Tag: Biotech

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WuXi’s Facility in China Receives Brazilian GMP Certification for Dengue Vaccine Manufacturing

CDMO WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, reports that its drug substance facility (MFG23) located in Suzhou, China, has received GMP certification from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA). The facility provides integrated manufacturing services for Instituto Butantan’s dengue vaccine (Butantan-DV) production project.

“The GMP certification of our DS facility, our second certification from ANVISA, represents a pivotal step in advancing our dengue vaccine project with Instituto Butantan and establishing a solid foundation to deliver on our shared commitment to expand access to high-quality dengue vaccines,” said Jian Dong, CEO of WuXi Vaccines. “Adhered to premier quality standards and powered by our integrated solutions and technologies, we remain committed to driving greater access to safe, effective, and affordable vaccines worldwide.”

Based on the commercial manufacturing agreement with Instituto Butantan and Fundação Butantan, WuXi Vaccines will provide end-to-end services, including drug substance and drug product manufacturing and quality control for the 5-dose dengue vaccine, according to Dong. The partnership plans to rapidly scale up vaccine capacity, aiming to deliver millions of doses to shield Brazil’s population from dengue. In November 2025, the single-dose Butantan-DV received ANVISA approval for use with individuals aged 12 to 59.

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Gene Therapy Shows Promise Against TDP‑43 Neurodegeneration in Mice

Among the proteins implicated in age‑related neurodegeneration, TDP‑43 has taken on growing importance: its misfolding and mislocalization are now linked to frontotemporal dementia (FTD), amyotrophic lateral sclerosis (ALS), and are estimated to be present in more than half of Alzheimer’s cases. Faster cognitive decline, greater brain atrophy, and worsening memory loss are all associated with TDP-43.

Now, researchers at the University of California, San Diego (UCSD), are testing a gene‑therapy strategy designed not to remove TDP‑43, but to help neurons withstand its toxicity. In a study published in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, the team reports that systemic delivery of a gene called SynCav1 to brain cells protected cognition and preserved neuronal structure in a mouse model of TDP‑43 proteinopathy. The study is titled, “Systemic delivery of synapsin-promoted caveolin-1 overexpression ameliorates pathological TDP-43–induced cognitive decline and neurodegenerative changes.”

The approach centers on caveolin‑1, a scaffolding protein that organizes membrane signaling domains and supports neuronal resilience. The researchers packaged SynCav1 into a modified AAV vector capable of crossing the blood–brain barrier—a notable departure from many CNS gene therapies that require direct injections into brain tissue. Once delivered, SynCav1 boosted caveolin‑1 expression across the brain and spinal cord.

“Many therapies for neurodegenerative disease focus on removing toxic proteins, but neurons are also losing their ability to cope with that stress,” said senior author Brian Head, PhD, professor of anesthesiology at UCSD School of Medicine and research career scientist at the Veterans Affairs San Diego Healthcare System. “Our findings suggest that strengthening the neuron’s resilience itself may be a powerful therapeutic strategy, even when toxic proteins are already present.”

In treated TDP-43A315T mouse models, SynCav1 preserved learning and memory deficits, behavioral domains typically impaired by TDP‑43 pathology. The therapy also reduced levels of pathological TDP‑43 in the cortex and hippocampus. At the subcellular level, SynCav1 protected mitochondrial structure, stabilized membrane lipid rafts (MLR), and maintained MLR-associated GluN2A receptor expression, which is essential for excitatory synaptic signaling.

The mechanistic insight emerged from a striking observation: in diseased mice, TDP‑43 mislocalized to membrane lipid rafts, disrupting signaling hubs and degrading synaptic ultrastructure. “We found that TDP‑43 is not only accumulating in the wrong subcellular compartments…but also disrupts cellular processes that are essential for neurons to communicate with one another,” said co‑corresponding author Shanshan Wang, MD, PhD, assistant professor of anesthesiology at UCSD School of Medicine. “SynCav1 appears to help preserve this molecular machinery and subcellular localization.”

Electron microscopy revealed that SynCav1 also mitigated mitochondrial hyper‑fragmentation and excessive fission signaling. Axonal myelin integrity was preserved as well, as reported in the study.

“What is especially exciting is that we saw protection across multiple levels—behavior, synapses, axons, membrane signaling, and mitochondrial structure,” Head added. “That kind of broad neuroprotection is exactly what is needed in complex disorders like TDP‑43‑related dementias.”

The authors emphasize that the work is preclinical, but the results support SynCav1 as a neuron‑centric therapeutic candidate that could be applicable across multiple TDP‑43‑linked diseases.

Brian P. Head, PhD, holds equity in and serves as a non‑paid scientific advisory board member for Eikonoklastes Therapeutics. Other authors reported no competing interests.

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Triple Play: Lilly Acquires Three Developers of Infectious Disease Vaccines for Up-to-$3.8B

Eli Lilly has agreed to acquire three privately-held developers of vaccines for infectious diseases for a combined up to $3.83 billion cash, the companies said today, in deals intended to expand the acquisitive pharma giant’s R&D efforts into infectious disease—and which represent Lilly’s eighth, ninth, and 10th planned buyouts of smaller biotechs this year alone.

Lilly announced planned acquisitions of Vaccine Company for up to $1.55 billion, Curevo for up to $1.5 billion, and LimmaTech Biologics for up to $780 million. The planned triple play of buyouts, Lilly said, will enable it to apply differentiated technology platforms toward attacking infectious diseases, focusing on viral pathogens linked to long-term neurological and oncological risk, plus bacterial pathogens long considered difficult to prevent or treat.

“These acquisitions reflect a deliberate strategy to prevent disease at its source rather than treat its consequences,” Daniel M. Skovronsky, MD, PhD, chief scientific and product officer, and president, Lilly Research Laboratories, said in a statement.

“Decades of evidence now link common infections to diseases that potentially emerge years later, including neurological disease, cancer and infertility. And as antimicrobial resistance erodes our ability to treat bacterial infections, vaccines are increasingly the only path to prevention,” Skovronsky added. “Combining these companies’ platforms and teams with Lilly’s global scale positions us to change that trajectory.”

Investors appeared to support the triple play, sending Lilly shares up 1.36% to $1,079.19 as of 11:56 a.m. ET, from $1,065 at Friday’s close of trading.

Capitalizing on tirzepatide billions

The deal spree reflects Lilly’s desire to capitalize on the billions of dollars it is generating from sales of its obesity and diabetes drugs based on glucagon-like peptide 1 (GLP-1) receptor analysts alone or in tandem with a glucose-dependent insulinotropic polypeptide (GIP).

Those drugs account for 58% or $49.329 billion of the $84.978 billion in revenues reported by Lilly in 2025 and the first quarter of 2026. Lilly markets tirzepatide, a GLP-1/GIP dual agonist, in obesity as Zepbound® ($13.542 billion in 2025, $4.16 billion in first quarter 2026) and in diabetes as Mounjaro® ($22.965 billion, $8.662 billion in Q1 ‘26).

Lilly executives did not mention infectious diseases as a potential area of future growth during the company’s most recent earnings call last month with analysts following Q1 results, even as it cited three other therapeutic areas: I&I (immunology and inflammation), neuroscience, and oncology.

“We’re proud of what we’re doing in those three areas, and I think each of them has very significant unmet medical needs that we can scale into as our medicines are successful. We like what we got, and we like the direction we’re going. Of course, in each of those areas, we also see opportunities to get a lot bigger, and we’ve highlighted some of the themes already in those areas,” Skovronsky said on the April 30 call.

“Even without the obesity and metabolic business, Lilly would be the fastest or surely one of the fastest-growing pharmaceutical companies in the industry,” Skovronsky added.

Parade of purchases

Lilly’s long parade of purchases began January 7 when it inked a $1.2 billion acquisition of Ventyx Biosciences, an NLRP3-targeting oral drug developer focused on inflammatory diseases. A month earlier, Lilly announced plans to buy out circular RNA cell therapy developer Orna Therapeutics for up to $2.4 billion, targeting advancements in cell therapy. And in March, Lilly committed up to $7.8 billion to acquire Centessa Therapeutics, a developer of sleep disorder drugs.

Last month, Lilly agreed to acquire three cancer drug companies—in vivo chimeric antigen receptor T-cell (CAR T) developer Kelonia Therapeutics for up to $7 billion; JAK inhibitor developer Ajax Therapeutics for up to $2.3 billion; and next-generation dual-payload antibody-drug conjugate (ADC) developer CrossBridge Bio for up to $300 million.

Just last week on May 20, non-viral DNA delivery-focused drug developer Engage Biologics announced it had been acquired by Lilly for up to $202 million cash, including an upfront payment and payments upon achieving specified development milestones.

As for the latest planned acquisitions:

South San Francisco, CA-based Vaccine Company is developing in vivo nanoparticle (IVN) technologies designed to enable the antigen display known to elicit durable immune responses associated with virus-like particle vaccines, while avoiding the manufacturing burden of traditional VLP production. The company is advancing a preclinical pipeline spanning multiple viral pathogens; the lead program applies this technology to Epstein-Barr Virus (EBV) with a five-antigen Phase I-ready candidate.

Preventing mono and consequences

Lilly and Vaccine Company reason that a prophylactic vaccine could prevent not only acute infectious mononucleosis but also long-term neurological and oncological consequences that may follow infection, given what it said was growing evidence linking EBV to multiple sclerosis and several malignancies,

Under the acquisition deal, Lilly agreed to give Vaccine Company shareholders up to $1.55 billion, which would include an undisclosed upfront payment and additional payments tied to achieving specified clinical and commercial milestones.

LimmaTech Biologics, based near Zurich in Schlieren, Switzerland, is a developer of vaccines targeting bacterial pathogens for which rising antimicrobial resistance is steadily closing therapeutic options, including Staphylococcus aureus, Neisseria gonorrhoeae, and Chlamydia trachomatis. LimmaTech’s platform is designed to generate broad, durable immune responses against complex bacterial targets by targeting the toxins and superantigens that drive disease.

LimmaTech’s lead program, LTB-SA7, is in Phase I development as a vaccine against S. aureus, the leading cause of surgical-site infection. The company has also developed a preclinical pipeline of candidates targeting additional bacterial pathogens, including those that drive infertility and other long-term consequences of infection that fall disproportionately on women.

Lilly has agreed to acquire LimmaTech for up to $780 million, which will include an undisclosed upfront payment and additional potential payments also tied to achieving specified clinical and regulatory milestones.

Seeking greater tolerability

Bothell, WA-based Curevo has an infectious disease vaccine pipeline led by amezosvatein, an adjuvanted subunit vaccine being developed for the prevention of shingles in adults. Curevo acknowledges that the current standard of care for shingles prevention, GlaxoSmithKline (GSK)’s Shingrix® (Zoster Vaccine Recombinant, Adjuvanted) is effective, but says tolerability challenges can limit overall vaccination rates and contribute to second-dose hesitancy, leaving a meaningful portion of patients with reduced or no protection against shingles and its long-term consequences.

To prevent that problem, amezosvatein has been engineered with a next-generation synthetic adjuvant. In a Phase II trial head-to-head against Shingrix, amezosvatein matched immune response across all primary endpoints and reduced side effects such as activity-limiting fatigue, chills, and pain at the injection site by more than half. Lilly and Curevo reason that in light of growing evidence linking shingles to elevated risk of stroke and tying shingles vaccination to lower risk of dementia, a better-tolerated vaccine could reduce these long-term risks, thus expanding the reach of shingles prevention.

Lilly’s up to $1.5 billion deal price for Curevo includes another upfront payment and an additional payment hinging upon achievement of a certain milestone, all unspecified.

All three deals are subject to customary closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Lilly said it will determine the accounting treatment of the transactions upon closing, in accordance with Generally Accepted Accounting Principles (GAAP). The transactions will be reflected in Lilly’s future financial results and financial guidance to investors.

That guidance was raised last month after Lilly reported stellar first quarter earnings tied to booming sale of its blockbuster tirzepatide-based drugs. Lilly raised its full-year 2026 revenue guidance to between $82 billion and $85 billion, and non-GAAP earnings per share (EPS) guidance to be in the range of $35.50 to $37.00.

In February, Lilly guided investors to between $80 billion and $83 billion in revenue, and non-GAAP EPS ranging from of $33.50 to $35.00.

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MOSAIC: Multimodal In Vivo Imaging Data Powers AI Models for Living Systems

In a new study published in Nature Methods titled, “A multimodal adaptive optical microscope for in vivo imaging from molecules to organisms,” researchers from University of California, Berkeley present high-powered microscopes that can track the development of live specimens, including cell movement through tissue, the evolution of internal cellular structures, and shuttling of proteins and other molecules within the cell. The system, named Multimodal Optical Scope with Adaptive Imaging Correction (MOSAIC), has been implemented in more than a dozen worldwide labs over the past six years. 

“Life has to be studied in living tissue, holistically, and over fast timescales and for long periods of time,” said Eric Betzig, PhD, professor of molecular and cell biology at UC Berkeley, 2014 Nobel Prize in Chemistry, and co-corresponding author on the study. “You can’t study something as complex as a cell or organism just by looking at the parts individually—there are something like 40 million protein molecules alone of 20,000 different types.” 

The microscope uses a large “vision” language model (LVLM), similar to ChatGPT, to measure petabytes of data, the equivalent of about 500 billion pages of text.  

Betzig, who is also a Howard Hughes Medical Institute (HHMI) investigator, refers to the imaging data as five-dimensional (5D) composed of three spatial dimensions, plus time and color. The color comes from fluorescent labels that allow scientists to track multiple subcellular structures simultaneously, such as organelles, membranes, the cytoskeleton and more, as they migrate, change shape, divide and interact over time. 

In one video, the authors capture a zebrafish regrowing its tail fin. The video revealed tiny events inside living tissue that are normally difficult to visualize, such as cells near the wound releasing small communication packets, microscopic fibers beneath the skin shifting as the tissue repaired itself, two repair cells fusing together and a red blood cell briefly getting trapped as new blood vessels were remodeled. 

Ian Swinburne, PhD, assistant professor of molecular and cell biology at UC Berkeley and collaborator on the work, emphasizes that there’s a wealth of information in these large movies across scales, but it can be difficult for a very well-trained biologist to interrogate the data.

“AI can help us interface with the data and ask or answer questions more easily. Like, ‘How many macrophages are crawling into my tissue during an infection?’ or ‘Can I predict when a cell’s going to start leaving its organ?’ That happens in development but also in cancer during metastasis,” said Swinburne. 

Building an LVLM or AI that can handle petabytes of imaging data is a main focus of Berkeley’s Advanced Bioimaging Center, which hopes to create a first-of-its-kind Cell Observatory. 

“The impact of MOSAIC will be minimal until we build an AI model that can deal with the data that comes out of those systems. We basically have a gold mine, but we have no ability to get the gold out,” said Srigokul “Gokul” Upadhyayula, PhD, assistant professor in residence of cell biology, development and physiology at UC Berkeley. “The primary output of our Cell Observatory Initiative will be an AI mind that’s able to be our scientific partner in extracting these observations.” 

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A framework for building a synthetic cell from the SynCell Asia Initiative

Nature Biotechnology, Published online: 26 May 2026; doi:10.1038/s41587-026-03153-w

Building a living cell from scratch requires overcoming a bottleneck that has remained unresolved despite decades of progress: orchestrating the spatiotemporal integration of core functional modules. To tackle this barrier, the SynCell Asia Initiative outlines a strategy for developing core functional modules followed by their systems-level integration through the establishment of a centralized, artificial intelligence (AI)-driven biofoundry.