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Wednesday, January 17, 2024

Instil in strategic reorg

 Instil has entered into an agreement with a collaborator that has a successful track record of manufacturing and dosing patients with cell therapies to conduct preclinical manufacturing feasibility studies in the ITIL-306 program. The feasibility studies have been initiated, and if the feasibility studies are successful, Instil’s collaborator may open an investigator-initiated clinical trial (IIT) to enroll patients with non-small cell lung cancer (NSCLC) in China. In the event the IIT generates compelling proof-of-concept clinical data in 2024, Instil may explore options for a potential transition of ITIL-306 to a US-based CDMO for manufacturing and clinical development primarily at US clinical trial sites.

With the objective of saving costs and improving time efficiency, the Company is announcing the closure of its UK manufacturing and clinical operations, thereby reducing its UK workforce which is expected to be substantially completed by the first half of 2024. Instil plans to retain key process development, research, and related personnel to advance early-stage pipeline development of CoStAR™ and other novel TIL technologies, and to support the company’s collaboration.

https://www.globenewswire.com/news-release/2024/01/16/2809827/0/en/Instil-Bio-Announces-Strategic-Update.html

Biote to Purchase Asteria Health

 biote Corp. (NASDAQ: BTMD) (“Biote” or the “Company”), a leading solutions provider in preventive health care through the delivery of personalized hormone optimization and therapeutic wellness, today announced a definitive agreement to acquire F.H. Investments, Inc., d/b/a Asteria Health, a privately held 503B manufacturer of compounded bioidentical hormones. The company operates an FDA-registered 503B outsourcing facility in Birmingham, Alabama and currently supports Biote-certified practitioners and Biote-partnered clinics in numerous U.S. states.

Through this transaction, Biote is strengthening the Company’s control over its supply chain and enhancing efficiency. Additionally, Asteria Health provides Biote with expertise in 503B manufacturing, enabling longer-term development of innovative therapeutic wellness products. Biote plans to phase in manufacturing from Asteria Health. Because Asteria Health is currently a supplier to Biote-certified practitioners, there is expected to be minimal near-term revenue impact to Biote from the transaction.

https://www.businesswire.com/news/home/20240117486263/en/

Taro Announces Merger Agreement with Sun Pharma

 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (together with its subsidiaries and/or associates referred as "Sun Pharma") and Taro Pharmaceutical Industries Ltd. (NYSE: TARO) ("Taro" or the "Company") today announced that they have entered into a definitive merger agreement in which Sun Pharma, Taro's controlling shareholder, has agreed to acquire all of the outstanding ordinary shares of Taro other than the shares already held by Sun Pharma or its affiliates for US$43.00 per share in cash without interest.

https://www.prnewswire.com/news-releases/taro-announces-merger-agreement-with-sun-pharma-302037499.html

Autoimmune disease biotech Kyverna Therapeutics files for a $100 million IPO

 Kyverna Therapeutics, a Phase 2-ready biotech developing cell therapies for autoimmune diseases, filed on Tuesday with the SEC to raise up to $100 million in an initial public offering.


Kyverna Therapeutics is focused on developing cell therapies for patients suffering from autoimmune diseases. Its lead program is KYV-101, an autologous CD19 CAR T-cell therapy made from an underlying chimeric antigen receptor licensed from the National Institutes of Health that previously completed a Phase 1 trial in oncology. Kyverna is developing KYV-101 across two broad areas of autoimmune disease: rheumatology and neurology. Its initial rheumatology development focus is on lupus nephritis (LN) and systemic sclerosis (SSc). The company plans to conduct two trials of KYV-101 in patients with LN, and has also received IND clearance for a Phase 1/2 study in SSc. In neurology, Kyverna is focused on myasthenia gravis (MG) and multiple sclerosis (MS), and it has received IND clearance for Phase 2 studies in both diseases.

The Emeryville, CA-based company was founded in 2018 and plans to list on the Nasdaq under the symbol KYTX. Kyverna Therapeutics filed confidentially on October 5, 2023. J.P. Morgan, Morgan Stanley, Leerink Partners, and Wells Fargo Securities are the joint bookrunners on the deal. No pricing terms were disclosed.

Milei Warns Of DEI Doom, As Dimon Touts Trump On 'Critical Issues'

 Argentina's President Javier Milei had a warning for those attending the annual WEF meeting in Davos, Switzerland; 'the Western world is in danger' from 'collectivist experiments' such as Diversity, Equity and Inclusion (DEI), and has called on the world to reject socialism and instead embrace "free enterprise capitalism" to end global poverty.

Fabrice Coffrini | Afp | Getty Images

"Today, I’m here to tell you that the Western world is in danger," Milei toild the audience. "And it is in danger because those who are supposed to have to defend the values of the West are co-opted by a vision of the world that inexorably leads to socialism, and thereby to poverty," he added.

The self-described "anarcho-capitalist" criticized Davos itself for its "socialist agenda, which will only bring misery to the world," according to Reuters.

"The main leaders of the Western world have abandoned the model of freedom for different versions of what we call collectivism. We’re here to tell you that collectivist experiments are never the solution to the problems that afflict the citizens of the world — rather they are the root cause," Milei said, adding "Do believe me, no-one [is] better placed than us Argentines to testify to these two points."

Dimon: Trump was right

Also at Davos, of course, was JPMorgan CEO Jamie Dimon, who told CNBC that people are voting for Donald Trump because he was right about the economy, immigration, and China, and that people should be respectful of MAGA.

"I don't like how Trump said things, but he wasn't wrong about those critical issues. That's why they're voting for him. People should be more respectful of our fellow citizens...I think this negative talk about MAGA will hurt Biden's campaign," said the billionaire.

Watch:

We're sure Davos elites are listening with bated breath.

https://www.zerohedge.com/geopolitical/western-world-danger-milei-warns-dei-doom-dimon-touts-trump-critical-issues

OpenAI Attempts To Dispel Fears Of AI-Meddling In Elections

 by Savannah Fortis via CoinTelegraph.com,

As 2024 anticipates a global election cycle, OpenAI says it wants to prevent AI misuse, bring transparency, and enhance voter access to accurate voting information.

OpenAI, the creator of the popular chatbot ChatGPT, released a new blog post outlining its approach to the 2024 elections on a global scale. 

Its main emphasis is to bring transparency, enhance access to accurate voting information and prevent the misuse of artificial intelligence (AI).

While highlighting the need to protect the integrity of the collaborative nature of elections, OpenAI wants to make sure its AI service “is not used in a way that could undermine this process.”

The company said protecting the integrity of elections is an effort involving everyone, and it wants to make sure its technology “​​is not used in a way that could undermine this process.”

“We want to make sure that our AI systems are built, deployed, and used safely. Like any new technology, these tools come with benefits and challenges.”

OpenAI says it has a “cross-functional effort” dedicated explicitly to election-related work that will quickly investigate and address potential abuse.

Among these efforts include preventing abuse, which it defines as “misleading deep fakes,” chatbots impersonating candidates or scaled influence operations. It said one of its measures has been implementing guardrails on Dall-E to decline requests for image generation of real people, including political candidates. 

In August 2023, regulators in the United States were even considering regulating political deep fakes and ads generated using AI before the 2024 presidential elections.

Politicians in the U.S. have expressed skepticism that tech companies will be able to rein in their powerful AI systems.

At a congressional hearing in May where OpenAI Chief Executive Sam Altman testified, Sen. Richard Blumenthal (D., Conn.) used a demonstration of his AI-generated voice reading a statement to highlight the risks.

“What if it had provided an endorsement of Ukraine surrendering or Vladimir Putin’s leadership?” he said.

Altman responded to some of the concerns by asserting that OpenAI’s chatbot was “a tool, not a creature,” and “a tool that people have great control over.”

OpenAI said building applications for political campaigning and lobbying is currently not allowed.

Already, a politician running for U.S. Congress already employs AI as a campaign caller to help reach more potential voters.

The AI developer said it’s also working on constantly updating ChatGPT to provide accurate information from real-time news reporting around the globe while directing voters to official voting websites for more information. 

AI’s influence on elections has been a major topic of discussion already, with Microsoft even releasing a report on AI usage on social media having the potential to sway voter sentiment.

Microsoft’s Bing AI chatbot has already been under scrutiny after Europe-based researchers found that it gave misleading election information.

Google has been particularly proactive in its stance regarding AI and elections. In September, it made AI disclosure mandatory in political campaign ads, along with limiting answers to election queries on its Bard AI tool and generative search.

https://www.zerohedge.com/technology/openai-attempts-dispel-fears-ai-meddling-elections

How Moderna Came Up With A Vaccine Against Vaccine Dissent: Lee Fang

 by Lee Fang via RealClear Wire,

Finances at the vaccine manufacturer Moderna began to fall almost as quickly as they had risen, as most Americans resisted getting yet another COVID booster shot. The pharmaceutical company, whose pioneering mRNA vaccine had turned it from small startup to biotech giant worth more than $100 billion in just a few years, reported a third-quarter loss last year of $3.6 billion, as most Americans refused to get another COVID booster shot.

In a September call aimed at shoring up investors, Moderna’s then-chief commercial officer, Arpa Garay, attributed some of the hesitancy pummeling Moderna's numbers to uninformed vaccine skeptics. "Despite some misinformation," Garay said, COVID-19 still drove significant hospitalizations. "It really is a vaccine that's relevant across all age groups,” she insisted.

To get past the “misinformation” and convince the public to take continual booster shots, Garay briefly noted that Moderna was “delving down” on ways to partner “across the ecosystem to make sure consumers are educated on the need for the vaccine.”

What Garay hinted at during the call, but didn’t disclose, was that Moderna already had a sprawling media operation in place aimed at identifying and responding to critics of vaccine policy and the drug industry. A series of internal company reports and communications reviewed by RealClearInvestigations show that Moderna has worked with former law enforcement and public health officials and a drug industry-funded non-governmental organization called The Public Good Projects (PGP) to confront the “root cause of vaccine hesitancy” by rapidly identifying and “shutting down misinformation.”

Part of this effort includes providing talking points to some 45,000 healthcare professionals “on how to respond when vaccine misinformation goes mainstream.” PGP and Moderna have created a new partnership, called the “Infodemic Training Program,” to prepare health care workers to respond to alleged vaccine-related misinformation.

The company has also used artificial intelligence to monitor millions of global online conversations to shape the contours of vaccine-related discussion. The internal files -- shorthanded here as the Moderna Reports -- show high-profile vaccine critics were closely monitored, particularly skeptics in independent media, including Michael Shellenberger, Russell Brand, and Alex Berenson. PGP, which was funded by a $1,275,000 donation from the Biotechnology and Innovation Organization, a lobby group representing Pfizer and Moderna, has identified alleged vaccine misinformation and helped facilitate the removal of content from Twitter, among other social media platforms, throughout 2021 and 2022.

Emails from that period show that PGP routinely sent Excel lists of accounts to amplify on Twitter and others to de-platform, including populist voices such as ZeroHedge.

The messages also suggested emerging narratives to remove from the platform. "People opposed to vaccines are capitalizing on the NYT [New York Times] article about the CDC withholding vaccine information. The articles do not contain misinformation themselves but are using the news to further prove the CDC is untrustworthy," wrote Savannah Knell, PGP's senior director of partnerships, in an email to a Twitter lobbyist in September 2022. In another email the following month, Kaitlyn Krizanic, PGP's senior program manager, told Twitter to be on the lookout for "reports that Sweden is no longer recommending the vaccine for children." In some cases, conservative accounts expressing outrage at restrictive pandemic policies, such as vaccination passports, were deemed by PGP as “misinformation” that warranted removal.

The Moderna Reports consistently show the company raising red flags about those reporting documented side effects of the vaccine the biotech company was selling. Such concerns, which may be typical of corporate public relations efforts that want their product shown in the best light, take on a darker cast when it involves medicine injected into people’s bodies.

Like the Twitter Files, the Moderna Reports highlight the push by powerful entities – especially government, Big Tech, and Big Pharma – to identify and brand dissenting opinions about establishment narratives as risky forms of speech. The growing network these efforts rely on shows the growth of what has been called the censorship industrial complex. Moderna’s faltering financials also suggest, at least for now, the limits of that project.

Public Good Projects and Moderna did not respond to repeated requests for comment.

Related: Moderna Is Spying on You by Lee Fang and Jack Poulson

In an internal email sent last July, Moderna notified its team of its latest efforts to shape the vaccine debate. “We have partnered with PGP (The Public Good Projects) and Moderna's Global Intelligence, Corporate Security, Medical Affairs, Corporate Communications, Clinical Safety and Pharmacovigilance teams to provide media monitoring for misinformation at scale,” Marcy Rudowitz, the company's customer program lead, wrote. “If and when a response is needed, our team will notify the appropriate stakeholders with recommendations,” she added.

The extent to which the company may intervene to shape content decisions is not clear. PGP continues to boast close relations with establishment institutions, including major medical associations. 

The rise of censorship is inextricably connected to the pandemic, which emerged in the U.S. in early 2020. As federal, state, and local governments imposed unprecedented regulations on Americans in the name of public health, efforts arose to discredit counter-narratives that could be spread easily on social media. Early in the pandemic, criticism of policies such as lockdowns and vaccine mandates came almost entirely from independent media, which faced shadowbans and outright censorship on various platforms.

When they introduced their vaccines in 2021, manufacturers such as Moderna, Pfizer, and Johnson & Johnson also had a powerful financial interest in bolstering such censorship.

Moderna, perhaps more than other drug firms, is overwhelmingly reliant on the continued success of its vaccine. The company announced a price hike of up to $130 a dose this month, far higher than the $15-26 for American federal contracts, according to the Wall Street Journal. “We’re expecting a 90% reduction in demand,” Modena CEO Stéphane Bancel said, when he was asked to defend the decision. “As you can see, we’re losing economies of scale.”

Far from acting as a neutral arbiter, the Moderna Reports show that the company blurred the lines between public relations and public health. In many cases, Moderna’s intelligence and communications team targeted accurate information that had “the potential to fuel vaccine hesitancy” as menacing forms of misinformation in its reports. Given the size and scope and the censorship industrial complex, it can be difficult to draw a clear straight line between Moderna’s surveillance and actions taken against specific articles, posts, and writers. Instead, as Garay suggested, the company is one stream in an evolving ecosystem aimed at undermining dissent.

Alex Berenson

Independent journalist Alex Berenson is a repeated subject of the company’s surveillance efforts. A former reporter for the New York Times, Berenson quickly emerged as one of the most outspoken critics of vaccine-related policies. He was among the earliest to cast doubt on the Biden administration's false claim that the vaccinated people could not transmit the COVID-19 virus to others. After government pressure on Twitter, Berenson was banned from the platform in 2021, only to return after successfully litigating against the company.

He appears to still be in the crosshairs. In September 2023, Moderna flagged a tweet from Berenson that highlighted the CDC's data showing that among 1 million mRNA-vaccinated teenagers, there were from zero to a single COVID death and up to 200,000 side effects.

The company cited Berenson's tweet under a report headline "Attacks on pediatric COVID-19 vaccines escalate" and claimed he had "cherry-picked data." However, the company did not directly rebut any of Berenson's claims in its report. Rather, Moderna noted the "high-risk" danger of Berenson's viral tweet related to the potential for low child COVID-19 vaccination rates. "Fears about side effects and long-term dangers are major reasons parents report not vaccinating their children," the report stated. It further concluded that "resistance to COVID-19 vaccines for children can be a gateway to broader anti-vaccine beliefs."

Other Moderna reports flag Berenson’s tweets for “misinformation about mRNA safety” and claim that he is a “conspiracy theorist” for suggesting that health authorities have not properly taken into account the documented risks of myocarditis (inflammation of the heart muscle) for young men receiving the vaccine. Such questions have been posed by an increasing number of health professionals, but the misinformation reports dismiss any Berenson criticism as inherently false.

“It's nice to know Moderna is watching me,” said Berenson, when asked about his response to the revelations. “I'm watching them too. mRNA shots carry unacceptably high heart risks for teenagers and young adults. Nearly the entire rest of the world accepts this reality and now discourages or bans people under 50 from taking mRNA Covid boosters. It is unconscionable that Moderna and Pfizer continue to market them to non-elderly adults."

“They can call me whatever they like,” he noted, “but they can't stop my reporting."

Russell Brand

Russell Brand, the British commentator and comedian, is also a repeated name in the Moderna misinformation files. The left-leaning populist routinely pillories the pharmaceutical industry for exploiting the pandemic to generate unprecedented profits.

Moderna has closely monitored Brand’s criticism of the drug industry.

In various “low-risk” reports produced in August 2023, Moderna flagged videos produced by Brand twice. In one, Moderna noted that Brand had broadcast a monologue about Jonathan Van-Tam, a former senior health official who helped formulate COVID-19 policies in Britain. Van-Tam had just taken a position with Moderna, a move that raised eyebrows with many in the press. In the video, Brand noted that the company had just “made a fortune during the pandemic selling vaccines to the government,” and that the “government worker that bought all those vaccines” was now moving through the revolving door.

In another report, Moderna alleged that Brand “claimed that COVID-19 vaccine mandates were based on a lie in a recent podcast episode.” The video was broadly accurate. The monologue highlights CDC documents that had come to light showing that officials were aware that the virus would “break through” and still infect vaccinated patients. In an ironic twist, Brand finished the segment with a discussion of efforts to censor debate around the vaccine.

Moderna noted they were not yet taking action on this broadcast, but “we are monitoring with our partner, the Public Good Projects.”

The following month, several media outlets reported that several women who insisted on anonymity were claiming that Brand had abused them nearly twenty years ago. The ensuing media firestorm, which led to YouTube demonetizing his account, became fodder for other Moderna misinformation reports. The company warned that the cancellation of Brand was sparking a backlash among social media users, who believed that he may be targeted by government and corporate censors for his outspoken opposition to pandemic narratives.

In a Moderna high-risk report, the company noted that speculation was swirling that "allegations are part of a conspiracy to silence the comedian, who has been a vocal opponent of COVID-19 vaccines." The report linked an X video of Brand sharply criticizing Moderna and Pfizer for generating “$1,000 of profit every second" in 2021. The specific claim of profiteering was a mainstream claim, a statistic that was produced by Oxfam.

Nowhere in its reports on Brand did Moderna highlight any incorrect information. But the reports noted that they monitored Brand because he "has a large platform with over 6.6 million YouTube subscribers and over 21 million followers across multiple social media platforms." Moreover, his "videos are widely circulated in anti-vaccine spaces where he is viewed as a truth-teller and threat to authority,” and that Brand maintained support from Tucker Carlson and Elon Musk.

Michael Shellenberger

The Moderna misinformation reporting system reveals that the pharmaceutical firm maintained an interest in pandemic-related issues that go beyond vaccine policy, overlapping with general issues surrounding the unexplained questions that still swirl around the source of the pandemic.

The company, for instance, flagged discussions around news last year of a congressional whistleblower who came forward with allegations that the CIA suppressed an assessment from analysts that COVID-19 originated at the Wuhan Institute of Virology. The story has garnered widespread coverage in NBC, Science, and ABC News, among other outlets.

But Moderna’s misinformation alerts flagged Sen. Rand Paul, R-Ky., and journalist Michael Shellenberger for distributing information about the CIA allegation. Shellenberger – with whom this reporter has worked on the Twitter Files – had exclusively reported earlier last year that U.S. government sources believed that the “patient zeros” of COVID-19 were a group of Chinese scientists at the Wuhan lab – a major revelation later confirmed by the Wall Street Journal.

Despite his work on the issue, Moderna dismisses Shellenberger in its reports as among its known “misinformation authors.”

"Moderna has spent years spreading disinformation about their vaccines and so it makes sense that they would smear the scientists and journalists who expose them as conspiracy theorists and sources of misinformation,” Shellenberger told RCI.

“The question is why is Moderna spreading disinformation on the high probability that Covid escaped from the Wuhan Institute of Virology lab?” he added. “A company that makes its money selling a coronavirus vaccine shouldn't care where Covid came from.”

Others

Moderna closely monitored other independent voices. The company flagged left-wing comedian Jimmy Dore for simply tweeting at a New York Times call for triple-vaccination with the two-word response, “Hard pass,” as an example of misinformation. The company also warned about the appearance of Robert F. Kennedy Jr. on the Joe Rogan podcast as well as Lex Fridman, a popular independent podcaster.

Other reports flag skeptics of vaccine efficiency and potential side effects. In September, Moderna’s system cited Megyn Kelly, the podcaster and former Fox News host, for a viral clip in which she said she regrets the COVID-19 booster after she developed an autoimmune condition that she believes was caused by the shot.

Moderna warned that such comments could "discourage people who are on the fence about getting vaccinated."  In its alert about Kelly, the company noted that her comments added to growing concern around autoimmune disorders and COVID-19 vaccinations. The Moderna misinformation email proceeded to offer data that appeared to reaffirm, rather than debunk, Kelly’s assertions. The alert concluded with a message about an NIH report that highlights a link between SARS-CoV-2 vaccination and inflammatory and autoimmune skin diseases. Moderna did not dispute the findings of the NIH study, but noted that it "is in rotation in anti-vaccine spaces online."

The merging of public health and corporate influence peddling has concerned many academics. Jay Bhattacharya, a professor of health policy at Stanford University who says the government violated his free-speech rights by trying to silence his questioning of federal policies regarding COVID, told RCI: “We have a problem that social media companies and the government have allied with pharma to treat information flows around the COVID vaccine as a propaganda problem, rather than a medical issue that is best resolved by patients talking with their doctor about what's best for them."

Bhattacharya was one of the most prominent academics who was shadowbanned under the previous owners of Twitter because of his criticism of the lockdowns and masking policy. He is now one of the plaintiffs litigating against the U.S. government’s role in shaping content decisions on social media platforms in the Missouri v. Biden case, which is now before the Supreme Court.

Bhattacharya’s outspoken advocacy has attracted attention from Moderna as well. In October 2023, shortly after I spoke to him for an interview, Moderna flagged one of the Stanford professor’s tweets that shared a link to a new Food and Drug Administration preprint study that documented "elevated risk of seizures in toddlers and myocarditis in teenagers associated with covid mRNA vaccination." Moderna did not directly dispute the study findings other than to note that its authors wrote that it “should be interpreted cautiously.”

In the attached report, Moderna added that it had highlighted the tweet and others like it because “concerns about safety and side effects are among the main reasons parents are hesitant about or oppose COVID-19 vaccines for their children.”

In other words, anything that might discourage children from vaccinations, despite any risks or lack of benefits, is dangerous information. That suggests a motive far from bringing truth to the vaccine debate, and far more about dominating it for financial gain.

Near the end of the Moderna call last September, as the biotech firm worked to highlight its stepped-up outreach to consumers, James Mock, the chief financial officer, spoke briefly to assure investors of the company’s ability to continue to make money.

“COVID is a very valuable product line of business and will continue to be,” said Mock, “and we'll make it more profitable.”

https://www.zerohedge.com/political/how-moderna-came-vaccine-against-vaccine-dissent-lee-fang