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Tuesday, June 9, 2026
Moderna jab on trial for cancer-causing syndrome
Moderna and the University of Oxford in the UK have been cleared to start human trials of what could be the first targeted treatment for Lynch syndrome, an inherited genetic condition that increases the lifetime risk of developing several types of cancer.
The phase 1/2 INTERCEPT-Lynch trial of Moderna's mRNA-based vaccine candidate mRNA-4194 will soon get underway at two of Oxford University's clinical trial units, with the first patients due to be dosed in the coming weeks. The phase 2 portion of the study, which will provide preliminary efficacy data, will follow in 2027 and involves several centres across the UK.
It is estimated that 1 in 400 people in England have Lynch syndrome (equivalent to around 175,000 people), but just 5% are aware they are living with the condition, which carries a lifetime cancer risk of up to 80%.
It is caused by alterations in genes responsible for repairing DNA, leading cells to accumulate DNA errors that can lead to cancer, and is the most common hereditary predisposition condition, raising the risk of several solid tumours, including colorectal, endometrial, ovarian, stomach, and prostate cancers.
At the moment, patients with Lynch have few treatment options other than surveillance to try to spot the signs of cancer early, low-dose aspirin for prevention, and surgery for prevention or where tumours have developed.
mRNA-4194 is drawing on Moderna's cancer vaccine platform, headed by melanoma candidate intismeran autogene (mRNA-4157), which reduced the risk of cancer recurrence and death by 49% when added to immunotherapy with MSD's Keytruda (pembrolizumab) in new, five-year data from the KEYNOTE-942 study, which were reported at this year's ASCO congress.
The Lynch syndrome vaccine is designed to generate immune responses against several molecular targets associated with pre-cancerous cells, with the aim of preventing cancer from taking hold in the first place. This initial trial will assess its safety and immunogenicity, and help select a dose for further testing, assuming the results are positive.
"People with Lynch syndrome live with a very high risk of developing cancer, often at a younger age than the general population," said Prof David Church of the University of Oxford's Centre for Human Genetics, who is the lead investigator in the trial.
"The INTERCEPT-Lynch trial represents a meaningful step in our efforts to prevent Lynch syndrome-associated cancers before they develop," he added.
Moderna has a close connection with the UK, and the new study is part of a 10-year partnership between the company and the UK government, which aims to strengthen the country's mRNA capabilities and pandemic preparedness and saw the opening of a £150 million ($200 million) vaccine facility in Harwell, Oxfordshire, last year.
https://pharmaphorum.com/news/moderna-jab-trial-cancer-causing-syndrome
ADA: Kailera ‘back at work’ after record-breaking IPO with China data in hand
After a $625 million IPO, the biggest ever in biotech, obesity-focused Kailera Therapeutics is readying a commercial strategy that puts patients at the center.
Kailera Therapeutics’ bridging study revealed over the weekend at the American Diabates Association Scientific Sessions provided evidence that the biotech’s lead obesity asset worked in a non-Asian population.
It’s a check the box moment, Chief Commercial Officer Jamie Coleman told BioSpace—one that could be seen as a run-of-the-mill update. But Kailera isn’t a run-of-the-mill company.
After exploding onto the scene about two years ago, Kailera headed into ADA fresh off the largest biotech IPO of all time. The company reeled in $625 million in April, enough to fund a pipeline of obesity assets from China’s Jiangsu Hengrui Pharmaceuticals.
“It was clearly a huge success,” said Coleman, who was part of the IPO roadshow team. “We celebrated. It was very exciting. . . . But at the end of the day, now we’re back to work, and we have to do it right.”
That Kailera broke records doesn’t really matter to what comes next, Coleman insisted. “You won’t hear [CEO Ron Renaud] talk about the biggest IPO. You won’t hear us talk about that. I think it’s really an important milestone, and we’re quite proud of it, but that’s not going to define our success.”
An underappreciated market
Coleman’s role at Kailera is a strong signal of what’s to come. She led the launch of Eli Lilly’s Zepbound brand, from the direct-to-consumer LillyDirect platform to making single-dose vials available, before jumping to Kailera in January 2025. She remembers that launch defying expectations at every turn.
“When I was leading Zepbound, to be honest, we didn’t have a lot of foresight at that time. It’s kind of obvious by Novo’s challenges, Lily’s challenges with supply and otherwise, that the opportunity was a bit under underappreciated,” Coleman said.
Underappreciated indeed. With both Novo and Lilly initially struggling to meet the unprecedented demand, compounding manufacturers rose up to serve patients—a problem both companies are still trying to fight.
“Every time we thought something, we were kind of wrong,” Coleman said. “It was always bigger than we thought it could be.”
Coleman arrived at Kailera with lessons learned from that launch, a renewed focus on delivering what patients want and a different kind of mission: build a commercial biotech.
“I’m not going to build Eli Lilly within the walls of Kailera,” Coleman said. “We can certainly think big and think aspirational and then find ways to do it in an efficient way that makes sense for our company.”
And that means finding the right patient segments to target. Like Kailera’s peers in the weight loss space, Coleman will have to contend with a fragmented market that is for now dominated by her alma mater and rival Novo Nordisk.
“The way you solve for fragmentation is finding a place where you can really win, and then you’ve narrowed your competitive set to who else is going after that same patient,” Coleman said.
For Kailera, that means patients seeking greater weight loss, perhaps more than tirzepatide can provide, rather than someone looking to fine-tune their body composition with longer dosing intervals. Kailera’s pipeline has been built out to cover many bases with that underlying theme.
After ADA, Kailera has plenty of data to come, particularly for lead asset ribupatide, a dual agonist of the GLP-1 and GIP receptors. A China-based Phase 2 study from Hengrui with a high dose will read out in 2027. Kailera is looking to take the therapy straight into late-stage global trials, pending the blessing of FDA officials, of course.
Coleman said the Kailera team is pretty confident the regulatory hurdles will be cleared, as “there’s some precedent for that.” And they have confidence in the translatability of the data given the ADA presentation.
In Kailera’s Phase 1 trial, participants of Asian and non-Asian descent received a single dose of injectable ribupatide and were followed for 29 days. Safety and tolerability were similar in both populations, with mostly mild gastrointestinal-related adverse events.
While the trial’s main goal was safety and tolerability, early indicators suggest that body weight was reduced in a dose dependent manner and there was no difference between the two populations. Weight was reduced by 1.4 to 5.5% in the low and high dose groups, respectively, compared to 0.4% for the group that received placebo.
“The bridging study is the first example showing we did not see [pharmacokinetic] differences between the two populations,” Coleman said.
Kailera is testing ribupatide in a global Phase 3 weight loss program called KaiNETIC featuring adults living with obesity or overweight, with key data expected in 2028.
The small biotech experience will be different, but Coleman is excited to work within a more flexible operation that can listen and adapt.
“My job is to figure out how do we leverage our small company mentality to compete with the big guys,” Coleman said. “I’m unlikely to go try to build a 1,500-person sales force like Eli Lilly’s, but I can probably get the bulk of the value through smarter targeting and AI driven approaches.”
ADA: AstraZeneca hands Structure a win with ‘relatively underwhelming’ GLP-1 pill data
AstraZeneca is pushing its small molecule GLP-1 drug to Phase 3 development for weight control, diabetes and other cardiometabolic conditions despite the asset failing to best one from Structure Therapeutics.
AstraZeneca’s GLP-1 pill significantly and meaningfully reduced weight and blood sugar levels in a pair of mid-stage studies—but not enough to sufficiently outperform a key competitor from Structure Therapeutics.
The pharma’s asset, dubbed elecoglipron, showed “promising efficacy” in the Phase 2b VISTA study in patients with overweight or obesity, BMO Capital Markets wrote in a Monday evening note. Indeed, AstraZeneca’s data at the 2026 annual conference of the American Diabetes Association showed a 10.5% average decrease in body weight at 25 weeks, as compared with 0.6% in placebo counterparts.
Elecoglipron also did not show plateauing during the study, with weight reduction increasing further to 11.8% at 36 weeks, while placebo was 0.3%.
Still, BMO called these findings “relatively underwhelming,” especially when compared against Structure’s aleniglipron, which was also on display at ADA with 15.3% placebo-adjusted weight loss at 36 weeks when 120 mg dosing was escalated to 240 mg. A 120-mg dose of aleniglipron resulted in an 11.3% reduction in weight at the same time point.
Elecoglipron and aleniglipron are both orally available small-molecule agonists of GLP-1. There hasn’t yet been a direct head-to-head study comparing the two drugs, and cross-trial comparisons are inconclusive.
AstraZeneca might have a slight edge in terms of safety, according to BMO, but the difference may not be enough to set back Structure. “While rates of nausea and [adverse events] leading to treatment discontinuation are slightly lower, we do not see this difference as particularly meaningful,” the analysts wrote.
Also at ADA, AstraZeneca presented data from the Phase 2b SOLSTICE study, testing elecoglipron in patients with type 2 diabetes. HbA1c, an indicator of blood sugar levels over the past two to three months, dropped 1.9% at 26 weeks versus baseline, versus 0.2% in placebo comparators.
BMO handed AstraZeneca the victory on this front, writing on Monday that elecoglipron’s HbA1c findings “appear slightly improved” versus Eli Lilly’s orforglipron, a similar drug recently approved as Foundayo for obesity. Still, this mild edge “is unlikely to be a material drag” on Lilly’s shares, given the Indiana pharma’s head start, the analysts added.
Kalshi trading in ‘perps’ crosses $1 billion in volume within a week of launch
- Kalshi told CNBC that volumes on its perpetual futures, or “perps,” have crossed $1 billion in trading volume.
- Perps first launched on the platform on Wednesday, and originally saw more than $100 million in trading volumes in 24 hours.
- The asset class was previously not accessible in the U.S., but does $90 trillion in annual global volume.
Prediction market platform Kalshi’s perpetual futures have already crossed $1 billion in trading volume within a week of their launch last week, the company shared exclusively with CNBC.
The company officially launched trading on crypto perpetual futures, or “perps,” on Wednesday, and in the first 24 hours saw more than $100 million in volume. Volumes are notional, which means leverage traders take in their contracts is included in that figure.
Perps are futures contracts with no expiration date that allow traders to speculate on a price without owning the underlying asset. Contracts track the price of an asset continuously, with funding payments keeping the perpetual contract price aligned with the market.
The asset class has over $90 trillion in annual global volume, according to Bank of America, but before Kalshi there wasn’t a way to trade the contracts in the U.S.
(Kalshi CEO Tarek Mansour will make an appearance on CNBC’s “Fast Money” on Tuesday at 5 p.m. ET.)
Kalshi received regulatory approval from the Commodity Futures Trading Commission on May 29 to be the first company in the U.S. to offer perp contracts. Coinbase on the same day also received approval from regulators to offer its U.S. traders access to global perp contracts through an affiliate.
Pent up domestic demand has been reflected on Kalshi since the launch. A spokesperson said that at one point the waitlist to access perps on the platform had more than 1 million people on it, and that it’s the fastest growing product in the company’s history. It took Kalshi 40 months to see $1 billion in trading volumes across its event contracts.
Perpetuals marked the company’s biggest product launch since it first launched its prediction markets.
Disclosure: CNBC and Kalshi have a commercial relationship that includes customer acquisition and a minority investment.
'Warning: AI Agents With Crypto Could Escape And Become 'Unstoppable''
by Martin Young via CoinTelegraph.com,
Artificial intelligence agents that have autonomous access to crypto wallets could become unstoppable if deployed maliciously or if they escape from sandboxes, observers from a leading academic research consortium warned.
“Unstoppable Autonomous Agents” (UAAs) pose a clear threat if they are deployed to persist automatically and have access to digital assets, according to a June 8 industry review written by 25 academics rom top US universities for the Initiative for Cryptocurrencies and Contracts (IC3).
“When combined systematically, crypto tools can channel AI’s fluid power into secure, reliable, and highly autonomous systems,” the researchers wrote.
However, this combination could have “far-reaching consequences for users and the financial system,” they added.
UAAs may also be equipped with access to cryptocurrency wallets, social media accounts, APIs, and other external tools, said the researchers.
“The capabilities enabling such agents are already emerging and improving rapidly.”
The warning comes as crypto projects and executives have been pushing the agentic payment and micropayment economy narrative this year, suggesting it could be the biggest use case for decentralized digital assets.
AI self-replication alarm bells
The paper also revealed that existing models can already “surpass self-replication red lines” in local environments, by autonomously creating a live, separate copy of themselves on the same machine, “a capability that could let a system evade shutdown and proliferate.”
Because reward signals used in training often fail to perfectly capture the intended objectives, “UAAs deployed for benign purposes may inadvertently cause harm,” or pursue resource acquisition as a default strategy, they said.
However, the authors noted that models have yet to replicate themselves onto external infrastructure.
Potential AI agent insider trading advantages
A fleet of self-replicating, resource-acquiring agents could also create unpredictable demand and liquidity dynamics in crypto markets.
“AI-powered trading systems could enable collusion between autonomous agents and create unfair insider advantages through opaque strategies.”
The tech sector is already dealing with difficult questions about the threat of unmitigated AI.
Models such as Anthropic’s Claude Mythos have already been shown to be capable of finding and exploiting zero-day vulnerabilities in major operating systems.
Professor Ari Juels, IC3 co-director and Chainlink Labs chief scientist, presents the paper at ETHConf. Source: IC3
Meanwhile, Gartner warned in late May that governance failures around autonomous AI agents could trigger widespread enterprise failures, predicting 40% of companies will be forced to decommission their agents by 2027.
“The harms that could follow from fully autonomous agents of this kind are severe,” the researchers said, suggesting circuit breaker guardrails.
https://www.zerohedge.com/crypto/ai-agents-crypto-could-escape-and-become-unstoppable-experts-warn
European surgeon training announcement for GelrinC drives RGNT
European surgeon training announcement for GelrinC drives RGNT 137% premarket surge
- Regentis issued June 8 PR detailing Q3 2026 start of hands-on EU surgeon training for CE Mark-approved GelrinC hydrogel implant.
- Training begins at Humanitas Research Hospital in Milan; additional sessions and Centers of Excellence planned across Europe.
- News marks key step accelerating commercial launch preparations for off-the-shelf knee cartilage repair product.
- Low-float nano-cap stock (post-Dec 2025 IPO at $8, recent ~$1.28 close) reacted sharply to positive commercialization update.
- After-hours/premarket trading pushed shares from $1.28 close to ~$3.00–$3.30 range (+127–160%), with elevated volume.
- Builds on prior EU collaboration with Humanitas and manufacturing improvements; no other major catalyst identified.
- Retail momentum amplified move in this small-cap regenerative medicine name per forum and news coverage.
