ReportWire

Tag: Biotech

  • A Gene Editing Therapy Cut Cholesterol Levels by Half

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    In a step toward the wider use of gene editing, a treatment that uses Crispr successfully slashed high cholesterol levels in a small number of people.

    In a trial conducted by Swiss biotech company Crispr Therapeutics, 15 participants received a one-time infusion meant to switch off a gene in the liver called ANGPTL3. Though rare, some people are born with a mutation in this gene that protects against heart disease with no apparent adverse consequences.

    The highest dose tested in the trial reduced both “bad” LDL cholesterol and triglycerides by an average of 50 percent within two weeks after treatment. The effects lasted at least 60 days, the length of the trial. The results were presented today at the American Heart Association’s annual meeting and published in The New England Journal of Medicine.

    The Nobel Prize–winning Crispr technology has mostly been used to address rare diseases, but these latest findings, while early, add to the evidence that the DNA-editing tool could be used to treat common conditions as well.

    “This will probably be one of the biggest moments in the arc of Crispr’s development in medicine,” Samarth Kulkarni, CEO of Crispr Therapeutics, tells WIRED. The company is behind the only approved gene-editing treatment on the market, Casgevy, which treats sickle cell disease and beta thalassemia.

    The American Heart Association estimates that about a quarter of adults in the US have elevated LDL levels. A similar number have high triglycerides. LDL cholesterol is the waxy substance in the blood that can clog and harden arteries over time. Triglycerides, meanwhile, are the most common type of fat found in the body. High levels of both raise the risk of heart attack and stroke.

    The Phase I trial was conducted in the UK, Australia, and New Zealand between June 2024 and August 2025. Participants were between the ages of 31 and 68 and had uncontrolled levels of LDL cholesterol and triglycerides. The trial tested five different doses of the Crispr infusion, which took about two and a half hours on average to administer.

    “These are very sick people,” says Steven Nissen, senior author and chief academic officer of the Heart, Vascular and Thoracic Institute at Cleveland Clinic, which independently confirmed the trial’s results. “The tragedy of this disease is not just that people die young, but some of them will have a heart attack, and their lives are never the same again. They don’t get back to work, they develop heart failure.”

    One trial participant, a 51-year-old man, died six months after receiving the lowest dose of the treatment, which was not associated with a lowering of cholesterol and triglycerides. The death was related to his existing heart disease, not the experimental Crispr treatment. The man had a rare, inherited genetic form of high cholesterol and previously had several procedures to improve blood flow to his heart.

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    Emily Mullin

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  • A New Startup Wants to Edit Human Embryos

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    In 2018, Chinese scientist He Jiankui shocked the world when he revealed that he had created the first gene-edited babies. Using Crispr, he tweaked the genes of three human embryos in an attempt to make them immune to HIV and used the embryos to start pregnancies.

    The backlash against He was immediate. Scientists said the technology was too new to be used for human reproduction and that the DNA change amounted to genetic enhancement. The Chinese government charged him with “illegal medical practices,” and he served a three-year prison sentence.

    Now, a New York–based startup called Manhattan Genomics is reviving the debate around gene-edited babies. Its stated goal is to end genetic disease and alleviate human suffering by fixing harmful mutations at the embryo stage. The company has announced a group of “scientific contributors” that includes a prominent in vitro fertilization doctor, a data scientist who worked for de-extinction company Colossal Biosciences, and two reproductive biologists from a major primate research center. A scientist who pioneered a technique to make embryos using DNA from three people is also involved.

    “I like to take on challenges when I see them,” says cofounder Cathy Tie, a former Thiel fellow who left college at 18 to start her first company, Ranomics, a genomics screening service. As Tie sees it, that challenge is to make the idea of human embryo editing more acceptable in society.

    The idea of editing human embryos is tantalizing, because any changes made to the reproductive cells are heritable. Snip out a disease-causing mutation in an embryo and it would be deleted from future generations as well. But gene-editing technology also has the potential to cause unintended “off-target” effects. Edit the wrong gene by mistake and it could give rise to cancer, for instance. Those mistakes would also be passed down to any future children.

    While newer forms of gene editing are more precise, there are still ethical issues to contend with. The prospect of being able to manipulate the DNA of a human embryo has raised fears of a new kind of eugenics, where parents with the means to do so could make “designer babies” with traits that they select.

    Tie says the goal of Manhattan Genomics—originally called the Manhattan Project when the company first launched in August—is disease correction, not enhancement. Unlike the original Manhattan Project, a secretive US government program during World War II that produced the first nuclear weapons, Tie says her venture will operate openly and transparently. “We’re revolutionizing medicine, and this technology is definitely very powerful. That’s what I think is the commonality here with manipulating the nucleus of the atom and manipulating the nucleus of the cell,” she says.

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    Emily Mullin

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  • Jona Health’s Mail-Order Kit Helps You Decode Your Microbiome

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    Look, there’s nothing quite like starting your day by pooping on a little paper hammock affixed to your toilet seat and then poking it a bunch of times with a cotton swab. It was more of a mental hurdle than a practical one, though, as the collection and disposal (you just flush the hammock down when you’re done) was easy enough. You then swish the stick around in a solution, cap it, and send it off. Twenty days later, I got an email that my results were in.

    On the website, your results are broken down into a few sections: Summary (with tabs for Brain Health, GI Health, Metabolic Health, Skin Health, and Physical Performance), Action Plan (with tabs for Highest Impact, Diet, Lifestyle, and Probiotics), and the Organisms page, which shows you every single organism it found in your sample, and their relative abundance. Mine held some surprises.

    On the positive side, my Microbiome Diversity came in at 4.19, which is above average (normal range is 2.80–3.99, as measured by the Shannon Index), which it says is a sign of a healthy microbiome, and it didn’t find any pathogens or parasites. It says I digest lactose well (thank goodness). It didn’t find any associations for things like depression, celiac disease, IBS, ulcerative colitis, leaky gut, hypertension, eczema, or a bunch of other things that I’m thankful to not have. Some of these were actually a bit puzzling, frankly, as I’ve struggled with insomnia pretty much my entire life, but it didn’t find any associations there, or for fatigue, and I am most assuredly a tired human.

    As far as associations that it did find, some were things I suspected, while others were total surprises. Under Brain Health, I had a moderate association for stress and a low association for ADHD, neither of which shocked me. Under Metabolic health was a “very low” association for prediabetes, which I actually thought would be higher, unfortunately. I had a moderate association with osteoarthritis, which made sense, given my family history.

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    Brent Rose

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  • FDA Adds Label Warning to J&J’s and Legend Biotech’s Cancer Therapy

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    The U.S. Food and Drug Administration approved on Friday labeling changes for the blood cancer therapy of Johnson & Johnson and its partner Legend Biotech to include a warning for a potentially fatal gastrointestinal condition.

    Such a warning appears on the medicine’s label and is the most serious issued by the FDA.

    The FDA said it received reports that some patients treated with Carvykti developed a serious gut inflammation called IEC-EC, which in some cases led to life-threatening complications like bowel perforation and sepsis.

    Reports were received from clinical trials and postmarketing adverse event data, the FDA said.

    IEC-EC is a form of inflammation of the intestines triggered by the immune system. It was observed weeks to months after CAR-T therapy treatment with Carvykti in both clinical trials and after approval, the regulator said.

    Symptoms included persistent diarrhea, stomach pain and weight loss, often requiring intensive care and immune-suppressing drugs.

    A spokesperson for Johnson & Johnson said: “With more than 8,500 patients treated, the overall benefit/risk for Carvykti continues to be favorable, demonstrating durable responses with statistically significant progression-free survival and overall survival benefits.

    “The Carvykti label was also updated to include data showing a superior overall survival benefit versus standard therapies… at nearly three years of follow-up in patients receiving one to three prior lines of therapy.”

    Carvykti was first approved in February 2022 and received expanded approval in April 2024 for adults with relapsed or refractory multiple myeloma who had received at least one prior line of therapy.

    Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, found in the bone marrow.

    The FDA also updated the “clinical studies” section of the drug’s prescribing information to include overall survival data from the late-stage trial.

    The interim data of the late-stage study showed a statistically significant improvement in survival for patients receiving Carvykti compared to those on standard therapy, with a median follow-up of 33.6 months.

    Despite the new safety concerns, the FDA said the overall benefit of Carvykti continues to outweigh the risks for its approved use.

    Reporting by Siddhi Mahatole in Bengaluru; Editing by Alan Barona and Muralikumar Anantharaman

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    Reuters

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  • Life sciences advocates, economic development agencies launch centralized hub | Long Island Business News

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    New York Bio Connect, a new and life sciences hub, has officially launched to serve as a central resource for New York’s life science community. Designed to accelerate innovation and strengthen collaboration within the state’s life-science community, the hub offers streamlined access to information, tools and support to help organizations advance across the state, including on Long Island.

    The initiative is a joint effort by NewYorkBIO, which advocates for life sciences in the state,  the New York City Economic Development Corporation (NYCEDC) and Empire State Development. It was unveiled at NewYorkBIO’s annual Innovation Summit in Manhattan earlier this week.

    “The launch of New York Bio Connect marks an important milestone for our state’s life sciences community,” Jennifer Hawks Bland, CEO of NewYorkBIO, said in a news release about the initiative.

    “This platform reflects the collective strength of New York’s ecosystem – bringing together companies of every size, academic institutions, investors and support organizations,” Bland added. “By making it easier to access resources and opportunities, New York Bio Connect will empower innovators to advance research, accelerate development and bring groundbreaking treatments and technologies to patients.”

    Described by its organizers as the first information hub of its kind for New York’s bioscience industry, New York Bio Connect aims to bring together funding opportunities, facility details, career openings, services, programs and statewide news and to help life science professionals and companies gain traction across the state.

    “By centralizing essential resources, opportunities, and information, this platform breaks down barriers and empowers entrepreneurs, researchers and companies of all sizes to reach their highest potential – driving discoveries, supporting job growth and ultimately improving health outcomes for communities across New York and beyond,” NYCEDC President and CEO Andrew Kimball said in the news release.

    Supporting companies of all sizes and stages, NewYorkBIO, NYCEDC and Empire State Development say they identified an opportunity to reduce barriers in the industry. Their solution: a central hub where life science companies and professionals — whether based in New York or considering a move — can access the resources needed to thrive.

    “With New York Bio Connect, we are creating a powerful economic development asset for the entire state,” Hope Knight, president, CEO and commissioner of Empire State Development, said in the news release.

    “This platform will not only spotlight the tremendous work happening across our life sciences ecosystem, but also expand access to capital, facilities, talent and partnerships – helping New York attract investment, grow companies, and create good jobs in every region,” she added.

    More information about the platform is available here.


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    Adina Genn

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  • Neuralink’s Bid to Trademark ‘Telepathy’ and ‘Telekinesis’ Faces Legal Issues

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    The United States Patent and Trademark Office has rejected Neuralink’s attempt to trademark the product names Telepathy and Telekinesis, citing pending applications by another person for the same trademarks.

    Neuralink, the brain implant company cofounded by Elon Musk, filed to trademark the names in March. But in letters sent to Neuralink in August, the trademark office is refusing to allow the applications to move forward. It says Wesley Berry, a computer scientist and a cofounder of the tech startup Prophetic, previously filed trademark applications for Telepathy in May 2023 and Telekinesis in August 2024. Prophetic is building a wearable headset to induce lucid dreaming, but only Berry is the author of the trademark applications, not Prophetic. (Berry declined to comment for this story.)

    In response to Neuralink’s application for Telepathy, the trademark office also references the existing trademark for Telepathy Labs, a Tampa-based company that provides interactive voice and chatbot technology to businesses.

    Musk’s Neuralink, meanwhile, is developing a brain-computer interface that involves a device, surgically implanted in the skull, that collects brain activity. The company has been using the name Telepathy to describe its first product, which is designed to allow paralyzed people the ability to operate their phones and computers with just their thoughts. Musk unveiled the Telepathy name in a January 2024 social media post, shortly after the company implanted its first volunteer with the technology. A total of nine people now have the Neuralink device, according to a July announcement. (Neuralink did not respond to a request for comment.)

    Both Berry and Neuralink filed “intent-to-use” applications, which allow businesses and inventors to reserve trademark rights before using the mark in commerce. Berry’s application for Telepathy was accepted in December 2024 and for Telekinesis in August 2025 but the trademarks aren’t fully registered until he shows that he’s actually using them in commerce. Berry has three years to do that from acceptance, otherwise his applications would be considered abandoned and Neuralink’s application would take priority.

    Berry has not marketed nor commercialized a product called Telepathy or Telekinesis, but in his trademark applications describes both as “software that analyzes EEG to decode internal dialogue to control computer or mobile devices.” EEG, or electroencephalogram, data refers to the electrical activity of the brain recorded through electrodes worn on the scalp.

    The trademark office’s letters to Neuralink are not final decisions. Neuralink filed a response letter on August 28 addressing the existing Telepathy Labs trademark, saying that Neuralink’s Telepathy product is not likely to be confused with Telepathy Labs. Neuralink did not address Berry’s applications in its response.

    “The standard for likelihood of confusion is, if a random consumer encountered both of these products, would they think that they’re coming from the same company?” says Heather Antoine, an intellectual property partner at Stoel Rives in Sacramento, California.

    The trademark office will consider Neuralink’s response and decide if there is a likelihood of confusion. But there’s still the fact that Berry filed to register the Telepathy and Telekinesis marks first. If Berry succeeds in registering the marks, Neuralink would have a few options. It could attempt to buy the trademarks from Berry or negotiate a consent agreement, in which Berry could agree to allow Neuralink to also use the marks. These types of agreements are usually made when the trademarks are not likely to cause consumer confusion.

    If Berry is successful in registering Telepathy, Neuralink could be sued if the company continues to use it.

    Josh Gerben, a trademark attorney and founder of Gerben IP in Washington, DC, says it’s difficult to know how things will shake out because there’s a lot of nuance to a trademark claim. “Certainly at the moment, though, advantage goes to this other applicant,” he says, referring to Berry. “He could become a considerable thorn in the side of Neuralink in terms of these trademarks.”

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    Emily Mullin

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  • A Neuralink Rival Says Its Eye Implant Restored Vision in Blind People

    A Neuralink Rival Says Its Eye Implant Restored Vision in Blind People

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    One of these, called the Argus II, was approved for commercial use in Europe in 2011 and in the US in 2013. That implant involved larger electrodes that were placed on top of the retina. Its manufacturer, Second Sight, stopped producing the device in 2020 due to financial difficulties. Neuralink and some others, meanwhile, are aiming to bypass the eye completely and stimulate the brain’s visual cortex instead.

    Hodak says the Prima differs from other retinal implants in its ability to provide “form vision,” or the perception of shapes, patterns, and other visual elements of objects. What users see isn’t “normal” vision though. For one, they don’t see in color. Rather, they see a processed image with a yellowish tint.

    The trial enrolled people with geographic atrophy, an advanced form of age-related macular degeneration, or AMD, that causes gradual loss of central vision. People with the condition still have peripheral vision but have blind spots in their central vision, making it difficult to read, recognize faces, or see in low light.

    In AMD, specialized cells called photoreceptors are damaged over time. Located at the back of the retina, photoreceptors convert light into signals that are sent to the brain. “The photoreceptors are lost but the retina is preserved to a large extent. In our approach, the implant takes the place of the photoreceptors,” says Daniel Palanker, a professor of ophthalmology at Stanford University, who invented the Prima implant.

    The Prima implant is a honeycomb pattern of 378 independently controlled pixels that convert infrared light into electrical signals. It measures 2 mm x 2 mm.

    Image Courtesy of Science Corp

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    Emily Mullin

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  • MCC’s biotechnology program receives Pathmaker Validation from Mass Life Sciences Center

    MCC’s biotechnology program receives Pathmaker Validation from Mass Life Sciences Center

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    On Aug. 13, Middlesex Community College’s biotechnology program received a Pathmaker Validation from the Mass Life Sciences Center. Representatives from MLSC joined Middlesex President Phil Sisson, Provost Arlene Rodríguez, and biotechnology faculty to visit the lab and award a plaque of recognition for the success and effectiveness of MCC’s program.

    “We are thrilled to receive the Pathmaker Validation from Mass Life Sciences Center and are proud to display our plaque of recognition in our state-of-the-art biotechnology lab,” Sisson said. “This honor from MLSC proves that our combination of interactive lab experiences, comprehensive curriculum, and ample networking opportunities offer robust and life-changing programs that lend to the stability and success of our students, the biotechnology industry, and the Massachusetts workforce. Our partnership with MLSC will help us continue to provide a diverse population of students with skills and training to enter and advance in their careers in an in-demand and much needed field.”

    “The Pathmaker program provides career seekers from all backgrounds with the proper training needed to enter the exciting world of life sciences,” said MLSC Acting CEO and Vice President of Economic Development and Partnerships Jeanne LeClair. “This effort wouldn’t be possible without the collaboration of our training program partners, including Middlesex Community College, who contribute to developing a substantial workforce to meet the needs of the ever-growing Massachusetts life sciences industry.”

    The MLSC Pathmaker program funds industry-aligned training programs that address critical skills and talent supply gaps and connects skilled, diverse workers with life science career opportunities in Massachusetts. Additionally, one of the goals of Pathmaker is to serve as a stamp of approval on specific training programs that meet the most up-to-date industry criteria, thereby sending a strong signal to prospective career seekers.

    Pathmaker validation ensures that programs up to and including associate degrees receive a stamp of approval, affirming their alignment with industry standards and Pathmaker Core Competencies. This helps ensure top-tier quality in biomanufacturing education and industry readiness.

    Both MCC’s biotechnology associate degree and certificate program were recognized as Pathmaker programs. The college’s programs are taught by experts who have worked in the biotechnology field, and include lab experiences and conditions that are similar to those found in a work environment.

    Middlesex also offers an award-winning Biotechnology Learn and Earn program to provide students with the opportunity to work full-time for a partner company while earning a degree.

    “We are excited to be a Pathmaker-recognized program and to partner with MLSC to continue to help strengthen the biotechnology field,” said Dean of STEM Marie Tupaj. “The Massachusetts biotechnology industry is comprised of many of MCC’s current and former students who are leaders of their field and are eager to give back to the college community. Students come to MCC at different stages of their lives and discover opportunities that get them into the workforce as soon as possible, prepare them to further their education, and help them pursue dream careers.”

    Visit middlesex.mass.edu/registration for more information on MCC’s biotechnology program and to register for classes.

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  • An Ultrathin Graphene Brain Implant Was Just Tested in a Person

    An Ultrathin Graphene Brain Implant Was Just Tested in a Person

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    In 2004, Andre Geim and Konstantin Novoselov at the University of Manchester in England achieved a breakthrough when they isolated graphene for the first time. A flat form of carbon made up of a single layer of atoms, graphene is the thinnest known material—and one of the strongest. Hailed as a wonder material, it won Geim and Novoselov a Nobel Prize in physics in 2010.

    Twenty years later, graphene is finally making its way into batteries, sensors, semiconductors, air conditioners, and even headphones. And now, it’s being tested on people’s brains.

    This morning, surgeons at the University of Manchester temporarily placed a thin, Scotch-tape-like implant made of graphene on the patient’s cortex—the outermost layer of the brain. Made by Spanish company InBrain Neuroelectronics, the technology is a type of brain-computer interface, a device that collects and decodes brain signals. InBrain is among several companies, including Elon Musk’s Neuralink, developing BCIs.

    “We are aiming to have a commercial product that can do brain decoding and brain mapping and could be used in a variety of disorders,” says Carolina Aguilar, InBrain’s CEO and cofounder.

    Brain mapping is a technique used to help plan brain surgeries. When taking out a brain tumor, for instance, surgeons place electrodes on the brain to determine the location of motor and speech function in the brain so that they can safely remove the tumor without affecting the patient’s ability to move or speak.

    During today’s surgery, the implant was installed for 79 minutes. The patient was already undergoing brain surgery to have a tumor removed and consented to the experiment. In that time, researchers observed that the InBrain device was able to differentiate between healthy and cancerous brain tissue with micrometer-scale precision.

    The University of Manchester is the site of InBrain’s first-in-human study, which will test the graphene device in up to 10 patients who are already undergoing brain surgery for other reasons. The goal of the study, which is funded by the European Commission’s Graphene Flagship project, is to demonstrate the safety of graphene in direct contact with the human brain.

    David Coope, the neurosurgeon who performed the procedure, says the InBrain device is more flexible than a conventional electrode, allowing it to better conform to the surface of the brain. “From a surgical perspective, it means we can probably put it in places where we would find it difficult to put an electrode,” he says. The mainstay electrodes used for brain mapping are disks of platinum iridium set in silicon. “So they’re reasonably stiff,” Coope says.

    By contrast, the InBrain device is a transparent sheet that sits on the brain’s surface. Half the thickness of a human hair, it contains 48 tiny decoding graphene electrodes measuring just 25 micrometers each. The company is developing a second type of implant that penetrates the brain tissue and can deliver precise electrical stimulation.

    The surface device alone can be used for brain mapping, but Aguilar says the company is also integrating the two devices and plans to eventually test them together as a treatment for neurological disorders such as Parkinson’s disease.

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    Emily Mullin

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  • This Brain Implant Lets People Control Amazon Alexa With Their Minds

    This Brain Implant Lets People Control Amazon Alexa With Their Minds

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    “It’s pretty exciting and freeing to keep my independence,” Mark says. “Some days can be more challenging, especially depending how I’m feeling, but the layout of the Amazon tablet makes it pretty easy to interact with and complete the tasks I need to.”

    Amazon declined to respond to a request for comment.

    Synchron has also connected Mark’s BCI to OpenAI’s ChatGPT and the Apple Vision Pro, a mixed-reality headset. Released earlier this year, the Vision Pro requires hand gestures to make item selections. After Synchron’s integration, Mark could use his thoughts to control the cursor on the Vision Pro to play Solitaire, watch Apple TV, and send text messages. In addition to Mark, one of Synchron’s trial participants in Australia is now using these applications as well.

    Alexa and the Vision Pro both connect to Mark’s BCI via Bluetooth. A Synchron field engineer visits Mark at his home in Pennsylvania twice a week while he practices using his BCI. Mark says the different platforms provide a range of capabilities that he can use in his daily life, but the experience isn’t always smooth. “We’ve been working through accessibility challenges on all platforms to make it better for the next generation of users,” he says.

    Synchron’s BCI resembles a mesh stent and is dotted with electrodes that collect neural signals. Instead of being directly implanted in the brain, it’s inserted into the jugular vein at the base of the neck in a minimally invasive procedure. A surgeon pushes the device through the vein until it sits against the motor cortex—a region of the brain that controls voluntary movement. Once implanted, it’s designed to detect and wirelessly transmit movement intentions out of the brain so that paralyzed people can control personal devices hands-free.

    While virtual assistants are already helpful for people with disabilities, they don’t always afford privacy since they rely on voice commands that can be overheard. “Restoring any amount of independence is really important to people, but restoring independent private use is even better,” says Emily Graczyk, an assistant professor of biomedical engineering at Case Western Reserve University, who is working on restoring sensation with BCIs.

    She thinks Synchron’s approach could also help provide a sense of normalcy to people with limited mobility because it means they can use the same devices as their families and friends, rather than special assistive devices.

    Ian Burkhart, a quadriplegic who participated in a trial of a different company’s BCI, sees Synchron’s efforts as a positive thing for patients as long as the devices are seamlessly integrated and users can interact with them in a practical way in their day-to-day lives. “It’s really interesting,” he says. “I see the future of BCI as just being a pipe that can let data flow from the brain to control anything that you can control with a computer.” Burkhart received an implant made by Blackrock Neurotech in 2014 but had it removed in 2021 after developing an infection.

    Oxley says Synchron is working on more features and says it is talking to other big tech companies about further integrations. The most common thing that paralyzed patients say they want is to be able to multitask, he says.

    “Things like scroll, click, drag, menu drop-down, back—all these different things that we use our fingers to do—we’re figuring out ways to identify unique signatures from the brain and can then generate product features to control operating systems,” Oxley says.

    Mark is hoping his BCI will eventually allow him to do more complex tasks. For one, he wants to get back to painting.

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    Emily Mullin

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  • Woman Who Received Pig Kidney Transplant Has It Removed

    Woman Who Received Pig Kidney Transplant Has It Removed

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    Surgeons in New York have removed a pig kidney less than two months after transplanting it into Lisa Pisano, a 54-year-old woman with kidney failure who also needed a mechanical heart pump. The team behind the transplant says there were problems with the heart pump, not the pig kidney, and that the patient is in stable condition.

    Pisano was facing heart and kidney failure and required routine dialysis. She wasn’t eligible to receive a traditional heart and kidney transplant from a human donor because of several chronic medical conditions that reduced the likelihood of a good outcome.

    Pisano first received a heart pump at NYU Langone Health on April 4, followed by the pig kidney transplant on April 12. The heart pump, a device called a left ventricular assist device or LVAD, is used in patients who are either awaiting heart transplantation or otherwise aren’t a candidate for a heart transplant.

    In a statement provided to WIRED, Pisano’s medical team explained that they electively removed the pig kidney on May 29—47 days after transplant—after several episodes of the heart pump not being able to pass enough blood through the transplanted kidney. Steady blood flow is important so that the kidney can produce urine and filter waste. Without it, Pisano’s kidney function began to decline.

    “On balance, the kidney was no longer contributing enough to justify continuing the immunosuppression regimen,” said Robert Montgomery, director of the NYU Langone Transplant Institute, in the statement. Like traditional transplant patients, Pisano needed to take immunosuppressive drugs to prevent her immune system from rejecting the donor organ.

    The kidney came from a pig genetically engineered by Virginia biotech company Revivicor to lack a gene responsible for the production of a sugar known as alpha-gal. In previous studies at NYU Langone, researchers found that removing this sugar prevented immediate rejection of the organ when transplanted into brain-dead patients. During Pisano’s surgery, the donor pig’s thymus gland, which is responsible for “educating” the immune system, was also transplanted to reduce the likelihood of rejection.

    A recent biopsy did not show signs of rejection, but Pisano’s kidney was injured due to a lack of blood flow, according to the statement. The team plans to study the explanted pig kidney to learn more.

    Pisano is now back on dialysis, a treatment for kidney-failure patients, and her heart pump is still functioning. She would not have been a candidate for the heart pump if she had not received the pig kidney.

    “We are hoping to get Lisa back home to her family soon,” Montgomery said, calling Pisano a “pioneer and a hero in the effort to create a sustainable option for people waiting for an organ transplant.”

    Pisano was the second living person to receive a kidney from a genetically engineered pig. The first, Richard Slayman of Massachusetts, died in May just two months after the historic transplant. The surgery was carried out on March 16 at Massachusetts General Hospital. In a statement released on May 11, the hospital said it had “no indication” that Slayman’s death was the result of the pig kidney transplant. The donor pig used in Slayman’s procedure had a total of 69 different genetic edits.

    The global donor organ shortage has led researchers including the NYU and Massachusetts teams to pursue the possibility of using pigs as an alternative source. But the body immediately recognizes pig tissue as foreign, so scientists are using gene editing in an effort to make pig organs look more like human ones to the immune system. Just how many gene edits will be needed to keep pig organs working in people is a topic of much debate.

    Pig heart transplants have also been carried out in two individuals—one in 2022 and the other in 2023—at the University of Maryland. In both cases, the patients were not eligible for human ones. Those donor pigs had 10 genetic edits and were also bred by Revivcor. Both recipients died around two months after their transplants.

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    Emily Mullin

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  • WTF Is With the Pink Pineapples at the Grocery Store?!

    WTF Is With the Pink Pineapples at the Grocery Store?!

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    On a recent trip to Giant Eagle, my local grocery store in Pittsburgh, I noticed something new in the fruit section: a single pineapple packaged in a pink and forest-green box. A picture on the front showed the pineapple cut open, revealing rose-colored flesh. Touted as the “jewel of the jungle,” the fruit was the Pinkglow pineapple, a creation of American food giant Fresh Del Monte. It cost $9.99, a little more than double the price of a regular yellow pineapple.

    I put the box in my cart, snapped a picture with my phone, and shared the find with my foodie friends. I mentioned that its color is the result of genetic modification—the box included a “made possible through bioengineering” label—but that didn’t seem to faze anyone. When I brought my Pinkglow to a Super Bowl party, people oohed and aahed over the color and then gobbled it down. It was juicier and less tart than a regular pineapple, and there was another difference: It came with the characteristic crown chopped off. Soon enough, my friends were buying pink pineapples too. One used a Pinkglow to brew homemade tepache, a fermented drink made from pineapple peels that was invented in pre-Columbian Mexico.

    At a time when orange cauliflower and white strawberries are now common sights in American grocery stores, a non-yellow pineapple doesn’t seem all that out of place. Still, I wondered: Why now with the flashy presentation? And why pink? And why had my friends and I snapped it right up?

    When I brought my questions to Hans Sauter, Fresh Del Monte’s chief sustainability officer and senior vice president of R&D and agricultural services, he began by offering me a brief history of the fruit. You may assume, like I did, that pineapples have always been sweet and sunny-colored—but that wasn’t the case prior to the 1990s. Store-bought pineapples of yesteryear had a green shell with light yellow flesh that was often more tart than sweet. Buying a fresh one was a bit of a gamble. “Nobody could tell, really, whether the fruit was ripe or not, and consumption of pineapples was mostly canned product, because people could trust what they would eat there,” Sauter says. The added sugar in some canned pineapple made it a sweeter, more consistent product.

    In 1996 the company introduced the Del Monte Gold Extra Sweet, yellower and less acidic than anything on the market at the time. Pineapple sales soared, and consumers’ expectations of the fruit were forever changed. The popularity of the Gold led to an international pineapple feud when fruit rival Dole introduced its own varietal. Del Monte sued, alleging that Dole had essentially stolen its Gold formula. The two companies ended up settling out of court.

    With the success of its Gold pineapple, Del Monte was looking for new attributes that could make the pineapple even more enticing to consumers, Sauter says. But breeding pineapples is a slow process; it can take two years or longer for a single plant to produce mature fruit. Del Monte had spent 30 years crossbreeding pineapples with certain desired characteristics before it was ready to launch the Gold. Sauter says the possibility of waiting 30 more years for a new variety was “out of the question.” So in 2005 the company turned to genetic engineering.

    Del Monte didn’t set out to make a pink pineapple per se, but at the time, Sauter says, there was interest from consumers in antioxidant-rich fruits. (Acai bowls and pomegranate juice, anyone?) Pineapples happen to naturally convert a reddish-pink pigment called lycopene, which is high in antioxidants, into the yellow pigment beta-carotene. (Lycopene is what gives tomatoes and watermelon their color.) Preventing this process, then, could yield pink flesh and higher antioxidants. The company set its dedicated pineapple research team to the task of figuring out how to do it.

    The team landed on a set of three modifications to the pineapple genome. They inserted DNA from a tangerine to get it to express more lycopene. They added “silencing” RNA molecules to mute the pineapple’s own lycopene-converting enzymes, which also helped reduce its acidity. (RNA silencing is the same technique used to make non-browning GMO Arctic apples.) Finally, Del Monte added a gene from tobacco that confers resistance to certain herbicides, though representatives for the company say this was simply so its scientists could confirm that the other genetic changes had taken effect—not because Del Monte plans to use those herbicides in production.

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    Emily Mullin

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  • There’s New Hope for an HIV Vaccine

    There’s New Hope for an HIV Vaccine

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    Since it was first identified in 1983, HIV has infected more than 85 million people and caused some 40 million deaths worldwide.

    While medication known as pre-exposure prophylaxis, or PrEP, can significantly reduce the risk of getting HIV, it has to be taken every day to be effective. A vaccine to provide lasting protection has eluded researchers for decades. Now, there may finally be a viable strategy for making one.

    An experimental vaccine developed at Duke University triggered an elusive type of broadly neutralizing antibody in a small group of people enrolled in a 2019 clinical trial. The findings were published today in the scientific journal Cell.

    “This is one of the most pivotal studies in the HIV vaccine field to date,” says Glenda Gray, an HIV expert and the president and CEO of the South African Medical Research Council, who was not involved in the study.

    A few years ago, a team from Scripps Research and the International AIDS Vaccine Initiative (IAVI) showed that it was possible to stimulate the precursor cells needed to make these rare antibodies in people. The Duke study goes a step further to generate these antibodies, albeit at low levels.

    “This is a scientific feat and gives the field great hope that one can construct an HIV vaccine regimen that directs the immune response along a path that is required for protection,” Gray says.

    Vaccines work by training the immune system to recognize a virus or other pathogen. They introduce something that looks like the virus—a piece of it, for example, or a weakened version of it—and by doing so, spur the body’s B cells into producing protective antibodies against it. Those antibodies stick around so that when a person later encounters the real virus, the immune system remembers and is poised to attack.

    While researchers were able to produce Covid-19 vaccines in a matter of months, creating a vaccine against HIV has proven much more challenging. The problem is the unique nature of the virus. HIV mutates rapidly, meaning it can quickly outmaneuver immune defenses. It also integrates into the human genome within a few days of exposure, hiding out from the immune system.

    “Parts of the virus look like our own cells, and we don’t like to make antibodies against our own selves,” says Barton Haynes, director of the Duke Human Vaccine Institute and one of the authors on the paper.

    The particular antibodies that researchers are interested in are known as broadly neutralizing antibodies, which can recognize and block different versions of the virus. Because of HIV’s shape-shifting nature, there are two main types of HIV and each has several strains. An effective vaccine will need to target many of them.

    Some HIV-infected individuals generate broadly neutralizing antibodies, although it often takes years of living with HIV to do so, Haynes says. Even then, people don’t make enough of them to fight off the virus. These special antibodies are made by unusual B cells that are loaded with mutations they’ve acquired over time in reaction to the virus changing inside the body. “These are weird antibodies,” Haynes says. “The body doesn’t make them easily.”

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    Emily Mullin

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  • China Has a Controversial Plan for Brain-Computer Interfaces

    China Has a Controversial Plan for Brain-Computer Interfaces

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    At a tech forum in Beijing last week, a Chinese company unveiled a “homegrown” brain-computer interface that allowed a monkey to seemingly control a robotic arm just by thinking about it.

    In a video shown at the event, a monkey with its hands restrained uses the interface to move a robotic arm and grasp a strawberry. The system, developed by NeuCyber NeuroTech and the Chinese Institute for Brain Research, involves soft electrode filaments implanted in the brain, according to state-run news media outlet Xinhua.

    Researchers in the US have tested similar systems in paralyzed people to allow them to control robotic arms, but the demonstration underscores China’s progress in developing its own brain-computer interface technology and vying with the West.

    Brain-computer interfaces, or BCIs, collect and analyze brain signals, often to allow direct control of an external device, such as a robotic arm, keyboard, or smartphone. In the US, a cadre of startups, including Elon Musk’s Neuralink, are aiming to commercialize the technology.

    William Hannas, lead analyst at Georgetown University’s Center for Security and Emerging Technology (CSET), says China is quickly catching up with the US in terms of its BCI technology. “They’re strongly motivated,” he says of the Asian superpower. “They’re doing state-of-the-art work, or at least as advanced as anybody else in the world.”

    He says China has typically lagged behind the US in invasive BCIs—that is, those that are implanted in the brain or on its surface—choosing instead to focus on noninvasive technology that’s worn on the head. But it’s quickly catching up on implantable interfaces, which are being explored for medical applications.

    More concerning, though, is China’s interest in noninvasive BCIs for the general population. Hannas coauthored a report released in March that examines Chinese research on BCIs for nonmedical purposes.

    “China is not the least bit shy about this,” he says, referring to ethical guidelines released by the Communist Party in February 2024 that include cognitive enhancement of healthy people as a goal of Chinese BCI research. A translation of the guidelines by CSET says, “Nonmedical purposes such as attention modulation, sleep regulation, memory regulation, and exoskeletons for augmentative BCI technologies should be explored and developed to a certain extent, provided there is strict regulation and clear benefit.”

    The translated Chinese guidelines go on to say that BCI technology should avoid replacing or weakening human decisionmaking capabilities “before it is proven to surpass human levels and gains societal consensus, and avoid research that significantly interferes with or blurs human autonomy and self-awareness.”

    These nonmedical applications refer to wearable BCIs that rely on electrodes placed on the scalp, also known as electroencephalography or EEG devices. Electrical signals from the scalp are much harder to interpret than those inside the brain, however, and there’s a huge effort in China to use machine learning techniques to improve analysis of brain signals, according to the CSET report.

    A handful of US companies are also developing wearable BCIs that arguably fall under the category of cognitive enhancement. For instance, Emotiv of San Francisco and Neurable in Boston are starting to sell EEG headsets intended to improve attention and focus. The US Department of Defense has also funded research on wearable interfaces that could ultimately enable control of cyber-defense systems or drones by military personnel.

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    Emily Mullin

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  • He Got a Pig Kidney Transplant. Now Doctors Need to Keep It Working

    He Got a Pig Kidney Transplant. Now Doctors Need to Keep It Working

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    Other than rejection of the organ, one of the most common transplant complications is infection. Doctors have to strike a balance when prescribing immunosuppressive drugs: too low a dose can lead to rejection, while too much can make a patient vulnerable to infection. Immunosuppressants are powerful drugs that can cause a range of side effects, including fatigue, nausea, and vomiting.

    Despite the deaths of the two pig heart recipients, Riella is optimistic about Slayman’s transplant. For one, he says, Slayman was relatively healthy when he underwent the surgery. He qualified for a human kidney but because of his rare blood type he would likely need to wait six to seven years to get one. The two individuals who received pig heart transplants were so ill that they didn’t qualify for a human organ.

    In addition to close monitoring and traditional immunosuppressants, Slayman’s medical team is treating him with an experimental drug called tegoprubart, developed by Eledon Pharmaceuticals of Irvine, California. Given every three weeks via an IV, tegoprubart blocks crosstalk between two key immune cells in the body, T cells and B cells, which helps suppress the immune response against the donor organ. The drug has been used in monkeys that have received gene-edited pig organs.

    Photograph: Massachusetts General Hospital

    “It’s pretty miraculous this man’s out of the hospital a couple of weeks after putting in a pig kidney,” says Steven Perrin, Eledon’s president and chief scientific officer. “I didn’t think we would be here as quickly as we are.”

    Riella is also hopeful that the 69 genetic alterations made to the pig that supplied the donor organ will help Slayman’s kidney keep functioning. Pig organs aren’t naturally compatible in the human body. The company that supplied the pig, eGenesis, used Crispr to add certain human genes, remove some pig genes, and inactivate latent viruses in the pig genome that could hypothetically infect a human recipient. The pigs are produced using cloning; scientists make the edits to a single pig cell and use that cell to form an embryo. The embryos are cloned and transferred to the womb of a female pig so that her offspring end up with the edits.

    “We hope that this combination will be the secret sauce to getting this kidney to a longer graft survival,” Riella says.

    There’s debate among scientists over how many edits pig organs need to last in people. In the pig heart transplants, researchers used donor animals with 10 edits developed by United Therapeutics subsidiary Revivicor.

    There’s another big difference between this procedure and the heart surgeries: If Slayman’s kidney did stop working, Riella says, he could resume dialysis. The pig heart recipients had no back-up options. He says even if pig organs aren’t a long-term alternative, they could provide a bridge to transplant for patients like Slayman who would otherwise spend years suffering on dialysis.

    “We’ve gotten so many letters, emails, and messages from people volunteering to be candidates for the xenotransplants, even with all the unknowns,” Riella says. “Many of them are struggling so much on dialysis that they’re looking for an alternative.”

    The Mass General team plans to launch a formal clinical trial to transplant edited pig kidneys in more patients. They received special approval from the US Food and Drug Administration for just one procedure. For now, though, their main focus is on keeping Slayman healthy.

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    Emily Mullin

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  • This Bag of Cells Could Grow New Livers Inside of People

    This Bag of Cells Could Grow New Livers Inside of People

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    In early experiments, Lagasse found that if he injected healthy liver cells into the lymph nodes of mice, the cells would flourish and form a second, smaller liver to take over the functions of the animal’s failing one. The new livers grew up to 70 percent of the size of a native liver. “What happened is that the liver grew to a certain size and then stopped growing when it reached the level necessary for normal function,” Lagasse says.

    At the University of Pittsburgh, Lagasse and his colleagues also tested the approach in pigs. In a study published in 2020, they found that pigs regained liver function after getting an injection of liver cells into an abdominal lymph node. When the scientists examined the lymph nodes with miniature livers, they found that a network of blood vessels and bile ducts had spontaneously formed. The more severe the damage in the pigs’ native liver, the bigger the second livers grew, suggesting the animals’ bodies may be able to recognize the healthy liver tissue and transfer responsibilities to it.

    “It is remarkable to identify lymph nodes as a reproducible and fertile bed for the regeneration of a variety of tissues and organs in two different animal species,” Abla Creasey, vice president of therapeutics development at the California Institute for Regenerative Medicine, says of the company’s approach. “These findings suggest that such an approach could present an alternative tissue source for patients with failing organs,”

    Elliot Tapper, a liver specialist at the University of Michigan, is also excited by the prospect of turning a lymph node into a new liver. “Even though it’s not where the liver was intended to sit, it can still do some liver functions,” he says.

    The most likely benefit of the LyGenesis treatment, he says, would be removing ammonia from the blood. In end-stage liver disease, ammonia can build up and travel to the brain, where it causes confusion, mood swings, falls, and sometimes comas. He doesn’t think the new mini organs could do all the jobs of a natural liver though, because they contain cell types other than hepatocytes.

    One of the big questions is how many cells it will require for humans to grow a liver big enough to take over certain vital functions, such as filtering blood and producing bile. In the LyGenesis trial, three additional patients will get an injection of 50 million cells into a single lymph node—the lowest “dose.” If that seems safe, a second group of four will get 150 million cells into three different lymph nodes. A third group would get 250 million cells in five lymph nodes—meaning they could have five mini livers growing inside them.

    The effects of the therapy won’t be immediate. Hufford says it will likely take two to three months for the new organ to grow big enough to take over some of the functions of the native liver. And like organ donor recipients, trial participants will need to go on immunosuppressant drugs for the rest of their lives to prevent their body from rejecting the donor cells.

    If the approach works, it could provide a life-saving alternative to liver transplantation for some patients. “If they prove it’s effective and safe,” Tapper says, “there will definitely be candidates that are interested in this kind of intervention.”

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    Emily Mullin

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  • A Gene-Edited Pig Kidney Was Just Transplanted Into a Person for the First Time

    A Gene-Edited Pig Kidney Was Just Transplanted Into a Person for the First Time

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    Slayman received his first kidney transplant in 2018 from a human donor. The donor kidney initially functioned well, but Slayman started to go into kidney failure after years of living with diabetes. Diabetes is the leading cause of kidney disease, which can eventually result in kidney failure.

    He had no choice but to go on dialysis, a treatment that removes excess fluid and waste from a person’s blood. But the dialysis caused complications—his blood vessels were clotting and failing. Slayman wound up in the hospital regularly and endured dozens of procedures to try to fix the problem.

    “Slowly but surely, I witnessed my patient becoming increasingly despondent and depressed over his dialysis situation,” Winfred Williams, a kidney specialist and member of Slayman’s medical team, said on Thursday.

    Finally, Williams suggested a pig kidney transplant. Slayman agreed. “I saw it not only as a way to help me, but a way to provide hope for the thousands of people who need a transplant to survive,” Slayman said in a statement released by Massachusetts General Hospital.

    The procedure was performed under the Food and Drug Administration’s “compassionate use” pathway, which allows a patient with a life-threatening condition to access an experimental treatment when no other options exist. Slayman is also receiving an infusion of novel immunosuppressant drugs to prevent rejection of the organ. His medical team is currently monitoring his kidney function using ultrasound.

    The Massachusetts team thinks the ideal candidate for a pig kidney will be a patient who was approved for a regular human kidney transplant but has a long wait time for a donor.

    The pig kidney transplant comes on the heels of a procedure in January, in which surgeons at the University of Pennsylvania successfully attached a gene-edited pig liver to a braindead person and found that the organ functioned normally for 72 hours. The liver, also from eGenesis, contained the same 69 edits as Slayman’s kidney.

    The liver is a more complicated organ because of the many functions it performs, so researchers don’t think pig livers are ready to be used in place of human ones just yet. Instead, they could be used outside the body and connected to patients who are waiting for a human organ or those who need temporary support while their own liver recovers.

    Researchers have been working up to transplanting a modified pig kidney in a person. Last year, eGenesis reported that a kidney from one of its edited pigs functioned in a monkey for more than two years. And scientists at New York University and the University of Alabama at Birmingham have transplanted gene-edited pig kidneys into braindead patients to observe how well the organs function.

    Jayme Locke, an abdominal transplant surgeon at the University of Alabama at Birmingham who has overseen some of those experiments, was thrilled to hear about the Boston kidney transplant. “This is wonderful news, and it’s great to see it move into the clinic,” she told WIRED in an interview.

    Locke says the recent flurry of xenotransplantation experiments shows that the idea of using pig organs in people is gaining momentum and is here to stay. “I think it really has staying power and it’s going to really revolutionize the field and hopefully offer organs to all those in need,” she says.

    Locke’s team is also looking to do pig-to-human kidney transplants. She said she has several patients in mind for the procedures and is just waiting on the FDA to give the greenlight. “We’re ready to go.”

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    Emily Mullin

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  • The American Academy of Stem Cell Physicians Recently Concluded Its Seventh Scientific Session in Miami

    The American Academy of Stem Cell Physicians Recently Concluded Its Seventh Scientific Session in Miami

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    Physicians and healthcare providers can attend the instructor course of TAI Chi now available at the conference. Dr AJ Farshchian held classes for Physicians.


    MIAMI, February 15, 2024 (Newswire.com)
    –
    The American Academy of Stem Cell Physicians recently concluded its seventh scientific session at the Hyatt Hotel in Miami. The event served as a platform for innovation, collaboration, and education within the field of stem cell research and regenerative medicine.

    Dr. A.J. Farshchian led an engaging session on Tai Chi for arthritis, providing attendees with valuable insights into holistic approaches for managing arthritis, highlighting the importance of alternative therapies in enhancing patient well-being.

    On Sunday, the 11th of February, participants had the opportunity to undertake the Board Examination Part One, a critical step towards advancing their expertise and credentials within the Regenerative community.

    A moment of recognition and celebration was reserved for Dr. Frank Shallenberger, who was honored with the distinguished Scientist of the Year award. Dr. Shallenberger’s exceptional contributions and leadership in the realm of regenerative medicine research have been instrumental in shaping the future of regenerative medicine.

    Furthermore, the event witnessed the recognition of five outstanding physicians who were awarded the status of Diplomates of the American Academy of Stem Cell Physicians, acknowledging their commitment to excellence and expertise in the field.

    The seventh scientific session of the American Academy of Stem Cell Physicians was an important event fostering meaningful discussions, knowledge sharing, and professional growth among attendees.

    The Academy looks forward to building on this success and continuing to drive innovation and excellence in the dynamic field of regenerative medicine.

    For more information about the American Academy of Stem Cell Physicians and upcoming events, please visit https://www.aascpconference.miami (https://www.aascpconference.miami).

    Contact:
    Claudia Salazar
    Executive Coordinator
    American Academy of Stem Physicians
    claudia@genorthix.com

    Source: American Academy of Stem Cell Physicians

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  • Endless biotechnological innovation requires a creative approach

    Endless biotechnological innovation requires a creative approach

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    BYLINE: Laura Thomas

    Newswise — Scientists working on biological design should focus on the idiosyncrasies of biological systems over optimisation, according to new research.

    In a study, published today in Science Advances, researchers from the Universities of Bristol and Ghent have shown how exploring the unknown may be the crucial step needed to realise the continual innovation needed for the biotechnologies of the future.

    Recognising the role of open-endedness in achieving this goal and its growing importance in fields like computer science and evolutionary biology, the team mapped out how open-endedness is linked to bioengineering practice today and what would be required to achieve it in the lab.

    For success, algorithms used for biological design should not solely focus on moving toward a specific goal – such as better yield ­– but also consider the creation and maintenance of novelty and diversity in the solutions that have been found.

    Dr Thomas Gorochowski, co-author and Royal Society University Research Fellow in the School of Biological Sciences at Bristol, explained: “When we try to design a complex biological process, it’s often tempting to just tweak something that partially works rather than take the risk of trying something completely new.

    “In this work we highlight that in these situations the best solutions often come from unexpected directions, because we don’t always fully understand how everything works. With biology, there are lots of unknowns and so we need a vast and diverse toolkit of building blocks to ensure we have the best chance of finding the solution we need.”

    Professor Michiel Stock, lead author from Ghent University, added: “Biological systems have a natural capacity for innovation that has led to the overwhelming biodiversity we see in nature today.

    “Our own attempts to engineer biology, in contrast, lack this creativity – they are far more rigid, less imaginative, and often doesn’t make the best use of what biology is capable of.

    “With all life around us originating from the open-ended process of evolution, wouldn’t it be awesome if we could harness some of that power for our own biological designs.”

    The ability to create new biotechnologies is becoming increasingly important for tackling global challenges spanning the sustainable production of chemicals, materials and food, to advanced therapeutics to combat emerging diseases. Fueling this progress are innovations in how biology can be harnessed in new ways. This work supports this goal by offering a fresh direction for new research and design approaches.

    The study was made possible due to a travel grant from the FWO Flanders and funding from the Royal Society, BBSRC and EPSRC.

    Paper:

    ‘Open-endedness in synthetic biology: a route to continual innovation for biological design’ by Michiel Stock and Thomas E. Gorochowski in Science Advances (DOI: https://doi.org/10.1126/sciadv.adi3621)

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    University of Bristol

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  • Johnson & Johnson: Biotech a shot in the arm for future growth? | Entrepreneur

    Johnson & Johnson: Biotech a shot in the arm for future growth? | Entrepreneur

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    Johnson & Johnson (NYSE: JNJ), a healthcare sector powerhouse with over 130 years of experience, has long dominated diverse sub-sectors within the industry. From groundbreaking pharmaceuticals like Remicade to innovative medical devices, JNJ has established itself as a leader in multiple healthcare domains. However, the landscape is evolving, and JNJ is making a strategic shift to stay ahead of the curve.

    J&J navigates a multi-pronged landscape

    Recent headlines have been dominated by two key developments: the $2 billion acquisition of Ambrx Biopharma (NYSE: AMAM) and the series of patent settlements surrounding Stelara, JNJ’s top-selling treatment for psoriasis and arthritis. While seemingly disparate, these moves represent a calculated pivot in JNJ’s strategic focus. They signal a deliberate push towards the burgeoning field of biotechnology, specifically a subfield known as antibody-drug conjugates (ADCs).

    Expanding into antibody-drug conjugates (ADCs)

    In a $2 billion deal, JNJ’s headlines report that the company has acquired Ambrx Biopharma. Ambrex is a company specializing in developing next-generation antibody-drug conjugates (ADCs). ADCs are essentially targeted drug delivery vehicles in the fight against cancer.

    They combine potent anti-cancer agents with monoclonal antibodies, proteins that selectively bind to tumor cells. This targeted approach minimizes harm to healthy tissue, offering a potentially safer and more effective option than traditional chemotherapy. The ADC market is poised for explosive growth, projected to reach an estimated $35 billion by 2028. JNJ’s acquisition of Ambrx positions the company as a major player in this promising field, gaining access to Ambrx’s proprietary platform and promising ADC candidates in the pipeline.

    Breathing room for JNJ’s revenue

    Stelara, JNJ’s blockbuster drug for psoriasis and arthritis, was facing the imminent threat of biosimilar competition, cheaper versions of the original drug manufactured by other companies. However, JNJ has secured a series of patent settlements that delay the entry of these biosimilars until at least 2025. This provides JNJ with valuable breathing room, allowing them to maximize Stelara’s revenue stream for the next few years and prepare for the inevitable decline in sales when biosimilars finally enter the market.

    Can Stelara biosimilars threaten JNJ’s future?

    Despite the patent settlements, a lawsuit filed by CareFirst BlueCross BlueShield casts a shadow of uncertainty over Stelara’s future revenue. The lawsuit alleges that JNJ engaged in anti-competitive practices to delay the entry of biosimilars, artificially inflating drug prices. If successful, the lawsuit could significantly impact JNJ’s finances and accelerate the decline in Stelara sales.

    Gauging the expert perspective

    Given J&J’s recent moves and the changing market environment, investors naturally look to Johnson & Johnson industry analysts for their insights. The analyst community paints a relatively optimistic picture for J&J. Based on a survey of recent ratings, the consensus estimate places the average 12-month target price for JNJ shares at $168.94, representing a potential upside of 5% from current levels. Some analysts predict prices as high as $215.00, representing close to a 25% upside for the stock. This positive outlook reflects analysts’ confidence in JNJ’s long-term prospects, fueled by factors like the Ambrx acquisition and the successful Stelara patent settlements.

    J&J’s strategic playbook for future growth

    Johnson & Johnson’s recent moves indicate a clear roadmap for future growth, focusing on two key pillars: diversifying its portfolio beyond Stelara and capitalizing on high-growth markets. These strategies paint a picture of JNJ actively expanding its reach and positioning itself for sustainable success in the evolving healthcare landscape.

    Beyond Stelara: Pipeline for the future

    While Stelara remains a critical revenue driver, JNJ recognizes the need to move beyond its dependence on a single blockbuster drug. To achieve this, the company is actively investing in a diverse pipeline of innovative medicines and treatments across various therapeutic areas. Some noteworthy examples include:

    • Spravato: This nasal spray medication, approved for treatment-resistant depression, represents a potentially significant growth opportunity in a large and underserved market.
    • Darzalex: This antibody-drug conjugate, already successful in multiple blood cancers, is being investigated for additional indications, expanding its market reach.
    • Epclusa: This combination therapy for hepatitis C virus (HCV) boasts a high cure rate and shorter treatment duration, positioning it well in the competitive HCV market.

    By actively developing and introducing novel treatments in both established and emerging markets, JNJ aims to reduce its reliance on Stelara and build a more diversified and sustainable revenue stream for the future.

    Global expansion and high-growth segments

    JNJ also recognizes the importance of geographical expansion for future growth. Emerging markets like China, India, and Brazil present significant untapped potential, with rapidly growing healthcare spending and aging populations. JNJ is strategically increasing its presence in these regions through targeted investments, acquisitions, and collaborations with local partners.

    Furthermore, JNJ is aligning its focus with high-growth segments within the healthcare market. Areas like oncology, immunology, and specialty pharmaceuticals are projected to experience significant growth in the coming years, and JNJ is actively developing drugs and expanding its portfolio in these segments.

    Examples include the Ambrx acquisition for its innovative ADC platform and ongoing research in areas like CAR-T cell therapy for cancer. By actively venturing into high-growth markets and therapeutic areas, JNJ aims to tap into new revenue streams and stay ahead of the evolving healthcare landscape.

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    Jeffrey Neal Johnson

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