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Sanofi swaps R&D leaders; Merck’s Prometheus deal pays dividends

Today, a brief rundown of news involving Sanofi and Merck & Co., as well as updates from Definium Therapeutics, Eli Lilly and Nura Bio that you may have missed. Sanofi has announced a new head of research and development. Houman Ashrafian , a former venture in

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Today, a brief rundown of news involving Sanofi and Merck & Co., as well as updates from Definium Therapeutics, Eli Lilly and Nura Bio that you may have missed. Sanofi has announced a new head of research and development. Houman Ashrafian , a former venture investor who’s led global R&D at the French pharmaceutical giant since 2023 , is leaving to “pursue an opportunity outside the company,” Sanofi said Monday. Effective Sept. 1, he’ll be replaced by Paulo Fontoura , a longtime Roche executive and most recently the Chief Medical Officer of AI drug discovery startup Xaira Therapeutics . Fontoura will report directly to new CEO Belén Garijo and attempt to end an ongoing slide for Sanofi, which has recently reported several pipeline setbacks . — Ben Fidler An experimental drug at the center of Merck & Co.’s 2023 buyout of Prometheus Biosciences has succeeded in a late stage trial . Merck didn’t provide specifics, but said Monday that the drug, tulisokibart , met its primary goal in a Phase 3 study in people with moderately to severely active ulcerative colitis. A second late-stage study is ongoing, but in the meantime Merck will share the results with regulatory authorities and present them at an upcoming scientific meeting. Tulisokibart is part of a new class of inflammatory disease medicines aimed at a protein called TL1A. It’s one of many drugs Merck is counting on to boost revenue when the cancer immunotherapy Keytruda loses patent protection. — Delilah Alvarado Shares of Definium Therapeutics were up roughly 50% late Monday morning, after the psychedlics specialist reported positive results from a Phase 3 trial. The experiment pitted a single dose of Definium’s “ DT120 ” — a formulation of LSD — against a placebo in adults with major depressive disorder, and found that, after six weeks, patients in the drug arm experienced significantly greater reductions on a widely used scale that measures depression symptoms. Definium said DT120 also worked quickly and was generally well-tolerated, with nearly all treatment-emergent adverse events being transient and mild to moderate in severity. Marc Goodman , an analyst at Leerink Partners , wrote in a note that the data were “about as good as we could have hoped for” and increased his peak sales for the drug in major depression to a range of $1.5 billion to $2 billion. — Jacob Bell Eli Lilly will work with Sweden-based biotechnology company BioArctic to develop a new drug candidate for neurodegenerative diseases. Through a collaboration announced Monday, the companies will pair a proprietary Lilly molecule with a transporter technology BioArctic uses to get medicines into the brain. BioArctic will receive $30 million up front and could get up to $770 million in future milestone payments, as well as sales royalties, should the resulting drug reach market. Lilly will lead global development and commercialization. — Delilah Alvarado Nura Bio , a small, San Francisco-area drugmaker, has completed a nearly $74 million Series B round led by The Column Group . Nura said Monday it plans to use the money to further develop its experimental medicines, which are designed to inhibit a protein, “SARM1,” that destroys the electrical signaling “axon” portion of nerve cells. The company’s most advanced medicine is in a Phase 1b/2a study focused on ALS. Euclidean Capital , Samsara BioCapital and Sanofi Ventures also particiated in the round. — Jacob Bell

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01What 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 ↗
02Lifestyle 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 ↗
03What 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 ↗
04China: 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 ↗
05Why 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 ↗
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Peptide Therapy Guide Editorial Team

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