Dapirolizumab pegol

Biogen’s current immunology pipeline is led by dapirolizumab pegol, a UCB-partnered anti-CD40L drug that notched a phase 3 win in systemic lupus erythematosus last year.\n Biogen plans to beef up its early-stage immunology pipeline by handing over $70 million in upfront cash for the rights to Vanqua Bio’s preclinical C5aR1 antagonist.Biogen described C5aR1 as a “well-validated target involved in neutrophil-mediated inflammation.” The biopharma is banking on applying the oral C5aR1 antagonist’s mechanism across “multiple immune-mediated diseases” with an ambition of entering the clinic in 2027.C5aR1 plays an important role in the immune cascade that causes tissue inflammation, particularly in neutrophil-mediated conditions. There’s an obvious overlap with Biogen’s own izastobart, an antibody directed against C5aR1 the company has been evaluating in a phase 1 study.Beyond the $70 million upfront payment from this morning’s deal, Chicago-based Vanqua is in line for up to $990 million in potential development, regulatory, commercial and sales milestone payments as well as tiered royalties should a drug make it to market.“This agreement reflects our strong commitment to building a comprehensive immunology pipeline with a strategic focus on both innate and adaptive immune pathways,” Biogen\'s head of research Jane Grogan, Ph.D., said in this morning’s release.“C5aR1 is a well-validated target involved in neutrophil-mediated inflammation, which plays a central role across a range of inflammatory disorders,” Grogan added. “Advancing this program enables us to deepen our scientific and clinical focus in immunological diseases where we believe Biogen can make a meaningful difference for patients.” Biogen’s current immunology pipeline is led by dapirolizumab pegol, a UCB-partnered anti-CD40L drug that notched a phase 3 win in systemic lupus erythematosus last year. Also in late-stage development for lupus is the anti-BDCA2 antibody litifilimab, along with felzartamab, a monoclonal antibody designed to deplete CD38+ plasma cells, which is being evaluated for antibody-mediated rejection and various types of nephropathy.Both felzartamab and the phase 1-stage izastobart were acquired as part of Biogen’s buyout of Human Immunology Biosciences (HI-Bio) last year.“Biogen’s scale, development rigor, and global commercialization capabilities make them uniquely positioned to advance this compound for patients with inflammatory disorders,” Vanqua CEO Jim Sullivan, Ph.D., said in today\'s release.“The discovery of a highly differentiated C5aR1 inhibitor validates the small molecule drug discovery capabilities of the Vanqua team,” Sullivan added. “Furthermore, this transaction allows Vanqua to remain focused on our CNS pipeline while ensuring that this program can be developed to its full potential.”William Blair analysts said the deal with Vanqua “adds an intriguing, albeit early, preclinical-stage asset to Biogen’s growing immunology pipeline aligned with its therapeutic pipeline strategy.” “We continue to see developing excitement about Biogen’s late-stage neurology and immunology pipeline, which may provide a longer-term solution to the eroding MS franchise and slower-than-anticipated Leqembi launch,” the analysts added in an Oct. 24 note.The deal follows Biogen’s reorganization at the beginning of the year that included layoffs and a shift to focus on external opportunities. Shortly after announcing the restructure, Biogen paid Stoke Therapeutics $165 million upfront for ex-U.S. rights to a phase 3-ready molecule that could become the first disease-modifying treatment for Dravet syndrome.Since then, the company has abandoned work on adeno-associated virus gene therapies while penning a big biobucks deal with RNAi-focused City Therapeutics and buying drug delivery specialist Alcyone Therapeutics.

Dapirolizumab pegol (DZP) Phase 3 study presentations in SLE to show efficacy results across multiple clinical endpoints, including low disease activity/remission, flares, fatigue, joint pain and quality of life Presentation of preclinical study of DZP showing minimal to no human placental transfer CAMBRIDGE, Mass., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming presentations from studies evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, in systemic lupus erythematosus (SLE) to be presented at the American College of Rheumatology (ACR) Convergence 2025 (October 24-29) in Chicago, Illinois. The presentations will show efficacy results of DZP across multiple endpoints including low disease activity/remission, flares, fatigue, joint pain and quality of life. Additional preclinical data will also be presented, demonstrating minimal to no placental transfer of DZP supporting further study in women before, during and after pregnancy. “The data we are presenting at ACR Convergence strengthen our understanding of the range of effects dapirolizumab pegol has in systemic lupus erythematosus, suggesting it has the potential to broadly impact this chronic and debilitating disease,” said Diana Gallagher, MD, Head of AD, MS and Immunology Development Units at Biogen. “The novel flare analysis of the Phase 3 data presented at ACR, as well as data on quality-of-life metrics and disease activity, further support the potential of dapirolizumab pegol to be a meaningful new therapy in systemic lupus erythematosus. Biogen is committed to advancing its late-stage clinical pipeline which includes programs focusing on the diverse unmet needs of the lupus community.” Dapirolizumab pegol is one of only three biologics to report positive Phase 3 data in a global SLE study. The additional data presented from the PHOENYCS GO trial at ACR suggest a broad impact across endpoints in this Phase 3 study. In the Phase 3 study, DZP met the primary endpoint of improvement of moderate-to-severe disease activity as assessed by achievement of BICLA after 48 weeks. As the first key secondary endpoint had a p-value = 0.1776, all subsequent secondary and tertiary endpoints are descriptive and nominal p-values are included. A second Phase 3 study, PHOENYCS FLY (NCT06617325), is ongoing.1,2 Dapirolizumab pegol is being developed under a collaboration between Biogen and UCB. Details of the presentations are as follows: Title: Improvement of Fatigue, Musculoskeletal Pain, and Morning Stiffness in Patients with Systemic Lupus Erythematosus Treated with Dapirolizumab Pegol: 48-Week Results from a Phase 3 TrialPoster Presentation Date & Time: Sunday, October 26, 2025, Poster Session A, 10:30 AM -12:30 PM CT / 11:30 AM – 1:30 PM ETPoster Number: 0644 Title: Achievement of Low Disease Activity and Remission in Patients with Systemic Lupus Erythematosus Treated with Dapirolizumab Pegol: 48-Week Results from a Phase 3 TrialPoster Presentation Date & Time: Sunday, October 26, 2025, Poster Session A, 10:30 AM -12:30 PM CT / 11:30 AM – 1:30 PM ETPoster Number: 0645 Title: Alternative Definitions of Moderate Flares that Simulate Clinical Practice in Systemic Lupus Erythematosus: Post Hoc Exploration of Moderate Flares in Patients Treated with Dapirolizumab Pegol in a 48-Week Phase 3 TrialPoster Presentation Date & Time: Monday, October 27, 2025, Poster Session B, 10:30 AM -12:30 PM CT / 11:30 AM – 1:30 PM ETPoster Number: 1542 Title: Dapirolizumab Pegol Demonstrated Improvement in Quality of Life of Patients with Systemic Lupus Erythematosus: LupusQoL Results from a Phase 3 TrialPoster Presentation Date & Time: Tuesday, October 28, 2025, Poster Session C, 10:30 AM -12:30 PM CT / 11:30 AM – 1:30 PM ETPoster Number: 2441 Title: Dapirolizumab Pegol, a Novel CD40L Inhibitor, Showed No Adverse Outcomes in an In Vivo Non-Human Primate Reprotoxicity Study and Displayed Minimal to No Human Placental Transfer in an Ex Vivo StudyAbstract Presentation Date & Time: Tuesday, October 28, 2025, Abstract Session, 4:00-4:15 PM CT / 5:00-5:15 PM ETAbstract Number: 2631 About Dapirolizumab PegolDapirolizumab pegol is a novel investigational humanized Fc-free polyethylene glycol (PEG)-conjugated antigen-binding (Fab’) fragment. Dapirolizumab pegol inhibits CD40L signaling which has been shown to reduce B cell activation and autoantibody production, mitigate type 1 interferon (IFN) secretion and attenuate T cell and antigen-presenting cell (APC) activation.3 Dapirolizumab pegol is presently in Phase 3 clinical development for the treatment of systemic lupus erythematosus (SLE) under a collaboration between UCB and Biogen.1,2 About BiogenFounded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, LinkedIn, X, YouTube. Biogen Safe HarborThis news release contains forward-looking statements, including, among others, relating to: the potential benefits, safety and efficacy of dapirolizumab pegol (DZP); the potential of dapirolizumab pegol to be a meaningful new therapy in systemic lupus erythematosus; the anticipated benefits, risks and potential of Biogen's collaboration arrangements with UCB; the potential of Biogen's commercial business and pipeline programs, including dapirolizumab pegol; potential regulatory discussions, submissions and approvals and the timing thereof; and the risks and uncertainties associated with drug development and commercialization. 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These statements speak only as of the date of this presentation and the discussions during this conference call and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned “Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. References: