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Lyell starts first-of-its-kind CAR-T trial; New coalition aims to boost European biotechs

Today, a brief rundown of news from Lyell Immunopharma and Biogen as well as updates from the European Life Sciences Coalition and Novocure that you may have missed. Lyell Immunopharma said Thursday it has begun dosing patients in a first-of-its-kind Phase 3 t

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Today, a brief rundown of news from Lyell Immunopharma and Biogen as well as updates from the European Life Sciences Coalition and Novocure that you may have missed. Lyell Immunopharma said Thursday it has begun dosing patients in a first-of-its-kind Phase 3 trial testing ronde-cel , an experimental, dual-acting cancer cell therapy, directly against an investigator’s choice of approved CAR-T treatments for large B-cell lymphoma. The trial is expected to enroll 400 people whose lymphoma relapsed or hasn’t responded to initial treatment with Rituxan and chemotherapy. Investigators will measure whether ronde-cel can extend survival or delay disease recurrence or progression longer than those who got the marketed treatments. Lyell acquired ronde-cel when it bought startup ImmPact Bio in 2024, and has since positioned the therapy as its lead research candidate. It’s also running a single-arm pivotal study that could yield a U.S. approval filing in 2027, if the results are positive. — Jonathan Gardner Several prominent biotech venture firms joined together with the trade group Invest Europe to launch on Thursday the European Life Sciences Coalition , or ELSC, an initiative meant to spur investment in drug startups in Europe. Novo Holdings , Sofinnova Partners , Omega Funds and Forbion are among the members of the new group, which collectively manages more than 24 billion euros in life science-related assets and has helped start over 1,400 companies. The coalition aims to help close the funding gap between European biotech investors and their counterparts elsewhere, as European funds account for just 7% of of the global venture financing going to life sciences companies versus 63% in the U.S. and 14% in China. The launch comes "at a pivotal moment for Europe," which "risks a progressive hollowing-out of its life sciences VC ecosystem," the ELSC wrote. — Ben Fidler The Food and Drug Administration on Wednesday approved an electrical-field emitting device Novocure developed for pancreatic cancer. The device, Optune Pax , has been cleared alongside chemotherapy for pancreatic tumors that can’t be surgically removed. The approval was supported by study results showing that the addition of Optune Pax to chemo helped people survive a median of 16 months, about two months longer than those on chemo alone. Novocure’s device is meant to trigger an immune response while disrupting tumor cell division and spread. It’s also cleared for use in glioblastoma, mesothelioma and non-small cell lung cancer. — Jonathan Gardner Caroline Dorsa , chair of Biogen’s board of directors, plans to retire and will not stand for reelection at the company’s annual meeting scheduled for June 9. Biogen said Dorsa, who replaced longtime chair Stelios Papadopoulos in 2023, will be succeeded by fellow board member Maria Freire . Biogen’s board — which totaled 10 members at the end of 2025 — has undergone significant changes in recent years. Three members stepped down around the same time of Dorsa’s chair appointment. One of those seats was then filled by Susan Langer , who is the daughter of prominent biotech founder Bob Langer and had held various positions at Biogen. Freire joined the board in 2021, and currently serves on committees for corporate governance as well as compensation and management development. — Jacob Bell

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01Lifestyle Matters: How do environmental and lifestyle factors influence Alzheimer’s disease?

Dr. Harrison and Finnish neuroscientist Dr. Miia Kivipelto explore the complex interplay between genetics and lifestyle in Alzheimer's development. Learn how the groundbreaking FINGER study demonstrates potential prevention strategies, and discover the latest evidence on how environmental factors, diet, and chronic conditions influence Alzheimer's risk.

Source: www.biopharmadive.com ↗
02Why Muscle Cells Might Do Some Heavy Lifting

Brown was studying gene therapy in the 1990s when he designed a technology to turn mRNA expression on or off in different cells. For the new mouse study, published in Nature Biotechnology , he adapted the technology to turn off mRNA expression in dendritic cells, muscle cells, or liver cells. The researchers then vaccinated the mice with each version, delivering the vaccines both intravenously and intramuscularly. “The results were pretty stunning,” Brown said. When mRNA expression was turned off in muscle cells, T-cell response went down, suggesting muscle cells play a role in immunity. When expression was turned off in liver cells, T-cell expression tripled — indicating liver cells dampen immunity. Turning off expression in dendritic cells had no effect on T-cell activation, though it did reduce the number of killer T cells by as much as half. (Interestingly, no such reduction occurred when the antigen was SARS-CoV-2 spike. Brown is now investigating why different antigens had varying effects.) Knowing all this is crucial for designing effective mRNA vaccines and therapies. That’s because different mRNA therapies require different strategies. Cancer vaccines must boost tumor-fighting killer (CD8+) T cells. For genetic disease treatments, scientists want to avoid triggering the immune system to prevent killing the very cells the mRNA is meant to modify. “Understanding the immunology is extremely important for this class of drug,” Brown said. The finding doesn’t mean dendritic cells aren’t important for mRNA vaccines to work. “It just means that the mRNA doesn’t have to get into those cells to induce an immune response,” Brown said. Instead, the antigen can be transferred to those dendritic cells.

Source: www.medscape.com ↗
03China: Threat or opportunity?

One of the biggest biotech news stories of recent years is China’s continued rise as a biotech and life sciences powerhouse. China conducts a quarter of all clinical trials and drug development and has almost 1,500 new drugs in development.¹ Many China-based biotechs have benefitted from government funds, out-licencing deals with large pharmas and venture capital funding. However, policymakers in the US and EU have concerns about the possible threat to their region’s biosecurity and competitiveness as centres for health and life science research. Given China’s increased importance, ICON Biotech conducted the same biotech sector survey with 100 China-based biotech leaders. The results show that Chinese biotechs face many of the same challenges as biotechs located elsewhere. They share the same funding challenges and burdens associated with increasingly complex clinical trials and regulations.

Source: www.biopharmadive.com ↗
04What the Artificial Neuron Cannot Do

Hersam’s next goal is a small circuit — perhaps 10 artificial neurons — where each one fires differently, and together they accomplish what would require thousands of conventional transistors. “ Silicon achieves complexity by having billions of identical devices,” Hersam said. “The brain is the opposite. It’s heterogeneous. The complexity is at the device level.” But Gaudet sees a gap no circuit design can yet fill: Biological neurons grow new connections and prune old ones, strengthening pathways that are used and weakening those that aren’t. Hersam’s lab’s printed neurons — or any other neuromorphic technology that mimics neuronal dynamics — can’t achieve that level of complexity yet. Brown is careful about the distance remaining between these printed neurons and the real thing. “Neurons are just so flexible,” he said. “They can totally change what they’re doing based on whether they’ve learned something and based on your emotional state. There’s a lot of hidden mysteries.” Sangwan suspects the device has more to reveal. “It’s a nonlinear dynamical system,” he said. “We don’t fully know how many different variables you need to explain it. It’s just the beginning.” Hersam, Sangwan, Brown, Holla, and Gaudet reported having no relevant financial disclosures. Disclosure information for study authors is available in the original study publication.

Source: www.medscape.com ↗
05What Comes Next

With data expected in the fourth quarter of 2026, we are prioritizing histology alongside patient-reported outcomes using the Celiac Disease Symptom Diary, one of only two instruments developed in line with U.S. Food and Drug Administration (FDA) guidance, to capture changes in symptoms such as abdominal pain and nausea. Ultimately, the broader aim is to give gastroenterologists and patients a therapeutic option for a disease that has long been managed without one. The future of drug development will not be defined by statistical significance alone, but by whether new therapies also improve the daily burden of living with celiac disease. “The first therapy to cross the line could change the field,” Geller concluded. “It would help establish celiac as a serious medical condition with options beyond a restrictive diet and open the door for what comes next.” Dr. Paul Lizzul is chief medical officer at First Tracks Biotherapeutics, a clinical ‑ stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases. Marilyn Geller serves as an advisor to First Tracks Bio. Footnotes Abadie V, Jabri B. IL-15: a central regulator of celiac disease immunopathology. Immunol Rev . 2014;260(1):221-234. https://doi.org/10.1111/imr.12191. Yokoyama S, Watanabe N, Sato N, et al. Antibody-mediated blockade of IL-15 reverses the autoimmune intestinal damage in transgenic mice that overexpress IL-15 in enterocytes. Proc Natl Acad Sci U S A . 2009;106(37):15849-15854. https://doi/full/10.1073/pnas.0908834106. Anthony S, Schluns KS. Emerging roles for IL-15 in the activation and function of T-cells during immune stimulation. Research and Reports in Biology . 2015;6:25-37. https://doi.org/10.2147/RRB.S57685.

Source: www.biopharmadive.com ↗
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Peptide Therapy Guide Editorial Team

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