Cellares reported that the first two patients have been dosed with Cabaletta Bio’s investigational CAR T cell therapy rese-cel (resecabtagene autoleucel) manufactured on Cellares’ Cell Shuttle instrument. The administration of an autologous cell therapy, which met all release criteria and was manufactured on an automated manufacturing platform, represents an important step on the journey to realizing a future where scalable manufacturing of autologous products to supply thousands of patients per year can be achieved with minimal capital investment and a low cost of goods, according to a Cellares spokesperson.
While the transformative clinical benefits of autologous CAR T cell therapy are well established in oncology, the high manufacturing costs, lack of scalability, process inconsistency, and operational inflexibility associated with the current highly manual way of manufacturing have created meaningful barriers to patient access, reducing patient accessibility to these therapies.
“This is an important milestone that reflects three years of focused collaboration between the teams at Cabaletta and Cellares,” said Steven Nichtberger, MD, co-founder, chairman, and CEO of Cabaletta Bio. “The dosing of these first two patients is an important demonstration of Cellares’ GMP manufacturing and supply chain capabilities with their automated manufacturing platform and thus represents a significant achievement toward our goal of securing high-capacity flexible supply with minimal capital investment and a low cost of goods.”
“This milestone is a transformative moment for the field of autologous cell therapy,” added Fabian Gerlinghaus, co-founder and CEO of Cellares. “For years, the promise of autologous CAR T has been constrained by manufacturing models that were never designed to scale.”
Rese-cel (formerly referred to as CABA-201) is an investigational, autologous CAR T cell therapy engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain, designed specifically for the treatment of autoimmune diseases. Administered as a single, weight-based infusion, rese-cel is intended to transiently and deeply deplete CD19-positive cells, with the goal of resetting the immune system and achieving durable clinical responses without the need for chronic therapy.
Cabaletta is evaluating rese-cel in the RESET (REstoring SElf-Tolerance) clinical development program, which includes multiple ongoing company-sponsored trials across a diverse and growing range of autoimmune diseases in rheumatology, neurology, and dermatology.
Regeneron Pharmaceuticals plans to expand its pipeline into radiopharmaceutical therapies through an up to $4.3 billion collaboration with Telix Pharmaceuticals to co-develop and co-commercialize precision oncology treatments and companion diagnostics.
The companies have agreed to partner on next-generation radiopharmaceutical therapies aimed at up to eight solid tumor targets from Regeneron’s portfolio of antibodies, generated from VelocImmune® technology, which uses the company’s own mouse platform engineered with a genetically humanized immune system.
Regeneron and Telix also said they plan to develop radio-diagnostics designed to support patient selection and treatment response assessment.
The collaboration is intended to combine the biologics expertise of Tarrytown, NY-based Regeneron, including bispecific antibody discovery, with the radiopharmaceutical development platform, global manufacturing capabilities, and supply chain infrastructure of Telix, which is headquartered in Melbourne, Australia.
“Regeneron is excited to enter the targeted radiopharmaceuticals space and explore the utility of these agents either as monotherapy or rationally combined with our immunotherapy platform, particularly in areas of high unmet patient need such as lung cancer, where our PD-1 inhibitor is a global standard of care,” Israel Lowy, MD, PhD, Regeneron’s senior vice president and clinical development unit head, oncology, said in a statement.
Lowy referred to Libtayo® (cemiplimab-rwlc), a programmed death receptor-1 blocking antibody approved for multiple oncology indications including forms of non-small cell lung cancer (NSCLC), as well as cutaneous squamous cell carcinoma, and basal cell carcinoma. Libtayo finished 2025 with $1.453 billion in worldwide net product sales, up 19% from $1.217 billion in 2024. Figures include $425 million in Q4 2025 global net product sales, up 16% from $367 million in the year-ago quarter.
‘An ideal partner’
“In our view, the deal with Regeneron validates Telix’s differentiated capabilities in radiopharmaceutical development and handling of complex supply chain logistics,” Andy T. Hsieh, PhD, a partner and biotechnology analyst with William Blair, wrote Monday in a research note. “Furthermore, given Regeneron’s track record of developing successful commercial therapeutics, we believe it is an ideal partner in bringing forth antibody-based theranostic assets.”
Telix investors appeared to somewhat agree with that analysis. The company’s ordinary shares traded on the Australian Stock Exchange climbed nearly 8% from A$14.64 ($10.34) to A$15.77 ($11.13). Telix’s American depositary shares traded on NASDAQ rose about 7%, from $10.56 to $11.24.
Hsieh reiterated William Blair’s “Outperform” rating for Telix shares based on several potential value-creating inflection points, including:
Continuing gains in market share gains within the prostate-specific membrane antigen (PSMA) positron emission tomography (PET) diagnostic imaging market, based on rising sales and price stability as payers have offered clarity on reimbursement—factors he said enable Telix to expand its precision medicine franchise “from a position of strength.”
Therapeutic franchise potential, as supported by recent positive preliminary data from part 1 of the ongoing Phase III ProstACT GLOBAL trial (NCT06520345) assessing TLX591 in metastatic androgen pathway modulation resistant prostate cancer.
Potential approvals of two PET imaging agents—TLX250-CDx (Zircaix®, 89Zr-DFO-girentuximab), designed to non-invasively detect and characterize clear cell renal cell carcinoma (ccRCC); and TLX101-Px (Pixclara®, Floretyrosine F 18 or 18F-FET), designed to image glioma. Both could “meaningfully” contribute to Telix’s profit-and-loss statement next year, the analyst predicted.
The FDA rejected both Zircaix and Pixclara last year via separate complete response letters. The agency held in April 2025 that Zircaix required additional confirmatory clinical evidence, which the company agreed to provide. On Friday, Telix said the FDA accepted its resubmitted New Drug Application (NDA) for Pixcara, assigning a target decision date of September 12 under the Prescription Drug User Fee Act (PDUFA).
In August 2025, the FDA rejected Zircaix via complete response letter, alleging deficiencies relating to its chemistry, manufacturing, and controls (CMC) package—deficiencies the company said were “readily addressable.”
“We look forward to additional updates pertaining to efficacy parameters, such as progression-free survival, an approvable endpoint, likely later this year,” Hsieh added.
Growth through acquisitions
Telix has built up its radiopharma infrastructure in recent years through acquisitions, spending $13.6 million to purchase IsoTherapeutics, a contract development and manufacturing organization (CDMO) focused on providing services to Telix and other radiopharmaceutical companies—followed by an up to $82 million buyout of radioisotope production technology firm ARTMS, which stands for alternative radioisotope technologies for medical science.
In September 2024, Telix expanded its manufacturing footprint by acquiring RLS Radiopharmacies for up to $250 million, part of an investment strategy focused around creating vertically integrated supply chain, manufacturing, and distribution.
The global radiopharmaceuticals market is predicted to grow at a compound annual growth rate of 10.1%, more than doubling from $14.2 billion this year to $31 billion in 2032, then soaring again to $54.6 billion by 2040, according to a Roots Analysis report issued in January.
Telix briefly pursued a U.S. initial public offering, which it withdrew in June 2024. The company cited market conditions as biotech IPOs met with chilly receptions on Wall Street and asserted that the offering was not predicated on the need to raise capital.
Regeneron has agreed to pay Telix $40 million in upfront cash for access to its radiopharmaceutical manufacturing platform for four initial therapeutic programs, with Regeneron holding an option to expand the collaboration to include four additional programs with additional upfront payments.
Telix and Regeneron have agreed to share equally their global commercialization costs and potential profits, with Telix retaining the option to co-promote certain potential products. However, if Telix were instead to opt out of the co-funding model for any of the original four programs, it would then be eligible to receive up to $535 million in development and commercial milestone payments, plus low double-digit royalties on future net sales, for that program.
If Telix opts out of co-funding for all four, company could achieve $2.14 billion in payments tied to achieving milestones.
For the diagnostics to be covered by the collaboration, Telix and Regeneron have agreed to jointly develop diagnostic assets, with Telix leading commercialization and Regeneron receiving a set percentage of profits.
“The collaboration with Regeneron reflects a highly complementary set of capabilities and a unique opportunity to explore what true ‘next gen’ biologics-based radiopharmaceuticals can potentially do for patients,” added Christian Behrenbruch, DPhil, managing director and group CEO at Telix. “We are well positioned to work toward the shared goal of advancing next-generation precision radiopharmaceuticals for patients with hard-to-treat cancers.”
AWS has now unveiled Amazon Bio Discovery, an AI platform that grants researchers direct access to a broad library of biological foundation models that can be fine-tuned for specific use cases in drug discovery. Announced at the AWS Life Sciences Symposium at the Javits Center in New York, the platform is supported by an AI agent that can select models for research goals, and evaluate candidates for synthesis and testing to enable a rapid lab-in-the-loop experimentation cycle.
While rising AI models show promise, they require coding skills and the ability to manage computing infrastructure. Additionally, diverse models face benchmarking challenges and moving candidates from computational design to physical synthesis remains a multi-step process. Given that data live in disconnected systems, scientists must manage multiple lab partners and manually coordinate timelines and execution.
Amazon Bio Discovery addresses these challenges with three capabilities: a benchmarked library of AI models and analysis packages, an AI agent that supports experimental lab, and integrated lab partners that test top antibody candidates and route results back to the researchers. This feedback loop improves the next round of design.
“AI agents make powerful scientific capabilities accessible to all drug researchers, not just those with computational expertise,” said Rajiv Chopra, PhD, vice president of AWS Healthcare AI and Life Sciences.
Currently, 19 of the top 20 global pharmaceutical companies use AWS to power research workloads. Amazon Bio Discovery will bring enterprise-grade scale, privacy, and security to researchers across pharmaceutical, biotech, and academic research organizations. MSK, Bayer, the Broad Institute, and Voyager Therapeutics are among early adopters of Amazon Bio Discovery.
Among the Amazon Bio Discovery broad catalog includes open-source and commercial models from Apheris and Boltz. Biohub and Profluent are expected to join the platform.
Amazon Bio Discovery enables scientists to fine-tune the model by feeding prior experimental data from their organization’s lab results into the application without complex training pipelines or custom code. In-house models can also easily be deployed and hosted within Amazon Bio Discovery.
To support model selection, an antibody benchmark dataset is available to evaluate the likelihood of a drug candidate to have favorable biological properties, such as manufacturability and stability.
Candidates selected for experimental validation can be directly sent to Amazon Bio Discovery’s integrated network of laboratory partners, including Twist Bioscience, Ginkgo Bioworks. A-Alpha Bio is also anticipated to join the network.
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Good morning. My colleague recently had a chance to talk with former senator Ben Sasse about his experience taking Revolution Medicines’ pancreatic cancer pill. Read on for what he said.
Ben Sasse thinks Rev Med drug ‘extended both quality and quantity of life’
Yesterday, we got highly promising results from a trial of Revolution Medicines’ pancreatic cancer pill, showing that patients on the medication lived nearly twice as long as those on chemotherapy.
Twenty years ago, Sven Bocklandt, PhD, sought to create a hypoallergenic cat. He had the genetic engineering chops to do it, but the embryology was beyond his capabilities. At a small animal genetic engineering conference, known as TARC (Transgenic Animal Research Conference), held near Lake Tahoe, he met James Kehler, VMD, PhD, whose research at that time was to make transgenic and knockout cats as models of human disease.
The two men bonded, agreed the hypoallergenic cat idea was “crazy enough,” and decided to move forward with it. They worked together, completely unfunded, for years—FedEx’ing samples back and forth as Bocklandt was on the west coast and Kehler on the east coast—trying to make their “garage cat” while each one worked different day jobs.
Bocklandt, passionate about animal genome engineering, continued to develop different ideas for genome engineering in animals. Around the same time that he started sharing his ideas with scientists like George Church, PhD, a start-up focused on animal genome engineering was taking shape—Colossal Biosciences, co-founded by Church. Introductions were made, and Bocklandt joined in 2022 as species director to work on the dire wolf project. Kehler joined a short time later as VP. And everyone knows the rest of that story (there was no shortage of media coverage).
The pair eventually succeeded with the cat project: his name is Archie, and he is, Kehler noted, only partially hypoallergenic. But the generation of Archie and the dire wolves may not be the successes of this story. The real success may be what Bocklandt and Kehler learned along the way—and what they are going to do next.
Chickens as the next biologic factory
Neion Bio, co-founded by Dimi Kellari and Sam Levin, PhD, and located on the Rockefeller University campus on the east side of Manhattan, is aiming to re-engineer eggs to produce drugs in chickens. The team uses genetic engineering to integrate therapeutic proteins into native egg proteins, creating a new manufacturing platform for drugs that runs on grain and water.
Bocklandt joined the team at Neion Bio as CSO after leaving Colossal in 2024; Kehler joined more recently, as head of avian sciences.
When thinking about producing complex proteins, using the chicken “makes a lot of sense,” Bocklandt told GEN. Breeding and genetic engineering are all established in the chicken. And the vaccine industry has established an existing infrastructure to grow eggs under disease-free conditions. Purifying proteins out of an egg, Bocklandt added, is easier than purifying them out of a Chinese hamster ovary (CHO) culture (the traditional cell choice for drug production) because there are fewer host proteins.
Sven Bocklandt, PhD [Marco Figueroa]
It makes “far more sense” than what we’re doing right now, Bocklandt noted, which is using CHO cells. “Everyone is doing that because everyone has been doing it that way,” he asserted.
“The fact that we’re now seriously questioning whether CHO cells should remain the default manufacturing platform for biologics is long overdue,” noted Ola Wlodek, PhD, CEO of Constructive Bio. “Any credible new approach that breaks this decades-old lock-in is ultimately good for patients and for the field.”
For Kehler, who did his graduate work in the lab of stem cell pioneer Hans Schöler, PhD, the chicken is a clear choice because it is the only species, besides the mouse, where the primordial germ cells have been used to transmit genetically modified gametes to the next generation.
Mike McGrew, PhD, group leader at the Roslin Institute in the U.K., and an advisor to Neion Bio, demonstrated years ago that modifying chicken primordial germ cells is a reliable way of making gene-edited chickens. This background is comforting to Kehler, who noted that, “unlike at Colossal, where everything was bleeding edge, we are able to focus on a single species and capitalize on some pretty tried and true technology.”
Drugs in eggs meet biomanufacturing reality
The lab space on the Rockefeller University campus can support research and even house chickens. But it cannot support the production of a drug. When asked about turning their egg-borne proteins into drugs, the company leans on the existing infrastructure that supports vaccines in specific pathogen free (SPF) eggs. The idea is that the egg whites will be frozen in giant batches and then processed in a CDMO.
When asked about potential challenges, Bocklandt noted that, “technically, there’s not much to worry about. I have no concerns about Neion Bio being able to do what we want to do or what we need to do.”
But there may be hurdles ahead. Rahul Dhanda, co-founder, president, and CEO of Syntis Bio, told GEN that “at the beginning, everything can look like it has infinite potential—it’s when you actually build and operate the system that the real challenges show up.”
More specifically, Dhanda pointed out that biomanufacturing “ultimately comes down to reliable, consistent, and cost-efficient production.” Leveraging animal biology for drug manufacturing is exciting, he noted, “but scalability and cost are still open questions, especially at this early stage. Biological variability between animals and individual outputs, like eggs, introduces additional risk compared to more controlled cell-based systems,” Dhanda added.
Wlodek agreed: “because egg-based production is inherently a biological supply chain, it will face avian flu risks, batch-to-batch variability from seasonal and flock effects, animal-welfare/regulatory overhead, and practical limits on how fast you can expand output compared with stainless-steel or single-use fermenters.”
Microbial and yeast systems still “win decisively on GMP containment, land/water footprint,” she noted, and “the ability to go from a few liters to tens of thousands of liters in weeks rather than months.”
Dhanda agreed that “getting it to work in principle is far different from getting it to work at scale, and that seems far off.”
If these challenges can be addressed at scale, safely and humanely, Dhanda noted, the approach could deliver meaningful health benefits—”but there are still significant logistical and technical hurdles to work through.”
Engineering the chicken genome
Creating dire wolves at Colossal started with deriving wolf cells, editing them, and cloning them back into a live animal. But cloning doesn’t exist in birds. To genetically engineer chickens, the Neion Bio team edits the germline, starting the process with a fertilized egg.
Neion Bio [Marco Figueroa]
The egg is incubated for 65 hours, at which point germ cells float in the blood because the ovaries and testes don’t exist yet. A microliter of the blood is removed, put into cell culture media, and the germ cells grow out. The transgene that codes for the therapeutic protein is inserted using CRISPR-Cas enzymes, in the coding region of a gene that codes for Ovalbumin—which makes up a bit over 50% of the egg white protein. This protein is made “on a massive scale” by the oviduct, the company noted.
The genome is screened for correct integration and potential off-target edits. Once the clone is approved, several thousand cells are injected back into another embryo (also at 65 hours old). After incubation, the egg hatches and becomes a chicken.
Kanuma set the precedent—but not the scale
In 2015, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) to treat Lysosomal Acid Lipase (LAL) deficiency, also known as Wolman disease. The drug, an enzyme replacement therapy, was the first treatment for patients with the rare disease and the first drug to be made in chickens. Kanuma is produced by Alexion Pharmaceuticals, which was acquired by AstraZeneca in 2021.
This historical precedent may provide a proof of concept for Neion Bio. That said, “the scale required for Kanuma is very different from what would be needed for large biosimilars,” explained Wlodek.
An Odyssean journey
For both Bocklandt and Kehler, the move to Neion Bio feels like their careers are coming full circle. When Bocklandt first left Colossal, he was not sure how he would surpass that level of excitement. But the move came at an interesting time for him; the call to join Neion Bio came just weeks after he learned that his sister had been diagnosed with leukemia.
He thought, “Well, maybe this is not such a bad use of my skills.”
Earlier in his career, he didn’t think that he had anything special to add to a field like cancer research. But now Bocklandt sees it differently: throughout his career, he has pushed the state-of-the-art of genetic engineering. Now, he said, “I bring something to the field. And the fact that I can do my passion, animal genetic engineering, and apply that to make drugs better, cheaper, and more accessible, is really exciting.”
As for Kehler, Neion’s goal was his goal all along. He went to the University of Pennsylvania to make better animal models to test drugs for humans. “It never really dawned on me that we could use animals to make the drugs for humans. But taking everything I know about stem cell biology, germ cell biology, and gene editing, and bringing that to bear to make what should be a disruptive, transformational approach to making drugs—it feels like the culmination of my career.”
Neion (pronounced Neon) Bio is named after the birthplace of Odysseus; Mount Neion is a mountain mentioned in Homer’s The Odyssey as a landmark on Ithaca—Odysseus’ island home. As described by the company, the name is a testament to the shared qualities between the Greek hero and the company’s goals: relying on intelligence and resourcefulness over strength. And yes, Odysseus was successful in his return home to reclaim his throne. But it was a bittersweet success given the enormous cost and hardship.
Neion Bio’s name may mirror the resilience and ingenuity required to undertake the journey, but time will tell how long the similarities in the namesake are shared between the two.
This is today’s edition of The Download, our weekday newsletter that provides a daily dose of what’s going on in the world of technology.
Want to understand the current state of AI? Check out these charts.
If you’re following AI news, you’re probably getting whiplash. AI is a gold rush. AI is a bubble. AI is taking your job. AI can’t even read a clock. Stanford’s 2026 AI Index—the field’s annual report card—cuts through the noise.
Stanford’s 2026 AI Index is full of striking stats. It also reveals a field riddled with inconsistencies, most notably in the gap between experts and non-experts.
On jobs, 73% of US experts view AI’s impact positively, compared to just 23% of the public. Similar divides emerged on the economy and healthcare. What’s driving this disconnect?
Part of the answer may lie in their diverging experiences. Those using AI for coding and technical work see it at its best, while everyone else gets a more mixed bag. The result is two very different realities. Read the full story on what they are—and why they matter.
This story is from The Algorithm, our weekly newsletter on AI. Sign up to receive it in your inbox every Monday.
—Will Douglas Heaven
Job titles of the future: Wildlife first responder
Grizzly bears have made such a comeback across eastern Montana that in 2017, the state hired its first-ever prairie-based grizzly manager: wildlife biologist Wesley Sarmento.
For seven years, Sarmento worked to keep both bears and humans out of trouble. He acted like a first responder, trying to defuse potentially dangerous situations. He even got caught in some himself, which led him to a new wildlife safety tool: drones. Find out the results of his experiments in digital ecology.
—Emily Senkosky
This article is from the next issue of our print magazine, which is all about nature. Subscribe now to read it when it lands on Wednesday, April 22.
The must-reads
I’ve combed the internet to find you today’s most fun/important/scary/fascinating stories about technology.
1 Human scientists still trounce the top AI agents at complex tasks The best agents perform only half as well as experts with PhDs.(Nature) + Can AI really help us discover new materials? (MIT Technology Review)
2 OpenAI is escalating its fight with Anthropic while pulling away from Microsoft A leaked memo exposes plans to attack Anthropic. (Axios) + And says Microsoft “limited our ability” to reach clients. (The Information $) + While touting a budding alliance with Amazon. (CNBC)
3 Carbon removal technology is stalling—and that may be good news Better solutions could now emerge.(New Scientist) + Here are three that are set to break through. (MIT Technology Review)
4 AI is finding bugs faster than we can fix them—and hackers will benefit Welcome to the bug armageddon. (WSJ $) + AI may soon be capable of fully automated attacks. (MIT Technology Review)
5 A Texas man has been charged with the attempted murder of Sam Altman He allegedly threw a Molotov cocktail at the OpenAI CEO’s home last Friday. (NPR) + The suspect reportedly had a list of other AI leaders. (NYT $)
6 AI is beginning to transform mathematics It’s proving new results at a rapid pace. (Quanta) + One AI startup plans to unearth new mathematical patterns. (MIT Technology Review)
7 Students are turning away from computer science It’s had a massive drop in enrollments. (WP $) + AI coding tools have diminished the degree’s value. (NYT $)
8 India’s bid to become a data center hub is sparking a fierce backlash Farmers are protesting Delhi’s courtship of hyperscalers. (Rest of World)
9 Meta is set to overtake Google in advertising revenue this year And become the world’s largest digital ad platform for the first time. (WSJ)
10 AI influencers are taking over Coachella Synthetic content creators are “everywhere” at the festival. (The Verge)
Quote of the day
“These people are almost nothing like you. They are most likely sociopathic/psychopathic and, in the case of Altman, consistently reported to be a pathological liar.”
—The alleged firebomber of Sam Altman’s home shares his distrust of AI leaders in a blog post.
One More Thing
We’ve never understood how hunger works. That might be about to change.
A few years ago, Brad Lowell, a Harvard University neuroscientist, figured out how to crank the food drive to the maximum. He did it by stimulating neurons in mice. Now, he’s following known parts of the neural hunger circuits into uncharted parts of the brain.
The work could have important implications for public health. More than 1.9 billion adults worldwide are overweight, and more than 650 million are obese. Understanding the circuits involved could shed new light on why these numbers are skyrocketing.
Each year we compile our 10 Breakthrough Technologies list, featuring our educated predictions for which technologies will have the biggest impact on how we live and work.
This year, however, we had a dilemma. While our final picks encompass all our core coverage areas (energy, AI, and biotech, plus a few more), our 2026 list was harder to wrangle than normal. Why? We had so many worthy AI candidates we couldn’t fit them all in! (The ones that made it were AI companions, mechanistic interpretability, generative coding, and hyperscale data centers.) Many great ideas fell by the wayside to keep the list as wide-ranging as possible.
Well, that got us thinking: What if we made an entirely new list that was all about AI? We got excited about that idea—and before we knew it we had the beginnings of what we’re calling 10 Things That Matter in AI Right Now. It’s an entirely new annual list that we’re proud to be publishing for the first time on April 21, 2026. We’ll unveil it on stage for attendees at our signature AI conference, EmTech AI, held on MIT’s campus (it’s not too late to get tickets), and then publish the list online later that day.
The process for coming up with the list was similar to the way we pick our 10 Breakthrough Technologies. We petitioned our AI team of reporters and editors to propose ideas, put them all in a document, and engaged in some robust discussion. Eventually, we voted for our favorites and whittled the long list down to a final 10.
But there’s a slight difference between this list and our 10 Breakthrough Technologies. AI is already such a big part of our lives that we didn’t want to restrict ourselves to nominating only technologies. Instead, we wanted to put together a definitive annual list that highlights what we believe are the biggest ideas, topics, and research directions in AI right now. So yes, it will include cutting-edge AI technologies, but it will also feature other trends and developments in AI that we want to bring to our subscribers’ attention.
Think of it as a sneak peek inside the collective brain of our crack AI reporting team: These are the things that our reporters will be watching this year. We intend to follow the items on this list really closely, and you will see it reflected in the news and feature stories we publish in 2026.
For us, 10 Things That Matter in AI Right Now is a guide to how we view the current AI landscape. It will be a source of discussion, debate, and maybe some arguments! We are so excited to share it with you on April 21. If you want to be among the first to see it—join us at EmTech AI or become a subscriber to livestream the announcement.
Immune system aging, known as immunosenescence, is associated with changes in immune cell composition and function that increase susceptibility to disease. The results of a study by researchers at the Barcelona Supercomputing Center – Centro Nacional de Supercomputación (BSC–CNS) have now shown that immunological aging follows different dynamics between men and women.
The team analyzed single-cell RNA sequencing data from the peripheral blood mononuclear cells (PBMCs) of 982 female and male donors across adulthood, to identify cells and genes involved in immunosenescence, and potentially provide a molecular explanation for the differences that had previously only been observed globally in the population.
“Until now, most studies analyzed the immune system based on the average of many cells at once, which makes it difficult to capture the progressive effects of aging,” said Maria Sopena-Rios, PhD. “With cell-by-cell analysis and a much larger sample, we were able to detect these patterns and compare them robustly between biological sexes.” Their strategy identified sex-related differences in immunological aging may help to explain why women have an 80% higher incidence of autoimmune diseases than do men, and why men are more likely than women to develop hematological cancers and chronic infections.
Sopena-Rios is co-first author of the team’s published paper in Nature Aging, titled “Single-cell analysis of the human immune system reveals sex-specific dynamics of immunosenescence,” in which the investigators concluded “Together, our findings provide a high-resolution map of sex-specific immune aging and lay the groundwork for tailored sex-specific strategies to monitor and improve immune health across the lifespan.”
Statistics show clear differences in the population’s immune system according to sex: men are more susceptible to infections and cancers, while women have stronger immune responses, which translate, for example, into better responses to vaccines. Even so, with a more reactive immune system, the probability of the body attacking itself also increases, causing 80% of autoimmune disease development to occur in women. In this context, understanding the aging of the immune system is key since, with age, the composition of immune cells changes and their protective functions deteriorate, causing a greater susceptibility to diseases.
Aging of the immune system, or immunosenescence, refers to “… the gradual decline of the immune system, which predisposes to multiple diseases, including infection, cancer, and autoimmune and vascular diseases,” the authors wrote. “Importantly, the age-related decline of the immune system involves both changes in the composition of immune cell populations and molecular alterations.” However, understanding how sex influences this profound transformation was not possible until now. “…how biological sex shapes immune aging at the cellular level remains poorly understood,” the investigators stated.
For their reported study, the team analyzed blood samples from nearly 1,000 people of different ages covering the entire adult life, and carried out single-cell RNA sequencing to analyze the activity of 20,000 genes in more than one million blood cells. This approach allowed them to identify how the immune system changes over the years and detect clear differences between sexes. Although evidence existed that the immune system ages differently according to sex, women have been traditionally underrepresented in studies, the authors comment. This is the first time that large quantities of samples were analyzed with a balance between men and women, a fact that was decisive in obtaining these results.
“Many studies still do not take sex into account in their analyses, or directly only use data from men, so they leave key questions unanswered,” said study director Marta Melé, PhD, leader of the Transcriptomics and Functional Genomics group at BSC. “Our research was born precisely from this need and combines a scientific outlook with a sex perspective, inclusive data, and great computational power.”
BSC researchers Aida Ripoll-Cladelles (left), Marta Melé (center) and Maria Sopena-Rios (right) in front of MareNostrum 5 supercomputer. [Mario Ejarque / BSC–CNS]
The results revealed that women present more pronounced changes in the immune system with age, with an increase in inflammatory immune cells. This finding could help explain why autoimmune diseases are mainly developed by women, especially at advanced ages, as well as the worsening of certain inflammatory pathologies after menopause.
“Female individuals typically mount stronger immune responses, enhancing resistance to infections and vaccine efficacy, but also contributing to an 80% higher incidence of autoimmune diseases,” the authors noted. “Aging further increases autoimmune risk, and we showed that this is accompanied by the female expansion of cell subpopulations with pivotal roles in autoimmunity.”
On the other hand, the study found that changes associated with immune system aging observed in men are globally less extensive, but an increase in certain blood cells presenting pre-leukemia alterations was observed, a fact that could explain why some blood cancers are more frequent in older men. “Male immune aging is less transcriptionally pronounced, with fewer sex-specific signatures and subtler shifts in immune cell abundance,” the investigators wrote. “.… a subset of male participants shows an age-associated expansion of a B cell population linked to an asymptomatic precursor state of chronic lymphocytic leukemia … Our findings suggest that male immune remodeling may contribute to increased vulnerability to hematological malignancies and chronic infections.”
To manage, process, and analyze a volume of data of this magnitude, the scientific team required the use of advanced computational methods that had never been applied to such complex data sets, with the MareNostrum 5 supercomputer as a key piece to make possible a study that would not have been viable without high-performance computing infrastructure.
With these discoveries, the study establishes the bases for incorporating biological sex as a key variable in precision medicine for aging. The identification of sex-specific aging cells and biomarkers opens the door to the development of preventive, diagnostic, and therapeutic strategies better adapted to women and men, contributing to more individualized and equitable healthcare in an increasingly aging population.
“The immune system plays a fundamental role throughout the organism; therefore, the differences we observed have a very important generalized impact on the entire body. Better understanding the aging of the immune system can help us understand processes that go beyond the blood and affect multiple tissues,” noted co-first author Aida Ripoll-Cladellas, PhD.
Treating aging as a homogeneous process in the entire population hides key biological differences, and understanding how it varies between women and men, the authors concluded, will be essential to improve immune health and promote healthy aging within everyone’s reach. “Stratifying analyses according to sex uncovers key sex-specific features of immunosenescence that may otherwise be misinterpreted as shared effects,” they stated. “This underscores the importance of considering sex as a biological variable to ensure biologically accurate conclusions. Ultimately, our findings lay the foundation for sex-tailored strategies to monitor immune aging and mitigate the burden of age-related immune dysfunction.”
The scientists responsible for developing sonogenetics, which refers to the application of low-intensity ultrasound to noninvasively achieve precise control of cellular proteins, have secured an influx of federal funding that will allow them and their collaborators transform the technology into a potential therapy for various conditions starting with peripheral neuropathies.
Late last week, Salk Institute for Biological Studies announced that Sreekanth Chalasani, PhD, an associate professor in Salk’s molecular neurobiology laboratory, and his partners in collaborating laboratories elsewhere, were awarded $41.3 million from the Advanced Research Projects Agency for Health (ARPA-H), an agency within the United States Department of Health and Human Services. Working on multiple fronts over the next five years, the partners will develop core biological tools and ultrasound delivery systems while generating the preclinical evidence needed to move sonogenetics into human clinical trials.
“This award is a major step toward a long-held goal—a drug-free way to deliver therapy exactly where it’s needed and only when it’s needed,” said Chalasani, who serves as the principal investigator for the grant and is also the co-founder of SonoNeu, a startup launched to commercialize therapies based on the technology. Key to accomplishing that goal is “a platform that pairs engineered ultrasound-sensitive proteins with wearable ultrasound technology, which, unlike conventional pharmaceutical treatments, could let us treat conditions with cellular and temporal control.”
Reaching cells through sound
In 2011, armed with support from Salk’s Innovation and Collaboration Grants program, Chalasani and his team pioneered sonogenetics, a technique for sensitizing specific cell types to ultrasound by equipping them with ultrasound-responsive proteins. In 2015, his group first identified a particular protein in the roundworm Caenorhabditis elegans (C. elegans) that makes cells sensitive to low-frequency ultrasound. When they added this protein to C. elegans neurons that did not usually have it, they were able to activate these cells using ultrasound waves.
Since that initial discovery, Chalasani’s team and others have shown that they can use sonogenetics to manipulate mammalian cells. Some of their work was published in a 2022 Nature Communications paper which describes efforts to engineer a human channel protein in cultured mammalian cells and living animal models to confer cell-specific sensitivity to ultrasound stimulation.
Chalasani noted in an interview with GEN that the pace of their progress from an idea to potential clinical translation in the span of about 15 years is remarkable, compared to the typical multi-decade timeline for most new therapies. “In terms of how quickly this has gone from a [research] idea to what patients should we look at [and] how are we going to help them? The pace has been overwhelming,” he said. He attributed much of that progress to the work of the trainees, post-doctoral students, and collaborators through the years who were willing to take on “this crazy idea and work on this project, even though there was no guarantee it would get anywhere.” He also highlighted the early investment from Salk and other entities including the National Institutes of Health’s Brain Initiative as key to project’s success.
Though Chalasani and his lab pioneered sonogenetics, the next phase of its development is not a solo effort. It involves a multiple institutions and teams all of whom are contributing essential and specialized expertise. The list of collaborators includes Scripps Research, where a team led by 2021 Nobel Laureate Ardem Patapoutian, PhD, will support the discovery and engineering of ultrasound-sensitive proteins. Then a team at St. Boniface Hospital Research and the University of Manitoba led by Paul Fernyhough, PhD, will help define how ultrasound-triggered signals move through cellular machinery and drive nerve repair pathways.
Another team, led by Aravind Asokan, PhD, at Duke University will work on targeted vectors for delivering ultrasound-sensitive proteins to specific cell types. Separately, a team led by Xuanhe Zhao, PhD, at Massachusetts Institute of Technology will work on targeted mechanisms for delivering ultrasound to animal and human targets. Then scientists at the University of California, San Diego, led by Nigel Calcutt, PhD, will validate the efficacy of sonogenetics across established paradigms and in mammalian systems. Finally, Ghassan Kassab, PhD, and his team at California Medical Innovations Institute, will support advanced translational validation and clinically relevant assessment in preclinical systems.
For their part, Chalasani and his team at Salk will work on finding additional actuators or sensors for ultrasound that will be optimized for targeted delivery. “What we have are proteins that can respond to that small amount of mechanical deflection that ultrasound can cause,” Chalasani explained. “These proteins are channels [that] sit on the membrane of the cell and when the cell experiences ultrasound, the protein gets activated, it opens up, and allows calcium [for example] into the cell. Because these proteins can actuate an effect, they are called ultrasound actuators.”
Currently, the group has identified proteins that can move things like calcium and chloride into cells in response to ultrasound but they are hunting for other proteins that can activate various signaling pathways. Besides new actuators, the Salk scientists will work on validation studies in mouse models, and lay the groundwork for experiments in larger animal models, specifically pigs, Chalasani told GEN.
There is a plan in place to commercialize therapies developed using sonogenetics technology. Salk spinout SonoNeu will receive a portion of the ARPA-H funding to help move potential therapies through the regulatory process and commercialization. Chalasani is listed as a co-founder as is Venkat Reddy, chief scientific officer of General Inception, a firm that partners with scientific founders to build their companies. The target, Chalasani said, is to have something ready for the U.S. Food and Drug Administration in the next five years.
The initial treatment target condition is peripheral neuropathies and in that context, “there are a lot of interesting places for us to evaluate,” he said. “But I think the real question is going to be what pathway are we targeting? We can do calcium and chloride [but] is that enough to get a therapeutic benefit in a patient or should we have to activate something else other than that? Do we have to activate an enzyme [or] a kinase? And how would we do that? Can we link these proteins to those signals? So there are some unknowns here.”
If all goes well, other patient populations could benefit from sonogenetics-based therapies besides peripheral neuropathies including people with diabetes, heart conditions or it could help with bladder control, Chalasani said. There are even possible applications in the context of brain-computer interfaces.
instrument. The administration of an autologous cell therapy, which met all release criteria and was manufactured on an automated manufacturing platform, represents an important step on the journey to realizing a future where scalable manufacturing of autologous products to supply thousands of patients per year can be achieved with minimal capital investment and a low cost of goods, according to a Cellares spokesperson.
![BSC researchers Aida Ripoll-Cladelles (left), Marta Melé (center) and Maria Sopena-Rios (right) in front of MareNostrum 5 supercomputer. [Mario Ejarque / BSC-CNS]](https://www.genengnews.com/wp-content/uploads/2026/04/Low-Res_NdP_Envelliment-Sistema-Immune-1-1-300x200.jpg)