his hapless predecessor, “Hate has no place in our city,” when it is clear “hate” has developed quite a foothold in New York where Jews are concerned.

It’s gotten so bad that even Comptroller Brad Lander and Rep. Alexandria Ocasio-Cortez, both normally good friends to Jew-haters, feigned alarm at the open antisemitism they helped to foster.

City Council Speaker Adrienne Adams, meanwhile, is looking to stoke these flames of antisemitism further by working on a completely pointless cease-fire resolution.

The war in Gaza won’t stop because some City Councilwoman says so.

But violence against Jews in her city will increase as she pushes the lie that Israel is committing genocide.

Jews in New York find themselves in a very hard place.

The city had long been a haven for the Jewish population.

Antisemites existed elsewhere, out there in the hinterlands, not in the city home to Zabar’s and Seinfeld.

The last few years have exposed something else.

Now it’s hard not to notice that the worst eruptions, the vilest hate, is happening in New York specifically.

The mob is masked to conceal their identity and able to be violent then disappear into crowds.

It’s worth noting that when the regular attacks on Jews were happening during de Blasio’s terms, with hundreds of attacks caught on video, only one perpetrator ever served a day in prison.

Jews are getting the message that no one will protect them and they’re largely not allowed to protect themselves.

At the Nova exhibit, Mayor Adams told influencer Lizzy Savetsky “We have the largest Jewish population outside of Israel right here in New York. This is not going to be a city where you’ll have to take off your yarmulke, be afraid to walk inside a synagogue,” but then added “or church or mosque” as if anyone is afraid to walk into those.

He seemed to want to cut off the obvious criticism that Jews have largely been left exposed in his city saying “A minority of those who want us to live in fear, who want us to say ‘police departments you’re not doing enough,’ who want us to turn on our allies, we can’t turn on each other.”

What would Mayor Adams do if he were on that subway without a security detail?

Would he raise his hand as a Zionist?

What does he advise his city’s Jews do?

It’s not turning on each other to demand more than words.

Hate has no home in New York? Prove it.

https://nypost.com/2024/06/12/opinion/protesters-are-harassing-jews-every-day-in-nyc-when-will-pols-protect-them/