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Gilead delays arrival of Biktarvy copycats; CDC updates vaccine schedule

Today, a brief rundown of news involving Gilead Sciences and Stoke Therapeutics, as well as updates from the Centers for Disease Control and Prevention, AstraZeneca and Trogenix that you may have missed. Gilead Sciences has entered into an agreement to settle

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Today, a brief rundown of news involving Gilead Sciences and Stoke Therapeutics, as well as updates from the Centers for Disease Control and Prevention, AstraZeneca and Trogenix that you may have missed. Gilead Sciences has entered into an agreement to settle patent litigation with a few drugmakers looking to sell generic versions of the world's highest-earning HIV medication. Per terms of the settlement, generic Biktarvy isn't expected to enter the U.S. market before April 1, 2036. A once-daily tablet that combines three key antivirals, Biktarvy first received Food and Drug Administration approval in 2018. It has since become Gilead's biggest product, accounting for almost half of the $13.7 billion in sales the biotechnology company recorded during the first half of this year. Gilead shares were up nearly 4%, to $117 apiece, at one point Monday, though they came back down to trade flat by mid-afternoon. — Jacob Bell The Centers for Disease Control and Prevention on Monday updated its immunization schedules to recommend splitting childrens’ measles and varicella shots and promoting “individual-based decision making” for COVID vaccines. The former decision comes after the panel, known as ACIP and reformed by Robert F. Kennedy Jr. , voted to separate MMR and chickenpox shots to lower seizure risk, despite concerns doing so might reduce how many children are vaccinated . The latter was based on a softer ACIP recommendatio n than the universal endorsement previously given to COVID shots. — Delilah Alvarado Ian Smith , formerly the head of finance and operations at Vertex Pharmaceuticals , has, since March, been serving as the interim CEO for a Massachusetts-based genetic medicines developer named Stoke Therapeutics . On Monday, Stoke announced that interim title is no more , and Smith will stay on as chief executive. He succeeds Edward Kaye , who departed Stoke not long after the company sold some rights to its most advanced experimental drug. That drug, "zorevunersen," is in late-stage testing as a potential treatment for a rare, severe type of epilepsy. Arthur Tzianabos , chairman of Stoke's board, said in a statement that Smith demonstrated "strong execution" over the past six months and is "uniquely qualified" to helm the company as it works to get zorevunersen approved. — Jacob Bell AstraZeneca said Tuesday its experimental blood pressure pill baxdrostat succeeded in a second Phase 3 trial in people whose hypertension isn’t under control with standard medications. The trial tested the drug against a placebo in 218 people already on at least three blood pressure medicines and evaluated their 24-hour average systolic blood pressure over 12 weeks. Baxdrostat achieved a “statistically significant and highly clinically meaningful reduction” by that measure, AstraZeneca said, though it didn’t provide specifics. Baxdrostat, which AstraZeneca acquired in a buyout of CinCor Pharma , previously succeeded in a larger trial that measured blood pressure reductions after 12 weeks. — Jonathan Gardner AstraZeneca is also teaming up with fledgling startup Algen Biotechnologies in an AI-focused research pac t that will bring up to $555 million to the San Francisco company. Under a deal announced Monday, AstraZeneca will receive exclusive rights to develop and commercialize drugs discovered with Algen’s platform. They’re also focusing on a “defined set of targets,” but didn’t provide further details. Algen was founded in 2018 , based on research developed in the lab of gene editing pioneer Jennifer Doudna at the University of California, Berkeley. — Gwendolyn Wu Biotechnology startup Trogenix banked £70 million, or $95 million , in a Series A round announced Monday. Trogenix is developing what it claims are “potentially curative cancer therapies,” and is specifically targeting aggressive solid tumors. Its therapies package artificially made “super enhancers” into a viral delivery tool and send them directly into tumor cells, where they help reveal cancers to the immune system for destruction. Trogenix’s lead program, for glioblastoma, should start human testing next year. The company’s Series A backers include IQ Capital , which led the round; 4BIO Capital , which spun out the company from the University of Edinburgh; and five other investors, among them Eli Lilly . — Gwendolyn Wu

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01How Real Brain Cells Respond to Artificial Neurons

Holla, who completed her PhD in Raman’s lab and is now a postdoctoral researcher studying memory at New York University in New York City, designed and ran experiments in mouse cerebellar slices. She positioned a stimulation electrode on the parallel fibers, the main pathway that excites Purkinje cells, and a recording electrode on the Purkinje cells themselves. She played recordings of the artificial neurons’ waveforms into the tissue through a standard stimulation electrode at four different speeds: 7, 60, 218, and 740 spikes per second. At every speed below 200 spikes per second, the Purkinje cells fired in response. The strongest results came at 60 spikes per second, where each artificial spike lasted 0.7 milliseconds, which is fast enough to trigger the cell but brief enough to avoid flooding the tissue with unnecessary current. Above 200 spikes per second, the cells stopped responding. They simply cannot fire that fast. The team included the 740-spikes-per-second condition on purpose to directly challenge the many engineering groups building artificial neurons that operate at those speeds. “We had to show them [740 spikes] wasn’t sufficient,” Brown said. “You can’t work that fast.” “You can see the living neurons respond to our artificial neuron,” Hersam said. But he is careful to note a caveat: The printed artificial neurons were not touching the brain tissue. The waveforms they generated were recorded and then played back into the slice through standard laboratory stimulation equipment. The next step is to prove the printed device itself can interface with living tissue.

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 ↗
03Why 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 ↗
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 ↗
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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