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Monday, September 9, 2024

Terns Investigational GLP-1 Pill Spurs 5% Weight Loss After 28 Days

 

Terns Pharmaceuticals will advance TERN-601 into Phase II after early-stage data showed the oral therapy led to weight loss of 4.9%, comparable with weight loss pills Lilly and Pfizer are developing, according to analysts.

Terns Pharmaceuticals’ oral GLP-1R agonist led to mean weight loss of nearly 5% after just 28 days when compared to placebo during an early-stage trial, sending the biotech’s shares climbing over 18% in early-morning trading Monday.

BMO Capital Markets analysts called the data “compelling” in a Monday morning note. BMO compared the Phase I results for TERN-601 to oral competitors such as Eli Lilly’s orforglipron, which has achieved 3.9% weight loss in a similar study, and Pfizer’s danuglipron, which led to 5.2% weight loss.

The Phase I study featured adult patients who have obesity or are overweight across three doses. The 4.9% placebo-adjusted mean weight loss was achieved in the highest dose arm of TERN-601, which patients received once daily, according to a Monday press release. Terns also said that 67% of participants in this group lost 5% or more of their baseline body weight.

“With operational preparations well underway, we look forward to swiftly advancing this promising product candidate into Phase II clinical development in 2025,” Terns CEO Amy Burroughs said in the announcement.

TERN-601 was well-tolerated with no treatment-related dose interruptions, reductions or discontinuations, the company noted. Gastrointestinal events were mild to moderate and consistent with the wider class of GLP-1R agonists. Terns also reported that there were no clinically meaningful changes in liver enzymes.

“These compelling results underscore TERN-601’s potential to be a class-leading GLP-1R agonist based on its composite profile of initial indications of efficacy, tolerability and manufacturing scalability,” said Burroughs.

Terns’ oral therapy has an edge in the oral weight-loss drug space because it is dosed once daily, which has been difficult for some competitors, BMO noted. Pfizer discontinued twice-daily dosing of danuglipron in December 2023 after high discontinuation rates. The drug was revived in July with a once-daily regimen. Lilly’s orforglipron is being tested with a once-daily dose.

“TERN-601’s profile, in our view, supports advancement as a monotherapy or in combinations,” BMO wrote.

Terns could look within its pipeline for such a combination to TERN-501 or TERN-800, BMO noted.

Data from the TERN-601 Phase I trial will be presented at a future medical meeting.

https://www.biospace.com/drug-development/terns-shares-climb-as-investigational-glp-1-pill-spurs-5-weight-loss-after-28-days

Biden-Harris World Is Afire

 by Victor Davis Hanson via American Greatness,

Somehow the United States ended up this summer with no engaged president and an absent vice president who avoids the missing president and is frantically repudiating everything she co-owned the last three years.

The world was already confused over how President Joe Biden was apparently declared by unnamed Democratic insiders and donors unfit and unable to continue as their presidential candidate—as if he were a dethroned Third-World usurper.

It further wondered how those who staged his removal had no problem allowing him, in his debilitated state, to continue as America’s commander-in-chief until January 20, 2025. They demonstrated their priorities that focus on retaining power, not the welfare of the nation or the will of over 14 million Biden primary voters.

Vice President Kamala Harris, until Biden’s forced abdication, was judged by these same backroom fixers as too incompetent to ever be commander-in-chief and thus for three years a good reason why Biden apparently was not forced out earlier.

Now nominal Vice President Harris is on the campaign trail nonstop, while Biden has taken the most vacation time off and worked the shortest workweek in presidential memory.

The world again wonders who is in charge, what they believe, who is a friend, and who is an enemy. Harris is busy trying to get elected on three premises: disowning her prior co-ownership of what was mostly a disastrous Biden term and certainly no recommendation for reelection; reinventing her affluent radical past and present as moderate and working-class; and keeping absolutely silent about any detailed agenda or policy plan for governance as president.

Our rivals and opponents abroad cannot decide which is better for their own anti-American agendas—a derelict and absent Biden-Harris or dealing with a cognitively challenged Biden and a linguistically loopy Harris?

So, again, who or what now governs America?

Is it Biden again at the beach or closing up shop at noon for his nap and early bedtime?

Or is it Vice President Harris, far from the White House, out campaigning and confused over who she really is or wants to be, what, if anything, she plans on doing if elected president, and how to avoid any unscripted moment?

Or are our real rulers the stealth cabal of Democratic grandees and billionaire donors who arranged the Biden presidency by forcing out his 2020 primary rivals, staged the conspiratorial silence about his real disabilities for well over three years, ambushed him, and forced him off the Democratic ticket, and are now frantically reinventing Kamala Harris as capable and centrist when just a few months ago they had written her off as incompetent and a hopeless wannabe California radical?

As a result, a confused but also encouraged world of enemies watches the listless United States and wonders whether to try something stupid.

In this widening vacuum, lots of foreign opportunists, outright enemies, and nihilists are seizing the day—on the assurance that Biden is not a lame duck, but a lame, lame duck, and Harris is a near functionary in search of an identity and an idea.

The Houthis, a ragtag cabal of terrorists who hijacked Yemen after shaking off a few prior Biden “precision” retaliatory strikes, now “own” the Red Sea. They just hit a Greek-flagged oil tanker that is now adrift and polluting the Red Sea. It serves as their warning for commercial ships to keep clear of their mare nostrum.

The Houthis expect neither a Western nor an American response to ensure safe transit in and out of the southern Mediterranean by the world’s commercial fleet. Apparently, they believe that they are so backward, and their drones are so cheap and simple that the top-heavy U.S. cannot afford to hit their ad hoc launches with sophisticated, multimillion-dollar, and often misapplied weapons. And they are probably right.

Indeed, under Biden-Harris, the world has now lost free and safe transit in the Red Sea, the Black Sea, the South China Sea, the Strait of Hormuz, and the Eastern Mediterranean. Will the Caribbean or mid-Atlantic be next? The military is short thousands of troops, the merchant marines idling ships.

Our NATO enemy/“ally” Turkey—when it is not threatening to send missiles against fellow NATO member Greece, bragging about once again ethnic cleansing Armenians, leveling more warnings to Cyprus, bombing the Kurds, colluding with the Russians and Chinese, trying to veto Finnish and Swedish NATO membership, or claiming US nuclear weapons based in Turkey are virtually its own—apparently has created such an anti-American climate that its pro-Erdogan street thugs feel they can beat up visiting American sailors, docking at Izmir to help aid the Turkish navy.

Not a peep follows from the White House. If it had, President Recep Erdogan would have leveled one of his accustomed unhinged responses.

Hamas just murdered more of its Israeli hostages, among them an American citizen.

Now non-candidate Biden is apparently still more worried about 250,000 Muslim voters in Michigan (who profess more solidarity with Hamas than lament the murder of a fellow citizen) than US interests in the Middle East. He customarily and matter-of-factly issued one of his empty editorials before returning to form by performance art blasting Israel.

In Biden’s world, our closest and only democratic ally in the Middle East is at fault because it will not, this election year, give constant concessions to the murderous Hamas clique. Biden-Harris forget that Hamas started the current war by butchering 1,200 Israelis at a time of peace, scrambled back to its subterranean labyrinth with over 250 hostages, hid their terrorist killers under schools, hospitals, and mosques, murdered any who were about to be rescued by Israeli forces, and promised to kill more if rescue attempts continue.

The Biden-Harris messaging seems simple: pro-Western, civilized, and consensually governed nations are rational and so listen to the U.S. and therefore should be leveraged and often punished for rationality; anti-American, medieval, and theocratic terrorist cabals do not and therefore should be appeased and exempted from criticism or retaliation given their lawlessness.

Normally, when asked about foreign threats to harm Americans or their interests, Biden gives one of his accustomed blowhard, one-word threats, “Don’t!” That empty and tired banality is now interpreted abroad as zero consequences will follow when you harm America. As a general rule, an animated Biden is far more likely to threaten to beat up or go after Trump than Hamas or Iran.

Harris has been mum—other than her usual on the one hand/on the other hand vacuity. Her vice presidential candidate running mate, the usually frenetic and loquacious Tim Walz, when asked directly about the murder of an American hostage, similarly goes mum—and simply waved off the question and turned away. Walz seems as terrified as Harris of any unrehearsed utterance, as if he knows only his silence masks his foolery.

Brazil, as was warned by many, is heading toward full-scale Latin American communism of the Venezuela/Nicaragua/Cuba sort. It is now waging a censorship war against Elon Musk with the tacit approval of the Biden-Harris consortium—for the crime of turning the former useful Twitter leftwing and censored megaphone into a global free speech pavilion.

Ukraine has now been inside Mother Russia for weeks, which is strategically understandable but geo-strategically dangerous against a nuclear hyperpower run by a ruthless dictator. Biden has no clue what the U.S. is doing other than supplying enough arms to Ukraine not to lose but more than enough to trigger a wider theater war. Ask Biden and Harris what the U.S. strategy is on Ukraine, and one will mumble incomprehensibly, the other, if unguarded, plunge into a circular word salad about the “art of diplomacy” or “democratic fragility.”

Iran is more afraid of an Israeli response than U.S. threats.

Or is it worse than that? Does the theocracy now rely on Biden-Harris to restrain any Israeli retaliation for the tens of thousands of rockets launched by Hamas, Hezbollah, and Iran against the Jewish state.?

All Biden-Harris had to do was continue the Trump protocol of warning Iran to stay out of the conflict. Instead, it de facto greenlighted the Iranian supply chain to Hamas and Hezbollah and turned all of them loose to murder.

In truth, US foreign policy toward Iran is the resumption of the Obama-era embrace of the supposed underdog Shiite/Persian counterweight to Gulf moderates and democratic Israel. Biden-Harris cares not a whit whether Iran goes nuclear and might even in their warped Ben-Rhodes/Barack Obama-era imbecility tacitly support such nuclearization to “rein in” the Jewish state.

Mexico’s outgoing “president,” Andrés Manuel López Obrador, has now unabashedly also gone full communist. As he preps the way for his even harder-left successor, Obrador is seeking to destroy what is left of Mexico’s democracy.

AMLO, remember, bragged of the tens of millions of illegal aliens that Mexico drove out and into the U.S.—especially given the $60 billion in remittances they send to prop up an otherwise failed narco-state. In retirement, he will brag that he was the first Mexican president to destroy the U.S. border.

He even urged all Mexican-American expatriates to vote anti-Republican. For the next few months, he will cooperate with the US to slow down the influx northward in order to allow Harris-Biden to claim they are for pre-November 5 election-cycle “border security.” And thereby help Harris get elected and welcome in another 10 million illegal aliens.

In his delusions, AMLO—who proved one of the truly dangerous anti-Americans on the world stage—thinks he is winning phase two of the 19th-century Mexican War. In fact, all he is proving is that millions of Mexicans want out of his country and only romanticize it when they are safely and permanently distant from its numerous failed paradigms.

In sum, there really is no President Biden or Vice President Harris. The former is non compos mentis and failing ever more rapidly. The latter has no clue who she is or what she should do. The cabal that engineered their respective exits and entrances cares more about retaining power than using it for American interests.

So, we are in perilous times.

All of our enemies and even former neutrals are coming out of the woodwork. They are convinced that the next two months offer one-time advantages—unless Harris is elected and thus can extend their opportunities for four more years of what Americans see as a chaotic decline, but the world abroad views as a rare and ripe opportunity.

https://www.zerohedge.com/geopolitical/vdh-biden-harris-world-afire

Kamala Harris Is Secluded In A Hotel With A Trump Impersonator

 by Steve Watson via modernity.news,

Fox News reporter Bryan Llenas revealed at the weekend that Kamala Harris’ campaign has got her in a hotel in Pittsburgh on a fake stage with a Trump impersonator, desperately practising for Tuesday’s debate.

“We know that Vice President Kamala Harris is in her hotel in Pittsburgh. They’ve got the lights as if it’s in a studio,” Llenas claimed, adding “They’ve got the stage. They’ve even brought in somebody who’s dressed and acting like the former President.”

This is almost exactly what they did with Biden before the debate that ultimately ended him.

They secluded him away for a week, trying to make his pudding brain function in order to take on Trump.

Now they face a whole different challenge of drilling Harris so she can function without cheat notes, something she hasn’t done since becoming the nominee, and without being able to goad Trump into soundbite traps because of the muted microphones rule that the Harris campaign failed to get changed.

The polls are once again showing Trump leading Harris in in the crucial states.

And overall.

There is no where left for Harris to hide.

CIA, MI6 Chiefs Praise Ukraine's Kursk Invasion For Bringing War To 'Ordinary Russians'

 by Dave DeCamp via AntiWar.com,

CIA Director William Burns and Richard Moore, the head of the UK’s MI6 foreign intelligence agency, spoke at an unprecedented joint public event in London on Saturday, where they praised Ukraine’s invasion of Russia’s Kursk Oblast.

Moore said the Kursk invasion was "typically audacious and bold on the part of the Ukrainians, to try and change the game" and said it had "brought the war home to ordinary Russians."

Burns said the operation in Kursk was a "significant tactical achievement" that boosted morale in Ukraine. While the fighting continues in Kursk, Russian forces have been making more rapid gains in Ukraine’s Donbas region since the invasion was launched.

The US and its allies claim they weren’t involved in the planning of the Kursk invasion, but a Ukrainian soldier said Western intelligence was crucial for the attack.

Ukrainian forces have been using US and British weapons in the assault, marking a significant escalation of the proxy war.

At the event, which was hosted by the Financial Times, Burns downplayed concerns about potential Russian escalations in response to the Western support for Ukraine. Burns said the following:

I think there was a moment in the fall of 2022 when there was a genuine risk of the potential use of tactical nuclear weapons.

I have never thought, however, and this is the view of my agency, that we should be unnecessarily intimidated by that. Putin’s a bully and he is going to continue to saber-rattle from time to time.

And Burns acknowledged that despite the Kursk operation being an 'achievement' it has actually done little or nothing toe weaken President Putin's power:

Burns described the Kursk offensive as a "significant tactical achievement" that has served to boost Ukrainian morale as well as expose some of the vulnerabilities of Putin’s Russia and his military. Last year’s short-lived insurrection carried out by former Wagner chief Yevgeny Prigozhin also helped to dent this narrative, Burns said.

The CIA chief does not, however, see Putin’s grip on power weakening. "He does one thing really well, and that’s repress people at home."

The event marked the first time the heads of the CIA and MI6 had appeared in public together. Both spy agencies have been deeply involved with Ukraine’s intelligence agencies following the 2014 coup in Kyiv that ousted former Ukrainian President Viktor Yanukovych.

https://www.zerohedge.com/geopolitical/cia-mi6-chiefs-praise-ukraines-kursk-invasion-bringing-war-ordinary-russians

Goldman Finds "Thrift Trends Outperform" Amid Consumer Slowdown

 Goldman cited new data in a note to clients on Monday from Placer.ai, a startup that tracks and analyzes foot traffic from mobile devices at brick-and-mortar retailers. The data revealed that consumers continue trading down to 'off-price' stores as elevated inflation and high interest rates financially squeeze low- and mid-tier consumers. 

The team of Goldman analysts, led by Brooke Roach and Evan Dorschner, told clients they updated their "trackers for August store traffic on a visits per venue basis (sourced via Placer.ai) for department stores, off-price, and select specialty retailers and others within our coverage." 

"On balance, traffic trends sequentially improved in August across every retailer we track following weaker results in July," the analysts said. 

However, they pointed out, "Within this, off-price and thrift trends continue to outperform other consumer discretionary retailers, while department store and specialty retail traffic results have been fairly choppy YTD. Athletic brands (lululemon and Nike Factory Store) have underperformed." 

Thrift is in...

What's not in is paying full retail at Lululemon Athletica and Nike stores. 

And we wonder why. 

The big takeaway from the latest earnings season in corporate America is extreme weakness from low/mid-tier consumers. Last month, we noted that earnings call mentions of a "consumer downturn" soared to the highest levels since the financial crisis. Also, "trading down" mentions have surged in recent years as the middle class implodes under failed Bidenomics. The last time this happened was around GFC

Welcome to America under Biden-Harris. The inflation storm has transformed a nation of consumers into Walmart and Dollar General shoppers.

Goldman told clients on July 15 that Walmart had the best grocery deals

https://www.zerohedge.com/markets/goldman-finds-thrift-trends-outperform-amid-consumer-slowdown

The Blair Witch Project: Former UK PM Calls For Global Censorship

 by Jonathan Turley,

In the 1999 cult classic The Blair Witch Project, one character tells his friends “I could help you, but I’d rather stand here and record.” For free speech advocates, we often feel that other citizens have become passive observers as an anti-free speech movement grows around us, threatening our “indispensable right.”

One of the most infamous figures in this movement has been former British Prime Minister Tony Blair, who has long been the smiling face of censorship. As the head of the Labour Party, Blair pushed through some of the early crackdowns on free speech in the United Kingdom. He is now calling for global censorship to expand these efforts.

In an interview on LBC Radio, Blair declared:

The world is going to have to come together and agree on some rules around social media platforms. It’s not just how people can provoke hostility and hatred but I think… the impact on young people particularly when they’ve got access to mobile phones very young and they are reading a whole lot of stuff and receiving a whole lot of stuff that I think is really messing with their minds in a big way.

We recently discussed how the UK is already using recent rioting to crackdown further on those with opposing or “toxic” views.

For years, I have been writing about the decline of free speech in the United Kingdom and the steady stream of arrests.

A man was convicted for sending a tweet while drunk referring to dead soldiers. Another was arrested for an anti-police t-shirt. Another was arrested for calling the Irish boyfriend of his ex-girlfriend a “leprechaun.” Yet another was arrested for singing “Kung Fu Fighting.” A teenager was arrested for protesting outside of a Scientology center with a sign calling the religion a “cult.”

Last year, Nicholas Brock, 52, was convicted of a thought crime in Maidenhead, Berkshire. The neo-Nazi was given a four-year sentence for what the court called his “toxic ideology” based on the contents of the home he shared with his mother in Maidenhead, Berkshire.

While most of us find Brock’s views repellent and hateful, they were confined to his head and his room. Yet, Judge Peter Lodder QC dismissed free speech or free thought concerns with a truly Orwellian statement: “I do not sentence you for your political views, but the extremity of those views informs the assessment of dangerousness.”

Lodder lambasted Brock for holding Nazi and other hateful values:

“[i]t is clear that you are a right-wing extremist, your enthusiasm for this repulsive and toxic ideology is demonstrated by the graphic and racist iconography which you have studied and appeared to share with others…”

Even though Lodder agreed that the defendant was older, had limited mobility, and “there was no evidence of disseminating to others,” he still sent him to prison for holding extremist views.

After the sentencing Detective Chief Superintendent Kath Barnes, Head of Counter Terrorism Policing South East (CTPSE), warned others that he was going to prison because he “showed a clear right-wing ideology with the evidence seized from his possessions during the investigation….We are committed to tackling all forms of toxic ideology which has the potential to threaten public safety and security.”

Blair’s views have been echoed by Speaker of the House Sir Lindsay Hoyle who declared:

Misinformation is dangerous. Social media is good but its also bad when people are using it in a way that could cause a riot, threat, intimidation, suggesting that we should attack somebody, it’s not acceptable. What we’ve got to do is factually correct what’s up there, if not I think the government has to think long and hard about what they are going to do about social media and what are they going to put through parliament as a bill.

“I believe it should be across, it doesn’t matter what country you are in, the fact is that misinformation is dangerous and no misinformation, or threats, or intimidation should be allowed to be carried out on social media platforms.”

As with the effort in Brazil to block X entirely for refusing to censor political opponents of the government, Blair’s call for global censorship is where the movement is going next.

Notably, after Musk purchased Twitter, Hillary Clinton called upon European officials to force him to censor American citizens under the infamous Digital Services Act (DSA). Recently, Democratic leaders like Minnesota Attorney General Keith Ellison praised Brazil for its action to prevent citizens from having access to unfettered news sources.

Interviews like the one with Tony Blair are not just meant to intimidate or scare others. They reflect a comprehensive campaign from our political elite to enforce censorship on a national and transnational scale. If you think that this latest Blair Witch Project is just another scary production, you have not been paying attention.

*  *  *

Jonathan Turley is the Shapiro Professor of Public Interest Law at George Washington University and the author of “The Indispensable Right: Free Speech in an Age of Rage.”

https://www.zerohedge.com/geopolitical/blair-witch-project-former-uk-pm-calls-global-censorship

Instil Bio shares positive on external trial data

 On Monday, Baird maintained its Outperform rating and $32.00 price target for Instil Bio Inc (NASDAQ:TIL), expressing optimism following recent data from an external clinical trial. The trial results, which were presented at the World Conference on Lung Cancer (WCLC) 2024 on Sunday, showcased Akeso/Summit's ivonescimab, a PD-1xVEGF bispecific antibody, demonstrating a significant progression-free survival (PFS) benefit in the first-line treatment of non-small cell lung cancer (NSCLC).


The HARMONi-2 trial data revealed that patients treated with ivonescimab experienced a median PFS of 11.1 months, compared to 5.8 months for those treated with Keytruda, resulting in a hazard ratio (HR) of 0.51 and a p-value of less than 0.0001. This robust PFS benefit is expected to generate increased investor interest in the PD-1/L1xVEGF class of medications.


Baird's outlook for Instil Bio is buoyed by the anticipation that the positive reception of ivonescimab's trial outcomes will extend to Instil's own SYN-2510, a PD-L1xVEGF bispecific antibody. The firm suggests that the positive data from the trial could lead to heightened enthusiasm for this category of treatments, which would benefit Instil Bio, especially considering the current valuation gap between Instil and Summit.


Instil Bio's SYN-2510 is part of a similar class of drugs as Akeso/Summit's ivonescimab, and the positive results from the ivonescimab trial are seen as a good sign for Instil's product. The firm believes that the success of ivonescimab could hint at a promising future for Instil's SYN-2510 in treating NSCLC.


The maintained price target reflects Baird's continued confidence in Instil Bio's stock performance, as the market processes the implications of the recent clinical data and its potential read-through to Instil's pipeline. As the market evaluates this new information, Instil Bio's share value is anticipated to reflect the positive outlook for its PD-L1xVEGF bispecific antibody, SYN-2510.

https://www.investing.com/news/company-news/instil-bio-shares-positive-on-external-trial-data-baird-maintains-price-target-93CH-3606947