TheChek News Flow

2024.Sabirnetug is the first humanized monoclonal antibody to demonstrate in patients with early symptomatic AD selective target engagement of AßOs, a soluble and highly toxic form of Aß that accumulates early in AD and is a persistent trigger of synaptic dysfunction and neurodegeneration. Acumen is developing sabirnetug as a potential best-in-class antibody treatment for early symptomatic AD.Comments: “These findings from our Phase 1 study of sabirnetug highlight not only the strength of the study design with participants having early symptomatic AD but also continue to support the potential for sabirnetug as a best-in-class treatment," said Eric Siemers, M.D., Chief Medical Officer of Acumen. “Our research reflects our focus on incorporating the patient voice into drug development, provides further support for the mechanism of action of sabirnetug, and includes developing powerful tools for drug development with an assay that can measure even small amounts of sabirnetug bound to toxic soluble amyloid beta oligomers in patients in our clinical trials. These insights can help us as we advance clinical studies of sabirnetug, including our ongoing Phase 2 study. As recently approved therapies for Alzheimer’s gain traction, we have an opportunity to advance a next-generation treatment that has the potential to optimize the benefit-risk ratio compared to first-generation disease-modifying treatments for AD.”

- INVOKE-2 is the first global Phase 2 trial evaluating the safety and efficacy of a TREM2 agonist, AL002, in slowing disease progression in individuals with early Alzheimer’s disease (AD)

- Baseline characteristics data for the INVOKE-2 study confirm a representative study population that enables testing of the effects of a novel TREM2 agonist in early ADnnounced the presentation of a poster on baseline characteristics for the global INVOKE-2 Phase 2 clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD) at the Alzheimer's Association International Conference® 2024 (AAIC®). The conference is being held online and in Philadelphia, Pennsylvania from July 28 – August 1, 2024.

INVOKE-2 is the first global Phase 2 trial exploring a novel TREM2 agonist, AL002, in early AD. AL002 is an investigational humanized monoclonal antibody (mAb) that binds to triggering receptor expressed on myeloid cells 2 (TREM2), and it is the most advanced TREM2 agonist product candidate in clinical trials. The candidate is being developed in collaboration with AbbVie.Baseline characteristics are important in Phase 2 trials because they ensure the reliability and interpretability of trial results, help manage patient safety, and facilitate appropriate statistical analyses. A total of 381 participants were randomized in INVOKE-2. The median age of participants was 71 years (range: 51-85 years), with 78% of participants 65 years of age or older. Overall, 50% of participants were female and 94% were Caucasian. The clinical diagnosis at enrollment was mild cognitive impairment due to AD for 67% of participants and mild dementia due to AD for 33% of participants.Treatment-emergent brain MRI changes resembling amyloid-related imaging abnormalities (ARIA) have been observed in the trial. These changes were of greater incidence and severity in homozygous APOE e4 carriers, and the company chose to discontinue homozygous APOE e4 carriers early in the trial. Of the 381 enrolled participants, 59% were heterozygous APOE e4 carriers. Amyloid positivity was confirmed in all participants prior to enrollment by analysis of cerebrospinal fluid or amyloid PET (Positron Emission Tomography). For those participants (n=244) with amyloid PET assessed at baseline, the mean standard deviation (SD) in centiloids was 100.1 (38.9).

Additional details will be presented during the poster presentation, “Baseline Characteristics for INVOKE-2: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating AL002 in Early Alzheimer’s Disease” (#95594) on Sunday, July 28, 2024, from 8:00 a.m. – 4:15 p.m. ET at AAIC®.A Phase 1 study of AL002 demonstrated dose-dependent target engagement and dose-dependent effects on microglial signaling biomarkers, and the treatment was well-tolerated in healthy volunteers at multiple doses.

Results of the INVOKE-2 trial are expected in the fourth quarter of 2024, and the long-term extension (LTE) study is ongoing for those who completed the planned treatment period. Thus far, nearly all eligible participants have rolled over into the LTE study, which will facilitate better understanding of the long-term effects of AL002.

The luxury sector is going to be profoundly transformed by the adoption of ultra-powerful computer systems that use artificial intelligence (AI) for every step of the value chain.

From the initial creative process to producing and managing stock, AI will be everywhere. Luxury brands – like governments – are investing massively in this technology because they know that if they don’t, they will lose the race and battle for supremacy.

AI helps you win time, reduce costs and produce quantities for which you have a pretty good idea of what the demand for them is. In the luxury business, AI does mainly a few concrete things: it frees humans from tedious tasks, it helps make predictions about prices, market trends and turnover. It also generates texts, images, sounds and videos. The latter is called generative AI.

Already many people use generative AI for composing mood boards, creating collections, photos and videos and music for ad campaigns that will be posted on Instagram, TikTok, other social networks and billboards, or printed in glossy magazines.

The only catch with generative AI is that whatever it creates is not protected by intellectual property (IP) rights.Creations by computers are not creations of the mind, and therefore not protected by IP rights.There has to be an author, some human being behind it.

“What is created by AI cannot be IP protected,” explains Zeeger Vink,former president of the International Trademark Association and now Intellectual Property Director of the Swiss group MF Brands (Lacoste, The Kooples, Aigle) controlled by the Maus and Nordmann families.

“Some courts have accepted that there may be so many different human-led prompts that in fact the creation is with human assistance. But it creates a legal loophole, as you need to keep track who is creating what with AI,” Vink explains.

Vink argues that one of the problems with AI creations is that they can and will be copied. It may be acceptable for a small capsule collection, but it will not work for a bigger business, he believes.

THE KOOPLES

The fashion brand The Kooples has just produced a small capsule collection of eight pieces created by AI. It was helped by imki, a French company that provides brands with AI solutions that speed up the creative process and the production of a prototype. The collection, which includes items such as a jacket and a skirt, will be in stores at the end of September. It’s not clear yet if the brand will communicate or not about the fact that these new products were designed with the assistance of AI. The brand’s CEO Anne-Laure Couplet was not available for comment.

Raul Cruz Bonilla, EMEA Vice-Presidident of imki, argues that the designs his company helped create with AI do belong to The Kooples. They use the company’s proprietary database of images, fabrics and colors that were “tagged” or identified by its graphic processing unit (GPU) so that the machine can exploit them using AI. “Driven by their DNA, brands integrate their codes, their identifying product attributes, and the foundations of their brand” into a GPU which then uses them to create new products, imki explains on its website.

Just this week,Cruz Bonilla said, imki delivered to some of its clients the first web app that allows them to use their own graphic processor unit to make prompts in a highly securized digital environment and be autonomous in the creative process. “These images will belong to them since they created them with their own proprietary data,” he argued. Prompting means giving specific instructions to the system on what it is to generate.

More and more brands were digitalizing their design heritage (such as images) and other forms of data that belongs to them on secured servers, he said. This data can in turn be used by AI systems, analyzed and potentially be used to create new content.

At the Paris technology fair VivaTech in May, Cruz Bonilla showed how imki was able to create a collection in 21 days, from the moment the concept was decided to the reception of a prototype that met production specifications. “This is an incredible gain of time in making products arrive on the market,” he told Miss Tweed. “By bringing the product closer to demand, we reduce the risk of unsold, overstocked and wasted products.” Cruz Bonilla was one of the keynote speakers at Miss Tweed’s “Luxury at the Summit” event in Val d’Isère in April.

PANDORA’S BOX

Pierre Diringer, who works as a freelance creative director, argues that AI helps designers widen the scope of their creativity and test new ideas. It also automates repetitive tasks. However, it also has a dark side. “I see AI like a Pandora’s box,” Diringer told Miss Tweed. “Once people get used to the incredible gains of time and efficiency thanks to AI, they will not go back,” he predicted. Already many creatives are panicking about the arrival of IA. You no longer need photographers, film production and post-production people. You also don’t need to travel far away to get images of spectacular landscapes that can be generated by a computer. “I think AI is a real revolution and it’s going to completely overhaul the creative industries,” predicts Diringer.

Already, some creative agencies are seeing some clients warning them that they are planning to reduce the budget they were going to allocate to a given project. They know that AI will be used and therefore fewer highly qualified human hours will be required. “It’s a bit of a worrying trend,” one manager from a major Paris-based creative agency said.

BULGARI

Some luxury executives like Bulgari CEO Jean-Christophe Babin have been testing AI applications to check out how they work and see how people react to them. In May, Babin posted on his own Instagram account a series of beautiful women in stunning jewelry, with idealistic scenes of Rome in the background.“I wanted to personally test AI to see how it works,” Babin said. “For me it helps you materialize your dreams.”

However, the public’s response to these AI-generated images published on his personal Instagram account was mixed. Some thought it was great, others were shocked by the exercise.

AI is great for back-office functions, analyzing data and other things consumers do not see. But when it comes to what people call “consumer-facing” things such as design and advertising, where is the limit? European legislation forces brands to say “generated with AI” on any creation they produce, sell and post publicly. Brands cannot fool consumers on that front.

Luxury products command high prices because they are supposed to be of high quality, made by humans and created by humans. Will something created and produced by a robot make people dream as much as something that is designed by a human spirit and made by hand? It’s a question worth asking.

The answer is probably “no.” This debate is similar to the one regarding lab-created diamonds versus natural ones. The former, which took millions of years to form, will always make people dream more than a diamond that came out of a powerful furnace, some people argue. There is also a debate about whether lab-made diamonds better preserve the environment than their natural counterparts considering the vast amounts of energy they use.

Stéphane Galienni sees a bright future for AI in the luxury world. He will publish a book in September in French Luxe et Intelligence Artificielle: Opportunités et Révolution des usages (Dunod).

He argues that AI not only helps win time but also tests consumers’ appetite for certain products. For example, brands can put up on their website a product that was designed by AI but has not yet produced and tell them that If they want it, they can buy it, and it will be shipped to them in a few months’ time when it’s ready. Spanish brand Desigual already does that, he says. “This helps create desirability,” Galienni argues.

Computers make choices based on statistics. Hence, they are devoid of any judgment of whether their creations can be offensive or shocking to certain people.

Some brands have already paid the price for letting computers produce images that people found terrible. The French handbag brand Lancel recently displayed a campaign featuring surreal images of a cyclist carrying piles of suitcases on the back of his bike. He was dressed in red, as if he worked for Cartier, and thus was misappropriating the jeweler’s brand’s codes.

Lancel boasted that it had only spent six hours on generating the images. Is that going to make consumers dream? Probably not. Galienni produces avatars and images for luxury brands which they use for their social media. Since they need to generate new images all the time, it is a low-cost and speedy solution for them, he says. Galienni also sees growing demand from brands to train their staff to use AI.

Not all campaigns backfire like Lancel’s. The private champagne brand Taittinger and the fashion label Jacquemus have been putting images that people found fun to watch and gave life to the brand.

Most luxury groups such as LVMH, Kering and Richemont have already invested vast amounts in AI to remain competitive. Microsoft already works with LVMH to help the group develop its own internal AI systems. LVMH’s Louis Vuitton has long used AI to manage supply chains, track demand for products and also design sneakers. Dior has a system called Astra using AI to monitor everything that happens with the brand online, from complaints on social media to problems with its e-commerce website.

Jonathan Siboni, CEO of data analysis firm Luxurynsight, uses AI to predict price fluctuations and help brands predict what sales a given boutique should be generating. That latter task not only takes into account its historical performance but also where it is located and the profile of people living or shopping in that area. This helps executives decide whether or not they should keep a given boutique open or closed it if it’s performing badly. If the revenue of a boutique is particularly high, it may also mean that it is selling stock abroad through unofficial channels, called the “grey market.” This is particularly true for stores in touristic areas.

“For me, AI helps people validate or contradict managers’ instincts,” Siboni said. “Actually, most successful people in luxury use AI and have strong instincts.” In light of the high stakes in profitability and sales, using AI to leverage data helps luxury executives make better informed decisions, he argued.

“AI also helps you take more risks and try out new things, because you have data that tells you how to maximize opportunity.”

AI is like the Internet. Only those luxury brands that have adopted it fast and well will win the race.

Ford, GM, Tesla see their stocks fall amid mounting signs of near-term pressure on profits

Automakers are warning of profit pressures in their traditional car businesses, a fresh worry that adds to the challenges already posed by the industry’s costly transition to electric vehicles.

Ford Motor, Tesla and Jeep-maker Stellantis last week saw their share prices hammered after posting results that fell short of Wall Street’s expectations. General Motors beat estimates and raised its full-year profit outlook, but its shares also sank.

Reasons for the pressure on profits ranged from warranty expenses and bloated vehicle inventory to trouble in overseas operations. Taken together, they signaled to investors that carmakers—while pushing toward a transformation to tech-infused electric vehicles—are facing speed bumps.

One particular concern among auto investors has grown louder: The strong pricing power that carmakers have enjoyed in the pandemic era is slowly fading. Several auto executives warned that in the second half of the year, they expect the average price paid by customers will edge lower.

“The results of our competitors are not demonstrating that price pressure is going to vanish,” said Carlos Tavares, chief executive of Stellantis STLA -2.38%decrease; red down pointing triangle, which also makes Ram vehicles.

Car companies for years have made the case that they are ready to become technology companies, with plans to transform cars into battery-powered smartphones on wheels. Those ambitions, coupled with an unprecedented run of profitability fueled by stout pricing, lifted stocks.

Wall Street’s enthusiasm for that vision has faded, as U.S. electric-vehicle demand hasn’t taken off as expected. Now, with signs that pricing is losing steam as the American car buyer grapples with high interest rates, investors are looking for reasons to stick around.

“The overarching feeling for the auto industry is that the good times can’t last,” said Martin French, managing director at auto consulting firm Berylls Strategy Advisors.

Pointing to brighter future

Automotive CEOs tried to persuade Wall Street to look beyond the emerging trouble spots in their current operations to focus on the promise of their future bets.

Tesla TSLA -0.20%decrease; red down pointing triangle last week posted a second straight quarterly profit decline as earnings fell short of analysts’ forecasts, hurt by pricing pressure on EVs, especially in China. Chief Executive Elon Musk reiterated his view that Tesla’s future is tied to autonomous cars and humanoid robots, rather than screwing together cars.

“The value of Tesla overwhelmingly is autonomy,” Musk said in response to a question about whether Tesla’s EV business would be hurt if EV-related tax subsidies in the U.S. were curtailed. “These other things are an annoyance relative to autonomy.”

Tesla’s stock price fell 12% the next day and finished the week down 8%.

Ford badly missed profit forecasts largely because of costs related to safety recalls and other fixes on older models. On a call with analysts, Chief Executive Jim Farley tried to steer the conversation back to Ford’s software for commercial fleets and the company’s plans to develop low-cost EVs.

Wall Street remained fixated on the unexpected profit shortfall, sending shares down 18% the next day, the biggest one-day drop in more than 15 years.

“The market is not ready to give the company credit for these new and exciting projects,” Morgan Stanley analyst Adam Jonas said.

Automakers have touted bold makeovers before, only to see their visions fade and return to their industrial, low-margin roots. Many automakers invested heavily in driverless cars and vehicle-sharing ventures in the mid-2010s, for example, only to unwind those projects after they hit technical hurdles or the business case didn’t materialize.

Executives from the traditional automakers say they aren’t abandoning their push into electrics, although some continue to curtail investments in new factories and EV models. Government crackdowns on tailpipe emissions and the expanding threat from Tesla and Chinese EV makers are creating a sense of urgency.

Those massive investments are pressuring legacy carmakers to wring every penny from their traditional combustion-engine businesses. The record sums American shoppers have been paying in recent years have helped, driven by pandemic-related vehicle shortages that created a seller’s market.

Analysts say that if pricing reverses too much, it will eat into the profits the automakers are counting on to help fund that EV transition.

Last week GM said it expects to spend more on discounts to keep buyers interested, a move that will likely ding its bottom line by about $1 billion in the second half of the year. That was enough to rattle investors, despite GM’s record second-quarter pretax profit of $4.4 billion.

Higher car prices have stuck around longer than many analysts expected, even as the number of vehicles available on dealership lots has rebounded steadily this year. But analysts and auto executives are factoring in more pricing pressure in the months ahead.

Some analysts point to Stellantis’ hefty backlog of Ram pickup trucks and Jeep SUVs. Tavares said the company is considering deals and price adjustments to clear inventory, but also said it might curb vehicle output to tamp down its surplus of cars. Stellantis shares sank 10% over two days following its earnings report.

“Investors are concerned that Stellantis’ elevated inventory could eventually lead to aggressive discounting” that would spill over to GM, Ford and other rivals, Barclays analyst Dan Levy said.

That sort of price battle—once a hallmark of the car business—hasn’t happened since before the pandemic’s onset in early 2020.

Ford’s Farley summed things up this way while explaining the rough quarter to investors: “The remaking of Ford is not without growing pains.”

Foreign ministers say Beijing is ‘greatest strategic challenge’ in Indo-Pacific region

The US and Japan have outlined the most significant upgrade to their joint military alliance since 1960, warning that China’s aggressive posture posed the “greatest strategic challenge” in the Indo-Pacific region and beyond.

The allies want to bolster their security ties to respond to what they view as a growing threat from China. At a bilateral meeting on Sunday, Antony Blinken, Lloyd Austin and their Japanese counterparts, discussed how China employs political, economic and military coercion of countries, companies and civil society, a statement said.

“Such behaviour is a serious concern to the Alliance and the entire international community, and represents the greatest strategic challenge in the Indo-Pacific region and beyond,” said the statement. 

At the start of his meeting with Japanese foreign minister Yoko Kamikawa, Blinken said: “We see the US and Japan side by side in so many places where it matters around the world.”

Central to their agreement, first reported by the Financial Times, is a landmark upgrade to America’s military command structure in Japan, which will involve placing greater operational control in the hands of locally based US leadership.

Co-ordination between the allies had long been hampered because although roughly 50,000 American military personnel are based in Japan, the US Forces Japan (USFJ) lacked command and control authority. Japan has had to deal more with the US Indo-Pacific Command in Hawaii, which is 19 hours behind Tokyo and is 6,500km away. 

The upgrade involves placing a three-star commander and accompanying staff in Japan, according to officials with knowledge of the talks. The USFJ will be reconstituted as a joint force headquarters to allow their militaries to co-operate and plan more seamlessly, particularly in a crisis such as a Taiwan conflict. The three-star commander, who would report to the Indopacom commander, was unlikely to be from the US Navy, one of the officials said.

The details were unveiled three months after President Joe Biden and Japanese Prime Minister Fumio Kishida agreed at a summit in Washington to modernise their alliance structure.

Officials involved on both sides of the preparations for Sunday’s meeting expressed surprise at how quickly the agreement had translated into action, but noted an increasingly fragile regional security situation with instability being created by China, Russia and North Korea.

In the joint statement, the US and Japan also agreed to bolster bilateral training and exercises in Japan’s Southwest islands, which Tokyo calls the Nansei islands, where China has recently increased its naval presence

Central-bank officials meet in the coming week looking ahead to a September rate cut to maximize chances of a soft landing

While Federal Reserve officials aren’t likely to change interest rates in the coming week, their meeting will nonetheless be one of the most consequential in a while.

At each of their four meetings this year, interest-rate cuts have been a question for later. This time, though, inflation and labor-market developments should allow officials to signal a cut is very possible at their next meeting, in September.

As a result, the coming week’s meeting, which wraps up Wednesday, could resolve the trade-off Chair Jerome Powell has been weighing between the risks of cutting rates too soon and waiting too long, in favor of acting sooner.

One reason officials aren’t likely to deliver a cut this time despite the growing case for one is that it would likely be the first reduction in a sequence to recalibrate rates lower. Officials have been surprised by inflation in the past and want more evidence it is truly cooling before crossing the rate-cut threshold.

Nonetheless, officials have grown more wary of waiting too long and blowing a soft landing. Bringing inflation down to the Fed’s 2% goal while maintaining a healthy labor market “is the No. 1 thing that just does keep me awake at night,” Powell told lawmakers this month.

In a recent interview, New York Fed President John Williams signaled that a July reduction wasn’t warranted, saying officials would “learn a lot between July and September” and pointing to solid economic activity recently. But he added that “there is a decision ahead of us at some point to decide” how to “lower interest rates in a way that lessens how restrictive policy is.”

The Fed’s newfound readiness to cut rates reflects three factors: better news on inflation, signs that labor markets are cooling and a changing calculus of the dueling risks of allowing inflation to remain too high and of causing unnecessary economic weakness.

Inflation progress resumes

A measure of underlying inflation that excludes food and energy prices fell to 2.6% in June from 4.3% one year earlier and a peak of 5.6% two years ago. Williams said the decline has been broad based and dismissed concerns that bringing it all the way back to the Fed’s 2% goal would be unusually hard.

“It is not really a story about a ‘last mile’ or some part that’s particularly sticky,” said Williams. Different inflation measures are “all moving in the right direction and doing that pretty consistently.”

Inflation fell last year even though the economy grew solidly because labor- and product-market bottlenecks eased. Powell has repeatedly warned that because price measures lag behind changes in economic conditions, waiting until inflation hits 2% to cut rates means “you’ve probably waited too long.”

A cooler labor market

The unemployment rate has climbed this year to 4.1% in June from 3.7% at the end of last year, largely because hiring has slowed and it is taking new workers or those re-entering the workforce longer to find work. That limits workers’ ability to seek hefty wage gains that might sustain higher inflation.

Powell’s observation recently that the labor market is “not a source of broad inflationary pressures” suggests a major source of anxiety about the potential for an inflation flare-up has receded.

Two years ago, Fed officials argued the labor market was so unbalanced that companies might respond to higher rates and weaker demand by culling job vacancies rather than laying off employees. So far, that is what has transpired.

“Right now, the labor market is in a sweet spot,” said Fed governor Christopher Waller, one of the most vocal advocates of that thesis, in a recent speech. “We need to keep the labor market in this sweet spot.”

The same analysis predicted the labor-market cooling would remain painless for only so long, and at some point, the traditional trade-offs between less demand for labor and higher unemployment would return.

“If you’ve actually come this far along what was considered to be a very, very bold and out of consensus trajectory, then yes, you want to stick the landing,” said Richard Clarida, a former Fed vice chair.

Shifting risk-management calculations

With inflation resuming its progress and the labor market cooling, Fed officials face a shift in the trade-offs they often refer to as risk management, which boils down to which problem—somewhat elevated inflation or rising unemployment—they judge as harder to fix.

The Fed was late to raise interest rates two years ago in part because it had incorrectly judged inflation would subside rapidly. The Fed was able to correct that mistake, but to do so, had to rapidly raise rates from near zero in 2022 to around 5.3% in July 2023, the highest in more than two decades. One lesson: “When you’re too confident that your view is correct, you’re prone to mistakes,” said San Francisco Fed President Mary Daly.

The Fed doesn’t expect demand or hiring to weaken much in coming months, but if it is wrong, it probably won’t be able to cut rates quickly enough to forestall a recession. “If you’re behind on [cutting rates] when the labor market starts to falter, it’s really challenging to get that back on track. It is just not the same thing” as the belated start to rate increases two years ago, said Daly.

Some officials have previewed arguments they will likely use to persuade their colleagues it is time to cut. “We set this rate when inflation was over 4%, and inflation is now, let’s call it, 2.5%. That implies we have tightened a lot since we’ve been holding at this rate,” Chicago Fed President Austan Goolsbee said in an interview. “You only want to stay this restrictive for as long as you have to, and this doesn’t look like an overheating economy to me.”

Still, more policymakers, including Daly, have indicated they think they can take a little more time, underscoring their high-wire balancing act. Even with better inflation data recently, “we’re not at price stability yet,” Daly said at a conference this month. History warns against “pre-emptive action or urgent action when urgency isn’t required,” she said.

Candidate tells bitcoin enthusiasts he would ensure rules were written by people “who love” cryptocurrencies if elected

Donald Trump said he would end the “persecution” of the crypto industry, sack the chair of the Securities and Exchange Commission, and free a convict the community views as a martyr.

In a direct pitch to cryptocurrency devotees at the Bitcoin 2024 conference in Nashville, Tennessee, on Saturday, the Republican candidate promised to end the Biden administration’s “crusade” against bitcoin.

“I pledge to the bitcoin community, that the day I take the oath of office, Joe Biden and Kamala Harris’ anti-crypto crusade will be over,” said Trump.

“On day one, I will fire Gary Gensler,” Trump said to a massive roar from the roughly 5,000 people seated in the audience.

Crypto’s embrace of Trump comes against the backdrop of a difficult few years for the industry, which has faced an aggressive clampdown from the SEC. Crypto is “a field that has been rife with fraud and manipulation”, Gensler said earlier this year.

The SEC has pursued numerous crypto companies and executives, helping put FTX founder Sam Bankman-Fried and Binance founder Changpeng Zhao behind bars, and launched lawsuits against exchanges Coinbase, Kraken and Gemini, payments provider Ripple Labs and blockchain software company Consensys.

Trump on Saturday promised to end the “repression”, saying rules should be “written by people who love your industry, not by people who hate your industry”.

He also said he would instruct the Department of Treasury to abandon the creation of a central bank digital currency, and appoint a bitcoin and crypto advisory council.

The pitch was a dramatic reversal for Trump, who has previously claimed the value of cryptocurrencies was “based on thin air”, calling it “potentially a disaster waiting to happen.” He has described bitcoin as “a scam”.

But now both presidential candidates are courting the vote of ‘crypto bros’. Members of Kamala Harris’ campaign have met with people close to crypto companies in recent days in a bid to “reset” a relationship which soured during the Biden administration.

Trump, meanwhile, is the first major party candidate to accept donations in cryptocurrencies — and claimed on Saturday his campaign had raised $25mn in crypto donations. His running mate, JD Vance, at one point owned up to $250,000 in bitcoin in a Coinbase account, according to his 2022 financial disclosure form.

The support for Trump was obvious all over the conference centre. Trumpers in branded gear sporting “Make Money Great Again” slogans mixed with attendees in Satoshi T-shirts, orange cowboy hats, dresses and high heels. Trump spoke on “Nakamoto” stage,” in reference to Satoshi, the pseudonymous developer of bitcoin.

Some attendees wore T-shirts calling to free Ross Ulbricht, who was given a life sentence in 2015 for creating the online black market Silk Road, by voting for Trump. The GOP presidential nominee’s promise to commute his sentence caused the second biggest cheer of the speech, after the call to fire Gensler.

“They slander you as criminals but that happened to me, too, because I said the election was rigged,” said Trump.

Earlier at the conference, Cantor Fitzgerald CEO Howard Lutnick, who has given pro-Trump Pacs over $1.4mn this election cycle and will host a fundraiser for the ex-president next month, announced an initial $2bn lending program financing bitcoin. He added that his firm owns a “shitload of bitcoin”.

Some attendees said that Trump’s presence alone could flip their vote, hoping that they will have for the first time an ally in the White House.

Investor and attendee Nick Smith said he did not vote for Trump in 2020 but would choose him today over Harris.

“I think they like his F-U attitude towards the establishment,” said Smith of Trump fans.

The price of bitcoin has jumped 10 per cent to over $68,000 since Trump survived an assassination attempt on July 13. “I’m plugging for bitcoin to go over 70 — and even higher when the president speaks,” said David McIntosh, President of the Club for Growth, who is a Trump ally.

“Trump is a businessman and an entrepreneur — and he sees the opportunity that bitcoin affords the US and himself,” conference chief of staff Brandon Green said. “Over the past four years, you’ve seen a very hostile [Biden-Harris] administration towards the industry.”

“Bitcoin is on the ballot,” Green later said on stage.

At the conference on Friday, independent presidential candidate Robert F. Kennedy Jr promised to direct the US Treasury to buy 4mn bitcoins, make transactions between the digital currency and the dollar “unreportable” and “nontaxable.”

Among the guest speakers was Edward Snowden, the former National Security Agency contractor who leaked a tremendous amount of information about US government surveillance. He told the crowd: “Cast a vote, but don’t join a cult.”

North Carolina Democratic lawmaker Wiley Nickel called for Harris to lead a party “reset” on crypto. Nickel, Ro Khanna and other Democrats in Congress sent a letter to the Democratic National Committee on Saturday calling for the next administration to “select a pro-innovation SEC chair”. He got a smattering of applause — but then was shouted down when he read on stage past Trump tweets critical of cryptocurrencies.

“I want to say this as politely and respectfully as I can. Donald Trump was president for four years. He did nothing on this issue,” said Nickel. “Right now, I can tell you: He is totally full of shit.”

The hunt for a rare nuclear isotope that could redefine cancer care

Extreme shortages of actinium are holding up the promising field of radiopharmaceuticals

Shortages of rare nuclear isotopes that rapidly shrink tumours threaten to undermine the development of breakthrough treatments in which health companies have invested billions of dollars, experts in the nascent radiopharmaceuticals field have warned.

By combining a nuclear isotope with an antibody, the microscopic drugs — also known as radioligands — deliver a toxic payload directly to cancer cells. But actinium-225, the most common isotope used in the experimental treatment, whose decaying protons and neutrons emit powerful “alpha” radiation, is in increasingly low supply.

Reliant largely on dwindling supplies from Soviet and American cold war-era stockpiles of precursor radioactive materials, companies have struggled to obtain enough actinium to treat the thousands of patients being enrolled in clinical trials.

But they are betting that this highly targeted form of radiotherapy could become the next big innovation in cancer care if they overcome these supply chain challenges. With half of all cancer patients receiving traditional radiation therapy, radioligands have the potential to offer a more powerful treatment with fewer side effects to millions of patients.

Jeff Legos, global head of oncology at Novartis, said radiopharmaceuticals could become “a mainstream therapy” tackling the “big traditional cancers”, which make the disease the leading cause of death worldwide. Morgan Stanley analysts predict the radiopharma market will be worth $39bn in sales by 2032, up from $7bn in 2022.

The rollout of Novartis’ Pluvicto drug, which became its second approved radiopharma treatment in 2022 and is mainly being used to target prostate cancer, was hampered by shortages of lutetium, another isotope. While those issues have now been resolved, the industry is facing other bottlenecks — especially with actinium-225.

As actinium-225 is not naturally occurring, medical suppliers are having to hunt far and wide for starting materials from which they can extract the isotope.

British start-up PanMediso approached the UK’s Nuclear Decommissioning Authority about gaining access to decommissioned nuclear submarines as a source of radium-226, a precursor for actinium-225, but the talks fell through, according to people briefed on discussions.

Radiopharma biotech RayzeBio, which was acquired by Bristol Myers Squibb for $4.1bn this year, was forced to pause patient enrolment in a late-stage trial of an actinium-based cancer drug for several months before restarting this month.

Actinium’s “big cannonball punch” of radiation and a 10-day half-life, meaning its radio waves are quickly cleared from the body, made it the ideal cancer treatment, said Chris Levesque, chief executive of TerraPower, the Bill Gates-backed nuclear engineering company, which started commercial production of the isotope this year. “Nature couldn’t have planned it better.”

The rush for actinium-225 starting materials has disrupted the market. In 2019 Eckert & Ziegler, a German isotope supplier, tried to pay a nuclear waste company to dispose of radium, but the parties could not agree on a price, according to people close to the company.

A gramme of radium can create 1 curie — a measure of radioactivity named after pioneering French chemist Marie Curie — of actinium which can treat about 1,000 patients. That could be worth up to $10mn now, the people said.

“Companies would pay anything to get hold of actinium starting materials, but there are no willing sellers, everyone is hoarding what they have,” said John Carney, chief executive of Itheranostics, which advises pharma groups on nuclear medicine supply. Bristol Myers Squibb, AstraZeneca and Eli Lilly have spent nearly $8bn between them in the past year on acquiring biotechs with lead drugs based on actinium-225.

Industry estimates suggest there are no more than 2 curies of actinium-225 available each year worldwide. Actinium-225 for clinical trials is either sourced from Russia’s state-owned nuclear agency Rosatom or from dwindling US energy department reserves of thorium-229, which can be used to create actinium-225 in its decay process. Medical materials are exempt from the sanctions regime imposed on Russia after its invasion of Ukraine.

But these supplies are running out and now pharma groups are looking elsewhere for starting materials — and even exploring alternative isotopes, such as Lead-212.

“While actinium production methods are very well characterised, it never needed to be done at a large scale until today,” said Aryeh Sand, an investment banker at Solomon Partners who has advised on more than 10 radiopharma deals. “We have to now scale up those activities. Isotope production even with less complex starting materials is just tough, it’s not for the faint of heart.”

Most of Eckhert & Ziegler’s radium-226 supplies come from disused brachytherapy equipment — a rudimentary form of cancer treatment pioneered by Curie which involved injecting radioactive materials directly into a patient’s body. The company then uses a particle accelerator known as a cyclotron to blast the isotope with a proton beam to transform it into actinium-225.

Jay Simon, Eckhert & Ziegler’s chief operating officer, said the company had been approached by many pharma and biotech groups but it had been cautious about committing to new supply agreements until it was “more definite” about the speed at which it could deliver.

Levesque expected TerraPower would be able to produce enough actinium for 500,000 radioligand doses a year by 2030, but he said that “isn’t really enough” for a market that could eventually treat more than 50 types of cancer. TerraPower extracts actinium-225 from decaying thorium-229, which it purchased from the US government.

The intense procurement focus on actinium-225 — long heralded by researchers as the ideal isotope to attack cancer cells — means it could still become the go-to material to drive the radiopharma revolution, Levesque said.

But If supplies of actinium-225 cannot be swiftly increased, some predict a rush to other materials such as lead-212, which releases “beta” radiation that is less powerful but causes fewer side-effects.

“It’s very possible that companies will start to see the merits of lead-212 both in terms of supply chains and toxicity, as it deposits more of the isotope in the tumour,” said Itheranostics’ Carney.

“There is an alternative to actinium if pharma decides to push that button.”