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Merck adds to pharma’s AI push; Roche details MS drug results

Today, a brief rundown of news from Merck & Co. and Roche, as well as updates from Arcus Biosciences and Ray Therapeutics that you may have missed. Merck & Co. is the latest pharmaceutical giant to dig deeper into artificial intelligence, announcing Wednesday

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Today, a brief rundown of news from Merck & Co. and Roche, as well as updates from Arcus Biosciences and Ray Therapeutics that you may have missed. Merck & Co. is the latest pharmaceutical giant to dig deeper into artificial intelligence, announcing Wednesday a broad partnership with Google Cloud to boost its "digital backbone as an AI-enabled enterprise." Merck will make a multiyear investment worth up to $1 billion in the deal, through which it will apply AI tools to everything from research and development to manufacturing, commercial and corporate functions. The partnership comes amid a broader adoption of AI by large pharmaceutical companies, which are using one-off deals and grander alliances to help accelerate drug development. — Ben Fidler Merck has also won Food and Drug Administration clearance to begin selling a new, two-drug combination for HIV . Called Idvynso , it was approved on Tuesday as a replacement therapy for adults whose HIV-1 levels are currently suppressed by another drug regimen. Idvynso combines Merck's previously approved medication Pifeltro with the newer agent islatravir in a single tablet. The drug has had a winding development journey, with studies once halted due to safety concerns. But it's now earned the first of what could be two FDA nods, as the agency may afterward allow use in "treatment-naive" patients as well. The latter decision is the "key inflection point" for Idvynso, though it's unlikely the drug will "materially disrupt" the dominant position of Gilead Sciences' Biktarvy , wrote RBC Capital Markets analyst Trung Huynh . A once-monthly, oral preventive therapy Merck is working on has higher upside, he added. — Ben Fidler Roche presented detailed results from a pair of studies it's hoping will support approvals of fenebrutinib , an experimental pill for multiple sclerosis. Study data unveiled at the American Academy of Neurology meeting show that, when compared to Sanofi's Aubagio over 96 weeks, fenebrutinib led to a 51.1% reduction in annual relapse rates in one trial and a 58.5% reduction in another study. That performance equates to patients having one relapse every 17 years, Roche said. Some analysts have been skeptical of fenebrutinib's approval chances , given an imbalance in patient deaths in the studies and the presence of the kind of liver-related side effects that led U.S. regulators to reject a similar medicine . Roche noted, however, that the rates of liver enzyme spikes between patients who got Aubagio and fenebrutinib in its two trials were "comparable." — Ben Fidler Arcus Biosciences and Gilead Sciences halted, for futility, a Phase 3 trial testing two Arcus immunotherapies and chemotherapy against Merck's Keytruda and chemo in non-small cell lung cancer. Arcus also announced in a Monday regulatory filing that the partners are ending a longstanding, cancer-focused research collaboration that began in 2020 . The study stoppage followed a previous failure in gastroesophageal cancers that led Arcus to pivot away towards a different medicine it's advancing for kidney tumors. The deal's end is "an opportunity for the company to pursue broader business development strategies" with that drug, casdatifan , as well as other pipeline candidates, wrote Leerink Partners' Daina Graybosch . — Ben Fidler Ray Therapeutics has raised another $125 million to advance gene therapies meant to restore vision in people with blinding eye conditions. The financing announced Tuesday comes from nearly a dozen backers, including Janus Henderson Investors , Adage Capital Management , Deerfield Management and Novo Holdings. The funds will support late-stage development of its lead program in retinitis pigmentosa, and earlier testing of a therapy for Stargardt disease and geographic atrophy. Ray secured a $100 million Series A round upon launching in 2023. It’s making “optogenetic” therapies that deliver light-sensitive proteins into retinal cells, an approach researchers hope will help patients regain sight regardless of the genetic mutation underlying their disease. — Gwendolyn Wu

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

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