Natalizumab

iStock, JHVEPhoto The biotech is planning to expand antisense oligonucleotide capabilities and infrastructure on campuses that already produce drugs such as the ALS therapy Qalsody. Biogen unveiled a $2 billion investment in North Carolina on Monday, joining the list of biopharma companies that have moved to beef up their U.S. manufacturing capabilities amid the ongoing threat of tariffs from President Donald Trump. Multiple leading drugmakers committed to investing in U.S. manufacturing after Trump was elected for a second term and first began saying pharma-specific tariffs were coming. Most recently, Trump earlier this month threatened to impose tariffs of up to 200% on pharmaceutical imports but said companies will have at least one year to move to the U.S. Then he said such levies could come as soon as Aug. 1 . Novartis and others have warned the process of reshoring manufacturing operations will take three to four years. Of the Big Pharma U.S. manufacturing commitments made so far, North Carolina is among the main beneficiaries, with Johnson & Johnson, Merck, Regeneron and Roche all outlining plans to invest in the state. Biogen, which already has a big presence in the state, is on track to open its eighth plant in Research Triangle Park (RTP) there later this year. Looking beyond that milestone, Biogen plans to invest in multiple factories across its two campuses in RTP to expand its capabilities across a range of drug modalities over the next few years. Biogen said it will expand its antisense oligonucleotide capabilities and infrastructure and establish multi-platform fill-finish capabilities at clinical and commercial scales. The biotech will also continue to modernize its manufacturing technologies and controls, including by investing in advanced automation and artificial intelligence. Biogen said it has invested $10 billion to date in drug production in North Carolina, a state where it broke ground in 1995 and now employs 1,500 manufacturing and technical workers across two campuses. The investment tally includes $3 billion that the company said it has invested in recent years. Biogen began construction of its eighth RTP facility in 2021. The company is investing an estimated $195 million in the new 197,000-square-foot facility. However, Biogen has warned there is no guarantee that the plant will be fully used after it opens later this year. The facility was designed to produce gene therapies, create clinical packaging and perform other manufacturing tasks. After starting construction, Biogen refocused its investment in gene therapy. The pipeline prioritization led the company to start evaluating several alternative uses for the facility. Biogen produces Avonex, Plegridy, Tysabri and Qalsody at its existing RTP facilities. The company makes Qalsody at an oligonucleotide synthesis manufacturing facility that is equipped to produce clinical and commercial batches. Spinraza is joining the list of products made at the oligonucleotide facility this year. On the other hand, the company produces Leqembi and Tysabri at its large-scale biologics facility in Switzerland, making the drugs potentially vulnerable to tariffs.

Immuthera’s Scientific Advisory Board: World-Leading Expertise Driving Next-Generation Diabetes and Immunotherapy Solutions Distinguished experts Dr. Jay Skyler, Dr. Desmond Schatz, and Dr. Lawrence Steinman have joined Immuthera’s Scientific Advisory Board.Immuthera will continue expanding its Scientific Advisory Board over the coming months to build a truly world-class team.In collaboration with PolTREG and leading U.S. academic centers, Immuthera will be developing a pipeline of cutting-edge, clinically validated Treg cell therapies for autoimmune and neuroinflammatory diseases. 4 JULY 2025 - Immuthera, a pioneer in cell therapies for autoimmune diseases, and parent company, PolTREG (Warsaw Stock Exchange: PTG), are proud to highlight the exceptional caliber of the first three members of its Scientific Advisory Board (SAB)—a team whose collective expertise and groundbreaking achievements are shaping the future of diabetes and immunotherapy research. The support and guidance from these globally renowned scientists underscore Immuthera’s commitment to delivering innovative, safe, and effective therapies for patients worldwide. “The collective wisdom and leadership of Drs. Skyler, Schatz, and Steinman provide Immuthera and PolTREG with an unparalleled strategic advantage. Their guidance ensures that our research and clinical programs are aligned with the highest standards of scientific rigor and patient care. Immuthera plans on expanding our SAB over the next several months to build a truly world-class team that will guide our activities in the US and beyond. With their support, Immuthera is uniquely positioned to accelerate the development of transformative therapies for type 1 diabetes and other autoimmune diseases” - said Prof. Piotr Trzonkowski, CEO of Immuthera and PolTREG. Immuthera will be working closely with PolTREG, and US academic centers, to develop a pipeline of cutting edge and clinically validated Treg cell therapies for the treatment of autoimmune and neuroinflammatory diseases. “Regulatory T cells (Treg cells) play a crucial role in maintaining immune homeostasis. As such, Immuthera’s and PolTREG’s delivery of Tregs offers hope for curing or controlling autoimmune diseases, including type 1 diabetes” – said Dr. Desmond Schatz. "I am excited to provide advice as Immuthera and PolTREG test their exciting technology in the clinic" – add Dr. Lawrence Steinman. A Scientific Advisory Board of Visionaries: Unrivaled Leadership in Diabetes and Immunology Dr. Jay Skyler: Architect of Modern Diabetes Care Dr. Jay Skyler stands as one of the most influential figures in type 1 diabetes research. His visionary work has transformed patient care and set new standards for clinical excellence: Pioneering Intensive Insulin Therapy: Dr. Skyler’s development of patient self-monitoring and intensive insulin protocols revolutionized diabetes management, empowering millions to achieve better glycemic control.Leadership in Landmark Clinical Trials: As Chairman of the NIH-sponsored Diabetes Prevention Trial – Type 1 (DPT-1) and Type 1 Diabetes TrialNet, Dr. Skyler has overseen global efforts to prevent and delay the onset of type 1 diabetes.Trailblazer in Immune Intervention: He led the first NIH-funded studies using cyclosporine and monoclonal antibodies to preserve beta-cell function, paving the way for modern immune therapies.Editorial and Organizational Leadership: Founding Editor-in-Chief of Diabetes Care and past President of the American Diabetes Association, Dr. Skyler’s influence extends from laboratory to clinic, and from policy to patient advocacy.Recognition: His accolades include the Banting Medal for Service, the Distinction in Endocrinology Award, and the Mary Tyler Moore/S. Robert Levine Award from JDRF. Dr. Desmond Schatz: Champion of Prevention, Genetics, and Pediatric Care Dr. Desmond Schatz’s four-decade career has been dedicated to unraveling the mysteries of type 1 diabetes, particularly in children and adolescents: Pioneering Research: Dr. Schatz has led major NIH and JDRF-funded studies on the prediction, genetics, and immunopathogenesis of type 1 diabetes, including the TEDDY program for newborn genetic screening and the Human Islet Research Network (HIRN).Clinical Trial Leadership: As Principal Investigator for the University of Florida’s TrialNet Clinical Center and a founding member of DPT-1, Dr. Schatz has driven international efforts to prevent and manage type 1 diabetes.Mentorship and Advocacy: A prolific author with over 400 publications, Dr. Schatz is recognized for nurturing the next generation of diabetes researchers and clinicians.Honors: His distinguished service has been recognized with the Banting Medal, ISPAD Prize for Achievement, the George Eisenbarth Award, and the University of Florida College of Medicine Lifetime Achievement Award. Dr. Lawrence Steinman: Innovator in Neuroimmunology and Autoimmune Therapies Dr. Lawrence Steinman’s research has redefined the landscape of neuroimmunology and autoimmune disease treatment: Breakthrough Therapy Development: His work at Stanford University led to the creation of Natalizumab (Tysabri), the first approved monoclonal antibody for multiple sclerosis (MS), now a standard of care worldwide.Groundbreaking Discoveries: Dr. Steinman’s research unveiled the molecular link between Epstein-Barr virus and MS, earning him the 2023 Pioneer in Medicine Award.Expanding the Frontiers: His expertise in antigen-specific therapies and DNA vaccines spans MS, ALS, neuromyelitis optica, and type 1 diabetes.Recognition: Dr. Steinman is a recipient of the John Dystel Prize, the Charcot Prize for Lifetime Achievement, and is an elected member of both the US National Academy of Sciences and the National Academy of Medicine. About Immuthera: Immuthera is pioneering novel cell-based therapies for clinical development in the United States and Canada. Immuthera will be clinically developing assets initially developed by PolTREG under the US FDA regulatory framework. Immuthera will have full access to PolTREG’s Research and Development capabilities and asset pipeline along with the ability to explore novel modalities developed by US Institutions. Immuthera is currently seeking investment to pursue the manufacture and clinical development of these assets in the United States. About PolTREG: PolTREG is a global leader in developing autoimmune therapies based on T-regulatory cells (Tregs). Its lead product, PTG-007, autologous Treg treatment for early-onset Type-1 Diabetes (T1D) is ready for Phase 2/3 clinical testing, for which the company is seeking a partnership. PolTREG has established a robust platform encompassing a wide range of cell therapy approaches, including polyclonal TREG, CAR-TREG, allogeneic TREG, antigen-specific TREG, and TCR-TREG therapies.