Lecanemab

STOCKHOLM, Aug. 26, 2025 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the company has entered into an option, collaboration and license agreement with Novartis Pharma AG regarding a potential new treatment combining BioArctic's proprietary BrainTransporter technology with an undisclosed target in neurodegeneration. As part of the initial research collaboration, BioArctic will receive USD 30 million in upfront payment. Novartis will evaluate the data generated during the initial collaboration and decide whether to exercise their option to license any drug candidate generated. If Novartis exercises their option, BioArctic will be eligible to receive additional payments of up to USD 772 million. BioArctic will also be entitled to tiered mid-single digit royalties on future global product sales if the product reaches the market. Under the initial research collaboration, BioArctic will generate a new drug candidate combining the BrainTransporter technology with a Novartis proprietary antibody. Should Novartis decide to exercise their option following the evaluation of the generated drug candidate, Novartis will assume full responsibility for the global development and commercialization of the drug candidate and related products. "I'm excited by today's announcement. Novartis shares our passion for science and helping patients with severe neurological disorders. With yet another BrainTransporter agreement it is becoming evident that this versatile platform has huge potential to improve many different projects, internally as well as externally generated, and could support companies across the field in their pursuit of helping people with brain disorders," said Gunilla Osswald, CEO at BioArctic. "At Novartis, we are deeply committed to advancing science to help discover treatments for devastating nervous system disorders," said Sophie Parmentier Batteur, Head of Neurodegeneration Research at Novartis. "Collaborating with BioArctic allows us to explore the exciting potential of the BrainTransporter technology to promote brain uptake and optimize systemic delivery of novel therapeutic agents by leveraging the biology of the blood-brain barrier. Our focus is to pioneer innovative therapies that improve treatment outcomes by impacting disease progression, to provide meaningful therapies for patients with severe neurological conditions." This agreement is the third[1] collaboration BioArctic has entered into with partners using the BrainTransporter technology. BioArctic retains all rights for use of the BrainTransporter platform outside of the scope of these three agreements. The BrainTransporter platform can be used in a number of different therapy areas for delivery of biologics and other modalities, giving BioArctic many potential future partnering opportunities. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval. This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons below, on August 26, 2025, at 07.05 a.m. CET. For further information, please contact: Oskar Bosson, VP Communications and IR E-mail: [email protected] Phone: +46 70 410 71 80 About the BrainTransporter™ technology BioArctic's BrainTransporter technology is a technology for facilitating the passage of biological drugs as for example antibodies into the brain using the transferrin receptor (TfR). Active transport of biotherapeutics across the blood brain barrier can result in broader brain distribution enabling better efficacy, improved safety profile and dosing convenience. The technology is being applied to several in-house drug projects, and could become part of future collaborations with other pharma companies. About BioArctic AB BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit . [1] Previous agreements include a research evaluation agreement regarding BAN2802 with Eisai, and global license agreement with Bristol Myers Squibb for BioArctic's PyroGlutamate-amyloid-beta antibody program. This information was brought to you by Cision The following files are available for download: SOURCE BioArctic WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

A Phase 1, "first-in-mankind" trial of stem cells injected directly into the brain, is safe with early signs of efficacy; FDA submission made for Phase 2 trial. NEWPORT BEACH, CA, UNITED STATES, August 25, 2025 / EINPresswire.com / -- Regeneration Biomedical, Inc. (RBI), a pioneering biotechnology company developing stem cell therapies for neurodegenerative diseases, today announced results of its FDA-cleared Phase 1 trial evaluating the world’s first direct brain injections of autologous, Wnt-activated stem cells for Alzheimer’s disease. The company has submitted its Phase 1 results to the FDA in support of initiating a Phase 2 multicenter, placebo-controlled trial. The Phase 1 study, conducted at Hoag Memorial Hospital in Newport Beach, CA, involved six participants with mild to moderate Alzheimer’s disease. Each received an infusion of their own ex vivo expanded, Wnt-activated, adipose-derived stem cells in escalated doses. This was achieved by administering the cells through an implanted Ommaya reservoir directly into the brain’s ventricular system—bypassing the blood-brain barrier and allowing the cells to percolate throughout the brain. The trial’s primary endpoint of safety was achieved with a clean profile: no adverse events were observed that were directly attributable to the stem cell injection over 12–72 weeks. Secondary endpoints showed promising early efficacy signals at 12 weeks: p-Tau improved in 80% of evaluable participants, amyloid PET centiloid scores decreased in 60%, ADAS-cog cognitive scoring improved in 80%, and MMSE improved in 60%. “These are results the field has never seen before; certainly with a single agent. After decades of failed Alzheimer’s treatments, our approach not only proved safe but also showed measurable cognitive and biomarker improvements,” said Christopher Duma, M.D., FACS, neurosurgeon, inventor, and Founder & President of Regeneration Biomedical, Inc. “What makes this therapy unique is that we deliver the patient’s own stem cells directly into the brain, bypassing the blood-brain barrier, so they can reach every nook and cranny where Alzheimer’s does its damage. This represents a disruptive paradigm shift in the treatment of Alzheimer’s disease.” Why it’s different • Direct-to-brain vs. IV antibodies: Recently approved monoclonal antibodies (Biogen/Eisai’s Leqembi/lecanemab and Eli Lilly’s Kisunla/donanemab) are administered IV and carry known risks of amyloid-related imaging abnormalities (ARIA) and infusion-related reactions; they require baseline and frequent MRI monitoring per FDA labels. RBI’s autologous stem cells are delivered intraventricularly to bypass the blood-brain barrier and distribute broadly via cerebrospinal fluid. (FDA Access DataU.S. Food and Drug Administration.) • Factual safety context for antibodies (per FDA labels): In Leqembi’s pivotal study, ARIA-E occurred in 13% and ARIA-H in 14%, and infusion-related reactions in 26%, vs 2%, 8%, and 7% on placebo. Kisunla reported any ARIA in 36% (ARIA-E 24%, ARIA-H 31%) and infusion reactions 9% in Study 1; with a gradual dosing regimen (Study 2), ARIA-E ~16% and infusion reactions 16% were observed. MRI monitoring is specified before the 2nd, 3rd, 4th, and 7th infusions for Kisunla. (FDA Access Data U.S. Food and Drug Administration FDA Access Data.) There have been no such adverse events with the RBI cells. • Leqembi and Kisunla do not improve cognition, they only slow the cognitive deterioration. RBI’s autologous cells appear to improve cognition in this very early study. • Independent media context: At CTAD 2024, BioSpace covered RBI’s direct-to-brain approach and early signals (reduced p-Tau and amyloid, MMSE trending up in the initial cohort) alongside discussions of ARIA risk with antibody therapies. https://www.biospace.com/drug-development/leqembi-kisunla-and-beyond-the-next-wave-of-alzheimers-at-ctad-2024 Important note: Mechanisms differ (cell therapy vs. antibodies), and cross-trial comparisons have limitations. RBI’s Phase 1 was designed primarily for safety with a small, open-label cohort; findings are preliminary and will be tested in a larger, controlled study. Looking Ahead: Phase 2 Trial RBI has submitted its Phase 1 findings to the FDA and is preparing to launch a multi-site, placebo-controlled Phase 2 trial in the United States, and is pioneering autologous stem cell therapies for Alzheimer’s disease and other neurodegenerative conditions. Additional trials for Parkinson’s disease, ALS, multiple sclerosis, and chronic traumatic encephalopathy (CTE) are also planned. About Regeneration Biomedical, Inc. Founded in 2018 by neurosurgeon Christopher Duma, M.D., FACS, Regeneration Biomedical, Inc. is building on preclinical and early clinical experience. RBI is advancing first-in-human disruptive approaches aimed not only at slowing disease progression but at restoring brain function. Media Contact Christopher Duma, MD, FACS Regeneration Biomedical, Inc. Email: chris@regenerationbiomedical.com Phone: 949-689-9529 www.regenerationbiomedical.com Christopher Duma Regeneration Biomedical, Inc. +1 949-689-9529 CHRIS@REGENERATIONBIOMEDICAL.COM Visit us on social media: LinkedIn Instagram Facebook X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. 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